Sterile Services Cleanroom Testing
Meeting ISO Class 8 Cleanroom Requirements
Fortunately, you have now come to the right place because our testing service does just this. What’s more, if you do only require certain parts of the service, you can simply select those relevant to you.
Our Sterile Services Cleanroom Testing and Monitoring service includes:
- Active bio-burden sampling of the air
- Passive bio-burden sampling of the air
- Airborne particulate samplin
- Air pressure differential
- Instrument and hard-surface bio-burden samplin
- Endotoxin testing of washed instruments and sterile instrument
- Endotoxin testing of reverse osmosis (RO) water
Does our cleanroom testing meet the necessary requirements?
Yes, all our sampling and testing procedures have been designed and tested rigorously to comply with BS EN ISO 14644-1:2015 standards.
ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644‑7.
Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 µm to 5 µm are considered for classification purposes.
Our sampling and testing procedures also comply with the requirements of Health Technical Memorandum 01 (HTM 01). This covers the management and decontamination of a wide range of equipment used in medical settings including surgical instruments, flexible endoscopes and heating/ventilation systems.