Lancaster Labs offers dye ingress container closure testing
by Chrissy Leslie, manager; Krista Hipple group leader; and Vincent Lundgren, chemist, Pharmaceutical Drug Release Testing and Clinical Support
The FDA issued a guidance document in 2008 discussing alternative methods to sterility testing for confirming container closure integrity during stability studies. Sterility testing must be performed for sterile products at the initial timepoint and the final timepoint (expiration) of a study; however, additional testing is usually performed at other intervals within this time period. One alternative method that can be used is a dye penetration or dye ingress test.
Lancaster Laboratories offers method development and validation as well as method qualification services for Visual and UV method dye ingress testing. The team also performs routine dye ingress container closure testing for many clients. Laboratory personnel have experience developing methods for a variety of containers including glass vials (multiple sizes), plastic bottles, and IV bags. Currently, the team recommends that a method specific to the product (container/closure/product fill) be developed rather than using a generic method since this will provide a more accurate evaluation of closure integrity. During development, an appropriate dye is selected based on compatibility with the sample matrix and a limit of detection is determined. The team also offers method writing as well as validation protocol writing services for closure integrity testing. In summary, Lancaster Laboratories has the capability to provide clients with assistance in every step of this process from initial consultation to testing your product using a customized, validated method specific to your needs.
For more information about these services, please contact Pharmaceutical Business Development at (717)656-2300.