To verify that cleanroom and clean zones are adequately installed and functioning they are usually validated during three occupancy states. First, when the installation is complete with all services connected and functioning, as-built; secondly during at-rest conditions when equipment is installed and running in a manner agreed upon by customer and supplier; and finally during operational conditions with the specified number of personnel present and working in a manner agreed upon. This is described in the standard documents of ISO/EN 14644 Cleanrooms and associated controlled environment.
Sorry, this page is available to members only.
If you have not registered with us yet, why not
register today for FREE and receive exclusive online access. Interested in receiving European Pharmaceutical Review in print? Subscribe today and guarantee the next six issues delivered direct to your desk, plus gain exclusive access online.