For those who are affected by the implementation of USP 797, consider calling Medical Technology Resources! MTR will be stocking the key products that meet the USP 797 requirements. For those of you who are unfamiliar, USP 797 is a far-reaching regulation that governs a wide range of pharmacy policies and procedures. It is designed both to cut down on infections transmitted to patients through pharmaceutical products and to better protect any staff working in pharmacies in the course of their exposure to pharmaceuticals. Pharmacies must follow the regulations that USP 797 enforces and MTR will be stocking Texwipe products in order to assist pharmacies in conforming to these regulations. To see more information on USP 797, visit http://www.usp797.org/. If you’re interested in purchasing any Texwipe disposable products, please call 1-888-250-5699 or e-mail sales@mtrhealth.com. We will be more than willing to answer all of your questions!
Popularity: 49% [?]
USP 797 updated revisions became enforceable on June 1 2008. The USP has addressed CSP clean room regulations to the applause of industry professional with the new regulation outlines. The wording in USP Chapter 797 is precise, readable and well organized. The newly amended chapter provides specific regulatory validation standards with charts and definitions.
There is an on-line tool available at RAPWall.com which offers an easily useable tool to calculate the amount of HEPA Filtration required to maintain clean room standards as set forth by USP and ISO 14644-1. The tool is free and the user does not need to sign in or supply any user information to use the tool. It works well and supplies test data from actual HEPA Filtration Units, USP 797 requirements and definitions, as well as ISO 14644-1 definitions.
I have used this tool and can validate that it is useful and works very well. It is nice to be able to change the design of the room by lowering the ceiling to see how the change in room dimension can effect the HEPA needs.
J. P. Piesco
Head Geek
myLocalNetwork.net
Comment by J. P. Piesco — October 5, 2008 @ 9:15 pm
The link to the RAP Wall Clean Room Engineering Tool is RAPWall.com
Comment by Bill Barrett — October 5, 2008 @ 9:21 pm