The process of qualifying a bio/pharmaceutical product container has many elements. The 1999 FDA Guidance for Industry on container closure systems sets expectations to which package systems are still held today. Ultimately, the onus is on the manufacturer to demonstrate that the package system is suitable for its intended use. This phrase, while vague, is broken down into demonstration of compatibility with the drug product, safety, protection from elements such as light, moisture, and microbes, and performance in the case of, say, a rubber stopper which must reseal after being pierced multiple times in a multi-dose vial or a component or system that must deliver an accurate dose.
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.