Sterile and Non-Sterile Product Testing
Eurofins BioPharma Product Testing offers a comprehensive range of microbiology services with strict adherence to cGMP requirements in support of sterile and non-sterile product testing and facility monitoring for bio/pharmaceuticals, including raw materials, cell lines and unprocessed bulk testing.
Why Choose Eurofins BioPharma Product Testing?
- We have been a pioneer in the microbiology outsourcing industry for over 25 years, offering experience that includes more than 3,000 product validations.
- We have one of the largest networks of GMP Microbiology laboratories in the industry, including 14 laboratories in Europe and the US assuring that you will have the resources necessary to complete your project quickly and effectively.
- We routinely and deliberately drive collaboration on services, regulations and new technology across our network so that we operate with a consistent level of scientific expertise and offer a consistent, marketleading product to our customers
- We perform every year more than 10.000 sterility tests, more than 22.000 organism identifications, more than 2.200 preservative efficacy tests and overall we process more than 230.000 routine samples including product, water and environmental samples
- Our state-of-the-art controlled and HEPA-filtered microbiology laboratory facilities ensure contamination-free testing of your products.
- Our harmonized methods support multiple compendia including USP, EP, JP, PTC and 21 CFR.
- Particulate Matter
- Microbial Immersion Studies
- Sterilization Validation
- Media Fills
- Microbial Limits
- Antimicrobial Preservative Effectiveness
- Antibiotics potency assays
- MIC/MBC Studies
- Bioburden Studies
- Water Activity
- Process Water Testing
- Environmental Monitoring
- Disinfectant Efficacy Testing
- Biological Indicator Analysis
- Organism Identification
- MicroSeq® Microbial Identification Systems
- Isolator systems
- BactAlert 3D
- Endoscan V and Kinetic QCL systems for Kinetic Turbidimetric/ Chromogenic Endotoxin Testing
- More than 13 Sievers TOC analyzers
- More than 75 Biosafety cabinets - capable of handling Biosafety Level 2 materials