A ‘clean room’ or a ‘clean space’ is defined as a room, a suite of rooms or an area within a controlled environment. The concentration of airborne particles in these areas is strictly controlled. Other factors may also be controlled within the limits of this space.
Clean spaces are used in manufacturing, packaging, laboratories and research. They are most often seen in the pharmaceutical, biotechnology, semiconductor, microelectronics and aerospace industries. Hospital theatres have a similar ‘clean space’, however here there is a need to control particular types of contamination, rather than the quantities of particles present.
Typically a clean room will be specified by a classification from a certain standard. The classification relates the maximum allowable number of particles, of a certain size, within a standard volumetric air sample. Clean rooms in New Zealand are generally compliant to Australian Standard AS 1386-1989 and the combined standard AS/NZS ISO 14644.
Clean rooms are grouped according to the type of activity performed there.
- Class 3.5: Laminar flow clean rooms: acute surgery areas, transplants, open heart, insertion of orthopaedic prosthesis, neuro-surgery, plastic surgery.
- Class 350: Laminar flow clean rooms: major surgery and intensive care, cytotoxic drug suites.
- Class 3500: Non laminar flow clean room: minor surgery.
- ISO 14644.1 Cleanrooms and associated controlled environments Part 1: Classification and air cleanliness
We have the expertise and experience to perform particle counting across a full range of cleanliness classes – from 0.035 to 3500. We can also offer design and advice on fitting and using your clean room. As an IANZ accredited organisation we offer a full testing and validating service to operating theatres and clean rooms – including sound, lighting & vibration levels, workzone integrity tests, HEPA filter integrity tests, microbial contamination tests and air velocity & uniformity tests. Our technicians can also validate your equipment to US and other international classes.