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Blogs

27
May 2024

Securing Product Integrity: Techniques for Tyvek and Porous Packaging

Securing Product Integrity: Techniques for Tyvek and Porous Packaging

In this blog, we delve into various techniques employed to secure product integrity using Tyvek and porous packaging. These techniques encompass rigorous testing methods, innovative approaches, and industry best practices aimed at maintaining the quality, safety, and efficacy of packaged goods.

Overview of Tyvek and Porous Packaging

Tyvek is a brand of flash spun high-density polyethylene fibers, a synthetic material that's extremely durable and resistant to moisture, chemicals, punctures, and tears. Tyvek is valued for its combination of strength and breathability. It allows air and moisture vapor to pass through while blocking liquids, dust, and other contaminants. This makes it ideal for packaging items that need protection from moisture or dust buildup, such as medical devices, electronics, and sensitive documents.

Porous packaging, on the other hand, refers to packaging materials that are intentionally designed with tiny pores or perforations to allow airflow and gas exchange. These materials are often used for products that require a level of aeration or gas permeability, such as fresh produce, certain pharmaceuticals, and some types of chemicals. Porous packaging materials can include paperboard, certain types of plastics, and specialized membranes.

Both Tyvek and porous packaging serve specific purposes in different industries, offering protection and functionality tailored to the needs of the products being packaged.

Tyvek and Porous Package Integrity Testing Methods:

1. VeriPac Technology

VeriPac technology is a non-destructive system for Container Closure Integrity Testing (CCIT) that employs Vacuum Decay technology to identify leaks in packaging. This method, approved by ASTM (F2338), is recognized by the FDA as the consensus standard for assessing package integrity. VeriPac utilizes a vacuum chamber to meticulously test the integrity of packaging. The package is placed inside, and the chamber pressure is precisely lowered. VeriPac then monitors the rate of pressure change. Any leaks will cause the pressure to rise more rapidly, indicating a compromised seal. Vacuum decay leak testing technology is renowned for its high sensitivity and precision, capable of identifying leaks down to 20 microns.

2. Seal-Sensor Technology

Seal-Sensor™ utilizes Airborne Ultrasonic Technology to perform non-destructive inspections of the final pouch seal on the production line. It offers a deterministic, quantitative, rapid, and dependable approach to inspecting pouch seals for defects. Seal-Sensor identifies incomplete seals, areas of weakness or partiality, and various common faults in seals that may seem visually acceptable but harbor defects impacting product quality and shelf-life. The seal is positioned linearly between two transducers, and either the seal or the transducers are moved along its length. As the ultrasound encounters transitions between different materials, it is both transmitted and reflected. Greater differences in acoustic properties between the materials result in more sound being reflected and less being transmitted. Various configurations of Seal-Sensor are available including plug & play installations on existing conveyor lines and integrated solutions.

3. Seal-Scan Technology

On the other hand, Seal-Scan® is an Airborne Ultrasonic Technology (ABUS) designed for offline, non-destructive testing and analysis of pouch seal integrity. This method provides a deterministic, quantitative, and high-resolution inspection of pouch seal defects and consistency. It is non-destructive, non-invasive, and requires no sample preparation. Seal-Scan® features advanced digital imaging software tools for detailed analysis of seal quality. The system adheres to ASTM test method F3004-13. Seal-Scan technology is revolutionizing the way industries approach seal quality testing. By leveraging ultrasonic waves, Seal-Scan can detect inconsistencies and defects that are invisible to the naked eye and undetectable by other means. This capability ensures that every package leaving the production line meets stringent quality standards, safeguarding the end consumer and maintaining the manufacturer's reputation.

Through thorough testing, innovative sealing methods, and adherence to industry standards, manufacturers can effectively protect their goods from environmental hazards and contamination. As technology progresses, so will the methods for enhancing product integrity, ensuring that packaged items meet stringent quality requirements. By embracing these techniques, businesses can uphold consumer trust and deliver products of the highest standard.

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vacuum decay leak testing, seal quality testing, tyvek packages
87
17
May 2024

How to Enhance Assurance in Contact Lens Packaging?

How to Enhance Assurance in Contact Lens Packaging?

Contact lenses are a popular vision correction solution used by millions of people worldwide. Whether for vision correction, cosmetic enhancement, or therapeutic purposes, contact lenses require careful packaging to ensure their safety, sterility, and effectiveness. Contact lens packaging serves as the primary means of preserving the quality of lenses from manufacturing to the hands of the user.

