Site Profile
General Information
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| Site Name: | SGS INSTITUT FRESENIUS GmbH |
| Location (Address): | Im Maisel 14 D-65232 Taunusstein Germany |
| Phone: | +49 (0) 6128 744 245 |
| Fax: | +49 (0) 6128 744 700 |
| Year Established: | 1854 |
| Number of Full-Time Employees: | 350 (49 in GMP Pharma) |
Service Portfolio
- Analytical Chemistry
- Container Testing
- Environmental Testing
- Medical Device Testing
- Method Development & Validation
- Microbiological Testing
- Mycoplasma Testing
Facilities
Size in Square Meters Feet: 10000 m2 laboratory, GMP lab. 650 m2
Special Capabilities at this site: leachables/extractables screening on GC/MSD and LC/MS/MS; environmental risk assessment of medicine products, microbiology
Differentiating Factors from other Contract Laboratories in the region: Regularly FDA inspected, focus on raw material/finished product testing, microorganism identification by DNA sequencing (MicroSceq)
Regulatory
Routinely inspected by FDA and European Regulatory Authorities
Hesse state GMP, accreditated for medical products testing according to 93/42 EWG; handling of BTM (e.g. narcotics) according to §3 BtMG, judge surveyor for pharmaceuticals.
