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