Contact lens packaging typically consists of individual blister packs, vials, or sachets, each containing a single lens. These packaging units are designed to maintain the sterility of the lenses, protect them from damage, and provide clear labeling with essential information such as prescription details, expiration dates, and care instructions.

In recent years, advancements in contact lens packaging have focused on improving convenience for users, enhancing sustainability through eco-friendly materials, reducing packaging waste, and ensuring compliance with stringent regulatory standards to uphold product safety and quality.

As contact lens technology continues to evolve and consumer demand grows, innovation in packaging solutions remains crucial. By prioritizing the development of packaging that meets the diverse needs of users while maintaining the highest standards of safety and quality, manufacturers can enhance the overall experience of contact lens wearers and contribute to the continued advancement of eye care technology.

Contact Lens Packaging Challenges

Contact lens packaging faces several notable challenges, including:

  • Sterility Maintenance: Ensuring that contact lenses remain sterile until they reach the user is crucial for eye health. Packaging must provide an effective barrier against contaminants throughout manufacturing, distribution, and storage.
  • User Convenience: Packaging should be easy to open, handle, and store, especially for daily disposable lenses. Users value packaging that facilitates quick and hygienic lens removal and insertion without causing damage to the lenses.
  • Environmental Impact: Traditional contact lens packaging often involves significant plastic usage, contributing to environmental waste. Developing sustainable packaging alternatives, such as recyclable materials or reduced packaging, is essential for reducing the environmental footprint of contact lens products.
  • Regulatory Compliance: Contact lens packaging must adhere to strict regulatory standards to ensure product safety and consumer protection. Meeting these requirements for labeling, quality control, and hygiene adds complexity to the packaging design and manufacturing process.
  • Cost Considerations: Balancing the cost of packaging materials, production, and regulatory compliance with the need to deliver affordable products to consumers is a continual challenge for manufacturers.

Significance of VeriPac 410 in Contact Lens Package Testing

VeriPac 410 is a Container Closure Integrity Test (CCIT), that offers non-destructive detection of seal and leak issues in low headspace blister packs, sachets, and pouches. While various test methods are employed to assess package integrity in multi-cavity blister packs and packaging with limited headspace, most of these methods are destructive, subjective, and unreliable.

By utilizing the Vacuum Decay leak testing method and differential force measurement, the VeriPac 410 can effectively detect defective packages. It is capable of testing multiple packages within a single test cycle, depending on their specifications, and can pinpoint which package or blister cavity is faulty. The test results are quantitative, providing operators with a clear pass-or-fail result.

Quality assurance for packaging is ensured through accurate and reliable inspection methods that eliminate subjective factors from the testing process. With the VeriPac 410, tested products can seamlessly return to the production line, minimizing costs and waste typically associated with destructive leak testing methods. The VeriPac 410 provides comprehensive coverage for leak testing in low-volume flexible and semi-flexible packaging. Its return on investment (ROI) makes it an invaluable solution for the pharmaceutical industry.

Moving forward, the future of contact lens packaging holds exciting opportunities for further advancements in convenience, sustainability, and safety. By embracing technological innovations, adopting eco-friendly materials, and adhering to rigorous quality standards, manufacturers can continue to enhance the integrity and usability of contact lens packaging.

Ultimately, the goal of contact lens packaging is to ensure that users receive high-quality, safe, and comfortable products that meet their vision correction needs while also contributing to their overall eye health and well-being. With ongoing dedication to excellence in packaging design and production, the contact lens industry can continue to deliver superior products that enrich the lives of millions of users worldwide.

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vacuum decay leak testing, cci technologies, contact lens
109
16
Oct 2023

Ensuring Quality Revolutionizing Coffee Packaging with Precision Control

Ensuring Quality Revolutionizing Coffee Packaging with Precision Control

In the early days, coffee was often packaged in simple sacks or bags made from natural materials, such as burlap or hemp. These materials were not very airtight, so they could not keep coffee fresh for long periods of time. Vacuum sealed packaging was invented during the 1900s. This packaging removes all of the air from the packaging, which helps to keep coffee fresh for an extended period of time. Vacuum sealed packaging is also lightweight and relatively inexpensive, so it quickly became the most popular type of coffee packaging.

