Packaging Material Testing

Testing the quality of a medicinal product

Testing the quality of a medicinal product includes more than just analyzing the ingredients. It is becoming increasingly important to test pharmaceutical packaging materials, mainly the primary containers, which come in direct contact with the product. The regulatory demands in this field have increased significantly in recent years.

The guidelines include testing the raw materials used, the finished packaging, as well as the seals of the packaging.

The GBA Group can support you in the following areas:

• Testing Glass Containers according to Ph.Eur. 3.2.1 and USP <660>

• Testing Plastic Materials and Containers (e.g. PE, PP, PET) according to Ph.Eur. 3.2.3 – 3.2.6, USP <661>, <671>

• Testing Rubber Seals according to Ph.Eur. 3.2.9 and USP <381>

• Testing Silicon Elastomers according to Ph.Eur. 3.1.9

• Extractables & Leachables Studies

Integrity tests for container closures:

• Container Closure Integrity Tests (CCIT) according to USP <1207>

• Tracer Liquid Test

• Microbial Challenge Test (microbiological testing)