Microbiological and biological tests
MICROBIOLOGICAL MONITORING OF CLEAN ROOMS
Methods:
- active method: airideal device
- pasive method: settlements on petri dishes
2. Monitoring of surfaces and mechanical equipments contamination - contact plates, swab method
3. Contamination of staff - finger prints, overalls prints
4. Identification of found out microorganisms (biolog gen III)
MICROBIOLOGICAL TEST OF MEDICAL DEVICES
Method: the estimation of population of microorganisms on product (BIOBURDEN)
Methods:
- active method: airideal device
- pasive method: settlements on petri dishes
2. Monitoring of surfaces and mechanical equipments contamination - contact plates, swab method
3. Contamination of staff - finger prints, overalls prints
4. Identification of found out microorganisms (biolog gen III)
MICROBIOLOGICAL TEST OF MEDICAL DEVICES
Method: the estimation of population of microorganisms on product (BIOBURDEN)
MICROBIOLOGICAL MONITORING IN PRODUCTION OF DRUGS AND MEDICAL DEVICES
- performance: accorrding to GMP regulation No.229/2008.
- performance: according to rules governing medicinal products in the EU, volume 4 (qualification, Re-qualification and periodical measurement)
1. Monitoring of air contamination:
- performance: according to EN ČSN ISO 11737-1