A process validation protocol for verifying the effectiveness and reproducitibility of a cleaning process for 5mL vials used as primary product containers. Cleaning process incorporates Cozzoli Rotary Vial 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, <788> Particulate Matter in Injections, Small Volume Injections. The PV Report is available as 02-0039-PVR-1.0.
Document identifier
DOXPUB 02-0039-PVP-1.0
Title
Vial Cleaning Process Validation, Protocol
DOXPUB Category
PVP - Process Validation Protocol
Publication date
2004-10-01
International Relationship
| Price |
220 vnd |
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