Blogs CCIT

18
Nov 2022

Powdered Dairy Products Package Testing Using VeriPac FLEX Series

Powdered Dairy Products Package Testing Using VeriPac FLEX Series

The sensitivity of a test method is necessary for several reasons, but it is most crucial in ensuring the final product is of high quality. Powdered dairy products (milk powders, infant formula, protein-based powders) are kept in a modified environment to avoid spoilage and maintain the nutritional value of the product throughout its shelf life. Before usage, the product will quickly deteriorate due to oxygen and moisture intrusion, affecting the flavor and texture and finally converting any desirable commodity into a liability. The quantity and impact of oxygen ingress depend on a number of variables, and it will occur in the presence of tiny leaks. Leaks as small as 10 microns will have an immediate impact on the product for smaller packaging types. Current conventional test techniques are completely insufficient for identifying such defects, leaving manufacturing operations exposed to severe quality variations. Applying techniques with greater sensitivity provides the highest level of quality assurance, rather than just locating minor leakage.

Ensuring Dairy Products Package Integrity with VeriPac FLEX Series

For pouches and other flexible packaging, VeriPac FLEX systems are versatile non-destructive package inspection systems. These are available in a variety of configurations for the leak test instrument and the test chamber capacity, with solutions to accommodate small format sachets and stick packs up to bulk size pouches and bags. This is done to accommodate different package specifications and test sensitivity requirements. The Food and Drug Administration (FDA) has recognized the ASTM technique for Vacuum Decay leak testing (F2338) defined in ISO 11607 as a consensus standard for pharmaceutical package testing. This approach is used by VeriPac FLEX Systems.

VeriPac inspection systems are the best alternative for destructive testing since they eliminate the subjectivity of test results and reduce the waste and costs associated with these techniques. Comparing Vacuum Decay leak testing technology to destructive techniques like the water bath or blue dye leak test, it has been found to offer a quick return on investment. The VeriPac test provides reliable critical packaging failure detection and useful packaging process insight.

Technology Overview

The VeriPac test instrument is attached to the appropriate FLEX chamber based on the size range of the packages. Depending on the application, two VeriPac systems combined with the FLEX chamber offer varying levels of leak detection capabilities. The Integrated Flexible test chamber (IFC) is designed for low-headspace sachets or stick packs. Depending on the package size and requirements, the Drawer Style test chamber (D-Series) comes in two common sizes, the Small (D) or Large (DXL). Custom designs are capable of being produced for huge package forms and bulk products. The manner in which the package is tested is the unique difference with VeriPac FLEX systems. Multiple packages can also be tested in a single test cycle.

VeriPac FLEX Series Benefits

  • Non-destructive, deterministic and quantitative test method.
  • Does not require any sample preparation.
  • Perform a single test cycle for several packages.
  • USP < 1207> compliant.
  • Promote zero-waste initiatives and sustainable packaging.
  • Makes the inspection and validation procedure easier.
  • Reliable and repeatable outcomes.
  • FDA standard and ASTM test methods.
  • Inexpensive with a quick return on investment.

Flexible packaging is highly susceptible to routine microleaks that reduce shelf life and contaminate dairy proteins, considered a very high-risk product. VeriPac FLEX is an optimal solution for powdered dairy products package integrity testing. They offer a definite PASS or FAIL in addition to quantitative data corresponding to a leak rate.

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vacuum decay leak testing, pharmaceutical package testing, container closure integrity testing, cci technologies, container closure integrity
187
16
Nov 2022

A Complete Guide to Helium Leak Detection Technology

A Complete Guide to Helium Leak Detection Technology

The quality of the product and the maintenance of the sterile barrier against outside forces are both critically dependent on the packaging. Even a tiny hole in the packaging might allow moisture, reactive gases, or other dangerous elements to enter the product, limiting its ability to heal. Additionally, a contaminated pharmaceutical product can cause serious health issues to the user, making it more of a threat than a treatment. Maintaining Container Closure Integrity is extremely important due to the sensitive nature of pharmaceutical products.

Container Closure Integrity testing is a leak detection technique for determining how well sterile barriers are maintained against external contamination. These tests may be roughly divided into probabilistic and deterministic test methods. Manufacturers choose deterministic test procedures since they provide precise, guaranteed quantitative results. One such test method is helium leak detection technology.

Helium Leak Detection Technology Overview /h2>

Helium leak testing is the method of identifying leaks in various enclosed or sealed systems by utilizing helium as a "tracer" gas and measuring the concentration of the gas as it leaves due result of a leak. A vial is a good example of package system. A pre-filled syringe, a foil pouch, and a cold form blister card are some other examples. Each of these package types is intended to keep the pharmaceutical product contained while preventing the entry of potentially dangerous environmental contaminants like dust, bacteria, or even gases. Helium leak testing method can evaluate these package types. It is a highly efficient approach for finding leaks that provide quantitative leak rate data considerably beyond the capabilities of existing leak testing techniques.

The following describes how helium leak detection works: The package is initially vacuumed and helium-filled. The amount of helium escaping the package is then measured quantitatively and expressed as a leak rate using a helium leak detector. The technique is also ideally suited for packaging line setup and validation, failure analysis, tool qualification, monitoring product quality, and package design.

Why Use Helium as a Tracer Gas?

There are several reasons why helium is considered an ideal test gas for finding leaks.
  • Deterministic seal quality inspection method that produces quantitative outcomes.
  • Regardless of color, transparency, print, surface polish, or porosity, this method works for all material types and combinations.
  • Non-destructive and non-subjective test technique that does not require any sample preparation.
  • Technology may be used for 100% online final pouch seal defect detection.
  • Seal quality inspection results are repeatable, reproducible and reliable.
  • Cost-effective solution for testing seal integrity and seal analysis that characterizes the overall quality and uniformity of the seal.

Helium Leak Detection Merits

  • Practical and sensitive flow-based leak test method.
  • Enables the discovery of extremely small microleaks.
  • Detects leaks with sensitivity levels as low as 1x10-10 mbar L/sec.
  • Helium is a non-explosive, non-toxic and non-destructive tracer gas.
  • Applicable across package design, failure analysis, packaging line setup and validation.
  • Faster test cycle reduces cost and total processing time.

Applications of Helium Leak Detection

  • Vials
  • Pre-filled syringes
  • Blister packs
  • Combination products
  • Bottles
  • Foil pouches

Helium leak detection is the best option for evaluating the inherent integrity of specific primary container closure systems of pharmaceutical and parenteral products. It is a commonly used technology in early stage pharmaceutical package development and component compatibility evaluation. In comparison to other leak test techniques, helium leak testing has the highest level of sensitivity, making it the most used CCI test method. In accordance with ASTM F2391, helium leak detection is a widely used method in the pharmaceutical industry.

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container closure integrity testing, helium leak detection, cci technologies, helium leak testing, container closure integrity
184
22
Sep 2022

Industrial Applications of Vacuum Decay Technology

Industrial Applications of Vacuum Decay Technology

Vacuum Decay is a non-destructive method for testing the integrity of container closures for package integrity and leak path detection. The technology provides quantitative, deterministic, and reliable test results to assure package integrity in comparison to manual inspection and other non-deterministic test techniques. The vast range of package types that may be accommodated by Vacuum Decay technology includes filled and sealed rigid, semi-rigid, and flexible packaging consisting of non-porous or porous materials.

Vacuum Decay Technology

Vacuum Decay is one of the most efficient and accurate vacuum-based leak detection methods. The method operates by placing the package within a properly outfitted evacuation test chamber that contains an external vacuum source. To detect any deviations from a predetermined targeted vacuum level, the vacuum levels are continually monitored. If there is a defect in the packaging, air or liquid will leak into the chamber from the package and cause a change in pressure. On the other hand, non-defective packages do not leak any pressure into the chamber, maintaining the chamber vacuum level constant. The test cycle is quick, non-invasive, and non-destructive to both the product and the container. The Vacuum decay system can detect both major and minor defects, regardless of where they are located. The system has various applications in the field of pharmaceuticals and medical devices.

Applications of Vacuum Decay Technology in Various Industries

  • Pharmaceutical
  • Pharmaceutical products are a range of substances used for treating, diagnosing, or changing organic processes to help the management of public health. Pharmaceutical products are tested to make sure they adhere to strict safety and quality requirements. Previously, pharmaceutical packaging was only subjected to sterility testing. However, the United States has recognized that sterility testing alone is not sufficient to maintain the integrity of pharma products. FDA (Food and Drug Administration) has published guidance related to pharma industry on submission of documentation for sterilization process evaluation in human and veterinary drug products.

    Container closure integrity (CCI) testing is a non-destructive package inspection technology for finding leaks and avoiding potential contamination. A test like this is necessary since any defect in the container might allow foreign particles to enter the product and thereby reduce its shelf life. Since it impacts both the product and the patient, a manufacturer places high priority on implementing the proper container closure system. Thus, the relevance of container closure integrity testing in the pharmaceutical industry has increased substantially over time. Vacuum Decay and MicroCurrent HVLD are the most chosen technologies for testing pharmaceuticals.

  • Medical Device
  • Maintaining medical device package integrity is essential to make sure the product is delivered to the end user unharmed. Medical device packaging and delivery options range from rigid non-porous containers to flexible porous packaging. Every packaging format has a different set of characteristics and requirements, so choosing the right inspection technique requires a thorough approach. Package challenges have risen along with packaging format and material innovations. Among all medical equipment, Class III devices produce the greatest risk to maintaining package integrity. These implanted devices preserve or maintain life. Pacemakers, cardiovascular stents, respiratory ventilators, and breast implants are a few examples of Class III medical devices. Since these devices are inserted into human bodies directly, even a small packaging defect puts patient’s safety at risk. Therefore, it is essential to evaluate the container closure integrity of medical devices.