In recent years, there has been a growing trend towards more sustainable coffee packaging. This trend is driven by concerns about the environmental impact of traditional coffee packaging materials, such as plastic and tin.

Overview of Coffee Packaging

Coffee packaging refers to the process of packaging and presenting coffee beans or ground coffee for distribution, sale, and consumption. Coffee packaging serves several important purposes, including preserving the freshness and flavor of the coffee, protecting it from external elements such as light, moisture, and oxygen, and providing information to consumers.

Coffee packaging plays a crucial role in ensuring that coffee reaches consumers in optimal condition, with its flavor and aroma preserved. It also serves as a means of communication between coffee producers and consumers, conveying information about the coffee's characteristics and the values of the company that produces it.

Integrity testing of coffee packaging ensures that the packaging is free of leaks and defects that could compromise the quality of the coffee. This is important to do, as leaks can allow oxygen, moisture, and light to enter the packaging, which can all degrade the flavor of the coffee.

Here are some of the benefits of integrity testing for coffee packaging:

  • It can help prevent coffee from going stale or developing off-flavors.
  • It can help protect coffee from contamination.
  • It can help ensure that coffee meets quality standards.
  • It can help reduce product recalls.
  • It can help improve customer satisfaction.

Quality Testing Using Vacuum Decay Technology

Vacuum decay technology is a non-destructive method for testing the integrity of coffee packaging. It is a Container Closure Integrity Test (CCIT) method with a proven capability of non-destructively testing packaging at the production line with unmatched reliability and sensitivity. Non-destructive testing not only allows a greater understanding of package quality, but also reduces waste as compared to destructive test methods. Waste reduction, in turn, results in a higher return on investment and brings operations closer to green initiatives.

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. VeriPac series is a practical alternative 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 Vacuum Decay Test System

  • Non-destructive technology.
  • ASTM Test Method F2338, FDA Consensus Standard and referenced in USP 1207 Guidelines.
  • Accurate, repeatable results.
  • Pass/fail results backed by quantitative test data.
  • Completely tool-less with no changeover to test different packaging formats.
  • Identifies which cavity is defective.
  • Eliminates destructive, subjective testing methods.

Vacuum decay technology is a valuable tool for ensuring the quality of coffee packaging. It can help prevent coffee from going stale or developing off-flavors. It can also help protect coffee from contamination. If you are a coffee roaster or retailer, integrity testing of coffee packaging is an important quality control measure that you should implement.

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vacuum decay technology, vacuum decay leak testing, package integrity testing, cci testing, ccit
651
14
Aug 2023

Technology Solutions for Automated Pouch Seal Inspection

Technology Solutions for Automated Pouch Seal Inspection

Automated pouch seal inspection is a technology-driven quality control process used to evaluate the integrity of seals on pouch packaging. It employs advanced machinery, sensors, and algorithms to detect and analyze seal defects, ensuring the quality, safety, and reliability of packaged products.

The purpose of automated pouch seal inspection is to identify and address any issues that may compromise the integrity of the seals. By automating the inspection process, manufacturers can achieve higher inspection speeds, greater accuracy, and improved overall efficiency compared to manual inspection methods. By implementing automated pouch seal inspection, manufacturers can improve their quality control processes, minimize the risk of product defects, and enhance customer satisfaction. The technology allows for increased inspection throughput, reduced labor costs, and the ability to detect even subtle seal defects that may be missed by manual inspection methods. Read on to learn more about the automated pouch seal inspection techniques offered by PTI.

Seal-Sensor Technology

Seal-Sensor™ is an airborne ultrasonic technique that inspects the final pouch seal 100% online non-destructively. The Seal-Sensor is an accurate, quantitative, fast and reliable method of testing pouch seals for defects. The Seal-Sensor detects incomplete seals, partial or weak areas of seals, and many other common defects in seals that appear visually acceptable but affect product quality, value and shelf life. In less than a second, a single linear scan (L-scan) of the pouch seal provides a pass/fail result and quantitative, traceable data.

Benefits of Seal-Sensor Technology

  • Deterministic inspection method producing quantitative results.
  • Non-destructive, non-invasive, no sample preparation.
  • Works for any material and combinations, regardless of color, transparency, print, surface finish and porosity.
  • Can be integrated for 100% online defect detection of the final pouch seal.
  • Repeatable and reliable results.
  • Eliminates subjective, manual vision inspection methods.
  • Economical, cost-effective solution for seal integrity testing of the final pouch seal.

