Veripac
FDA Releases New "Guidance for Industry" Regarding Container Closure Integrity Testing in Lieu of Sterility Testing for Sterile Products
In February 2008, the FDA released a new guidance document that provides recommendations to manufacturers for using methods other than sterility testing to confirm container and closure system integrity as part of the stability protocol for all sterile products, including human and animal drugs and medical devices.
FDA Link: http://www.fda.gov/RegulatoryInformation/Guidances/ucm146074.htm
FDA Recognized Consensus Standard
The ASTM F2338, Standard Test Method for Non-destructive Detection of Leaks in Packages by Vacuum Decay Method, was developed using VeriPac PTI-225 and PTI-325 leak test instruments. This test method is a Recognized Consensus Standard by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), effective March 31, 2006 (Reference: Federal Register Notice FR Notice (list #014) [Docket No. 2004N-0226].
The FDA recognizes the entire standard and any annexes, for use in conjunction with AAMI/ANSI/ISO 11607:2000, Packaging for terminally sterilized medical devices, 2nd edition, and AAMI TIR 22: 1998, TIR 22/A1:2001. Processes affected include 510(K), IDE, PMA, PDP, HDE, Design Control Input, Quality System Regulation.
According to the FDA Consensus Standard Recognition Notice of March 31, 2006, devices that are affected include any devices that are sterilized and packaged. Packages that can be non-destructively evaluated by this method include: Rigid and semi-rigid non-lidded trays; trays or cups sealed with porous barrier lidding materials; rigid, nonporous packages; flexible, nonporous packages.
Important Links:
- A downloadable version of the US FDA notice for ASTM F2338.
- ASTM Test Method F2338 - www.astm.org Visit link (will open in new window)