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Documentation for a plant qualification

Project GMP-Upgrade

Testo Industrial Services carries out a GMP upgrade at the company B. Braun Medical AG in Sempach. This includes the qualification of clean rooms and equipment, the calibration of various measurement variables as well as process and cleaning validations.

The headquarters of B. Braun Medical AG Switzerland and the Center of Excellence (CoE) Infection Control are located in Sempach. Here, disinfectants and hygiene products are developed, produced and marketed for worldwide delivery via the B. Braun Group's distribution network.

The goal of the project "GMP-Upgrade" was the holistic handling of all compliance induced and technical services within the production area Center of Excellence Infection Control. Similarly, all optimization/qualification and validation activities were coordinated with the customer's existing three-shift operation with minimal impact on the production schedule.

Customer project GMP upgrade at B. Braun Medical AG in Sempach

The GMP upgrade was a very good project from a technical and organisational point of view. The employees of Testo Industrial Services were very well integrated into the project team and worked together with our employees in a trusting manner - without any fear of contact. Above all, I would like to emphasize the performance and commitment. The project was pulled through at all times, without exception, no matter what time of day or night, and without any complaining.
Sandro Di Labio
Head of Quality Assurance
B. Braun Medical AG, CH Sempach

Your advantage: Our competence

Implementation and documentation of the qualification of various plants: Preparation tanks, mobile agitator, filling systems (liquid/semi-solid) and many more
Support for the development of a Calibration management and Calibration of different measurands
Qualification of the clean rooms for production, development laboratory and microbiology
Consulting quality assurance, documentation and implementation of the process methods and cleaning validation

More about our services

Implementation of a qualification in a clean room

Qualification

GMP-compliant qualification of cleanrooms, facilities & utilities, transport & storage

GxP-compliant validation according to the V-model

Validation

Ensures process stability and robustness

Calibration of electrical measuring instruments

Calibration

On-site calibration and laboratory calibration of your quality-relevant test and measuring equipment