VeriPac LPX Technology

Based on decades of consistent performance in the pharmaceutical, biologics, and medical device sectors, VeriPac vacuum decay technology has been proven to be the most sensitive and reliable vacuum-based leak testing method available. It is a fully automated package quality inspection system for 100% inline testing. The LPX enables enhanced automated testing that offers a high degree of confidence in the efficiency of the packaging procedure. The LPX is an effective and reliable solution that enables process-related quality issues to be identified and resolved as soon as possible.

The VeriPac LPX has a dynamic robotic design that is adjusted to your production needs. To fulfill the demands of a manufacturing line, the LPX Series offers modular, scalable solutions. With the help of this flexible platform, a range of package forms may be reliably tested. Flexible packaging, rigid containers, and parenteral pharmaceuticals are some of the applications of LPX automation.

Benefits of VeriPac LPX Technology

  • Automated testing enables the highest level of container quality assurance.
  • Deterministic, quantitative test method.
  • ASTM Test Method F2338 and FDA standard, ISO 11607.
  • Highly accurate test results - low false positives and false negatives.
  • Non-destructive, non-subjective, no sample preparation.
  • Pick-and-Place option back into the production line.
  • Auto reject option of defects removed from the production line.
  • USP <1207> compliant.

Automated pouch seal inspection relies on various technologies to ensure the quality and integrity of pouch seals. Manufacturers can achieve comprehensive and reliable pouch seal inspection, ensuring product quality and customer safety. The specific technologies employed may vary depending on the industry, application, and quality standards. Automated pouch seal inspection plays a crucial role in maintaining the integrity of packaged products and preventing issues such as leaks, contamination, or compromised freshness.

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automated testing, automated solution, seal integrity testing, container closure integrity, vacuum decay leak testing
362
05
Jul 2023

Understanding Automated Parenteral CCI Solutions

Understanding Automated Parenteral CCI Solutions

Parenteral preparations are sterile medicinal products that are administered by injection, infusion or implantation into the body. They are used to deliver medications directly into the bloodstream, bypassing the digestive system and providing a rapid onset of action. There are different types of parenteral preparations, including intravenous (IV) injections, intramuscular (IM) injections, subcutaneous (SC) injections, and intradermal (ID) injections. Each type of administration is chosen based on the specific medication being delivered and the patient's condition.

Parenteral preparations can be single-dose or multi-dose and are usually packaged in vials, ampoules, or pre-filled syringes. These products must be sterile, pyrogen-free, and free from any particulate matter to prevent infections and other adverse reactions in patients. Parenteral preparations can include a wide range of medications, including antibiotics, anticoagulants, vaccines, chemotherapy drugs, and many others. They are typically prepared in a controlled environment, such as a hospital or pharmacy, and are subject to strict quality control measures to ensure their safety and efficacy.

Overall, parenteral preparations play a critical role in modern medicine, allowing for the delivery of life-saving medications directly into the bloodstream.

Overview of Automated Parenteral CCI Solutions

1. E-Scan MicroCurrent RTX

E-Scan RTX is a practical, reliable and entirely automated container closure integrity test (CCIT) approach for pre-filled syringes. The dynamic robotic design of the RTX platform can be customized to meet your manufacturing requirements. The E-Scan RTX uses MicroCurrent HVLD technology, a ground-breaking variation of HVLD, the optimal CCI solution for high-risk biological fluids. It can be used for batch release testing in the lab, on the production line, or in both environments. The test cycle only lasts for a short period of time. The HVLDmc test method checks the entire package for small pinholes, microcracks and defects in the closing seal. This ensures the integrity of the product seal. The HVLDmc has proven to be a highly sensitive leak test method for a variety of liquid-filled pharmaceutical packaging types, including pre-filled syringes, vials, blow-fill-seal containers, and other liquid-filled packages.

Benefits of E-Scan MicroCurrent RTX

  • MicroCurrent HVLD technology is effective across all parenteral products, including biologics and extremely low conductivity liquids including sterile water (WFI).
  • Listed in USP Chapter 1207 as recommended method for parenteral liquid package inspection.
  • Robust method and good Signal-Noise-Ratio between good and defective products.
  • Low voltage exposure reduces production of ozone.

