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

Consulting

• 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

Trainings 

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