Microbiology & Sterility testing
Microbiological Services
NextPharma has been providing microbiological services at its Göttingen facility for over 50 years. A major investment was undertaken in 2010, including the addition of five new laboratory rooms equipped with state-of-the-art air handling, laminar-flow benches and temperature-controlled incubators. The department is compliant with GMP, and all microbiological tests are performed and validated according to the required pharmacopoeia. The team provides a comprehensive range of services in microbiology and hygiene, including GMP-compliant environmental monitoring, hygiene training at customers facilities and compilation of hygiene plans.
With the recently acquired site of Tampere with years of experiences in the sterile products development and production, we have added additional services in this area in microbiological testing for sterile products and training for aspetic activities.
The services include:
Göttingen site
- Microbiological testing of non-sterile products
- Testing of purified water and raw materials
- Preservative effectiveness tests
- Tests for endotoxins
- Hygiene monitoring in production areas
- Training in advanced hygiene techniques
- Compilation of hygiene plans
- Consulting
Tampere site
- Sterility test
- LAL / Bacterial endotoxin test
- Bioburden test
- Efficacy of antimicrobial preservation (AET)
- PFMD (Preservative Free Multidose) development tests
- Method validation
- Long experience of microbiological contribution to product development projects and tech transfer projects including regulatory documentation