Microbiology
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 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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