A process validation protocol for demonstrating the effectiveness and reproducibility of depyrogenating vials and receiving vessels used in the aspetic filling of Biotin. Depyrogenation process incorporates Lytzen Class 100 Dry Heat Oven, model H1F1650 . Acceptance criteria includes Thermocouple values, three-log reduction in endotoxin spiked vial, and review of procedures pertaining to the monitoring, maintenance and operation of the system. Attached forms include a Depyrogenation Cycle Summary and Thermocouple & Endotoxin Spiked Vial Placement Diagram. Adheres to PDA Technical Report No. 7, "Depyrogenation". The PV Report is available as 02-0042-PVR-1.0.
| Edition : | 1 |
| File Size : | 1
file
, 140 KB |
| Number of Pages : | 9 |
| Published : | 10/01/2004 |
