It is now just over a year since our new Microbiological Laboratory in Radeberg, Germany opened.
This was built in response to Customer requests for support testing for the Gamma and Electron Beam businesses already at this location, and to offer a unique one-stop shop for Sterile Medical Device Manufacturers in Germany and Switzerland.
It has been a very successful first year and we now have a good number of Customers using us on a routine basis for ISO11137 validations plus supporting LAL, Bioburden, Sterility, Environmental Testing and Aging studies.
We are pleased to get feedback that these Customers have experienced a very high level of Customer service and the excellent quality levels in the Laboratory are also shown by the fact it has already obtained ISO13485 and GMP accreditation.
We are also in the process of obtaining ISO17025 certification after a very positive first audit in February.
The Laboratory is very closely linked to the STERIS Laboratories business globally – we have sister sites in the USA, Netherlands, Italy, Czech Republic, UK and Ireland, plus Asia and Africa – which has meant that the vast experience of testing Medical Devices we have built up in these countries is readily available to the Radeberg team to support Customers with adherence to this standard.
We look forward to a continued positive future for this Laboratory and if you are interested in the services we can offer, or would like to visit the Laboratory please contact us at email@example.com