Vacuum Decay Technology Benefits

  • Non-destructive, non-subjective and does not require sample preparation.
  • Detection of defects down to 0.01 cc/min.
  • Results show that they are more accurate than dye ingress.
  • Quantitative, deterministic testing technique.
  • Supports initiatives for waste reduction and sustainable packaging.
  • ASTM test method and FDA recognized standard.

When determining the integrity of pharmaceutical and medical devices, Vacuum decay leak testing is the best non-destructive option. The test measurement generates a reliable and accurate quantitative result, as well as a pass or fail decision. The FDA recognizes the standard Vacuum Decay leak test technique (ASTM F2338) as a consensus standard for evaluating container closure integrity (CCI). The test technique is referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207) and listed in ISO 11607.

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container closure integrity testing, container closure integrity, cci testing, vacuum decay leak testing, vacuum decay technology
234
13
Sep 2022

Evaluating Snack Food Package Integrity with VeriPac Vacuum Decay Series

Evaluating Snack Food Package Integrity with VeriPac Vacuum Decay Series

The difficulty of maintaining shelf life for packaged snack foods never end. The majority of snack foods are oxygen and moisture sensitive. Package integrity issues can lead to mold growth, oxidation, taste loss, and spoilage. Leaks smaller than 10 microns can contaminate a product with bacteria, and comparable leak sizes might allow moisture or oxygen in. Snack foods come in a wide range of packaging types, but they all require package integrity assurance for extended shelf life.

Even a tiny leak in the container might cause microbial contamination or oxygen penetration, and traditional test methods may not be able to find such leaks. The sensitivity of the testing method is crucial for preserving the quality of the product during its shelf life. In this blog, we will discuss how VeriPac Vacuum Decay technology can efficiently leak test snack food packages.

VeriPac Vacuum Decay Series for Snack Food Package Integrity Testing

VeriPac Vacuum Decay technology is an ASTM-approved, FDA-recognized test technique with the ability to deliver reliable, consistent, repeatable, and accurate quantitative data. It is a non-destructive container closure integrity testing method that can identify micro leaks while taking into consideration a variety of packaging types, including filled and sealed rigid, semi-rigid, and flexible packaging composed of non-porous or porous materials.

Vacuum Decay leak testing is recognized as an efficient alternative for destructive testing techniques like water bath or dye intrusion because it removes subjectivity and lowers waste and costs. It is proven to provide a short-term return on investment. Critical packaging defects are consistently found by the VeriPac test systems, which also provide useful packaging process insights. The VeriPac Series will evaluate a wide range of high-risk packaging applications and ensure that the final product satisfies consumer and regulatory requirements. The suitable VeriPac model is chosen, based on the intended package type and leak test sensitivity. Depending on the application, configurations can be optimized and customized.

Working Principle

Under this technique, VeriPac leak testers are connected to a test chamber specially designed to hold the sample package. The package that has been put inside the test chamber is subjected to vacuum. A single or dual vacuum transducer technology is used to monitor the vacuum level as well as how the vacuum changes during a predefined test period. The existence of leaks and other defects within the package is determined by monitoring variations in an absolute and differential vacuum.

VeriPac Inspection System Benefits

  • FDA Consensus Standard and ASTM Test Method F2338.
  • Cost-effective and quick return on investment.
  • Simplifies the inspection and validation procedure.
  • Non-destructive, non-subjective, no sample preparation.
  • Supports sustainable packaging and zero waste initiatives.
  • Referenced in USP Chapter 1207.

Flexible packaging such as sachets, stick packs, and pouches, composite cans, and modified atmosphere packaging (MAP) are common types for snack food packaging. For snacks like nuts, savory snacks, chips, crackers, cookies, beef jerky, nutrients, and granola bars, they provide the ideal packaging appearance. They offer shelf stability and simplicity of quick opening. While every packaging offers a different set of advantages and product appeal, every format also has a different set of difficulties for maintaining the integrity of the package and seal.

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container closure integrity testing, container closure integrity, vacuum decay leak testing, cci technologies, ccit
169
09
Sep 2022

Everything You Need to Know About Vacuum Decay Technology

Everything You Need to Know About Vacuum Decay Technology

To assure the safety of pharmaceutical products, during their distribution and storage, manufacturers perform Container Closure Integrity testing (CCI testing). CCIT helps in evaluating the integrity and stability of packaging or containers till they reach their destination. Although destructive CCI techniques such as water bath, and dye tests can find leaks, they are time-consuming, inaccurate, and provide subjective test results. Furthermore, they cause considerable product loss and waste. This leads to an increase in the demand for non-destructive deterministic CCI methods such as Vacuum Decay, MicroCurrent HVLD and Airborne Ultrasound.

Vacuum Decay is a non-destructive CCI testing method that focuses on package integrity and leak path detection. Unlike manual inspection and other non-deterministic testing techniques, Vacuum Decay provides quantitative, deterministic, and accurate test results to assure package integrity. Vacuum Decay technology can handle a wide range of package types, including filled and sealed rigid, semi-rigid, and flexible packaging comprised of non-porous or porous materials.

Technology Overview

The Vacuum Decay method operates by enclosing sample packages in a tightly fitted evacuation test chamber with an external vacuum source. The test chamber is monitored using single or dual vacuum transducer technology for both the level of vacuum and the change in a vacuum throughout a defined test duration. The existence of leaks and defects inside the package is indicated by variations in an absolute and differential vacuum. This inspection method is suitable for offline laboratory testing and can be customized for manual or completely automated operations. The test cycle is non-destructive to both the product and the packaging and only takes a few seconds. It saves money by not wasting products for leak tests and produces a return on investment in less than 6 months for many products.

VeriPac Vacuum Decay Technology

VeriPac Vacuum Decay technology is the optimal non-destructive solution for determining container closure integrity in a variety of package configurations. VeriPac Series will evaluate a wide range of high-risk packaging applications and ensure that the product fulfills regulatory and consumer integrity standards. The VeriPac product line systems analyze the package in a quick, repeatable, and reproducible way, providing quantitative and deterministic test results. Vacuum Decay technologies can identify package leaks and invisible defects utilizing a non-invasive, non-subjective technique that does not need sample preparation.

The VeriPac Series is a practical alternative to destructive testing methods and can detect leaks down to sub-micron levels. An appropriate VeriPac model is chosen based on the type of package and leak test sensitivity required. Configurations can be optimized and tailored to specific applications.

Vacuum Decay Technology Merits
  • Non-destructive technology
  • Defect detection down to 0.05 ccm
  • Accurate, reliable, and repeatable results
  • Pass/fail results backed by quantitative test data
  • No tools are required to evaluate alternative package formats
  • Identifies which cavity is defective
  • Eliminates destructive, subjective testing methods
  • Supports sustainable packaging and zero waste initiatives
  • FDA recognized standard for package integrity testing

Over the years, Vacuum Decay leak testing has proven to be one of the most practical and sensitive vacuum-based leak detection technologies. Vacuum Decay technology is recognized by the American Standard Testing Method ASTM F2338 and detects leaks in hermetically sealed containers, making it useful for both the pharmaceutical and medical device industries.

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container closure integrity testing, vacuum decay leak testing, cci technologies, pharmaceutical package testing, package integrity test solutions
230
06
Sep 2022

Techniques Involved in Leak Testing Vials

Techniques Involved in Leak Testing Vials

Pharmaceutical vials are small bottles or containers designed for parenteral administration (injection or infusion) in a single patient for a single case, procedure, or injection. They offer the highest Container Closure Integrity (CCI), which is a measure of how well a container protects the pharmaceutical ingredient against contamination by a variety of factors such as moisture, air, and chemicals.

In pharmaceutical manufacturing, the leak test is a critical parameter for vials. A visual inspection process may not detect defects that cause a sterile vial to leak. Thus, the pharma companies move toward CCI test methods. Many manufacturers are not sure how to conduct a container closure integrity test, but parenteral product leak testing is very important to assure that the product remains sterile in the packaging configuration throughout the duration of the product's shelf life.

What is CCIT?

Container Closure Integrity Testing (CCIT) is an important quality control technique for pharmaceuticals. It is an assay that evaluates the container closure and its capacity to keep possible contaminants out. Microorganisms, reactive gases, and other chemicals are examples of potential contaminants. This test is necessary for parenteral products since the seal quality is crucial to the drug product's sterility and quality throughout its shelf life. Inadequate sealing can accelerate the expiration of a drug product and cause significant risk to the patient's health if the product loses its sterility.

Previously, sterility testing was used to demonstrate container integrity. However, due to the insensitivity and other challenges associated with sterility tests, a variety of container closure integrity tests were developed. MicroCurrent HVLD, Vacuum Decay, and Helium Leak Detection are some of them. We give a brief overview of the above pharmaceutical package testing methods that can be used for testing pharmaceutical vials.

Leak Testing Vials Using Various CCI Techniques

  • MicroCurrent HVLD Technology

  • High Voltage Leak Detection (HVLD) is a non-destructive Container Closure Integrity technology that is used to evaluate the closure integrity of parenteral product packaging. HVLD technology makes use of quantitative electrical conductivity and resistance principles. The technology works by transmitting high voltage microcurrent impulses through sample packages. The electrical resistance of the sample lowers in the presence of a leak, resulting in an increase in current. HVLD technology relies on the “flow” of current, while other leak detection methods rely on the flow of gas or liquid. The MicroCurrent HVLD lowers product voltage exposure to less than 5% of that experienced while testing with similar HVLD technologies. When compared to conventional HVLD systems, reducing exposure voltage not only eliminates any risk that the voltage provides to the product, but also significantly reduces Ozone formation during operation. MicroCurrent HVLD can be used to test for leaks in nonporous, rigid or flexible packages, as well as packages containing liquid or semi-liquid products.