2. VeriPac LPX Technology

VeriPac LPX is an automated inspection solution for CCI testing of parenteral products. The VeriPac LPX series is a line of fully automated instruments for 100% inline testing of package quality inspection. The performance of the packing line may be highly assured due to the enhanced automated testing accessible by LPX. The dynamic robotic design of the VeriPac LPX can be customized according to manufacturing needs. The LPX series offers flexible and scalable solutions to satisfy manufacturing line needs. Rigid containers, parenteral products, and flexible packaging are some applications of LPX technology. Systems using VeriPac LPX use Vacuum Decay technology and ASTM Test Method F2338. The FDA recognizes the test technique as a consensus standard for pharmaceutical package testing and is listed in ISO 11607 and USP Chapter 1207 guidelines.

Benefits of VeriPac LPX Technology

  • Automated testing enables the highest level of container quality assurance.
  • Deterministic, quantitative test method.
  • ASTM Test Method F2338 and FDA standard, ISO 11607.
  • Non-destructive, non-subjective, no sample preparation.
  • Pick-and-Place option back into the production line.
  • Auto reject option of defects removed from the production line.
  • USP <1207> compliant.

Parenteral products are typically tested for their container closure integrity (CCI) to ensure that the product remains sterile and safe for use. Automated CCI solutions can provide a fast and reliable method for testing CCI in parenteral products. These solutions offer several benefits over traditional manual testing methods, including increased efficiency, consistency, and accuracy. Automated CCI solutions typically use non-destructive testing methods, such as vacuum decay or high voltage leak detection, to identify any leaks or defects in the container closure system. These methods are highly sensitive and can detect even the smallest leaks that may compromise the sterility of the product.

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vacuum decay leak testing, container closure integrity testing, pharmaceutical package testing, container closure integrity, e-scan microcurrent
283
20
Jun 2023

Automated CCI Testing for Parenteral Products Using VeriPac LPX

Automated CCI Testing for Parenteral Products Using VeriPac LPX

Automated Container Closure Integrity Testing (CCIT) is a process used to evaluate the integrity of containers for parenteral products, such as vials or pre-filled syringes, to ensure that they are free of defects or leaks. The goal of CCI testing is to ensure that the contents of the container remain sterile and protected from contamination.

There are several advantages to using automated CCI testing, including:

  • Speed and Efficiency: Automated CCI testing is much faster and more efficient than manual operator testing, which can save time and resources for manufacturers.
  • Accuracy: Automated CCI testing is less prone to human error, which can result in more accurate results and increased confidence in the integrity of the container.
  • Reproducibility: Automated CCI testing is designed to be repeatable, allowing manufacturers to consistently and accurately monitor the integrity of containers.

Parenteral Products and its Advantages

Parenteral products are medical products that are administered directly into a patient's bloodstream, bypassing the digestive system. This means that the product is delivered into the body through a route other than the orally, such as intravenously, intramuscularly, subcutaneously, or through other routes. Examples of parenteral products include injectable drugs, intravenous solutions, intravenous nutrition products, blood transfusions, and others. These products are subject to strict quality control and regulatory standards to ensure their safety, efficacy, and sterility, and to maintain the integrity of their packaging to prevent contamination. The specific form of the parenteral product (e.g. solution, suspension, etc.) depends on the product and patient needs.

Advantages of Parenteral Products

Here are some advantages of parenteral products:

  • Rapid onset of action: Parenteral products are delivered directly into the bloodstream, which allows for a faster onset of action compared to oral administration. This can be especially important in emergency or critical care situations.
  • Measures and verifies container closure system integrity
  • More effective for some conditions: Some drugs and therapies are more effective when delivered parenterally because they are absorbed more quickly or may not be well absorbed orally.
  • Alternative for patients unable to take oral medications: Parenteral products provide an alternative for patients who are unable to take oral medications, such as patients with gastrointestinal issues or patients who are unconscious.

CCI Testing of Parenteral Products

CCI Testing is performed on parenteral products using a variety of methods, including vacuum decay leak testing, high-voltage leak detection, and others. The specific method used will depend on the type of product, the packaging material, and the desired level of sensitivity. The goal of CCI testing is to provide confidence in the integrity of the packaging and prevent any incidents of contamination or product failure.

