I am going to have to hide behind my learning curve statement... When I asked my QE she stated there was an improvement...but when I looked at the CoA's it does not represent that. We are moving in the right direction in trying to understand what the heck we are suppose to be doing, but we still have a ways to go. And a wrench was thrown in due to our last 2 sample/tests not being cold enough once they reached the testing lab. It sounds like I need to regroup and ensure we are methodically, in a controlled manner, on track to confidently understand where we stand.
You're right. There is always a learning curve. For food there are often semi-anecdotal rules-of-thumb like the cleaning step achieves 70% of total bacterial reduction while sanitizers add the rest. Obviously the absolute level of initial contamination and the cleaning system used are relevant. + the effort/time put in.
I'm not a Packging person so i don't know if there is a textbook answer like there is for food where C/S is a sort of process standard. The 2 micro. contamination scenarios are presumably rather different in absolute terms. And from a product POV presumably related to the presence of a thermal killing step as usually present, i think.
I anticipate that for packaging, cleaning is routine (= GMP) but not necessarily sanitising. The latter is maybe likely to depend on factors such as (a) any related P. Standard, (b) the micro. Specification of the Finished product (if any), (c) the nature of the specific Packaging process, (d) the intended application.
With or w/o sanitising, I assume the cleaning requires validation for which micro.testing is I guess the logical choice. Ideally the surface level after cleaning should be substantially lower than the product on it ( a food rule-of-thumb is at least one tenth [not always achieved IMEX] but this probably unrealistic for packaging)
As previously noted there is often a substantial scatter in micro.results due sampling technique/random variation/low levels involved but it is obviously initially important that the "level" is "reasonable" compared to yr target/product spec. (Some published packaging micro.specs are quoted elsewhere on his forum)
@ Superchris/Christian - Apologies that yr SQF aspect has got a bit meandered. My guess without checking is that the text in Packaging Module (and Gudance) is relevant.