  • Helium Leak Testing

  • Helium leak testing is the method of locating leaks in enclosed or sealed systems by utilizing helium as a “tracer” gas and measuring the concentration as it exits owing to leakage. The package is filled with helium and vacuumed in this method. A helium leak detector is used to determine how much helium leaks from the container. The outcome is expressed as a leak rate. Helium leak testing is used in product design, product quality studies, failure analyses, and validation, in addition to being an effective container closure integrity test technique. Helium leak testing ensures high sensitivity leak detection, which is not achieved by many other leak test methods.

  • Vacuum Decay Technology

  • Vacuum Decay is a deterministic Container Closure Integrity testing methodology that relies on package integrity and leak path detection. Unlike human inspection and other non-deterministic testing techniques, Vacuum Decay provides quantitative and reliable test results to assure package integrity. Vacuum Decay technique can handle a wide range of package types, including filled and sealed rigid, semi-rigid, and flexible packaging comprised of nonporous or porous materials. This test involves placing packages in an evacuation test chamber with an external vacuum source. Vacuum levels are regularly monitored to detect deviations from a predetermined intended vacuum level. A defect in the packaging will allow air to escape into the test chamber. Packages with no defects, on the other hand, maintain a steady chamber vacuum level. Over the years, Vacuum Decay technology has proven to be one of the most practical and sensitive vacuum-based leak detection technologies.

Historically, dye immersion and microbiological immersion were the two most popular methods for leak testing vials. Recently, the USP has issued guidelines requiring the use of deterministic methods in order to produce more consistent and predictable results. USP<1207> recommends that dye immersion tests are avoided and HVLD or Vacuum Decay tests are used instead.

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parenteral product leak testing, pharmaceutical package testing, CCIT, container closure integrity, container closure integrity testing
172
10
Jun 2022

VeriPac 310 Package Integrity Solution for Food Package Industry

VeriPac 310 Package Integrity Solution for Food Package Industry

Packaging has a significant impact on the quality of the products and influences customer purchase decisions. Both of these factors provide significant issues for product design, particularly in the case of food packaging. No other product incorporates as many innovative and improved packaging advancements as food. Due to the increased need for convenience, packaging should be easy to handle, easy to open, resealable, or must be able to be heated directly in a microwave. Furthermore, food packaging must be properly sealed to protect product quality and shelf life. Ensuring safe food packaging through testing and analysis is key to safeguarding human health and protecting the food product.

Food Package Integrity Testing Using VeriPac 310

The VeriPac 310 is a non-destructive, non-invasive leak detection and container closure integrity testing method for the food industry. VeriPac systems eliminate waste and provide operators with a comprehensive view of package quality. The VeriPac 310 test cycle generates real-time results from accurate quantitative measurements, identifying packaging defects before important process concerns develop. Tests can be run in any order and even on the same sample several times. Good packages can be returned to the packing line intact. Testing is more dependable, sensitive, and efficient than destructive procedures like the water bath or burst test. The ASTM-approved patented vacuum decay leak test technique F2338-09, acknowledged by the FDA as a consensus standard for package integrity testing, is used in the VeriPac 310.

Technology Overview

The test method begins by connecting the VeriPac leak testers to a test chamber that is specifically designed to accommodate the package to be evaluated. The package is placed into the vacuum-sealed test chamber. The absolute transducer technology is used to monitor the vacuum level as well as the change in vacuum throughout a predetermined test period in the test chamber. The presence of leaks within the package is indicated by the changes in an absolute and differential vacuum. Test systems can be configured to operate manually or automatically. This inspection method is appropriate for offline laboratory testing as well as production applications for QA/QC statistical process control. The test cycle is non-invasive and non-destructive to both the product and the package, taking only a few seconds.

VeriPac 310 Benefits

  • Non-invasive inspection system for leak detection
  • Deterministic, quantitative test method
  • Non-destructive, non-subjective, no sample preparation
  • ASTM test method and FDA recognized standard
  • Cost-effective and economical
  • Supports zero waste initiatives
  • Measures integrity of the entire package

Every packaged food product has a seal that keeps the food item safe inside the packaging. Therefore, food package seal quality testing is performed to ensure that the food packaging used is safe for both customers and the environment. PTI offers a diverse range of testing methods that are applicable to food product packages.

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container closure integrity, container closure integrity testing, seal quality testing, seal integrity testing, cci technologies
277
23
Mar 2022

Parenteral Products Package Testing with E-Scan HVLDmc

Parenteral Products Package Testing with E-Scan HVLDmc

For parenteral administration, compounded sterile preparations are often made from manufactured sterile materials. As a means of drug delivery, patients commonly require the administration of parenteral formulations. When compared to other methods of drug delivery, this method has both advantages and disadvantages. Nowadays, the ways of administration of new drugs are increasing all over the world. The range of possibilities for drug delivery containers must be reviewed on a regular basis, with the objective of improving compliance and delivery accuracy.

The packaging around a drug product is critical when establishing a new drug product or even re-facing an old one. There has also been an increase in the number of packaging formats for parenteral over the last ten years. Liquid-filled containers such as vials, ampoules, syringes, blow-fill seals, and auto-injectors, as well as containers filled with lyophilized products, are common parenteral packaging methods. Parenteral drugs are directly injected into the human body. Therefore, it is necessary to ensure the product quality of parenteral throughout its shelf life. Highly sensitive and reliable test methods are required. In this blog, we will discuss about parenteral product leak testing.

Why Use E-Scan HVLDmc for Testing Parenteral Products Packages?

E-Scan 655 is a revolutionary deterministic offline micro leak test equipment that inspects vials, syringes, and other liquid-filled parenteral products for container closure integrity using a new class of HVLD technology. The technique utilizes a non-contact, non-invasive test procedure that does not need sample preparation. E-Scan 655 is compatible with a variety of liquid-based products, including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions, including vaccines. At high production rates, the offline E-Scan 655 approach may be converted from laboratory to 100 percent inline testing applications. The E-Scan 655 technology is a non-destructive MicroCurrent conductivity test technique for parenterals. This method exposes the packaging and product to a lower voltage than other conductivity-based solutions.

Using a series of electrode probes, the E-Scan tester scans a sealed non-conductive container. Glass, plastic, or poly laminate can be used to make the container. The liquid must be contained within the container or packet (minimum fill 30 percent). There is a resistance differential and a change in current flow if there is a pinhole, crack, or other flaw, indicating a container breach. The approximate position of the defect can be determined.

Benefits of E-Scan MicroCurrent technology

  • Non-destructive, non-invasive, and no sample preparation is required.
  • Greater accuracy and repeatability.
  • Lower voltage exposure eliminates risk to the product and environment.
  • Quick changeover and simple recipe set up to accommodate a wide range of products and applications.
  • E-Scan MicroCurrent technology is effective across all parenteral products, including extremely low conductivity liquids (WFI).
  • Listed in USP Chapter 1207> as a proposed methodology for parenteral liquid package inspection.
  • The inspection and validation process is simplified.

E-Scan HVLDmc is one of the highly effective CCI technologies for parenteral. It is applicable to pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, and pouches. The technology has a rapid test cycle and is easy to use. PTI’s E-Scan 655 is a patent-pending technology that uses a unique mode of MicroCurrent HVLD technique that requires less than half of the voltage required by existing high voltage technologies. MicroCurrent HVLD technology can be applied from the R&D laboratory to automated 100% inline CCI inspection.

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microcurrent hvld, container closure integrity, parenteral product leak testing, container closure integrity testing, cci technologies
417
28
Feb 2022

How VeriPac 355 Ensures Quality and Integrity of Pharmaceutical Packages?

How VeriPac 355 Ensures Quality and Integrity of Pharmaceutical Packages?

The pharmaceutical packaging industry is constantly developing as pharmaceutical manufacturers require reliable and efficient packaging solutions that meet a variety of requirements. Packaging is essential for the safe storage and administration of pharmaceutical products. Packaging pharmaceuticals is important not only for storing and protecting products but is also helpful in identifying, marketing, and promoting different brands, and making pharmaceutical products easier to use. Vials, blister packs, bottles, syringes, ampoules, etc are the most common pharmaceutical packages. The packages must perform correctly to ensure that the drug product remains uncompromised throughout the distribution cycle and shelf life. These packages are later tested to guarantee their quality and integrity.

Testing Package Integrity Using VeriPac 355 Series

VeriPac 355 is a non-destructive micro leak detection device for testing container closure integrity and package integrity on a variety of products and packaging types. This system is specially designed to test containers for dry product gas leaks as well as liquid leaks. Since it is non-destructive and does not need sample preparation, the VeriPac 355 can be integrated into protocols at any step in the handling process. The VeriPac 355 is the ideal non-destructive quantitative test technique for various pharmaceutical and food applications, with the capacity to detect leak rates as low as 0.2 cc/min depending on package parameters. The VeriPac 355 core technology is based on the ASTM vacuum decay leak testing method (F2338-09), which is recognized by the FDA as a consensus standard for package integrity testing. VeriPac leak test instruments were used to develop this test method.

Technology Overview

The VeriPac 355 leak tester is connected to a test chamber intended to hold the package to be tested. The package is placed inside the vacuum-sealed test chamber. High-resolution absolute transducer technology is utilized to monitor the test chamber for, both the level of vacuum and the change in vacuum during a pre-defined test duration. This is capable of detecting both gross and micro leaks. The test cycle is only a few seconds long and the results are objective. The testing is non-destructive to both the product and the package.

The sensitivity of a test is determined by the sensitivity of the transducer, the package design, the package test fixture, and the crucial test parameters of time and pressure. Test systems can be configured to operate manually or semi-automatically. This method is suitable for offline laboratory testing and QA/QC statistical process control.

