We help you meet all current regulatory requirements

Cleanroom measurement

Clean room measurements can be used to test and ensure that the production conditions in the clean room conform to clean room class ISO 4.8 or GMP A. In the process, we function test the terminal HEPA and hot gas filters on the sterilizing tunnel or laminar flow unit in your line.

B+S is continuously working on improving the measurement methods, for example by advancing the LinearTwinScan. This robot performs automatic filter integrity testing on sterilizing tunnels.
In addition, B+S offers various service packages.

Qualification

Bausch+Ströbel offers you reliable support for your qualification and validation activities. We accompany you through preparation, planning and the actual test activities, from order placement to production start of your equipment.

Depending on your requirements, Bausch+Ströbel offers the suitable qualification package. It goes without saying that Bausch+Ströbel covers the complete range of state-of-the-art qualification that complies both with your requirements in the URS and the valid regulations of FDA, PIC/S, EG-GMP guidelines, ASTM or GAMP.

We also provide you with on site-qualification for conversions and modifications as well as qualification documentation, if necessary.

Calibration

Bausch+Ströbel may implement calibration of the line at the customer’s site either with a one-time measurement or in the form of a regular service to maintain the calibration status of the line. B+S also provides the corresponding documentation for the calibration of all process-relevant measuring loops.