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. We offer both clean room and isolator technologies for sterility testing, enabling application of the most appropriate technology for your products.
With seamless project management, our laboratory becomes an extension of your own operations, producing additional capacity to complement your internal microbiology laboratories.
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 and thousands of sterility tests performed each year using isolator technology.
- We have one of the largest Microbiology Departments in the industry, assuring that you will have the resources necessary to complete your project quickly and effectively.
- Our state-of-the-art controlled and HEPA-filtered microbiology laboratory facilities ensure contamination-free testing of your products.
- Our harmonized sterility testing methods support multiple compendia including USP, EP, JP, PTC and 21 CFR.
- We have an assortment of specific instrumentation to suit your specific requests, including systems for Kinetic Turbidimetric/ Chromogenic Endotoxin Testing, Particle Counting systems, Water Activity meters, TOC analyzers dedicated to water testing, Genetic Analyzers and MALDI-TOF for microbial IDs and Rapid Microbial Screening Systems.
- Particulate Matter Testing
- Microbial Immersion Studies
- H2O2 D-value Studies*
- AAMII Sterilization Validation
- Media Fills
- Microbial Limits
- Antimicrobial Preservative Effectiveness
- Antibiotics Potency Assays
- Bioburden Studies
- Water Activity
- Process Water Testing
- Environmental Monitoring
- Disinfectant Efficacy Testing
- Biological Indicator Analysis
- Organism Identification
*Testing performed at Sydney, Australia site.
Request more information to start working with us today.