Advantages of VeriPac 355

  • Non-destructive, non-subjective, and no sample preparation is required
  • Deterministic, quantitative test method
  • Detection of defects down to 0.2 ccm (5 microns)
  • High sensitivity, repeatability, and accuracy
  • Operator receives a PASS/FAIL result within a short cycle time
  • Portable modular design with a small footprint
  • FDA standard and ASTM F2338 test method

VeriPac technology is the optimal non-destructive solution for determining container closure integrity in a variety of package configurations. The strategy for choosing the right VeriPac model is based on the package type and the required leak test sensitivity. Configurations can be optimized and customized to the needs of each application. The VeriPac Series will analyze a wide range of high-risk package applications and ensure that the product fulfills regulatory standards and customer requirements for integrity.

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container closure integrity testing, container closure integrity, vacuum decay leak testing, cci technologies, cci test
459
17
Feb 2022

Automation of Class III Medical Device Packaging

Automation of Class III Medical Device Packaging

Testing Container Closure Integrity (CCI) is crucial for ensuring the quality of Class III medical devices. Class III medical devices are sterile components that are designed to be inserted directly into the human body. These devices often sustain or support life, are implanted or pose an unreasonably high risk of disease or damage. A compromised package can serve as a vehicle for microbial transmission and compromised sterility, leaving patient safety at risk. When bacteria or other impurities enter the container, the device ceases to be a treatment and becomes a danger to the patient. Similarly, a breach of the seal affects the sterility of the device and may present a serious quality concern at a key point of usage.

Testing Challenges in the Medical Device Industry

There are three basic approaches to package integrity testing:

  • 100% in-line testing: All products in a batch are tested on a high-speed production line at an acceptable level of CCI assurance.
  • Small batch testing: Testing a statistically significant batch size for certain quality parameters and extrapolating to match the quality of the manufacturing lot.
  • Testing Offline: Operators test packages individually or in smaller batches.

Dye penetration is a technique for identifying defects in package body and seals that has a variable detection capacity. When carried out correctly, the approach can identify pinholes and channel defects as small as 20 microns. This method is only used to validate the packaging process and offers minimal value to in-process quality monitoring. The method is time-consuming to implement and provides limited information in the effort to ensure the quality of high-risk applications.

For CCI testing, the majority of medical device manufacturers use a 100% in-line manual visual inspection technique. Manual visual inspection has been proved to be one of the least reliable techniques for ensuring quality. The failure of manual visual inspection is caused by a number of factors. According to ASTM test method F1886, a manual visual inspection may detect 75-micron channel defects in a transparent seal 60-100% of the time. Although manual visual inspection can be applied as a 100% test method, performance on the task decreases significantly over time. This method is not applicable if the package format is not transparent or semi-transparent.

How Vacuum Decay and Airborne Ultrasound Technologies are Automated?

Vacuum Decay is a deterministic method proven to offer predictable and reliable results for CCI testing of high-risk package applications. This is an ideal solution for non-porous medical device applications. When the major focus of the inspection is the final seal of a porous package, Airborne Ultrasound is exceptionally efficient and reliable at detecting seal defects that are invisible to the manual visual inspector. Both approaches have shown to be reliable non-destructive testing methodologies, and one or the other can be used for inspection based on the unique features of the product and container.

The automation of each technology looks a little different. Vacuum Decay enables approximately 25 to 50 samples per minute, with low throughput detecting single-digit micron leak sizes. Airborne Ultrasound is a rapid-fire sensor that transmits 1000 pulses per second of sound through the seal. The final seal of Tyvek® pouches and other flexible packaging systems may be scanned at a rate of 20 inches per second (~40 cm/sec), with the capacity to detect the most frequent seal faults and seal quality concerns. Both methods enable a production line to ensure quality while reducing production throughput.

The Airborne Ultrasound technology offered by PTI can be automated in many ways. Basically, the technology can measure the quality of a quantitative seal in any way that the pouch seal can pass through the ultrasound inspection head. Ultrasound can be applied to the production flow, which captures seal quality when exiting a band-sealer or transferring pouches through a production line. Robotic handling may also be used to do a full 360-degree seal inspection on all pouch seals. Airborne Ultrasound has the flexibility to be deployed in a variety of production lines and has high reliability in detecting critical defects.

Vacuum decay is often utilized for both Tyvek® trays and non-porous container types. While a vacuum takes longer to do a test (about 5 seconds on a Tyvek tray), the sensitivity and stability of this technology make it perfect for low output applications with high sensitivity requirements. Robotic handling solutions can serve many test stations at the same time, allowing for increased product throughput without losing sensitivity.

Medical devices are packaged and delivered in a variety of ways, ranging from porous flexible packaging to non-porous rigid containers. The range of product types and packaging options create unique inspection challenges that must be overcome in order to assure seal strength, sterility, and quality. Airborne Ultrasound and Vacuum Decay offer 100% testing capabilities as well as an accurate inspection that includes quantitative test results and a pass/fail result. These new automated technologies, with more sensitive leak detection capabilities, inspect containers at a higher rate.

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airborne ultrasound, vacuum decay leak testing, container closure integrity testing, container closure integrity, cci testing
385
27
Jan 2022

A Quick Rundown on Package Inspection Guidelines for Sterile Medical Products

A Quick Rundown on Package Inspection Guidelines for Sterile Medical Products

Class III medical devices have a unique combination of criteria and package features that necessitate a comprehensive approach to determining the best inspection procedures. For medical package inspection, there are a variety of methods that require a thorough understanding to assure quality.

Manual visual inspection has been the most common form of inspection for medical device packaging. While an ASTM standard (ASTM F1886) covers this concept, it may not be applicable for all applications and has limitations. Even though a 75-micron channel defect can be detected by manual visual inspection, the ASTM method F1886 indicates that the chance of detection ranges from 60% to 100%. This vast range of uncertainty does not give the level of assurance required for the packaging of high-risk medical devices.

Although certain offline leak detection techniques can offer a quantitative evaluation of seal quality, they miss some of the most prevalent seal problems seen in Class III medical device packaging. Testing peel strength or utilizing other destructive methods will not reveal random seal problems. For class III medical devices, online non-destructive inspection procedures are excellent since they provide quality control with comprehensive manufacturing lot data.

All Class III medical devices must be sterile, however, container materials and design differ widely. A non-porous pouch or tray demands an entirely different technique than a porous pouch or tray. Tyvek® offers a sterile barrier, and the porosity of the material limits the leak test procedures that may be used on the package body. When it comes to porous packaging, the focus of online inspection moves away from leak detection and toward seal quality evaluation.

Technology Overview

Vacuum decay and Airborne ultrasound are the two main methods used by PTI/CCIT to inspect medical device packaging. Both methods are aimed at providing quantitative and deterministic test results in order to assess package quality. In terms of function and performance, the two technologies are entirely different. Package integrity and leak path detection are the main objectives of Vacuum decay. Meanwhile, Airborne ultrasound technology focuses on package seal inspection and seal quality. Both approaches aim to meet the basic requirements of being reliable and sensitive inspection procedures for Class III medical device applications.

Vacuum Decay (ASTM F2338)

Vacuum decay is the most practical and sensitive vacuum-based leak test method of CCI. When testing pouches, a versatile adjustable test chamber may be utilized to test pouches of various sizes. The package is then placed into the vacuum-sealed test chamber. The level of vacuum, as well as the change in vacuum during a pre-defined test duration, are both monitored during the short test cycle. The change in vacuum indicates the existence of leaks and defects within the package. Vacuum decay leak testing is a go-to standard for sterile products because of its sensitivity and dependability. The approach is ideal for laboratory offline testing and production applications for quality assurance process control, since test equipment may be developed for manual or automation operation.

The ASTM Vacuum decay leak test technique (F2338), which has been accepted by the FDA as a consensus standard for package integrity testing, was developed using PTI VeriPac technology. As a deterministic test technique for package integrity test solutions, Vacuum decay is mentioned in ISO 11607 and the new USP 1207 guideline document.

Airborne Ultrasound (ASTM F3004)

Airborne Ultrasound is an ASTM Test Method F3004-13 and is one of the most effective methods for non-destructive seal quality inspection of flexible packaging. It is mentioned in ISO 11607 and the new USP 1207 guidance document. Most inspection methods are challenged by the leaking nature of porous packaging, but Airborne ultrasound, with its non-destructive measure of seal quality, effectively overcomes those challenges.

The non-contact Airborne ultrasonic testing technique is used in both Seal-Scan (Offline) and Seal-Sensor (Online). Ultrasonic waves propagate through the material as a package seal passes through the sensor head, producing sound waves to be reflected. When defects are encountered, the signal intensity is reduced or eliminated. The larger the acoustic gap between mediums, the more sound is reflected and less sound is transferred through the seal.

The variety of package forms and materials makes inspecting the integrity of class III medical device packaging a challenge. CCIT's scientists and engineers have vast industry experience and can prove a complete solution, including test method development and equipment validation for Class III medical device packaging.

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package integrity test solutions, vacuum decay leak testing, container closure integrity testing, container closure integrity, cci technologies
539
24
Jan 2022

A Simple Guide to CCIT Services

A Simple Guide to CCIT Services

The integrity of the container closure system is crucial for ensuring that all portions of pharmaceutical products stay sterile during transportation, storage, and usage. Product contamination occurs as a result of leaking containers or closures. A non-destructive packaging inspection technology used to keep an aseptic barrier against possible contaminants is called Container Closure Integrity Testing (CCIT), commonly known as leak detection. The sterility and product quality of sterile final pharmaceutical and biological products should be maintained throughout their shelf life using container closure systems.

Various CCI Services

For testing the integrity of many package formats, CCIT offers expertise for the application of the best deterministic inspection technologies and test methodologies.

Feasibility Studies for Testing Package Quality

The first stage in evaluating and determining the optimal CCI technology and test technique for a certain application is to conduct an experimental or a more extensive feasibility study. To evaluate if a proposed CCI solution works and establish optimal test circumstances and Limit of Detection (LoD) is the goal of a feasibility study. CCIT’s aim is to provide clients with deterministic package integrity test solutions and help them in the installation of comprehensive CCI systems. This process starts with a client's problem description and ends with a clear approach to ensuring container closure integrity. Feasibility studies by CCIT for package quality testing provide customers with a complete report on the quantitative test technique.

