Container Testing

Understanding Container Suitability

Container materials can react with and/or migrate into the drug product they are designed to protect. Thorough analysis is required to ensure that specified containers meet quality, safety, and regulatory standards. Some of the critical aspects of pharmaceutical container testing include:

Scientist injecting fluid into medical pouch for testing.

Container Types Tested

Container Testing Services

Closure Integrity Testing

Standard: USP <1207>, USP <382>

Completed via a dye ingress method, closure integrity testing ensures that the utilized closure is capable of maintaining sterility.

Elastomeric Closures

Standard: USP <381>

Tests assess the functionality of closures, including penetrability, fragmentation, and self-sealing capacity, intended to be pierced by a hypodermic needle, as well as biological and physiochemical properties.

Permeation Testing

Standard: USP <671>

Seeks to understand the functional properties of the container, most notably water vapor transmission (permeation) and spectral transmission (light resistance).

Plastic Materials of Construction and Plastic Packaging Systems for Pharmaceutical Use

Standard: USP <661.1> and USP <661.2>

Extending USP <661>, these tests comply with more rigorous standards that demonstrate that a polymer raw material within primary packaging that comes in contact with the pharmaceutical product and any relevant secondary packaging is well-characterized and suitable for its intended use.

Plastic Packaging Systems & Materials of Construction

Standard: USP <661>

Identification, characterization, and physiochemical testing of high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene (PP), polyethylene terephthalate (PET), polyethylene terephthalate G (PETG), and other polymers.

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