Sterline Services Cleanroom Testing: ISO Class 8

Sterile Services Cleanroom Testing

As with all our monitoring and testing services for hospitals, our trained consultants can carry out the work at any time that suits you.

Meeting ISO Class 8 Cleanroom Requirements

If you have ever attempted to organise the testing of a hospital Sterile Services Cleanroom to the ISO Class 8 Cleanroom standard, you may well have struggled to be able to find a service which combines all the necessary tests into one package.

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.

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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.

Interested in our Sterile Services Cleanroom Testing?

As with all our monitoring and testing, our trained consultants can carry out the work at a time to suit you. Just call us on 0333 015 4345 to discuss your requirements and request a quote.