Test Method Development for CCI Testing

CCIT conducts feasibility studies and develops test methods for package quality testing, recommending test methods based on the customer's needs for a given package or container. CCIT's Test Method Development focuses on the package/product characteristics and the extent to which the package attributes must be challenged to ensure closure integrity. The Test Method Development comprises adjusting test parameter settings for a given test method, such as vacuum or high voltage, test cycle periods, and pass/fail criteria. The comprehensive report will include precise test processes and criteria, as well as test findings and leak rates that the customer may expect, along with conclusions and recommendations. Before being included in the final report, all of the worked-out test methods go through validation checks to verify that they are reproducible, accurate, specific, exact, and acceptable for their intended application.

Equipment and Application Support

CCIT offers analytical leak detection services as well as package integrity testing equipment and applications knowledge. We also provide demonstrations on equipment and application services.

At CCIT's laboratory, we have the following technological platforms:

  • VeriPac - Vacuum Decay applications
  • E-Scan - MicroCurrent High Voltage Leak Detection( MicroCurrent HVLD)
  • Seal-Scan®/Seal-Sensor - seal inspection through Airborne Ultrasound

CCIT also offers the following services:

  • Installation, training, and validation services for CCI applications
  • Calibration, technical assistance, and overall equipment maintenance
  • Navigating USP 1207/ASTM/ISO standards - CCIT and regulatory consultancy services

CCIT.s.a is Europe’s leading package testing equipment provider for pharmaceutical, medical device, food, and nutrition companies. We have expertise in Test Method Development & Feasibility Studies. We focus on non-destructive technologies like Vacuum Decay, MicroCurrent HVLD, Airborne Ultrasound, and Helium Leak Detection for package quality testing.

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container closure integrity testing, packaging integrity testing, container closure integrity, cci technologies, ccit
406
20
Jan 2022

MicroCurrent HVLD for Testing the Integrity of Ampoules

MicroCurrent HVLD for Testing the Integrity of Ampoules

Pharmaceutical package integrity testing has always been an important aspect of the quality control and manufacturing process. Container Closure Integrity is critical for protecting the product throughout its lifespan until it is delivered to the patient. CCIT uses non-destructive inspection technologies for ensuring container closure integrity of vials, ampoules, syringes, cartridges, and auto-injectors.

Ampoules must be properly sealed since any crack or defect might contaminate the sterile substance inside. Microbial contamination, exposure to gases, water vapor, and solvent loss can all cause product degradation if there is any breach in the package. Hence, container closure integrity is an essential stage in the lifecycle of a sterile pharmaceutical product. Patients may be at risk if the container closure integrity is compromised. Drugs that are meant to save lives might lose their effectiveness or cause fatal side effects. CCI defects can cause oxidation, which can reduce a drug's potency and shelf life.

Integrity Testing of Ampoules using MicroCurrent HVLD

MicroCurrent HVLD technology detects leaks in nonporous, rigid, or flexible packaging such as ampoules that contains liquid products. This is a non-destructive High Voltage Leak Detection Technology that is highly effective across all parenteral products (vials, syringes, ampoules and BFS). The test technique detects pinholes, microcracks, stopper/plunger leaks, non-visible leaks under crimping, and many other defects by scanning a non-conductive container sealed with electrode probes. Any crack or other defect in the container can cause a resistance difference and a change in the current flow, which would indicate a breach. It is also possible to determine the approximate position of the defect.

When compared to conventional HVLD technologies, MicroCurrent HVLD uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage. At high production speeds, this HVLD method may be simply transitioned from offline to 100 percent inline testing applications. It is a cost-effective online container closure testing solution that requires only minor infrastructure changes. This method is non-invasive and does not need sample preparation. For all parenteral and biologic products, MicroCurrent HVLD is one of the most effective CCI methods.

MicroCurrent HVLD Benefits

  • Effective in all parenteral preparations, even liquids with extremely low conductivity.
  • At high production speeds, inspection can be done both offline and online.
  • Non-destructive, non-invasive, and requires no sample preparation.
  • High level of accuracy and repeatability.
  • Deterministic method for parenteral liquid package inspection.
  • A robust technique for a variety of product classes and packaging forms with an estimated 3x Signal-Noise-Ratio.

Ampoules are such little glass bottles containing a sterile pharmaceutical liquid for parenteral administration. Microbes or other harmful pollutants may enter the ampoules through capillary pores or microscopic breaks, or the contents may leak to the outside. This may result in contamination of the sterile contents as well as a deterioration of the appearance of the package. MicroCurrent HVLD technology offered by CCIT can be applied to a variety of pharmaceutical packing formats including ampoules for testing integrity.

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microcurrent hvld, package integrity, packaging integrity testing, container closure integrity, container closure integrity testing
455
18
Jan 2022

Package and Seal Integrity Testing Techniques for Nutritional Packaging Inspection

Package and Seal Integrity Testing Techniques for Nutritional Packaging Inspection

Testing the integrity of package seals helps ensure that nutritional packaging provides required product protection. Maintaining the reliability of package seals is critical for product quality and food safety. Airborne Ultrasound and Vacuum Decay technology can be used for testing package and seal integrity of nutritional packages. These CCI technologies produce quantitative, and repeatable results, due to their deterministic nature. The primary purpose of implementing these testing methods is to ensure the safety of consumers.

Overview of Nutritional Packaging Inspection

Nutritional packaging plays a significant role in securely delivering the product. The majority of nutritional products are shelf-stable in nature, therefore package performance is typically a concern. Chemical reactions occur naturally in all nutritional products. Any break in the nutritional packing might lead to the products deteriorating due to air, moisture, and microbial exposure. Fats and other nutrients for infants might become rancid and inactive. The quality and safety of the contents that reach the customer are determined by nutritional packaging.

Package and seal integrity techniques have great expertise in the packaging industry, which helps in inspecting nutritional packages in the most efficient method in order to preserve package and product quality. For the food and nutritional packaging industries, CCIT provides a variety of technologies and solutions. The two most common nutritional package inspection technologies are vacuum decay and airborne ultrasound. While vacuum decay is utilized for applications such as filled and sealed rigid containers, dry products in pouches, and flexible packaging. Retort pouch final seal inspection can be achieved using non-destructive with airborne ultrasound technology.

Technologies to Assure Package and Seal Integrity

Vacuum Decay Technology

Vacuum decay is a package test method for vacuum-based leak detection. It is considered one of the most practical and sensitive test methods used in nutritional package inspection. When compared to destructive test procedures, this technology not only provides for a better understanding of package quality but also minimizes waste. As a result of the waste reduction, the return on investment is higher, and the operation is closer to green initiatives.

The Vacuum Decay leak testing method operates by enclosing package samples in an evacuation test chamber with an external vacuum source. The test chamber is monitored for both the level of vacuum and the change in vacuum during a pre-defined test duration using single or dual vacuum transducer technology. The existence of leaks and defects within the package is indicated by variations in an absolute and differential vacuum. Test systems can be designed to be operated manually or fully automated.

Airborne Ultrasound Technology

Pouches are the common form of packaging for most nutritional products. Hence, it is necessary to ensure the package integrity of such pouches. Airborne Ultrasound is a non-destructive and non-invasive method of inspecting seal quality. In this method, ultrasound waves are permitted to pass through the package seal, causing sound waves to be reflected. The fluctuation in the reflected signal intensity is used to detect defects.

Airborne Ultrasound technology is available in both online and offline solution options. It has been proven to be one of the most successful non-destructive testing procedures for flexible package seals. According to ASTM F3004-13, this is the standard test technique for evaluating seal quality and integrity using airborne ultrasound. This method has high applicability in the food and nutrition industry.

Vacuum Decay technology and Airborne Ultrasound technology are both ASTM test methods and also FDA consensus standards for package integrity and seal quality inspection of nutritional products. An appropriate testing method for inspecting nutritional packages is selected based on the nature of the product and its package.

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seal quality inspection, cci technologies, packaging integrity testing, vacuum decay leak testing, container closure integrity testing
421
02
Dec 2021

Assuring CCI in Parenteral Products

Assuring CCI in Parenteral Products

Container closure integrity (CCI) testing requirements and regulatory guidelines have been rising steadily in the pharmaceutical industry in recent years. Parenteral products are often packaged in a variety of ways. The most common packaging formats are - vials, ampoules, syringes, BFS, and autoinjectors.

Microbial contamination, exposure to gases, water vapor, and solvent loss can all cause product degradation if the packaging is breached. As a result, container closure integrity is an important part of the sterile medicine product's lifespan. Patients may be at risk if the container closure integrity is compromised. Drugs that are meant to save lives might lose their effectiveness or cause catastrophic adverse effects. CCI defects might cause oxidation, hydrolysis, or a loss of vacuum, which would have a major influence on the drug's efficacy and shelf life.

MicroCurrent HVLD to assure CCI in parenteral products

The criteria and purpose of the test determine the optimal container closure integrity testing technique. The sensitivity and reliability of the test method, the material of the basic package, and the necessity for inline vs. offline testing are all considerations to consider when choosing the right CCI test method. CCI test procedures such as MicoCurrent HVLD can detect breaches before they become an issue with the product and ensure patient safety.

MicroCurrent HVLD is a non-destructive, highly sensitive technology for parenteral product leak testing. This test technique detects pinholes, microcracks, stopper/plunger leaks, non-visible leaks under crimping, and a variety of other defects by scanning a non-conductive container sealed with electrode probes. A change in current flow indicates the presence of a leak, along with the approximate location of the defect in the container. This is a patent-pending high voltage leak detection technique that has been found to be extremely effective in a variety of applications, including pre-filled syringes, vials, cartridges, ampoules, BFS, bottles, and pouches. Being one of the most effective online CCI testing methods, MicroCurrent HVLD requires very minor infrastructure modifications. This method is non-invasive and does not need sample preparation. It is one of the most effective CCI methods.

