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In today's healthcare and pharmaceutical industries, ensuring the integrity of packaging is paramount. This is especially true for sterile products, where the failure of packaging can lead to contamination, posing serious risks to patient safety. Among the various packaging materials available, Tyvek has emerged as a popular choice due to its durability, breathability, and microbial barrier properties.

Tyvek, a synthetic material made from high-density polyethylene fibers, is widely recognized for its exceptional properties, making it a top choice for medical and pharmaceutical packaging. It combines outstanding durability, tear resistance, and breathability with superior microbial barrier protection. These qualities make Tyvek ideal for use in sterile barrier systems, medical device packaging, and pharmaceutical packaging. However, to ensure the highest levels of safety and quality, thorough integrity testing of Tyvek packages is essential.

Why is Tyvek Package Integrity Testing Important?

Ensuring the integrity of Tyvek packaging is crucial for several reasons:

• Patient Safety: Compromised packaging can lead to contamination of sterile products, posing significant health risks to patients. Integrity testing ensures that the packaging remains intact, maintaining sterility until the point of use.
• Regulatory Compliance: Regulatory bodies, such as the FDA and ISO, have stringent requirements for packaging integrity. Adhering to these regulations is essential for market approval and maintaining the reputation of the manufacturer.
• Product Quality: Integrity testing helps in detecting defects, such as pinholes, leaks, and weak seals, which can compromise the quality of the packaged product. Ensuring robust packaging helps in preserving the efficacy and shelf life of the product.
• Cost Efficiency: Identifying and rectifying packaging defects early in the production process can save significant costs associated with product recalls, rework, and liability claims.

Tyvek Package Integrity Testing Using PTI's VeriPac Series

Vacuum decay is a highly efficient and extensively validated Container Closure Integrity testing (CCIT) method, recognized as the most practical and sensitive technique for detecting leaks in vacuum-sealed containers. This method operates on the simple physical principles to evaluate container integrity, providing dependable and precise quantitative results, categorized as either pass or fail. It has become a non-destructive alternative to conventional methods such as the blue dye test.

PTI's VeriPac package integrity testing method offers a non-destructive alternative to traditional water bath leak tests, bubble leak tests, and blue dye leak tests. VeriPac leak test systems are suitable for package integrity testing of Tyvek and porous packaging, ensuring the product meets both regulatory and patient expectations. The VeriPac vacuum decay technology, an ASTM Test Method F2338 was first established in 2003, and was initially based on tests of Tyvek-lidded trays using PTI’s VeriPac instruments.

This technology functions by connecting VeriPac leak testers to a test chamber specifically designed to accommodate the sample package. Vacuum is applied to the package within the test chamber. The level of vacuum and the change in vacuum over a predetermined test period are monitored using single or dual vacuum transducer technology. Variations in absolute and differential vacuum are analyzed to detect the presence of leaks and defects within the package.

Benefits of VeriPac Inspection System:

• Non-destructive test method that ensures quantitative test results
• FDA recognized ASTM test method
• Referenced in USP 1207 guideline
• Cost-effective with rapid return on investment
• Simplifies inspection and validation process