The VeriPac LPX Series is a range of completely automated package quality inspection systems for container closure integrity inline testing. The VeriPac LPX has a dynamic robotic design that is customized to your production needs. To fulfil the demands of a production line, the LPX Series offers modular, scalable solutions. This adaptable platform offers a range of package forms that may be reliably automated. Flexible packaging, rigid containers, and parenteral pharmaceuticals are only a few examples of the applications for LPX automation.

The packages will be picked up and placed by a quick robotic gripper arm into the VeriPac LPX test chambers, where a quick vacuum-based test will be performed. Along with the quantitative test result data, a clear PASS/FAIL result is shown. In order to maintain continuous flow and seamless downstream processing, the packages will then be returned to the product line. Rejects are automatically taken off the production line.

Benefits of VeriPac LPX

  • Automated testing enables the highest level of container quality assurance.
  • Deterministic, quantitative test method.
  • ASTM Test Method F2338 and FDA standard.
  • Highly accurate test results - low false positives and false negatives.
  • Non-destructive, non-subjective, no sample preparation.
  • USP <1207> complaint.

CCI testing is used to evaluate the sealing of the product container and detect any leaks, breaches, or defects in the packaging. This is important because parenteral products are sensitive to environmental factors such as temperature and pressure changes, and any breaches in the packaging could result in contamination or degradation of the product.

Overall, automated CCI testing is an important tool for ensuring the safety and quality of parenteral products, and is increasingly being used by manufacturers to ensure that their products meet regulatory requirements and industry standards.

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container closure integrity testing, CCIT, pharmaceutical package testing, parenteral product leak testing, CCI technologies, vacuum decay leak testing
315
01
Mar 2023

Package Integrity Testing of MAP (Modified Atmosphere Packaging) Using VeriPac Series

Package Integrity Testing of MAP (Modified Atmosphere Packaging) Using VeriPac Series

Meat processors are relying on technologies to extend product shelf life more than ever before, which puts concerns like shelf-life stability and packaging quality to the forefront of challenges. Although meat-based snack products and pet products come in a variety of packaging formats, they all require package integrity assurance/container closure integrity testing for extended shelf life.

Flexible packaging, particularly pre-made pouches and form-fill-seal pouches and bags, is the most preferred format for meat-based snack foods and pet food products. With its capacity to provide shelf stability and ease of opening, flexible packaging makes for the best package appearance. The market for meat products for animals has grown rapidly, as consumers are willing to spend more and demand higher-quality products. Meat snacks intended for animal consumption as well as human use must be free of mold or product deterioration.

Modified Atmosphere Packaging (MAP) tray packs are a common packaging option for fresh beef, hog, and poultry products as well as many other processed meats. By significantly reducing spoilage and extending shelf life, the MAP method provides consumers with fresh items that look good. Once an MAP package is sealed, it is essential to maintain the seal integrity to avoid leaks that can let O2 or other environmental pollutants enter the package.

Explain MAP

Modified Atmosphere Packaging (MAP), which can detect leaks as small as 10 microns, is widely used for perishable products. Package integrity can be tested by monitoring the amount of residual oxygen in the headspace of the package. According to the method, the product must be set up for stability and the headspace must be measured at various time intervals. The six-day test, which frequently measures O2 levels over the maximum threshold (about 3%), is used for production purposes. A 50-micron defect significantly reduces a product's shelf life, but it typically passes a six-day O2 test with flying colors. Six days of output are already palletized and stored in case the O2 test identifies a quality issue. Vacuum Decay can find breaches as small as 10 microns, detect oxygen-critical defects in real time at the source, and prevent extensive quality issues.

VeriPac Series for Testing MAP Meat Packages

The VeriPac Vacuum Decay Series of inspection systems have a proven capacity to non-destructively test packaging down to O2 sensitive leak sizes, which reduces waste and enhances testing capabilities. By consistently detecting leakage as tiny as 10 microns, the technology may identify process issues before they become critical. VeriPac offers quantitative data that is correlated to leak rate and leak size in addition to a clear attribute result (PASS or FAIL).

The VeriPac D-Series uses a revolutionary FLEX-Chamber to test flexible packaging formats since it is resistant to package changes and removes the requirement for changeover when testing different size pouches. Additionally, more than one package may be tested during a single test cycle. The VeriPac Series utilizes a rigid packaging test chamber for MAP Meat Tray Package testing. Depending on the needs of the production, the test system operation can be set up for either semi-automatic or manual operation.

