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Ethylene Oxide Clinical Batch Release


How do you sterilize product when you only have enough product produced to make up one sterilization load? How do you demonstrate a sterility assurance level (SAL) of 10-6 when you do not have the time or sample quantity required for a full EO validation?,230903 The batch release method is a rap...

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How do you sterilize product when you only have enough product produced to make up one sterilization load? How do you demonstrate a sterility assurance level (SAL) of 10-6 when you do not have the time or sample quantity required for a full EO validation?,230903 The batch release method is a rapid and cost effective approach to sterilizing single or small batches of product needed for clinical or animal trials with minimal sample requirements. The presentation on batch release testing gives a general outline on the background and requirements on performing an appropriate sterilization validation for these small or infrequently produced lots. The overkill concept, properties of ethylene oxide, and testing requirements will be discussed.,230903 The webinar will demonstrate how the sterility assurance level can be achieved and outline all of the necessary testing required to be able to safely release product. The batch release method can be performed in small laboratory vessels as well as at contract sterilization facilities and provides the much needed flexibility to get product to trials or to market without the time and expense of waiting for the completion of a full sterilization validation.

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Duration:Available on Demand
Dates and locations:Tue, Nov 20, 2012 - 03:44 pm
Website:http://event.on24.com/r.htm?e=917326&s=1&k=9652D9165177323D3A17E7AA484A8DCA&partnerref=QmedWebsite
PDF:Click here

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Nelson Laboratories Inc.

www.nelsonlabs.com
E: sales@nelsonlabs.com
T: 801/290-7500
F: 801/290-7998

Address
6280 S. Redwood Rd., Salt Lake City, Utah, 84123, United States
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