Dear all:
Im about to OQ an UV Light sterilization chamber that is used to transfer some equipment to the inside of a sterile area.
Is there any kind of test that is standard to this kind of OQ?
Thanks
Hi,
Yes there are quite a number of tests to be done at IQ, OQ and PQ level. Perhaps your first task should be to establish a URS, since the regulatory stance is - you must have a documented requirement to work to. The whole validation effort is to verify that the end users requirements are fully satisfied.
Everything to do with sterilization is a prospective target for regulatory review.
You have to treat this item just as seriously as any other sterilizing process.
regards
Alex Kennedy
Yeah, there is already URS, and IQ from that equipment, but Im a little lost in about what test run in a OQ. There is a similar OQ of a UV chamber in the microbiology lab, where they used live bacteria to see if there was really some sterilization.
The problem is that they do not want me to do that, since this UV chamber conects to an sterile area in production. There where thinking that they could correlate “ilumination” (in lux) from the previously qualified chamber with this, but I think that this is in no way correlatable, since they are measuring light only in the visible spectrum, and there are some barriers (glass) that are transparent to visible light but no UV light.
So, any idea about a test to see if there is UV light emission on enough quantitites or not?.