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)
We Value Your Privacy
We use cookies on our website. Some of them are essential, while others help us to improve this website and your experience.
We Value Your Privacy
We use these technologies to analyze how this website is being used.
Name Google Analytics, Google Tag Manager
Provider Google Ireland Limited, Gordon House, Barrow Street, Dublin 4, Ireland
Purpose Cookie by Google used for website analytics. Generates statistical data on how the visitor uses the website.
Privacy Policy https://policies.google.com/privacy
Cookie Name _ga, _gat, _gid
Cookie Expiry 2 years
Customer Interaction
These technologies will allow you to contact us through our website, i.e. use the chat widget.
Name LiveChat
Provider LiveChat Software S.A., ul. Zwycięska 47, 53-033 Wroclaw, Poland
Purpose Communication with clients via online chat using the API of the chat service LiveChat.
Privacy Policy https://www.livechat.com/legal/privacy-policy/
Cookie Name __lc_cid, __lc_cst
Cookie Expiry 2 years
Technologies required to enable the core functionality of this website.
Name Cookie Consent
Provider Owner of this website, Imprint
Purpose Saves the visitors preferences selected in the cookie banner.
Cookie Name ws_cookie_consent
Cookie Expiry 1 year