SABEU - Plastics and Membrane Technology

Tel: +6012 332 0448
E-Mail: edwin.ng@sabeu.com

Process validation

SABEU carries out the system qualification, process and product validation in accordance with the EU guide to Good Manufacturing Practice (GMP), Annex 15, using the sub-areas IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) and DoE (Design of Experiments).

Other validation procedures:

  • Dosimetric validation in accordance with the DIN EN ISO 11137 standards. Conducted by external service providers.
  • Microbiological validation in accordance with the DIN EN ISO 11137-2 standards. Conducted by external service providers.
  • Shelf Life (Accelerated Aging Test) in accordance with the ASTM F1980-07 standards. Conducted by external service providers.

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