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
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
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
11
Aug 2021

How Automated CCI Testing Reduces Pharmaceutical Package Integrity Issues

How Automated CCI Testing Reduces Pharmaceutical Package Integrity Issues

Container Closure Integrity (CCI) is primarily intended to ensure parenteral bio-pharmaceutical sterility and product quality throughout its shelf-life and usage. Guidelines for initial qualification and standards for validation have been set out and are available in chapter 1207 of the US Pharmacopeia (USP<1207>) (1). Any common CCI testing (CCIT) approach can be used to obtain a method that is suitable for its intended application within an end-use cycle. the principles outlined in USAP<1207>. CCI is an integrative and comprehensive process.

Common challenges faced by the pharmaceutical packaging

Pharmaceutical packaging plays a very important role in ensuring protection and maintaining the quality of pharmaceutical products. As a result, a great number of challenges are faced by pharmaceutical packaging. Let us see some of the challenges.

1. Preserving the medical quality of products

The medicines may lose their therapeutic properties, which is one of the biggest challenges faced by the industry, owing to a continuous exposure to heat and moisture. Pharmaceutical materials must be carefully selected and must not be allowed to alter the product by external elements or the product may become totally waste.

2. Ensuring safe transportation of liquid medications and injections

The other big challenge faced by pharmaceutical packing involves ensuring the safe shipping of non-solid medications such as liquids medications and injections. Due to it’s fluid nature, these non-solid medications are considerably harder to handle, especially with glass packaging. There is a high chance of breaking down. In order to avoid this problem, modern technologies like foam packaging and roto molding cases are integrated into the pharmaceutical packaging industry so that the glass packaging does not break down.

3. Proper information of medicine and dosage

The specified dose consumption of medicine is very much important. Also the package must provide information on the required dose, and information about the medicine it is composed of, expiry date and the serial number in order to avoid any misunderstanding.

Role of CCI testing in reducing pharmaceutical package problems

CCI testing helps mitigate pharmaceutical package issues to a great extent. The capacity to describe elements and chemicals which are able to move through container closure system components and contaminate the therapeutic product is a crucial stage in knowing the biological safety and appropriateness of a container. The US Pharmacopeia (USP) and Food and Drug Administration (FDA) are the main forces behind the safety assessment of materials and container closure systems in the United States. These are complying with high Container Closure Integrity Testing criteria (CCIT).

Many damaging procedures were considered suitable to guarantee that container closures preserve the sterility of devices. Basically blue dye or water bath are the procedures. These procedures were actually time consuming, inaccurate and unreliable. Moreover, test operators may not be able to control some test aspects and the resultant findings may be subjective. As a result, the FDA led the industry to shift away from the probabilistic test techniques in favor of deterministic technologies that make it possible for variables to be checked better, performed in consistent circumstances and reliably detect major leakages. Until the emergence of new technologies such as Vacuum Decay and MicroCurrent HVLD, a proper balance between sensitivity and reliability was a difficult factor. These new technologies can successfully scan containers with a greater sensitive leak detection capacity at a much faster speed than ever before.

Vacuum Decay technology: A non-destructive Container Closure Integrity(CCI) testing method which measures leak by vacuum decay. This technology is usually used for sealed packages. In nonporous, stiff or flexible packaging the vacuum decay test identifies leaks. The vacuum decay leak test method is used to check the packages after they are filled to verify the integrity of the product. This method is mainly used by the food package manufacturer, beverages and pharmaceutical industries. This approach minimizes the number of precious completed medicines needed to evaluate stability because the test is not destructive of the samples. After the vacuum decay test, the same samples may be utilized for additional laboratory tests normally necessary for stability studies.

MicroCurrent HVLD technology: MicroCurrent HVLD is a non-invasive Container Closure Integrity(CCI) technology applicable for a broad variety of parenteral filled liquid goods, including exceptionally injecting low conductivity sterile water and protein-filled products. The test procedure assures CCI by scanning a container that is non-conductive and sealed with electrode samples to identify pinholes, micro cracks, leakage of stoppers/plungers, invisible leaks, etc. The resultant difference of resistance and change in current flow indicates a breakdown in the container. Thus a defect is detected with exact defect location.

In addition to offline laboratory systems for leak detection and package quality testing, CCIT offers configurations that provide the capability of fully automated inspection. These technologies do not compromise the reliability of test measurement and automatic inspections take the perfect time to manage and monitor expensive final goods. Automated inspection platform provides best in class CCI testing with no compromise within the parenteral process. PTI’s technologies provide the reliability and accuracy in test measurement, while the automation platform provides the flexibility needed to not compromise on quality.

