WebPTI is the leading manufacturer of non-destructive package inspection technologies for the pharmaceutical, medical device and food industries. We offer inspection systems for package leak testing, seal integrity and container closure integrity testing (CCIT). Our deterministic test methods eliminate subjectivity and conform to ASTM standards. This guidance document provides recommendations to you, manufacturers, for using methods other than sterility testing to confirm container and closure system integrity as a part of the stability protocol for sterile biological products, human and animal drugs, and medical devices. This guidance document … See more The definitions presented here are for the purposes of this guidance only. A container and closure systemrefers to the entirety of packaging components that together contain and … See more Products labeled as sterile are expected to be free from viable microbial contamination throughout the product's entire shelf life or dating period. For products labeled as sterile, we consider sterility to be a … See more Sterility tests have long been used to verify that products maintain their sterility throughout the product's entire shelf life or dating period. … See more
Packaging Validation Guidelines Part 2 - Packaging Compliance Labs
WebPackage integrity tests are used to detect packaging problems that could adversely affect the sterility of a medical device. Sterile products may be subjected to an environmental stress intended to simulate extreme conditions that a product might encounter in shipping or storage. ... PBL is FDA registered and is ISO 17025 accredited. Our animal ... WebFeb 1, 2024 · FDA and Accelerated Aging. FDA requires testing to demonstrate that the packaged product will maintain its integrity and sterility when stored over time, and this testing is required to establish an expiry date. Tests that meet these regulatory requirements are accelerated aging testing, real-time aging testing, or a combination of both. It is ... my moon titan is larger than planet mercury
Guidance for Industry - Food and Drug Administration
WebISO 11607- Package Validation Testing. ISO 11607 is the principal guidance document for validating terminally sterilized medical device packaging systems. Packaging must … WebProduct packaging integrity evaluations should take into consideration the maximum stress conditions encountered during the manufacturing and sterilization processes. Testing should also validate the integrity of the design when exposed to anticipated extreme conditions of storage, shipment, and distribution. During this phase, physical methods ... WebFor the right approach to package testing, rely on ISO 11607 and FDA consensus standards. ... According to ISO 11607, the same functional tests you have put in place—both seal … my morgan white admin