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PharmaGMP Testing – GBA Pharma LabsExtractables & Leachables

Extractables & Leachables

Our goal is to support manufacturers

Our goal is to support manufacturers of pharmaceutics to select the best primary packaging material for their products.

Primary packaging materials for products such as injectables, inhalers, and generally liquid and topical preparations are made of different materials. Extractables and Leachables (E&L) studies allow to analyse the impact of primary packaging material on the product and determine criteria for a selection and processing, which ultimately serve one purpose: to provide maximum patient protection.

Unfortunately, binding regulatory requirements on how to perform E&L studies are still missing and affected producers are often uncertain about the necessary efforts, costs and testing procedures.

In the field of E&L we have the experience, the know-how and the necessary equipment to offer you a comprehensive guidance when selecting the primary package material or planning E&L offer studies.

Our Services in Detail

  • Review and Optimization of the Packaging System
  • Analysis of the Production Process
  • Risk Assessment of Product Quality
  • Optimizing of the Manufacturing and Packaging Process
  • Characterizing and Selecting Suitable Packaging Materials for Maximum Product Protection
  • Examining Possible Interactions between Packaging Components and Product
  • Conducting Extraction Studies and Analysis with Coupled Techniques such as GC/MS and Headspace-GC/MS, LC-MS, ICP-MS

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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