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PharmaGMP Testing – GBA Pharma LabsPackaging Material Testing

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.

GBA Pharma 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
  • Container Closure Integrity Tests (CCIT)
  • Extractables & Leachables Studies

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

GBA Pharma Labs – GMP Testing

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GMP Quality Control

Method Development & Validation

Stability Studies

Dissolution

Extractables & Leachables

Packaging Material Testing

Particle Determination

Elemental Impurities Testing

Microbiology

Regulatory Services

Amino Acid Analysis

Instrumentation

GBA Pharma Labs Trace-level analytic for N-nitrosamines

N-nitrosamines

GBA Pharma Labs qPCR

qPCR

GBA Pharma Labs iCEF

cIEF

GBA Pharma Labs Protein characterization

Protein Characterization

GMP Testing

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To learn more about us and what we can do for you please contact us.

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