Cleanroom Monitoring ISO 14644/ ISO 14698
GMP Compliant

We offer a full range of cleanroom testing including air particle counting, settle plates, air-sampling, finger dabs and physical tests such as smoke tests. This data will be placed into a report to verify the classification of your cleanroom under ISO 14644/ ISO 14698. We also offer training to cleanroom operators to teach them how to maintain a compliant cleanroom. We test cleanrooms across the UK from Inverness to Plymouth. Our typical customers include Medical Device Manufacturers, Pharmaceutical Manufacturers, Biotech Research Company and Hospital Sterile Packing Facility.

Description of Test

Cleanroom monitoring provides information that the air quality is safe. This testing allows the air quality of controlled rooms or areas to be monitored to ensure that no contamination is present. Air sampling tests indoor environments such as operating theatres as well as any other microbial controlled areas for a variety of potential contaminants.

There are different methods that can be applied depending on the Standard the room/area complies to.

Testing may include:

• Surface monitoring using Contact plates– This involves swabbing certain areas or surfaces of the room. For example we can swab ventilation ductwork or floors. The contact plates are incubated and observed for colonies
• Passive monitoring using Settle Plates – Settle plates are left exposed to the atmosphere at certain areas of the room to collect particles by gravity. The plates are incubated and observed for colonies
• Active Air Sampling Using Air Slides – Samplers collect airbourne micro-organisms by drawing in a stream of air at a constant flow rate. The air stream is exposed onto a sterile culture medium in an air slide which is then removed and incubated. The number of colonies are counted and a calculation is made of the concentration of micro-organisms in the air
• Non-Viable Particle counts– A particle counter is used to sample different areas of the room by measuring a variety of particle sizes. The particle counts are recorded as the number of particles per volume of air sampled – 0.5µm to 5.0µm

Testing carried out allows the Cleanroom to be verified as complying with the relevant standard – ISO Classification or GMP.

MHRA Approved