To ensure GMP-compliant processes, a large number of different process steps are required. In this regard we provide you with our services in many areas to maintain or improve your approach.
We operate a set-packing line for packaging and sterilizing your own equipment and products. This work can be carried out under GMP Class B conditions or, in the case of particularly critical applications, in an aseptic environment. As part of this service, we pack and sterilize your equipment and products under clean room conditions in a professional and norm-compliant manner.
If the application area of our products within your processes is particularly critical, we can optionally offer our products in sterilized form (DIN EN ISO 11137). Sterilization reduces the risk of contamination in all areas of your cleanroom production to a minimum.
Sterility is of central importance for compliance with the new GMP Guideline, Annex 1. Sterility is of great benefit for an application area in GMP Class B, and is essential in all areas under GMP Class A, e.g. under the sterile workbench (laminar flow workbench) or the isolator.
Our employees are intensively trained in sterilization, medical devices and GMP guidelines, Annex 1, and are happy to provide you with their expertise. In an individual expert consultation, we will work with you to develop the best possible solution to optimize your contamination control.
Please contact us. We look forward to hearing from you.
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