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 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)
- 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