Production environment is monitored.
Bioburden limits are periodically tested-bioburden testing is performed in accordance with SR EN ISO 11737-1:2006 (ISO 11737-1:2006), “Sterilization of medical devices – Microbiological methods – Part I: Estimation of population of microorganisms on products“,
European Pharmacopoeia Cap. 2.6.12 and Production Environment Contamination is performed according Good Manufacturing Practice-National Medicines Agency-Romania 2015.
The “cleanroom” is validated according ISO 14644 series.
Training programs are implemented for cleanroom personnel.