We have a customer who is requiring our facility to test our finished product and perform environmental swabbing (no problem, it's expected, we'd perform these regardless) then have the samples analyzed using Process Control Testing (PCT).
We send samples out to an external lab. This is for an RTE FDA product.
This type of analysis is new to our facility and am wondering if anyone has experience or knowledge of it.
I'm simply trying to gather more information and anyone's thoughts on the process.
We haven't started production on the product yet, but will be soon, so I have no reference to taking this approach.
Process Control Testing = Process Control Testing MB491.01-4(PCR)(GNGC), EHEC /pSTEC = EHEC Molecular Indicators MB491.01-MI(PCR), LM = Listeria monocytogenes Molecular Indicators MB491.01MI(PCR), SAL = Salmonella spp. Molecular Indicators MB491.01-MI(PCR)
Target & Action Limits:
PCT Critical Limit: Process Control Testing (PCT) detects the presence of groups of organisms which share a common genetic target. All samples with a Process Control Index (PCI) <10 are deemed acceptable. When the PCT score is ≥10, the sample is considered Out of Specification, and actions are taken. PCT Upper Control Limit: Although Process Control Index (PCI) <10 are deemed acceptable, PCI scores between 5 and 9 require some investigative and sanitation activities to be conducted.