Bellevue, WA -- Pharmacy OneSource, creator of the Simplifi 797 quality assurance web application, is pleased to announce a complimentary teleconference presented by industry experts, James T. Wagner, President of Controlled Environment Consulting and Eric S. Kastango, MBA, RPh, FASHP, CEO of Clinical IQ, to review isolator use in compliance with USP's Revised General Chapter Pharmaceutical Compounding - Sterile Preparations.
"Sterile compounding facility requirements as described in USP Chapter 797 can be onerous and expensive to implement," said Wagner. "Compounding Aseptic Isolators have been presented as a low-cost alternative to building a cleanroom."
This complimentary presentation will differentiate the needs of hazardous applications from non-hazardous compounding. We will breakdown the components that make up a Compounding Aseptic Isolator in order to assess applicability to your operation. Specific facility requirements needed for installation of isolators will be summarized. Field certification requirements will be described.
"The use of isolators may be a viable alternative instead of a cleanroom, but it does not eliminate the other requirements of USP 797," Kastango said.
Use of Isolators in Compliance With USP 797
DATE: Tuesday, June 9, 2009
TIME: 12:00 PM - 1:00 PM EDT
WHERE: https://www2.gotomeeting.com/
About Pharmacy OneSource (www.rph.com)
Pharmacy OneSource is healthcare's #1 Software-as-
About James T. Wagner
James T. Wagner of Controlled Environment Consulting has been involved with certification and design of controlled environments since 1979. He is a recognized expert in the field of Quality Assurance for controlled environments as used in regulated industries. He serves on the NSF joint committee responsible for NSF standard 49 (Class II Biological Safety Cabinets), the Institute of Environmental Sciences and Technology working groups responsible for HEPA filters, laminar flow equipment, and cleanrooms, and the CETA working groups for the applications guides for certification of engineering controls used in sterile compounding. He serves on the 2005-2010 USP expert committee for sterile compounding. Mr. Wagner is the primary instructor for the Eagleson Institute's "Advanced Certification"
