Product/Service

Talecris Biotherapeutics Quality Control

Source: Talecris Biotherapeutics, Inc.
Talecris' Melville facility operates a cGMP compliant laboratory for testing raw materials as well as finished products.

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•Company Brochure: Talecris Biotherapeutics

Talecris' Melville facility operates a cGMP compliant laboratory for testing raw materials as well as finished products.

Analytical quality control:

  • Gas chromatography
  • High-performance liquid chromatography (HPLC)
  • USP Raw materials and WFI testing (including TOC)
  • Moisture content testing
  • Stability testing
  • Analytical method development and validation
  • Gravimetric analysis
  • Viscosity measurements
  • IR and UV spectroscopy

Microbial quality control

We also operate a cGMP compliant laboratory for testing the microbial quality of products and the raw materials used in their manufacture.

  • Bioburden analysis
  • Product sterility testing by membrane, filtration or direct inoculation
  • Bacteriostasis/fungistasis
  • Environmental monitoring, including:
    • total particulates
    • viable airborne particulates
    • viable surface particulates
  • Disinfectant efficacy
  • LAL endotoxin testing
  • Manual and automated microbial identifications
  • Growth promotion testing (nutrient media suitability)

Click Here To Download:
•Company Brochure: Talecris Biotherapeutics