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container closure integrity, vaccum decay technology, microcurrent hvld, pharmaceutical package testing, cci
598
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
08
Jul 2021

Evaluating Sterile Medical Device Package Integrity Solutions

Evaluating Sterile Medical Device Package Integrity Solutions

Package integrity testing of medical devices is important to ensure safety and security of the product throughout its shelf life. Medical device packaging aims to protect the product from physical damage, biological contamination, or any other external disturbance. Technological advancements have offered a wide range of sustainable as well as economical packaging materials and formats to the medical device industry. However, irrespective of whether the devices are packed in rigid thermoformed trays with Tyvek or film lids, or in pouches of porous or non-porous materials or sealed bottles or even blister packs, pharmaceutical package testing is critical to verify that their sterile barrier characteristics are not compromised. Today, the market offers a complete range of technologies that can non-destructively inspect medical device packages for container closure integrity.

Package Integrity Solutions for Sterile Medical Device

1. Airborne ultrasound Technology

Airborne Ultrasound technology is a seal quality testing method, which is capable of non-destructively conducting advanced seal quality inspection of pouches and flexible packaging. It is capable of accommodating multiple packaging materials like Tyvek, paper, foil, film, aluminum, plastic and poly and is also proven to provide deterministic, reliable and accurate test results.

As the name suggests, this method 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. Such signal strength variations are closely monitored to identify defects if any. Its ability to evaluate seal quality even under conditions where the defect may not result in a leak, makes Airborne Ultrasound technology a practical choice for seal quality inspection across different industries.

PTI’s Seal-Scan (Offline) and Seal-Sensor (Online) are the latest advancements to the ultrasound test series. Both these technologies make use of non-contact airborne ultrasonic testing technology and have been established as one of the most effective methods for inspection of flexible package seals. Airborne ultrasound is also an ASTM Test Method F3004 for seal quality inspection.

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.

2.Vacuum Decay Technology

Vacuum Decay is a non-destructive Container Closure Integrity test method focused on package integrity and detection of leak paths. Compared to manual inspection and other non-deterministic test methods, Vacuum Decay offers quantitative, deterministic and reliable test results to ensure package integrity. Vacuum decay technology is capable of accommodating a wide variety of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. This test operates by placing packages in a well fitted evacuation test chamber, which has an external vacuum source. The vacuum levels are continuously monitored to identify any variations from a pre-determined targeted vacuum level. A defect in the package will cause air to escape from the package into the test chamber. On the other hand, packages without any defect hold in the air, maintaining constant chamber vacuum level. Vacuum Decay technology has been proven over years to be one of the most practical and sensitive vacuum-based leak detection solutions.

Benefits of Vacuum Decay technology:

  • Non-destructive, non-subjective, no sample preparation.
  • Capable of detecting defects down to 0.05 cm.
  • Accurate, reliable, repeatable results.
  • Supports sustainable packaging and zero waste initiatives.
  • FDA recognized standard for package integrity testing.
  • ASTM test method F2338.
Readmore...
seal quality testing, pharmaceutical package testing, container closure integrity
607
23
Jun 2021

Evaluating Package Inspection Solutions for Pre-filled Syringes

Evaluating Package Inspection Solutions for Pre-filled Syringes

Did you know that majority of defects in high-risk pharmaceuticals including pre-filled syringes are caused by seal defects, attributed to both process and personnel error? While micro leaks pose a risk, the primary causes of defects are larger seal related quality deviations.

As the pharmaceutical industry is constantly seeking opportunities to develop convenient drug delivery methods, pre-filled syringes have come up as practical and reliable source for unit dose medication. The demand for glass syringes faded as the industry moved towards plastic and disposable syringes. Pre-filled syringes are applied across a wide range of medical sector including vaccines, blood stimulants, and therapeutic proteins.

Convenience in use and reduced dosage errors are the primary benefits associated with pre-filled syringes. They make injections easier and safer for both doctors and patients. In addition, pharmaceutical companies are able to minimize drug waste and increase product life span- which are important factors, particularly with costly biopharmaceuticals. However, considering the fact that pre-filled syringes are complicated combination products, manufacturers face a number of challenges in terms of quality control and stability concerns. Therefore, pharmaceutical package testing demands sound knowledge of various CCI testing methods. In this blog, we will understand how Microcurrent HVLD technology offers reliable seal quality testing of pre-filled syringes.

MicroCurrent HVLD Technology for CCI testing of pre-filled syringes.

High voltage leak detection (HVLD) has been a common technology in the market for decades. The latest evolution of HVLD, MicroCurrent technology, aims to achieve a high level of CCI assurance across the entire range of parenteral products. High voltage leak detection is a method included in USP 1207 as a deterministic test methodology and is an established and reliable solution for all liquid filled parenteral products.

