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Media Simulation Trials

Media Simulation Trials

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Published by Tim Sandle
Pharmaceutical manufacturing
Pharmaceutical manufacturing

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Published by: Tim Sandle on Aug 02, 2010
Copyright:Attribution Non-commercial

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10/25/2012

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Media simulation trials and the matrix approachTim Sandle, August 2010
Media trials are often validated based on the number of vials or bottles filled. Thenumber of vials or bottles filled then sets the maximum number of product vials thatcan be filled on the filling line (this is often with an upper tolerance of +10%).It is a matter of debate whether media trials are validated by time. If the maximumnumber of container is the requirement then it is assumed that, by filling themaximum number of vials during a media simulation trial and having the requiredshift change-over and typical production filling stoppages, that the length of time for amedia trial will be equal or longer than a typical product fill.The difficulty of simulating small product fills runs with media fill is that a largenumber of media containers need to be filled to give statistical confidence in a trialwhere no bottles show growth. However, an artificially increased broth trial may nolonger mimic the product fill. Therefore the numbers of contains to be filled isnormally established in a way which offers the best compromise between the need for a large batch size and the need to ensure that the media fill simulates the product fill.Thus it is often the case that a single container and fill volume is used to validate anumber of different product presentations. This cannot be applied across all types of  products. To capture all product types, the following principles, based on worst caseconditions, should be used:a)The smallest vial and neck diameter. b)The largest bottle and neck diameter.c)Maximum duration time.

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