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Environmental Monitoring Program (APC samples)


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silazirk

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Posted 05 February 2021 - 08:28 PM

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 :)



Charles.C

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Posted 05 February 2021 - 09:55 PM

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 ?


Kind Regards,

 

Charles.C


silazirk

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Posted 05 February 2021 - 11:34 PM

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!



Charles.C

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Posted 06 February 2021 - 06:06 AM

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)

Attached File  evm1 - Environmental monitoring,2016.pdf   15.32MB   38 downloads

(eg micro. Pg 45/76)

Attached File  evm2 - Environmental Monitoring Handbook,2019.pdf   4.46MB   33 downloads

(eg ATP-Pgs18-19, micro Pgs 6, 49 et seq, FSIS Pg 50, allergens Pg 77 et seq)

Attached File  evm3 - environmental micro. monitoring,2008.pdf   214.26KB   26 downloads

(micro-Pgs 4-6)

Attached File  evm4 - USP guidances on aseptic environmental control.pdf   896.54KB   20 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)


Edited by Charles.C, 08 February 2021 - 07:12 AM.
added

Kind Regards,

 

Charles.C


silazirk

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Posted 08 February 2021 - 03:18 PM

thank you, Charles C.






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