Berkshire Sterile Manufacturing is currently constructing a cutting-edge, isolator-based sterile filling line aimed to begin operations in 2022. This custom developed line contains equipment from five different suppliers who collaborated to build this one-of-a-kind machine.
Now, how do you validate a filling line that contains complex equipment from five different suppliers?
In this one hour webinar, BSM, Colanar, Steriline, and Genesis discuss how this can be done in an effective, efficient, and compliant manner.
Contents of this Video:
00:00 - Intro
02:14 - BSM's complex filling line
03:35 - BSM's validation strategy (what's involved and timeline)
7:46 - Process of designing & building a custom filling system
13:34 - IQ/OQ testing for filling system
16:57 - Validation process
17:47 - IQ tasks for all machines
18:32 - Vial Washer OQ
18:59 - Depyrogenation Tunnel OQ
22:08 - Isolator & RABs &VHP OQ
24:07 - Delid/Deliner OQ
24:27 - Robotic Tub Decontamination OQ
26:39 - Supervisory PC OQ
29:39 - Genesis Capper Validation
37:28 - QA's role in the validation process
39:30 - Closing Remarks
40:55 - Q&A