What sets MicroCurrent HVLD apart from traditional HVLD technology?

MicroCurrent HVLD, as referenced in USP 1207, is a unique High Voltage Leak Detection Technology for container closure integrity testing. When compared to traditional HVLD solutions, this method uses around 50% less voltage and exposes the product and environment to less than 5% of the voltage. MicroCurrent HVLD is a non-invasive CCI technique that does not require sample preparation, and has a high degree of reproducibility and accuracy throughout. This ground-breaking technique can be applied to a wide range of liquid-filled products including low conductivity sterile water for injection (WFI) and highly proteinaceous pharmaceutical products within suspensions.

Any breach in the sterile packaging systems can cause environmental pollutants to grow, turning a life-saving medicine into a potentially fatal microbial soup. This technology is highly effective across all parenteral and biologic products. At high production speeds, the MicroCurrent HVLD technique is scalable and can easily migrate from offline to 100% inline testing applications. It is a cost-effective online container closure testing solution.

The rapidly increasing preference towards parenteral products continues to fuel innovation, but it also faces distinct challenges in terms of implementing a container closure integrity testing strategy. Parenteral product packaging can be as complicated as the products themselves. To ensure package integrity, CCI testing in accordance with current USP 1207 guidance and regulation is required.

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container closure integrity testing, container closure integrity, microcurrent hvld, parenteral product leak testing, cci technologies
568
30
Nov 2021

Evaluating Package Integrity Solutions for Vials

Evaluating Package Integrity Solutions for Vials

Sterile pharmaceutical products including vials are manufactured with extreme accuracy and zero tolerance for error. As a result, pharmaceutical manufacturers place a high value on their quality control procedures. This is to guarantee that the items meet the quality requirements for their intended application. Packaging is essential for maintaining product quality and providing protection from harmful external forces. Package integrity testing, in addition to selecting suitable packing material, is a crucial component in preserving product quality. It prevents external contamination that can have a negative influence on drug quality by ensuring that there are no leaks within the package.

An effective package integrity solution for vials will ensure:

  • The vial is well-protected from external factors that might affect its quality, such as light, oxygen, moisture, and temperature
  • It is safe from contamination

Various Container closure integrity testing (CCIT) technologies are available today. Helium leak detection is one of the leading methods used for testing the container closure integrity of vials.

Helium Leak Detection Technology for CCI testing of Vials

The process of detecting leaks in various enclosed or sealed systems by utilizing helium as a tracer gas and measuring its concentration as it leaves due to leakage is termed Helium leak testing. Simply say, a vial that consists of a container and an elastomeric closure is a good example for package system. The vial is filled with helium and evacuated. The quantity of helium that escapes from the package is quantified and expressed as a leak rate. A prefilled syringe, a foil pouch, or a cold form blister card are another example. Each of these package types is meant to keep the pharmaceutical product enclosed while keeping out potentially harmful environmental pollutants like germs, or even gases.

Helium gas has a number of qualities that make it the best choice for package leak testing

  • As helium gas is one of the smallest molecules, it may reliably and rapidly breach pathways.
  • It is an inert gas that won't react with the components being tested, therefore it's perfectly safe to use.
  • Because of its limited presence in the atmosphere (less than 5ppm), instrument noise from atmospheric helium is intrinsically minimal, resulting in very precise findings.

Following are the advantages of using helium leak detection technology for CCI testing

  • Highly sensitive leak test method for CCI
  • Specially designed for detecting extremely small leaks that other leak test methods failed to detect.
  • The leak test thresholds might be adjusted as low as 1 x 10 -10 cc/s using a high vacuum technique. This allows unique comparison amongst package components.

Sterility of vials is essential for reducing and preventing infection in patients when using the medicine. As a result, package integrity testing is essential for regulatory approval of sterile pharmaceutical products, and medical devices. When it comes to package integrity testing of vials, the terms packaging integrity and container-closure integrity are sometimes used interchangeably.

At CCIT, we provide a wide range of quality leak testing equipment for pharmaceuticals including vials. With our high-grade non-destructive testing equipment, you can ensure that your products meet stringent quality requirements.

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container closure integrity testing, container closure integrity, cci technologies, seal integrity testing, seal quality inspection
468
23
Nov 2021

Pre-filled Syringes Leak Detection with Vacuum Decay Vs MicroCurrent HVLD Test Methods

Pre-filled Syringes Leak Detection with Vacuum Decay Vs MicroCurrent HVLD Test Methods

Pre-filled syringes have a significant role in the injectable drugs market. Because of its convenience, efficiency, and patient safety, pre-filled syringes are now widely utilized in a variety of medical areas. Pre-filled syringes, which are rapidly replacing traditional syringes are frequently used to deliver vaccinations. Defects in pre-filled syringes are mostly determined by pharmaceutical product design and syringe process design. Patient-related concerns are also a regulatory concern. As a result, it is critical for manufacturers to have a thorough understanding of the various tests involved in order to assure patient safety.

Evaluating leak test using Vacuum Decay Vs MicroCurrent HVLD Test Methods

Manufacturers perform Container Closure Integrity testing to ensure that the product maintains sterility and microbiological quality until the point of use. Container closure integrity testing evaluates a container closure system's capacity to maintain a sterile barrier against contaminants that might affect the quality of the resulting pharmaceutical and biological products. Various test techniques may be used to challenge Container Closure Integrity (CCI), however, not all of them are equally capable of finding package leaks. Vacuum Decay and High Voltage Leak Detection (HVLD) are the two deterministic test techniques for CCI mentioned in USP 1207, that are frequently used for parenteral products.

Technologies Overview

Vacuum decay leak testing is a CCI test method that has been proven over decades and improved with new technology innovations. When compared to destructive testing techniques, non-destructive testing not only provides for a better knowledge of package quality but also minimizes waste. As a result of the waste reduction, the return on investment will be higher.

Vacuum Decay method operates by enclosing sample packages in a tight-fitting evacuation test chamber with an external vacuum source. The test chamber is monitored for both the level of vacuum and the change in vacuum during a set test duration using either single or dual vacuum transducer technology. The existence of leaks or flaws within the package is indicated by variations in an absolute and differential vacuum. The Vacuum Decay method for leak detection of pre-filled syringes have proven to be an effective method of testing.

Benefits of Vacuum Decay

  • ASTM Test Method F2338 and referenced in USP 1207 Guidelines
  • Deterministic, quantitative test method
  • Repeatable, rapid, and reliable testing
  • Non-destructive technology
  • Completely tool-less with no changeover to test different packaging formats

High Voltage Leak Detection (HVLD) is a deterministic CCI test method for package inspection of non-porous pharmaceutical and parenteral goods. This technique is based on the fundamental characteristic of electricity. MicroCurrent HVLD technique, the latest evolution of HVLD developed by PTI, promises to provide a high degree of CCI assurance throughout the whole range of parenteral goods.

This method operates by scanning the container which can be done offline in the laboratory or online in an automated robotic platform. On one side of the container, a high voltage is supplied, while the other side has a ground probe. If there is no leak in the package, the two container walls (high voltage and ground) offer complete electrical resistance, and no substantial current is measured passing through the vial. The break-down resistance is achieved when there is a micro-leak or fracture in one of the container walls, and the current passes through. HVLD is the only leak detection technique that does not require mass to flow through a defect location, instead of relying on electricity to pass through a crack.

Benefits of MicroCurrent HVLD

  • Non-destructive technology
  • Non-invasive, no sample preparation
  • High level of repeatability and accuracy
  • Offline and 100% online inspection at high production speeds
  • Low voltage exposure to product and environment

Pre-filled syringes have emerged as a practical and dependable source for unit dosage medication as the pharmaceutical industry continues to seek possibilities to create convenient drug delivery techniques. We, at CCIT put a lot of effort into developing customized handling solutions that guarantee that syringes are moved without touching their piston to minimize product loss.

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container closure integrity testing, container closure integrity, CCI test, microcurrent hvld, vacuum decay leak testing
825
18
Nov 2021

Importance of Testing and Inspection of Pharmaceutical Products

Importance of Testing and Inspection of Pharmaceutical Products

Prior to commercialization, the development of new pharmaceuticals, particularly combination treatments, was a complicated process involving extensive research. When it comes to packing pharmaceuticals for patient use, several things must be considered to ensure that they satisfy the highest quality requirements and are safe to use.

Nowadays, the challenge of adopting traditional glass or specialized polymers as combination products has become common. Similarly, the demand for scientific evidence to support regulatory requirements for the pharmaceutical industry has also become more prevalent. For effective development and commercialization of a pharmaceutical product, it is important to understand the compatibility and performance of the primary packaging system with both, the pharmaceutical product and the delivery systems, regardless of the material.

Container Closure Integrity (CCI)

Container closure integrity (CCI) testing is important when ensuring the quality of all packaged products, especially when it comes to parenteral drugs. To evaluate the CCI of the packaging system, a pharmaceutical manufacturer must calculate the Maximum Allowable Leakage Limit (MALL) for the pharmaceutical product. MALL is defined by USP<1207> Package Integrity Evaluation – Sterile Products as the highest leak rate that may be tolerated for a specific packaging method while posing no harm to the safety and quality of the pharmaceutical product over its shelf life. In comparison to probabilistic approaches, USP <1207> provides guidelines on how to assess CCI, including deterministic methods, which are strongly encouraged. Helium leak detection, MicroCurrent HVLD, and Vacuum decay- are deterministic techniques. For the given system, these techniques must be created and validated.

Test methods

MicroCurrent HVLD

MicroCurrent HVLD is a non-destructive technique for determining the integrity of container closures for a variety of parenteral liquid products, including ultra-low conductivity sterile water for injection (WFI). A non-conductive container is examined for pinholes, micro-cracks, plunger leakage, and non-visible crimping leaks, among other things, using an electrode probe. Whenever a defect is identified, it causes a change in current flow and resistance differential, which indicates a breach in the container. The MicroCurrent HVLD is a High Voltage Leak Detection method effective across all parenteral products.

