Your business: Medical devices
Analytical Laboratory services
Bactimm - Farmalyse is your partner for medical device analytical services. We combine medical device product knowledge with quality control testing, method development and validation studies.
Reliable and fast throughput times together with high quality analytical services are key elements of our organization. Because we are part of a medical device company Bactimm – Farmalyse has extensive experience with testing and validation of medical devices.
With our state-of-the-art laboratories we offer a complete range of services including chromatography facilities (HPLC, UPLC, GC, LC-MS and TLC), spectroscopy (UV and IR) and GMP class A-D clean rooms. An overview of the main services is given below:
Microbiological analyses
- Routine quality control testing in accordance with ISO or ASTM guidance
- Validation of test methods on the basis of ISO or ASTM guidance
- Validation of sterilization with gamma irradiation (ISO 11137-2)
- Microbial clean room classification and monitoring (GMP, ISO 14644/ 14698)
- Stability studies including design & development of real time and accelerated aging studies as per ASTM F-1980 and ICH Q1
Chemical analyses
- Polymer and glass containers according to USP and PhEur. 3.1 and 3.2.
- Monomer acrylates in polymers (GC)
- Gentamicin sulphate in medical devices (UPLC)
Contract Manufacturing Services
Contract manufacturing services in the field of sterile medical devices and pharmaceuticals are provided in cooperation with the holding company aap Bio Implants.
As a contract manufacturer for various companies a broad range of specialty products (powders, suspensions, gels and liquids) can be offered.
Read more at: www.emcm.com