A process validation protocol for verifying the effectiveness and reproducitibility of a cleaning process for 5- & 10-Liter glass vessels used in bulk antibody receiving. Cleaning process incorporates Damas-AquaSan Washer, Model MK-4. Acceptance criteria includes bioburden, residual detergent, residual protein, and review of all procedures pertaining to the monitoring, maintenance and operation of the system. Attached forms include a Prerequisite Checklist, Document Review Checklist, Precleaning Test Data collection form, and a Cleaning Test Data collection form. The PV Report is available as 02-0041-PVR-1.0.
| Edition : | 1 |
| File Size : | 1
file
, 150 KB |
| Number of Pages : | 14 |
| Published : | 10/01/2004 |
