We provide services in the field of…

Quality systems

  • GMP (a także GMGMP (and GMP for ATMP and HE-ATMP)
  • GLP
  • ISO 13485
  • Technical documentation and clinical evaluation of all classes of medical devices
  • ISO 9001


  • Design of clean rooms according to ISO 14644
  • Consultation for preparation of URS, FP, conceptual designs
  • Investment supervision over construction and commissioning
  • Consultation for the ongoing room commissioning


Training for companies in ISO 14644 and GMP requirements

Open training

Training for Biotechnologia.pl and TUV Nord

 Sanitisation and disinfection of rooms

We offer a comprehensive sanitisation and disinfection service to meet clean room class requirements. The effects of our work are confirmed by microbiological testing in a renowned GMP-certified laboratory!

  • sanitisation and disinfection of pharmaceutical, medical device, ATMP, chemo- and radiopharmaceutical and related areas
  • sanitisation of automotive, electronic, optical and related areas
  • sanitisation and disinfection in the food production area

Qualification of clean rooms

  • Clean room qualification according to GMP and ISO 14644
  • OQ testing for ISO 14644-3:2019 requirements
  • particle count, tests of leakage and HEPA filter integrity
  • pressure cascade, number of air changes, T, H
  • recovery tests, air-tightness tests
  • Complete documentation for OQ tests