To demonstrate these attributes, compendial methods are often implemented, as encapsulated in multiple pharmacopeia worldwide, most notably the USP and EP. Testing can be thought of in two distinct “groups” , incorporating USP requirement chapters (those with a chapter number under <1000>), and guidance chapters (those over <1000>), summarized below. Whereas historically, USP packaging chapters were largely organized according to the test article, substantial efforts have been made to classify recent and pending chapters according to their evaluative purpose. Under this framework, the key differentiation made is between functional and physical performance tests and physicochemical tests.
In a general sense, functional and physical performance testing refers to the ability of the package or component to demonstrate suitability for an intended function, such as to protect from light or moisture or create an adequate seal. The ability of the component or system to adequately perform the intended function can be impacted by physical and chemical characteristics such as material composition, fit and finish, hardness, and other properties. Specific functional and physical performance tests include:
- USP <671> Permeation Testing
- USP <671> / USP <660> Light Transmission
- USP <670> Desiccant Adsorption Capacity
- USP <382> Elastomer Functionality
- Oxygen and Moisture Transmission
- Container Closure Integrity, or Leak Testing according to USP <1207>
- Numerous complementary services
With access to state-of-the-art laboratory equipment operating within a cGMP, fully electronic, Part-11 compliant quality and data management system, the team at CS Analytical is able to fulfill test requests for package components and systems to meet regulatory requirements.