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Packaging Material Testing

GBA Pharma Labs - 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)

The experienced and highly committed GBA Group team offers a variety of different services in the following Areas.

GBA Pharma Labs - GMP Testing

GMP Testing

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GBA Pharma Labs - GMP Quality Control

GMP Quality Control

GBA Pharma Labs - Method Development & Validation

Method Development & Validation

GBA Pharma Labs - Stability Studies

Stability Studies

GBA Pharma Labs - Dissolution

Dissolution

GBA Pharma Labs - Extractables & Leachables

Extractables & Leachables

GBA Pharma Labs - Packaging Material Testing

Packaging Material Testing

GBA Pharma Labs - Particle Determination

Particle Determination

GBA Pharma Labs - Elemental Impurities Testing

Elemental Impurities Testing

GBA Pharma Labs - Microbiology

Microbiology

GBA Pharma Labs - Regulatory Services

Regulatory Services

GBA Pharma Labs - Amino Acid Analysis

Amino Acid Analysis

GBA Pharma Labs - Instrumentation

Instrumentation

GBA Pharma Labs - N-nitrosamines

N-nitrosamines

GBA Pharma Labs - qPCR

qPCR

GBA Pharma Labs - iCEF

cIEF

GBA Pharma Labs - Protein characterization

Protein Characterization

GBA Pharma Labs - Limit test for DEG and EG by GC

Limit test for DEG and EG by GC

GMP Testing

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