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CD-Leiste
Mikrobiologie

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

GBA PHARMA GMBH

SPECIAL SERVICES:

Flyer "Microbiological Tests" download ›