DOXPUB 02-0041-PVP-1.0

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

Published:

10/01/2004

Number of Pages:

14

File Size:

1 file , 150 KB