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Microbiological Analysis – PHARMA (cGMP)

New Services (cGMP)

  • Performing Chromogenic Assays (e.g. Heparin according to Ph. Eur. 2.7.5 and USP <208>; ELISA for Penicillins)
  • Endotoxin Testing according to Ph. Eur. 2.6.14 (Methods C, D) and USP <85> using Turbidimetric and Chromogenic Methods

Tests in accordance with Ph. Eur. (cGMP)

  • Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests acc. to 2.6.12 
  • Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms acc. to 2.6.13
  • Microbial Examination of Herbal Medicinal Products for Oral Use and Extracts Used in Their Preparations acc. to 2.6.31
  • Bacterial Endotoxins acc. to 2.6.14 (Method A)
  • Microbiological Assay of Antibiotics acc. to 2.7.2 
  • Efficacy of Antimicrobial Preservation acc. to 5.1.3 
  • Water, Purified (Aqua purificata; Monograph 0008) 
  • Water for Injection (Monograph 0169) 
  • Water for Preparation of Extracts (Monograph 2249)

Tests in accordance with USP (cGMP)

  • Chapter <51> Antimicrobial Effectiveness Testing
  • Chapter <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Test
  • Chapter <62> Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms
  • Chapter <81> Antibiotics-Microbial Assay 
  • Chapter <85> Bacterial Endotoxins Test

Additional Services

  • Product-Specific Validations (acc. to Ph. Eur. and USP) 
  • Development and Validation of Rapid Test Methods (e.g. Simplate®) 
  • Microbial Assay of Vitamins 
  • Identification of Germs

Microbiological Tests - Hygiene Monitoring (cGMP) 

  • Sampling by Trained Stuff
  • Investigation
  • Germ Identification to Genus Level (Identification on a Species Level can be done via Subcontracting)
  • On request we can supply the necessary additional information about detected bacteria and their possible sources of contamination
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