Over the past 20 years, the world’s regulatory agencies have placed more significance on container closure integrity issues. Much of this focus is attributable to improved technology that enables the use of more effective test methods in place of sterility testing. The objective is to insure that contaminants cannot penetrate the intended barrier that a closed system is designed to maintain. Example of such contaminants include gases (especially reactive ones), any type of microorganism or any other foreign substance that can compromise or react with the enclosed drug product or compromise the sterility of the system.
As referenced on 21 CFR 211.94, the goal of an effective container and package system leak testing program is avoiding the receipt of an FDA generated warning letter that opens with the following sentence:
“Your firm failed to ensure your container closure system provided adequate protection against foreseeable factors in storage and use that can cause deterioration or contamination of the drug product”
The Leak Detection Associates team brings a level of experience and knowledge to the Container Closure Integrity testing market that that is unmatched. They are committed to assisting and ensuring that you understand and meet the strict regulatory requirements when it comes to your container and package system testing needs.