HVLD operates on the simple property of electrical current. The package barrier must be non-conductive and would resist voltage from passing through, while the package contents should generally be able to carry voltage. Liquid products with a conductivity of 5 microsiemens and greater meet the requirement for PTI’s MicroCurrent HVLD

The E-Scan 655 is a Microcurrent HVLD technology-based leak test instrument used to inspect vials, syringes, and other liquid filled parenteral products. It is completely non-destructive to the container and product; exposing the package and product to lower voltage than other conductivity-based solutions. The technology uses a non-contact and non-invasive test method that requires no sample preparation. E-Scan 655 can be used with a wide range of liquid-based products including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.

Benefits of MicroCurrent HVLD technology

  • Non-destructive, non-invasive, no sample preparation.
  • High level of repeatability and accuracy.
  • Effective across all parenteral products, including extremely low conductivity liquids (WFI).
  • Lower voltage exposure produces no ozone, eliminating risk to the product and environment.
  • Listed in USP Chapter as recommended method for parenteral liquid package inspection.
  • Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats.
  • Simplifies the inspection and validation process.
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pharmaceutical package testing, seal quality testing, CCI, Microcurrent HVLD
625
21
May 2021

Pharma Package Testing CCI of High-Risk Pharmaceuticals

Pharma package testing

The pharmaceutical industry is the backbone of our health care system. As the industry is continuously progressing, the requirement for package integrity while being stored and shipped across the world is also increasing. Pharma package testing now has become an integral part of pharmaceutical industry especially when it comes to high-risk pharmaceuticals.

High-risk pharmaceutical products are usually filled and sealed in combination devices. As the design and distribution parameters are critical to both the drug and container, it is highly important for the manufacturers to ensure that the components function well together. Often manufacturing discrepancies in combination packages that contain multiple components primarily contribute to container closure failure causing distribution & shipment issues. It can cause aftereffect not only down the supply chain but also for patient safety. Hence accurate pharma package testing is highly essential for high-risk pharmaceuticals. High-risk pharmaceutical products are usually filled and sealed in combination devices. As the design and distribution parameters are critical to both the drug and container, it is highly important for the manufacturers to ensure that the components function well together. Often manufacturing discrepancies in combination packages that contain multiple components primarily contribute to container closure failure causing distribution & shipment issues. It can cause aftereffect not only down the supply chain but also for patient safety. Hence accurate pharma package testing is highly essential for high-risk pharmaceuticals?

Container Closure Integrity of Pharmaceuticals

The United States Food and Drug Administration recommends container closure integrity testing as part of the stability protocol for sterile biological products, human and animal drugs and medical devices. Traditionally, dye immersion, bubble test and other probabilistic and destructive test methods were used. In 2016, United Stated Pharmacopeia (USP) released a guidance stating that deterministic methods are preferred over the probabilistic methods.

The container closure integrity testing landscape has advances drastically. The USP Chapter <1207> on integrity testing have recommended different deterministic and non-destructive container closure integrity technologies throughout their specific product package life cycle.

The different deterministic pharma package testing technologies include the following:

Vacuum Decay Technology

Vacuum decay is considered as one of the most sensitive, practical and reliable vacuum-based leak detection method. This method gives repeatable and accurate quantitative data result with a pass or fail determination and can be used effectively for different kinds of nonporous, rigid or flexible packages. Vacuum decay technology is referenced in USP 1207 chapter guidance and is also listed in 11607. The vacuum decay method developed by PTI’s VeriPac instruments is capable of detecting microleaks in the range of single digit micron. In this method, the package to be tested is placed inside the test chamber to which vacuum is applied. The changes in absolute and differential vacuum is monitored over period of predetermined test time & is used to detect the presence of leaks within the package.

Benefits of Vacuum Decay Technology:

  • Non-destructive & no sample preparation
  • Deterministic test method
  • Repeatable and quantitative test results
  • Can be deployed in a robotic automated platform
  • Highly sensitive & non- subjective

Microcurrent HVLD

Microcurrent HVLD Technology, the new breakthrough in the field of pharmaceutical package testing & highly effective for all parenteral and biological products. The microcurrent HVLD exposes the product and environment to less voltage and has transformed the conventional HVLD technology. It capable of detecting small pinholes, micro cracks and seal defects in applications that include liquid-based products ranging from extremely low conductivity sterile water for injection (WFI) to large molecule-based proteinaceous products with suspensions.

Benefits of MicroCurrent HVLD technology:

  • Non-destructive & requires no sample preparation
  • Deterministic & non-invasive
  • Higher levels of accuracy, reliability & sensitivity in test results
  • Offline and 100% online inspection at high production speeds
  • Can be deployed in a robotic automated platform
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Pharma package testing, pharmaceutical package testing, CCI of high-risk pharmaceuticals, container closure integrity of pharmaceuticals
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