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发表于 2016-7-12 15:41:43
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PDA TR29 2012 6.5.5
Recovery studies to determine percentage recovery from surfaces are not appropriate and are not normallydone for microbiological sampling. One reason for this is the question of enumeration in microbiologicaltests – “colony forming units” are typically counted as opposed to individual organisms.A second reason for this is that vegetative organisms will die or lose viability when dried on a couponin a standard sampling recovery procedure. A third reason is that it is unclear which species should be used for a recovery study. A fourth reason is that typically the limits set for bioburden are significantly below what could possibly cause either product quality issues orprocess performance (e.g., SIP) issues;therefore, even though recovery may be low (<50%), product quality and/or process performanceis not impacted by notincluding a recovery factor
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