A cleanroom is an important investment, so you probably have a lot of questions.
Here we've answered the questions we get asked the most, but if you have any questions which aren't covered please Contact Us.
High Efficiency Particulate Air (HEPA) filters are 99.99% efficient in removing particles 0.3 micron and larger. HEPA filters utilise glass fibre rolled into a paper-like material. This material is pleated to increase the fibre surface area and bonded, or potted, into a frame. Hot melt is used to hold the pleats far enough apart to allow air to flow between them.
Fan Filter Units (FFUs) enclose the HEPA filter in an aluminium lid and body and use a forward-inclined centrifugal-type fan/motor with permanently lubricated bearings to draw through the volume of air. 2 feet x 4 feet models are UL listed; 220V models are CE marked. The FFUs also contain a prefilter which filters out larger particles before they get to the HEPA filter, which prolongs the life of the HEPA.
The purpose of the cleanroom is to reduce and remove airborne contamination. Irrespective of which design of cleanroom you use you will always be asked to provide pest control documentation for any medical / Pharmaceutical producer.
The best approach is to organise a site survey for pest control (flying and crawling insects in this case) The pest control company will recommend the measures to control and leave and attend site to inspect and log findings and visits, the flying insect controls should be the sticky rotating role type and not the zap type that leaves debris.
Ensure that your chosen supplier will be fully auditable and be able to prove that you have sufficient controls in place.
We can fit solid walls with grills but this would reduce the effectiveness of the room and will not prevent insects getting into the room.
The addition of BS EN ISO 13485:2003 to ISO 9001:2000 will also help with additional systems for the medical device manufacture.
No this is not correct; the GMP guidelines state 2 particle count requirements. One of the particle counts is taken at rest and the other is taken in operation.
Example: Particle counts at rest ≥0.5µm for a GMP Grade B Cleanroom are 3,250 whilst in operation ≥0.5µm the guidelines state you are allowed up to 352,000. The in operation particle count is showing that an allowance is made for activity in the room but at rest the count would need to fall to the lower requirement.
For even more information please see the chart on the Cleanroom Information page or contact us today to speak to one of our cleanroom experts on 015242 74170.
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