Sterile and Non-Sterile Product Testing
Eurofins Lancaster Laboratories 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 Lancaster Laboratories?
- 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 more than 1,000 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 methods support multiple compendia including USP, EP, JP, PTC and 21 CFR.
- Particulate Matter
- Microbial Immersion Studies
- H2O2 D-value Studies
- AAMII Sterilization Validation
- Media Fills
- Microbial Limits
- Antimicrobial Preservative Effectiveness
- Bioburden Studies
- Water Activity
- Process Water Testing
- Environmental Monitoring
- Disinfectant Efficacy Testing
- Biological Indicator Analysis
- Organism Identification
- Applied Biosystems Genetic Analyzer
- MALDI-TOF (Bruker)
- Celsis Advance II Rapid Microbial Screening System
- La Calhene soft-wall isolator system for sterility testing, including three dual half-suit workstation isolators and three transfer isolators, as well as a Skan PSI-M Isolator with Sara-M Airlock
- Millipore Integral Steritest™ systems for membrane filtration sterility testing
- Steris VHP® 1000 systems for isolator decontamination
- HIAC Liquid Particle Counting System and PharmSpec software
- Endoscan V system for Kinetic Turbidimetric/Chromogenic Endotoxin Testing
- Aqualab water activity meters
- >15 Biosafety cabinets – capable of handling Biosafety Level 2 materials
Request more information to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.