Overview:We are a service company for medical device manufacturers and pharmaceutical industry with a broad and comprehensive range of services for the cleaning and packaging of medical devices as well as for the sterilisation of medical devices and pharmaceuticals.
Moreover, we operate a microbiological service laboratory which, in addition to classical microbiological test methods such as microbial count determination, sterility testing and endotoxin determination, also offers a comprehensive range of packaging tests. A further focus of the service range of our laboratory is the execution of cleaning, sterilisation and packaging validations.
Our company is certified according to ISO 13485 and ISO 9001. Furthermore, we have a manufacturing authorisation according to the German Drug Law and a GMP certificate. We are subject to regular audits by the FDA. Our microbiological laboratory is accredited according to ISO 17025.
We are working in the following fields:
- Gamma sterilisation
- Validation of gamma sterilisation
- Cleanliness of medical devices
- Medical devices
- Consultation and Training