Helium Leak Detection

Helium leak detection is a deterministic method used to detect leaks in pressure vessels and other enclosed systems. In this technique, helium is used as a tracer gas. The change in helium concentration as it escapes through the container is monitored. For helium-based leak detection systems, the Seal Integrity Monitoring System (SIMS) 1915+ is a perfect choice. Helium as a tracer gas delivers excellent levels of quantitative accuracy when compared to traditional vacuum bubble and dye penetration test techniques. Helium is an optimal solution for product quality monitoring across the product lifecycle.

Vacuum Decay

A non-destructive CCI test method for evaluating medical device package integrity. Non-destructive testing improves package quality while decreasing waste when compared to destructive testing. This testing also saves time and money while ensuring product quality. This method operates by enclosing sample packages in a tight-fitting evacuation test chamber with an external vacuum source. A single or dual vacuum transducer is utilized in the test chamber to measure the level of vacuum as well as the change in vacuum over a pre-defined time period. The existence of leaks and defects is indicated by fluctuations in the package's absolute and differential vacuum.

Regardless of the pharmaceutical product, type of materials, devices used, developing a complete testing plan from initial compatibility to stability and release is critical. To assure the availability of scientific data that helps ensure optimal results for patients as well as rapid regulatory approval and delivery to the market, proper testing is required.

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container closure integrity testing, high voltage leak detection, container closure integrity, seal quality inspection, microcurrent hvld
584
16
Nov 2021

Vacuum Decay Technology for Quality Control Assurance of Parenteral Products

Vacuum Decay Technology for Quality Control Assurance of Parenteral Products

A significant challenge faced by the pharmaceutical industry is insuring the container closure integrity of parenteral products. Therefore, maintaining the quality of parenteral products is critical in order to make sure they are actually sterile and safe for delivery to patients. Parenteral products are often packaged in a variety of formats. Liquid-filled containers, such as ampoules, syringes, and vials are the most prevalent forms. Microbial infection, exposure to gases, and water vapor can all lead to product degradation if the packaging is breached. Pharmaceutical products that save lives might lose their effectiveness or even cause adverse effects. As a result, container closure integrity is an important factor of the lifetime of a sterile pharmaceutical product.

Ensuring quality control with Vacuum decay technology

Vacuum decay is a test technique for determining closed container integrity (CCI) for high-risk packaging applications that provides quantitative and deterministic quality assurance with rapid, consistent, and reliable test results. The Vacuum decay method provides non-destructive and non-invasive leak detection in hermetically sealed containers. This is actually a simple test method and it tests container integrity using basic physical characteristics. It entails drawing vacuum on a package inside a test chamber and checking for any deterioration in the vacuum level, which would indicate a leak. As a non-destructive alternative to the water bath leak test, the approach has gained popularity. It saves money by not wasting items during the leak test.

This technique is applicable to a wide range of packaging formats. The Food and Drug Administration (FDA) has designated the standard vacuum decay leak test technique (ASTM F2338) as a consensus standard for container closure integrity testing. The test technique is mentioned in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207) and is listed in ISO 11607.  It may be used to evaluate rigid or flexible packaging, as well as plastic, glass, or metal containers, making it useful in the pharmaceutical and food and beverage sectors.

Benefits of using Vacuum decay technology

  • Non-destructive, non-invasive, no sample preparation
  • Cost effective with rapid return on investment
  • ASTM test method and FDA standard
  • Pass/fail results backed by quantitative test data
  • Capability to test multiple packages in a single test cycle
  • Non-subjective, accurate and repeatable results

CCIT.s.a are leading providers of various CCI test methods including Vacuum Decay, MicroCurrent HVLD, and Helium Leak Detection, manufactured by our affiliate PTI Inspection Systems in the United States. We specialize in test method development for all container closure integrity of pharmaceuticals, medical device and nutritional products and package quality testing projects. Our aim is to provide customers with deterministic non-destructive technologies for container closure integrity and then provide full support in the complete implementation of CCI systems.

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container closure integrity testing, container closure integrity, CCI test, seal integrity testing, vacuum decay technology
510
21
Oct 2021

Evaluating Pharmaceutical Package Sterility with Vacuum Decay Technology

Evaluating Pharmaceutical Package Sterility with Vacuum Decay Technology

The ability to resist microbiological ingress and the entrance or escape of substances is necessary for the packaging of sterile pharmaceutical products to maintain their quality. Pharmaceutical package integrity standards are quite strict since any packaging defect might have a direct influence on the health and safety of patients. USP 1207 explains how to ensure the integrity of non-porous containers used to transport sterile pharmaceuticals. Syringes, cartridges, flexible bags or pouches, plastic or glass ampules, capped vials or bottles, and containers for drug/device combination products are examples of pharmaceutical packaging.

How to ensure pharmaceutical package sterility with Vacuum Decay Technology?

The most feasible and sensitive Container Closure Integrity test method has been proven to be vacuum decay. The test measurement yields a quantitative result that is both dependable and accurate, as well as a pass/fail determination. Vacuum Decay technique works by enclosing sample packages in a tight-fitting evacuation test chamber with an external vacuum source. The test chamber is monitored for both the level of vacuum and the change in vacuum during a set test duration using single or dual vacuum transducer technology. The existence of leaks and defects within the package is indicated by variations in absolute and differential vacuum.

As it is a non-destructive test method, it saves money by not wasting product during leak tests and produces a return on investment in under 6 months for most of the products. Vacuum Decay has shown to be a non-destructive alternative to the blue dye leak test. Vacuum Decay is an ASTM Test Method F2338, which is also recognized by the FDA as a Consensus Standard for Package Integrity Testing. It is referenced as a deterministic test method for container closure integrity testing in the new USP 1207 Chapter Guidance.

Advantages of Vacuum Decay Technology

  • Non-destructive, non-subjective, no sample preparation
  • Pass/fail results backed by quantitative test data
  • Cost effective with rapid return on investment
  • Deterministic, quantitative test method
  • Identifies which cavity is defective
  • ASTM test method and FDA standard
  • Repeatable, rapid and reliable testing

Package integrity must be evaluated as part of a sterility program in order to determine the risk of new leaks occurring during pharmaceutical storage. After understanding the mechanism and the rationale for guaranteeing no contamination, it is recommended that test techniques with detection ability as near as feasible to the maximum permitted leakage limit be utilized.

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pharmaceutical package integrity, container closure integrity, container closure integrity testing, pharmaceutical package testing, cci technologies
552
30
Aug 2021

Airborne Ultrasound Technology - A Unique Method to Reduce Food and Nutrition Packaging Risk

Airborne Ultrasound Technology - A Unique Method to Reduce Food and Nutrition Packaging Risk

Airborne Ultrasound is a deterministic test method for seal quality inspection and analysis of material types such as aluminum, foil, paper, plastic, poly, film & Tyvek. In accordance with ASTM F3004-13, airborne ultrasound is a standard test technique for evaluating seal quality and integrity. It has been proven to be one of the most successful non-destructive testing methods for flexible package seals. As per research the standard seal inspection methods are inaccurate because they fail to detect invisible defects and mistakenly reject well sealed pouches. Airborne Ultrasound technology, on the other hand, has been proven in the field of both online and offline solution options

How does Airborne Ultrasound Technology mitigate the risk of food and nutrition packaging?

Packaging has been an integral part of food and nutrition preservation in recent decades. Food is packaged with the intention of being transported and stored. Quality, brand, safety, and value of a product are all affected by packaging. To ensure the safety of their products, food producers pack their products in a way that ensures they are correctly constructed, tamper-proof, defect-free, and complete.

In Airborne Ultrasound technology, sound waves are reflected when ultrasound waves are allowed to travel through the packaging seal. Change in the intensity of the reflected signal is used to identify defects. The seal is positioned in a straight line between a pair of transducers, then moves them along the seal. Transmission and reflection of the ultrasound occur at the transition from one medium to another. When the difference in acoustic properties between two materials is greater, only less sound is transmitted, and more sound is reflected. Thickness variations have a minor impact. It is possible to identify a wide range of defects, including those that are visible and invisible, leaking and non-leaking, process-related and random.

As one of the most successful methods for non-destructive testing of flexible packaging, Airborne Ultrasound technology was awarded the ASTM Test Method F3004-13 in 2013. The flow of gas or liquid through the seal is an example of seal defect. Inability to discover non-leak defects is a basic problem with leak testing methods. However, Airborne Ultrasound technology gives a complete way to evaluating seal quality, even when a seal has a defect but may not leak.

Key benefits of Airborne Ultrasound Technology

  • Deterministic inspection technique resulting in quantitative results
  • Non-destructive, non-subjective, zero sample preparations
  • Detects defects in the final pouch seal in real time
  • This method works with any material and combination, regardless of color, porosity, surface finish, transparency, and print
  • The subjective manual vision inspection procedures are no longer necessary
  • Results are repeatable and reliable
  • Testing the final pouch seal integrity at a low cost
  • Characterizes the seal's overall quality and consistency
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seal quality inspection, airborne ultrasound, nutritional packaging inspection solutions, seal integrity, container closure integrity testing
766
29
Jul 2021

Why is Seal Integrity Testing of Medical Device Packaging Important

Why Seal Integrity Testing of Medical Device Packaging is Important

For sterile medical devices, seal integrity testing ensures product efficacy, shelf-life stability, and microbial sterility. Common defects that can threaten the integrity of the seal include voids, wrinkles, dust or other random particles. Hence, inspecting seals after they have been formed is important. Earlier, visual inspection or other destructive testing methods were used for seal quality inspection. However, they lacked accuracy and reliability in test results. But technology is changing. Today, the market offers a range of non-destructive inspection techniques that ensure highly sensitive and reliable seal quality inspection. Even then, the suitability depends on the type of packaging and the size of defect that needs to be inspected.

