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Figure 1: A portion of the VHP Decontamination System at STERIS before shipment. Shown are the accessory skid (left) and the generator (right). Figure 2: Two VHP generators and skids installed in the mechanical space. A 50-gallon drum of peroxide can be seen in the foreground. The manifold that delivers VHP to the different cleanroom suites can be seen top center (white). Figure 3: A View of the manifold. It contains pneumatic butterfly valves and insulated CPVC piping. Only one of the outlets is connected. This can serve two cleanroom suites, one at a time. Figure 6: Air sampling results from the incomplete VHP cycle before (red) and after (blue). The cycle only achieved about 140 ppm. Fan filter units were run during the cycle. Significant reductions in airborne viables Fwere achieved. Figure 7: Surface sampling results from incomplete VHP cycle before (red) and after (blue). Figure 8: Air sampling results from completed VHP cycle before (blue) and after (orange). Room 223J-SAS-2 did not have a port and the door was closed. In rooms 223A-SAS1 and 223G-SAD-1, it may be useful to activate the FFUs briefly during peak concentration to determine if this reduces airborne viables. Figure 9: Surface sampling results from completed VHP cycle before (blue) and after (orange). Table 1: Recommended cycle for the testing environment. These are the approximate values used in the first cycle development run for the zone. Figure 11: The room with the concentration sensor achieve about 600 ppm in 12 minutes. The injection rate was reduced several times until it stabilized. The short increase in concentration prior to the large peak was an attempted run that was aborted by the BAS.

A Case Study Examining the Benefits and Challenges of Integrating VHP® Biodecontamination into a High-Volume Compounding Facility

Nephron Pharmaceutical Compounding Facility Integrates STERIS VHP Biodecontamination System

Background

Nephron is a rapidly growing manufacturer of generic respiratory medications and a contract manufacturer of blow-fill-seal products. Also, as a 503B compounder, Nephron has made significant investments in the production of high-volume pharmaceutical preparations for interstate distribution…
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