for pharmaceutical and biopharmaceutical quality control

Microbiological in vitro analysis

  • Microbiological examination of non-sterile products: microbial enumeration tests (Ph. Eur. 2.6.12)
  • Microbiological examination of non-sterile products: test for specified micro-organisms (Ph. Eur. 2.6.13)
  • Microbiological examination of non-sterile products: Test for Burkholderia cepacia Complex (USP <60>)
  • Microbiological examination of specific products:
  • Microbiological examination of cell-based preparations (Ph. Eur. 2.6.27)
  • Microbiological examination of herbal medicinal products for oral use and extracts used in their preparation (Ph. Eur. 2.6.31)
  • Microbiological examination of live biotherapeutic products (Ph. Eur. 2.6.36, Ph. Eur. 2.6.38)
  • Microbiological testing of cosmetics according to CTFA or ISO standards
  • Identification of isolates (16S rRNA-DNA, ITS sequence, MALDI-TOF)
  • Determination of bactericidal, fungicidal or yeasticidal activity of antiseptic medicinal products (Ph. Eur. 5.1.11)

Pyrogen determination

  • Bacterial endotoxins (Ph. Eur. 2.6.14)
    • Method B Gel-clot method: quantitative test
    • Method C Turbidimetric kinetic method
    • Method D Chromogenic kinetic method
  • Monocyte-activation test (Ph. Eur. 2.6.30)
  • Test for endotoxin using recombinant factor C (Ph. Eur. 2.6.32) – Coming soon.

Purified water analysis (Aqua purificata, WFI)

  • Microbiological monitoring using R2A Agar
  • Total organic carbon (TOC, Ph. Eur. 2.2.44)
  • Endotoxins (Ph. Eur. 2.6.14)
  • Elemental impurities (e.g. Nitrates, Aluminium)
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