SABEU - Plastics and Membrane Technology
Phone: +1 (609) 661 2444
Headquarter: +49 5551 9101-00
E-Mail: sales@sabeu.com

GMP

At SABEU, work hygiene is an essential component of the production process in clean rooms. The effectiveness of the hygiene requirements is monitored and documented with regular controls of the particle count in the ambient air and microbiological analyses in accordance with GMP guidelines.

Our hygiene monitoring includes the regular surveillance of the manufacturing conditions in accordance with the EC guide to Good Manufacturing Practice (GMP) by:

  • Counting airborne particles
  • Collecting airborne pathogens
  • Performing contact tests of surfaces and people

The samples are analyzed by certified accredited laboratories.

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Related topics

Certifications
DIN EN ISO 13485 : 2016 DIN EN ISO 9001 : 2015 DIN EN ISO 50001 ...
General QA considerations
SABEU’s focus is on Total Quality Management principles. All of our operations are in line with the DIN EN ISO 9001 and DIN EN ISO 13485 standards and the applicable normative, legal and regulatory re ...
Product validation
SABEU plans and implements validation protocols in consultation with the customers. First sample reports (PPA report – Production Process and Product Approval Report) as set forth in VDA [German Assoc ...
QA principles
We turn defined customer requests into describable and quantifiable requirements for the individual divisions of our company. Our actions are based on the compliance with the statutory provisions, the ...