NEWS FROM THE GMP WORLD
CLEANROOM TECHNOLOGY AND CONTAINMENT
Annex I and what to watch out for in material and/or personnel locks
The biggest contamination hazard in cleanrooms is from personnel. Transferring equipment and material into the cleanroom also involves critical contamination hazards.
All activities that could affect cleanroom classification status should be given careful attention. Suitable checks must be made regularly. Such checks include particulate and microbial monitoring. Particulate monitoring can be performed by a continuous measurement system or as spot checks at regular intervals.
Equipment and material transfer and personnel access to classified areas should be through material or personnel locks and in one direction only. Personnel must undergo washing and changing processes before entering classified areas.During the lock process, material is made cleanroom-friendly by unpacking or disinfection. For transfers to an aseptic or sterile area, a sterilisation step should be performed if possible.
If no sterilisation is possible, a suitable measure should be validated and performed so that contamination risk is minimised. Suitable measures include effective transfer disinfection, quick transfer systems for isolators, or, for gaseous or liquid materials, an anti-bacterial filter.
An innovation for personnel and material locks that has been added to Annex 1 is spatial separation between personnel and material locks. If such separation is not possible, at least a temporal separation should be considered.
We recommend using separate locks from at least Cleanroom Class B if our risk analysis indicates a heightened contamination hazard. This means separate locks for incoming and outgoing materials and separate locks for incoming and outgoing personnel.
Would you like consulting on material and personnel locks in cleanrooms? Don’t hesitate to contact us at:
juliane.schulz@pitzek-consulting.de
Mobil: +49 (0) 160 178 38 20