Product quality, safety and sterility testing methods and technologies have evolved, Tepnel can provide your business with cost saving methodologies such as validation of a quantitative leak test dye ingress or performing leak testing.
Closed container integrity testing (CCIT) evaluates the suitability of product packaging and biological safety, to ensure that a product maintains its sterility throughout its lifecycle.
US Pharmacopeia (USP) <1207.1> defines guidelines, protocols and requirements for these testing methods. Typically, sterility testing of this nature would be performed using a microbial ingress method, although in instances where justification can be provided, physiochemical leak test methods such as dye ingress can be justified to substitute for sterility testing.
These testing methods provide pharmaceutical companies with a more economical cost saving methodology for testing such as stability trials or in process controls for batch manufacture.
Tepnel have documented these ground-breaking solutions in our latest whitepaper, which explains these testing methods, and overview of the structure for the study used to measure likelihood of detection, which in turn will justify and validate physiochemical leak test methods.
We have over 40 years of experience with a proven track record of working in partnership with pharmaceutical companies, providing pharmaceutical testing services that are not core to their business, releasing people and management time to add value to the pharmaceutical drug development process.
To discuss your requirements for validation of a quantitative leak test dye ingress method or performing leak test methodology contact Tepnel Pharma Services.
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