Microbiological analysis

The manu­fac­turing process from devel­op­ment to the ready-to-use phar­ma­ceu­tical product is subject to strict regu­la­tory requirements.

This includes many micro­bi­o­log­ical tests such as the exam­i­na­tion for micro­bi­o­log­ical cont­a­m­i­na­tion of non-sterile prod­ucts, the measure­ment of the endo­toxin content and sterility testing required for market release.

These and addi­tional analyses are offered by VelaLabs.

Micro­bi­o­log­ical analysis

  • Micro­bi­o­log­ical analyzes according to the Euro­pean Pharmacopoeia
  • Sterility testing – visit our new clean­room here
  • Endo­toxin tests (Gel Clot Test – Limit Test, rFC Endonext, kinetic turbidi­metric method)
  • Analytic of non-sterile prod­ucts (bioburden)
  • Growth promo­tion test for Aseptic Process Simu­la­tion (APS)
  • Growth promo­tion test for nutrient media
  • Bioindi­ca­tors (spore density and inac­ti­va­tion exam­i­na­tion) according to USP
  • Water analysis (AP, WFI, process water)
  • Envi­ron­mental moni­toring (clean room qual­i­fi­ca­tion including docu­ments and performance)
  • Germ iden­ti­fi­ca­tions (16s, MALDI-TOF)

Chem­ical analysis

  • TOC (Total Organic Carbon according to EP)

Hygiene advice and monitoring

  • Micro­bi­o­log­ical measure­ment and analysis of air, work surfaces (according to Eudralex Volume 4 Annex 1)
  • Hospi­tals and medical centers
We Value Your Privacy
We use cookies on our website. Some of them are essential, while others help us to analyze how this website is being used and to allow you to contact us through our website, i.e. use the chat widget. You can change your decision at any time.
Privacy Settings
Statistics
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

 

Name LinkedIn Corporation
Provider LinkedIn Corporation, 605 W Maude Ave, Sunnyvale, CA 94085, USA
Purpose Cookie by LinkedIn used for website analytics. Generates statistical data on how the visitor uses the website.
Privacy Policy https://www.linkedin.com/legal/privacy-policy
Cookie Name
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
Essential
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