A process validation protocol for verifying the effectiveness and reproducitibility of a cleaning process for stoppers used as primary product closures. Cleaning process incorporates SMEJA Stopper Washer. Acceptance criteria includes endotoxin, bioburden, particulates, 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. Adheres to USP XXII, Particulate Matter in Injections, Small Volume Injections. The PV Report is available as 02-0040-PVR-1.0.
| Edition : | 1 |
| File Size : | 1
file
, 150 KB |
| Number of Pages : | 12 |
| Published : | 10/01/2004 |