Relevance of Airborne Ultrasound Technology in Seal Quality Inspection

Airborne Ultrasound technology is a non-destructive container closure integrity testing method, capable of examining seal quality for defects. Such tests are mainly conducted to provide enhanced seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology ensures in-depth seal quality analyses and is applicable for multiple packaging materials Tyvek, paper, foil, film, aluminium, plastic and poly. It is an ASTM Test Method F3004 and FDA recognized standard for seal quality testing. According to Oliver Stauffer, CEO of PTI-Packaging Technologies & Inspection, “Ultrasound is one of the only technologies that are telling us what the quality of that physical bonded nature of the seal materials are.”

Under this technology, ultrasound waves are passed through the package seal which causes reflections of sound waves. The signal strength is reduced or eliminated in the presence of a leak/ defect. Such variations are closely observed to identify the leak. Inability to detect non-leak defects is a common challenge faced by most leak test methods. However, with Airborne Ultrasound technology users can identify various types of seal defects; visible and invisible, leaking and non-leaking, process-related and random.

Latest improvements in Airborne Ultrasound Technology are in the form of Seal Scan (Offline) and Seal-Sensor. Both these technologies utilize non-contact airborne ultrasonic testing technology. Seal-Scan® technology has been proven in the field by several online and offline units installed. With the advancements in form of Seal Scan and Seal-Sensor, Airborne Ultrasound technology has been proven to be the most effective method for non-destructive seal integrity testing.

Benefits of Airborne Ultrasound technology

  • Deterministic seal quality inspection technique that assures quantitative and reliable results.
  • Applicable for multiple material types and combinations regardless of color, transparency, print, surface finish or porosity.
  • Eliminates subjective manual inspection methods.
  • Non-destructive, non-subjective, no sample preparation
  • Technology can be integrated for 100% online defect detection of the final pouch seal.
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container closure integrity testing, airborne ultrasound technology, medical device testing, ccit
822
23
Jul 2021

CCIT for Pharmaceutical Package Integrity

CCIT for Pharmaceutical Package Integrity

Over the last two decades, pharmaceutical industry has seen tremendous growth in the form of technological advancements and drug delivery system innovations. However, such innovations have increased quality assurance challenges for drug manufactures. For this reason, drug product manufacturers give at most importance to their quality control procedures as well as package integrity tests. All packaging forms, whether pouches constructed of porous or nonporous material, rigid thermoformed trays with Tyvek or film lids, bottles with induction-welded seals, or blister packs, need verification that their sterile-barrier characteristics are not compromised. Previously, only sterility testing was conducted on pharmaceutical packaging. However, when it was realized that sterility testing alone is not sufficient to hold the integrity of the medical products, the US FDA published Guidance for Industry for Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. This emphasized the importance of verification of microbial barrier properties of a pharmaceutical product package (i.e., CCI).

Relevance of CCIT in pharmaceutical package testing

Container Closure Integrity Testing is an assay to evaluate whether container closure systems can maintain sterile barriers against potential damage. Even a minute defect in the container can cause external elements to enter the product, thereby reducing its shelf life. Common threats that can pass through a defected container closure system include microorganisms, reactive gases, and other substances. Considering the ability of such threat to deteriorate product quality, undertaking appropriate CCI tests are beyond crucial. However, it should be noted that CCI is not a one-time process, rather an integral and comprehensive approach. It is evaluated throughout the manufacturing lifecycle of a sterile drug product -from primary package development until the products are dispatched.

Container closure systems are made up of primary packaging components and secondary packaging components. Components like vials or syringes that are in direct contact with the product are called primary packaging components. Although there are multiple CCI techniques available in the market today, regulatory guidelines have broadly classified methods into probabilistic and deterministic test methods. Under a probabilistic test method, results are generated through a series of events, each with a respective probability distribution. Thus, the accuracy of the results cannot be assured. In contrast to a probabilistic method, deterministic test methods assure quantitative results with higher level of accuracy and reliability. The United States Pharmacopeia in 2016 issued new guidelines stating that deterministic methods are preferred over probabilistic test methods. Container closure integrity testing can be performed in many different ways. All the testing methods have pros and cons. Given below is a list of non-destructive Container Closure Integrity test methods:

  • Airborne Ultrasound technology
  • Vacuum Decay technology
  • Microcurrent HVLD technology
  • Helium Leak Detection
  • Pressure Decay leak testing
  • Force Decay leak testing
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pharmaceutical package testing, container closure integrity testing, Vacuum Decay Technology, Airborne Ultrasound technology
823
15
Jul 2021

Vacuum Decay Technology Raising Standards for Pharmaceutical Package Testing

Vacuum Decay Technology Raising Standards for Pharmaceutical Package Testing

Right from clinical trials to drug packaging, all aspects for pharmaceutical industry are subject to strict quality control regulations. The process of selecting and validating appropriate packaging for pharmaceutical products takes a significant effort. Pharmaceutical package testing is conducted to ensure the suitability of drug packaging for its intended use. It included all components containing the product, even if they are in direct contact with the drug or not. As such, containers should be capable of retaining the healing properties of the drug product throughout its shelf life or until it is administered. Even a minute breach in container closure integrity can compromise the safety and effectiveness of the drug product. This realization has prompted pharmaceutical product manufacturers to conduct appropriate container closure integrity tests to ensure product sterility throughout its lifecycle.

Why use Vacuum Decay technology for pharmaceutical package testing?

PTI’s Vacuum Decay technology is a non-destructive container closure integrity testing method, capable of evaluating both liquid and air-filled containers and detecting defects as small as below 1 micron. Non-destructive testing provides a greater understanding of package quality while also reducing waste. Waste reduction delivers a fast return on investment and brings operations closer to green initiatives. Proven to be the most practical and sensitive vacuum-based leak test method, Vacuum Decay technology is an ASTM test method, FDA consensus standard, eliminating false positives and subjective results associated with manual visual inspection. Vacuum Decay technology can identify leaks in sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. It provides reliable, accurate and repeatable test results that ensure deterministic package testing and leak detection.

Vacuum Decay technology operates by placing sample packages in a closely fitting evacuation test chamber, which is equipped with an external vacuum source. Single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. Vacuum Decay technology is a practical alternative and significant improvement to destructive test methods and can precisely detect leaks as small as 5 microns, identifying process issues before they become critical, avoiding catastrophic quality deviations.

Benefits of PTI’s Vacuum Decay Test System

  • Better process control - reliable and sensitive leak detection of quality critical defects.
  • The advantage of test results that are both qualitative (pass/fail) and quantitative (Statistical data with each test result).
  • Repeatable test results demonstrate the reliability of the instrument and test data.
  • Cost savings - Eliminates product loss, waste and mess of both packaging and coffee that results from using destructive testing methods
  • Using a non-destructive leak test method allows an increase in the number of products samples tested.
  • Rapid test cycle and minimal training required to operate tester.
  • Rapid ROI due to substantial cost savings and elimination of product loss.
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container closure integrity testing, pharmaceutical package testing, vacuum decay technology
1021
02
Jun 2021

Evaluating Relevance of Seal Quality Inspection in Medical Device Industry

Evaluating Relevance of Seal Quality Inspection in Medical Device Industry

Talking about medical devices, ensuring seal quality or seal strength of sterile medical device packaging are extremely crucial as well as highly regulated. Medical device package seal contains a flexible barrier which is joined to the rigid container through an advanced adhesive. A defect in the seal such as an incomplete or weak seal can initiate leaks, contaminating the product and reducing its shelf life. Hence, for quality control purposes, seal quality inspection of medical device packages is mandatory.

Historically, manual inspection was the most popular method used to inspect seal defects. Although this is covered by an ASTM method (ASTM F1886), it lacked accuracy and reliability in terms of test results. “There is a huge shift in the industry towards deterministic and quantitative test methods,” comments Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection. “This includes Vacuum Decay and Airborne Ultrasound for medical device applications. The industry is currently moving away from dye ingress and manual visual inspection because there are so many blind spots in applying them and there’s a huge false sense of assurance.”

Airborne Ultrasound technology is a non-destructive seal integrity test method capable of advanced seal quality inspection of pouches and flexible packaging. Seal defects can be of two types- leak defects and non- leak defects. While it is easier to detect a leak defect, detecting non-leak defects can be a challenge for manufacturers. However, Airborne Ultrasound technology allows non-destructive Container Closure Integrity testing of multiple seal defects including visible and invisible, leaking and non-leaking, process-related and random- making it a practical solution for medical device seal quality inspection.

Technology overview

Airborne Ultrasound technology utilizes ultrasound waves to detect defects in package seals. Ultrasound waves are passed through the material as the package seal moves along the sensor head. This causes reflections of sound waves. In the presence of a leak, the signal strength is either eliminated or reduced. Such variations in signal strength are analyzed to identify the defects. Seal scan testing is a practical solution to recognize defects, such as inconsistent seals or areas of seals that fail to meet minimum width requirement. Seal-Scan® and Seal-Sensor utilize non-contact airborne ultrasonic testing technology for advanced seal quality inspection. Seal-Scan® technology has been proven in the field by several online and offline units installed.

Benefits of Airborne Ultrasound technology

  • Deterministic seal quality inspection method that produces quantitative results.
  • This method works for any material type and combinations regardless of color, transparency, print, surface finish or porosity.  
  • Non-destructive and non-subjective test method that requires no sample preparation.
  • Technology can be integrated for 100% online defect detection of the final pouch seal.
  • Repeatable, reproducible and reliable results for seal quality inspection.
  • Cost-effective solution for seal integrity testing and seal analysis that characterizes overall quality and uniformity of the seal. 
Readmore...
container closure integrity testing, seal integrity testing, seal quality inspection, airborne ultrasound technology
1166

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