Aug 2021

How to Evaluate Sterility of Pharmaceutical Packages?

How to Evaluate Sterility of Pharmaceutical Packages

Sterility testing of pharmaceutical products is crucial to ensure that drugs and other biopharmaceutical therapeutics are actually sterile and safe for human use. No pharmaceutical drug can be released into the market without appropriate sterility testing. Pharmaceutical drug products often contain complex active ingredients that stress the importance of sterility and CCI testing. Even a minute breach in the package can cause moisture, air, or other harmful substances to enter the product- thus compromising its healing properties. Moreover, a contaminated drug product can cause serious health issues to the user, making it more of a threat than treatment. Hence, ensuring container closure integrity holds high relevance.

Ensuring Package Sterility with Vacuum Decay Technology

Vacuum Decay is a non-destructive CCI test method that has been proven over decades and improved with new technology innovations. The test method is simple in principle and challenges container integrity based on fundamental physical properties. 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.

Being a non-destructive test method, it provides significant savings by not wasting product for a leak test and generates return on investment in under six months for many products. Vacuum Decay technology has established itself as a non-destructive alternative to the blue dye leak test. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity (CCI) testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207).

Overview of PTI’s VeriPac Vacuum Decay Technology

PTI's improvements in the form of VeriPac test systems have raised a bar for excellence and performance reliability in terms of non-destructive package testing equipment. Its ability to detect leaks down to the sub- micron level and identify process issues before they become critical has made it an ideal choice for pharmaceutical package integrity. The next generation of VeriPac systems combines both technological innovation and practical adjustments to current technology to make it the most sensitive and versatile vacuum-based leak detection technology to date. Through the introduction of unique test cycles, pneumatic controls and processing algorithms, the VeriPac technology is establishing itself as the foremost vacuum-based leak detection technology.

Benefits of Vacuum Deacy Technology

  • 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
pharma package testing, pharmaceutical package testing, container closure integrity of pharmaceuticals, CCIT, veripac test system, package integrity testings

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