Environmental Monitoring Program (APC samples)
Hi, how can I determine the frequency of APC (sponges) samples? Actually, ATP's and APC's are performed weekly. I work in a food manufacturing plant (RTE). I would like to know if I am in the most restrictive or can it be made more flexible. Any reference or information is welcome. Thank you :)
Hi,
How can I determine the frequency of APC (sponges) samples?
Actually, ATP's and APC's are performed weekly. I work in a food manufacturing plant (RTE).
I would like to know if I am in the most restrictive or can it be made more flexible.
Any reference or information is welcome. Thank you :)
Hi silazirk,
It likely relates to yr unknown product/process and the environmental "stability".
If you look at documented systems, afaik, you will find that there is no single, standardised, risk-based answers to yr query.
Do you wish to match FDA's sampling procedure which afaik is focussed more on specific pathogens for some processes?
Do you wish to adopt a zoning setup (approx. risk based) for which various suggested sampling densities exist ?
Thanks Charles, C
Second option adopting zoning setup.
I have an Environmental Risk Assessment, and almost 3 yrs ATPs and APCs results. For this reason, I'm looking a guideline or standard to determine if this frequency (weekly) is acceptable or based on the data I can change it. In 1 month, I take 40 ATP and 40 APC aprox.
Thanks again!
Thanks Charles, C
Second option adopting zoning setup.
I have an Environmental Risk Assessment, and almost 3 yrs ATPs and APCs results. For this reason, I'm looking a guideline or standard to determine if this frequency (weekly) is acceptable or based on the data I can change it. In 1 month, I take 40 ATP and 40 APC aprox.
Thanks again!
Hi silazirk,
Any specific EMPG comments will require product/process context and actual data such as noted Post2. The data attached below suggests that yr current frequencies are in a fairly similar "ball park" although the specific intensities will always be influenced by the prevailing site/product situation.
Yr frequency-related options presumably relate to yr own specific micro. acceptance criteria and the degree to which the accumulated data complies with such criteria, eg whether a stable baseline exists and allows control. IMEX, surface APC data typically exhibits considerable scatter so that statistical analysis is "challenging".
Environmental sampling protocols are not statistically designed sampling plans. Instead, they are based on experience and knowledge of the sites most likely to detect a failure in GHP. Many processors design their environmental sampling programs around zones having different levels of risk (ie "risk-based"). The term EMP typically is used to describe a program that verifies cleaning, sanitation, and other environmental pathogen control programs, and an EMP typically include sampling sites, frequency, testing methodology, acceptable criteria and corrective actions.
I have attached 4 texts illustrating the implementation of some practical programs. Nonetheless, some of the suggested sampling densities would likely overwhelm in-house micro. labs.
(Frequency-related comments/data is in brackets)
evm1 - Environmental monitoring,2016.pdf 15.32MB 64 downloads
(eg micro. Pg 45/76)
evm2 - Environmental Monitoring Handbook,2019.pdf 4.46MB 51 downloads
(eg ATP-Pgs18-19, micro Pgs 6, 49 et seq, FSIS Pg 50, allergens Pg 77 et seq)
evm3 - environmental micro. monitoring,2008.pdf 214.26KB 39 downloads
(micro-Pgs 4-6)
evm4 - USP guidances on aseptic environmental control.pdf 896.54KB 32 downloads
(air-surfaces,Pg 12/86)
The suggestions in attached texts above can be compared to frequencies in the various, implemented, Industrial programs attached within these linked posts -
https://www.ifsqn.co...ls/#entry100060
https://www.ifsqn.co...am/#entry119334
(Particularly, for numerical comparisons, see files env[4-8])
(some file material overlap exists)
(note FDA/FSIS material is not directly included although cross-referenced in various files)
thank you, Charles C.