Compositing is limited to 5 or less “like” samples and does not occur in areas with a recent history of positives. A separate sponge is used for each site. Compositing methods are validated to ensure
EMP is designed to seek and destroy Lm. The EMP team conducts a robust risk assessment that will lead to the determination of the sampling locations, timing and frequency of samplings. The assessment should include (at
EMP samples are collected at least weekly and include samples at eye level, below and above. Greater than 55 swabs are taken per 50,000 sq. ft. per week. (should be focused on risk assessments). As
Construction processes are evaluated prior to project inception. Personnel (internal and external) involved in construction activities are trained and monitored to comply with GMP requirements. Areas under construction are isolated. Dedicated foot traffic patterns are
All food contact equipment is inspected for cleanliness prior to starting production. Inspections are documented with corrective actions taken for non-conformance to standards. Results of ATP and APC swabs are trended and adjustments to sanitation
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Carol Blake
Acting Vice President of Communications
cblake@affi.com
571-451-6345