Cleanroom testing
Resanitec offers comprehensive programs for classification and validation of purity-controlled environment according to approved standards and client requirements.
Resanitecs expertise lies in identifying risks in hygiene and supporting our customers with appropriate solutions.
Within regulated environments, high requirements are placed on environmental control and traceability.
At Resanitec, we help our clients to maintain an appropriate plan for the identification of potential contamination risks of production facilities. This includes clean room validation, as well as routine control of classified facilities. Our methods are written according to relevant European Standards and adapted to client’s specific needs.
- Certified and validated equipment and materials are used for sampling and analysis.
- We analyze particles and microbiological samples in static and operational mode.
- We analyze microbiological samples from surfaces, textiles and liquids.
Methods
- Bioburden– EU pharmacopoeia 9.4
- Specific micro-organisms – EU pharmacopoeia 9.4
- Endotoxin – EU pharmacopoeia 9.4
- Active and passive sampling of airborne particles – ISO 14698
- Sampling surfaces – ISO 14698
- Particle counting – ISO 14644-1
- Airflow and Air circulation – ISO 14644-3 OVPN by HEPA Filter – ISO 14644-3
- Air pressure – ISO 14644-3
- Airflow direction and visualization test – ISO 14644-3
- Temperature