Advantages of VeriPac Series

  • Non-destructive, no sample preparation.
  • Deterministic, quantitative test method.
  • Defect detection down to 0.2 ccm.
  • High level of sensitivity, repeatability and accuracy.
  • Short cycle time provides operators with PASS/FAIL results.
  • Small footprint and modular portable design.
  • ASTM test method and FDA standard.
  • Referenced in USP 1207 guidance.

Since it eliminates subjective results, the VeriPac series is a practical alternative to destructive testing. Case studies have proven that Vacuum decay leak testing technology offers a rapid return on investment when evaluating the dramatic decrease in waste created by destructive test techniques.

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package integrity test solutions, container closure integrity testing, container closure integrity, vacuum decay leak testing, ccit
337
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
1283
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
1228
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
1437
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
1647
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
353
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
328
01
Feb 2022

Development and Validation of CCI Testing Method for Pre-filled Syringes

Development and Validation of CCI Testing Method for Pre-filled Syringes

Pre-filled syringes are becoming more popular as a preferred container closure system for biologics. Pre-filled syringes must offer an inherent barrier that maintains drug product stability and sterility throughout its entire shelf life as a primary container closure system. The ability of the system to retain its microbial barrier integrity must be checked and demonstrated by the drug manufacturers. In 2008, the FDA endorsed CCI testing as part of the sterile product stability protocol.

The pharmaceutical industry has witnessed substantial technical developments in CCI testing in response to rising regulatory demands. MicroCurrent HVLD, Vacuum Decay Leak Testing and Helium Leak Detection are examples of new technologies that have proven enhanced detection capabilities above traditional Dye and Microbial Ingress approaches. Many of the technologies have been employed for CCI testing of drug product stability.

CCI Testing Strategy for Development

Many CCI failure modes can occur throughout the life cycle of a syringe, from component production to drug product filling and sealing, device assembly and packaging, and finally distribution and storage. It is critical to create a comprehensive plan for conducting CCI testing across the whole syringe life cycle.

The creation of the CCI testing technique begins with a detailed study of the construction, design, and manufacturing procedures used in syringes. The failure modes and impacts associated with each aspect of CCI were identified first. The next step was to evaluate whether CCI testing is required, as well as the intended uses and testing frequencies, using a risk-based approach. Knowing that the needle shield compartment seal integrity had been verified by the component supplier, apply a non-routine CCI test to validate its seal integrity during drug product loading and sealing, as well as during device assembly. To ensure CCI was achieved and successfully maintained, implement a complete set of CCI tests across the entire product development cycle for the product-containing syringe barrel compartment.

Method Development and Method Validation

Method development consists of optimizing testing parameters and determining the appropriate pass/fail threshold.

  • Testing parameters optimization
  • Initially, several defect standards of known sizes were examined alongside undamaged samples using varied testing conditions. The relationships between key method parameters and instrument responses to intact and defect samples were comprehensively investigated, with the objective of determining a set of variables that give optimal separation between intact and defect samples. i.e. signal-to-noise ratio or SNR.

  • Pass/fail threshold determination
  • The improved method was utilized to evaluate different lots of filled intact syringes representing relevant product variations, such as drug product batches, and packaging locations and lines, in order to define the preliminary pass/fail threshold. For intact samples, the results of the tests were statistically assessed to determine the instrument baseline and variation (σ). Typically, the pass/fail threshold should be 10 σ higher than baseline. The pass/fail threshold was then further refined and verified by testing defect standards of known sizes.

CCI testing techniques were validated for the pharmaceutical product package. Since the drug product formulation and package design may change during the early development stages, a step-by-step approach was adopted to validate the methods in line with the product development stages. Once product design and packaging design are complete, the methods are fully validated to support CCI testing for initial consistency and process evaluation. The power of the additional long-term method may be further validated before this method is implemented in QC laboratories for routine testing.

During package and pharmaceutical product development and manufacturing, properly selected and verified methodologies are critical for demonstrating container closure integrity. It should be noted that existing CCI testing methods do not provide an optimal solution for all pre-filled syringe CCI testing requirements. To maintain total container closure integrity, an integrated solution involving CCI testing as well as additional engineering and administrative controls is required.

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parenteral product leak testing, container closure integrity, CCI testing, CCIT, vacuum decay leak testing
518
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
426
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
1377
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
1957

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