Collaborating for Professional, Integrated Qualification

Ralf Gengenbach, Managing Director & Owner of gempex GmbH

Dr.-Ing. Jürgen Blattner, Owner of BSR Engineering Office

The international GMP expert gempex and the BSR Ingenieur Büro, an integrated clean room measurement provider, concluded a cooperation agreement at the start of May. The two companies are bundling their specific expertise and offer a professional and integrated clean room qualification service to customers in all areas of the life sciences industry – pharmaceuticals, chemicals, biotechnology and more.

“Now customers can rest assured that the commissioned services are state-of-the-art and meet the highest quality standards,” says Ralf Gengenbach, Managing Director & Owner of gempex GmbH. “An all-round worry-free package.”

The comprehensive services range from GMP-compliant qualification planning to performing the required measurements according to DIN EN ISO 14644 and completing the work with the corresponding qualification reports that meet the requirements for official audits. Well trained and experienced specialists in the field along with a highly efficient approach save customers time and valuable resources.

The two companies have maintained a long-standing partnership based on mutual trust. “The step of formal cooperation was a logical consequence,” says Dr.-Ing. Jürgen Blattner, owner of BSR Ingenieur Büro. BSR and gempex have been offering their services jointly to companies for many years. “We are a well-rehearsed team and share a lot of practical experience!”

The jointly offered services cover all clean room qualification tasks required in the course of new construction projects and for existing facilities:

- Preparing user requirement specifications (URS)
- Performing risk analyses
- Planning – DQ, IQ, OQ, PQ
- Performing required calibrations and measurements according to DIN ISO 14644
- Raw data recording and analysis
- Deviation management
- Interim and final report preparation

What this means: Comprehensive qualification from one source for all companies performing research or production in clean rooms. Additional measurement and calibration activities can be carried out aside from clean room measurements.