22 replies to this topic

[beatlevi]

Hi Everyone,  I'm searching for micro standard of compressed air used on food equipment for pre-cleaning (remove flour and breadcrumb). We used 5 um air filter.

 

total bacteria count /coliforms/ : maximum count on plate (in minutes ?)

 

 

 

thanks

 

[Snookie]

Perhaps this link might help.

 

http://www.ifsqn.com...ltration/page-2

[Simon]

You may also want to check this link AirCheck Academy...lot's of useful information.

[Charles.C]

Dear beatlevi,

 

As per previous links, there is no universal standard as SQF are no doubt aware.

 

You are probably safe in selecting a random experience from above thread or perhaps (preferably?)  gettting a similar one from your own consulting laboratory.

I guess the details might be a bit more sensitive if you are making food for NASA ?

 

 @Simon - Trace Analytics were previously, directly, asked a similar question to the OP in related threads to this, twice   >  IIRC, No Reply.

IMO, the info. provided in the link you provided is interesting/helpful but, based on a quick look, incomplete as far as haccp is concerned (based on 1st ed Food&Drink).

 

Rgds / Charles.C

[Trace Analytics]

Good Morning Everyone-

 

As Charles C. stated at this time there are no hard and fast requirements on testing compressed air for the food industry. While there are several organizations like SQF and BRC that require the testing, the only limits that have been set at this time come from the BCAS. They refer to the popular mfg compressed air spec ISO 8573 as some have mentioned. ISO 8573 defines Classes and limits for each Class, but they do not say which Classes should be met for various uses of compressed air. That is left to the manufacturer to decide.

 

Specific to micro testing, ISO 8573-7 addresses this. But still they do not say what limits are acceptable and which are not. Again leaving this to the manufacturer to decide.

 

We do offer microbiological testing and you can find more on it here: https://www.aircheck...al-iso-8573-7/

 

The AirCheck Academy, as Simon said is a great resource for learning about compressed air testing and concerns. Charles C. I apologize for not seeing the direct question that was asked of us. If I have not addressed it in this reply please point me to it or ask in this thread and I will be happy to provide an answer. Anyone can contact us directly as well.  We are always happy to answer any questions you may have about compressed air testing or compressed gas testing. You can reach us at CDATest@AirCheckLab.com.

 

Trace Analytics, LLC

[Charles.C]

Hi Laura,

 

Thks for response.

 

From memory, the question(s) were similar to the OP of this thread, ie querying any published limits in common (food manufacturing) use for various micro. species  on settle plates, eg TPC, coliform, Y&M, pathogens, etc.

 

AFAI could see, the only recognized quantitative values existing are those of ISO, BCAS and similar bodies which tend to be effectively cross-linked and only consider "hits".  BCAS include some haccp-related context but IMO it seemed more of an evasion (only 2006 ed accessible to me ), ie -
 

 

6.2 Microbiological contaminants
HACCP shall establish the risk of contamination by microbiological contaminants. The level of viable microbiological
contaminants in the compressed air shall not be detectable using the method described in clause 7.6.

(eg see -

https://www.aircheck...ial-iso-8573-7/

 

Laboratories when requested seem to quote (varying) numbers, usually for TPC / Y&M,  possessing  no (volunteerable) validatory background. Some lab guidelines / the (very) few published numbers i saw (essentially ex Campden) relating to the food industry are in sub-links from this thread, eg this post/thread -

 

http://www.ifsqn.com...ge-2#entry64093

 

If you can provide any insights/refs/links to limits of above type, will undoubtedly be much appreciated by readers of this forum.

(Even a "negative" opinion would be useful ).

 

Thks and Best Rgds,

 

Charles

[Trace Analytics]

Charles-

I wish I could point you to a place with the definitive answer. At this time to our knowledge, no one of national or international authority has specifically identified microbiological limits for compressed air or gas used in food or pharma manufacturing. It is the responsibility of the manufacturer to decide what the acceptable limit is. I know that is not the popular answer!

The manufacturer needs to take many things into consideration. There is not one answer for all manufacturers. Determining the acceptable limit should be based on the end product. Does the end product get cooked before it is eaten? Or is it eaten immediately? Is the product going to spend time in an environment that will promote bacterial growth once it leaves the plant? We know that microorganisms reproduce rapidly. So if you detect one CFU from testing, you need to ask yourself…how long will that number remain one? Then ask yourself, how many colony forming units (CFUs) is too many? One, ten, or one hundred?

It would be tough to implement a one size fits all standard. It falls to the manufacturer who should know what the potential damage would be if contamination were to occur. A plan should be created from there. Then look to the bioburden or microbiological limits that are already in place for the final product. Maybe that is the next place to start. However, keep in mind that end product testing is not a substitute to testing the compressed air or gas. The British Compressed Air Society (BCAS) states in their latest guideline, “Microbiological testing of end products should not be relied upon for compressed air compliance.” There is a reason that they spell it out like that.

We are strictly a laboratory and provide reports based on the analytical findings of the samples submitted. It is not our place to create or enforce compressed air or gas standards. When seeking out a lab it is important to use an accredited lab. If a lab cannot provide analyses as low as needed, you could be wasting your time and money. This is where you may want to ask yourself…is measuring only as low as 25 or 50 CFUs good enough? It is important to work with a lab that can provide analysis of the total plate count (TPC) of any colony forming units (CFUs) found, as low as zero. Gram staining and identification should also be available for any CFUs found.

Pharma has been experiencing the same dilemma. There are no national or international limits for compressed air or gas used in the production of pharmaceuticals. Many in that industry are using the limits they have in place for their cleanrooms as a starting point to setting limits for their compressed air or gas.

Lastly I can share the International Society of Pharmaceutical Engineers' (ISPE) recommendation since there are so few to turn to. I hope this helps!

International Society of Pharmaceutical Engineers’ (ISPE) Good Practice Guide – Process Gases.

It states in Chapter 7, Risk Assessment, Table 7.1:

Microbial Count (Non-sterile applications) – Guideline limits to be established based on product bioburden limits. Typical level NMT 5 cfu/m3
Microbial Count (Sterile Applications) – As per viable particle requirements for Grade area where the product is exposed to the compressed gas (e.g. Grade A, Grade A/B, Grade B or Grade C)
(from US FDA 2004 Aseptic Processing Guidance.)

We welcome any insight others may have on the subject. We will continue to monitor this thread for updates. Excellent conversation all. LTG

[Charles.C]

Dear Laura,

 

Thank you for the detailed reply. Much appreciated. I have expanded a little on some of the comments in yr post / links.

 

Intro

 

I looked at  2 viewpoints, SQF/BCAS, on some desirable Quality characteristics of Compressed Air -

Purity is defined in the SQF Code (Appendix 2: Glossary) and means the absence of contaminants that could cause a food safety hazard. Pure air means the air is free of risk of cross-contamination to the products. Essentially, the air must not contribute any contamination to the product.

 

Strictly, use of the word “contamination”  as defined by SQF implies that  micro.standards based solely on APC limits could be regarded as safety (ie haccp) meaningless. (In a cleanroom context the situation would likely be rather different,  limits derived for sterile scenarios are in some articles recommended as not being arbitrarily transferred into the food scene without due caution).

 

Similarly to SQF, BCAS implicitly defines contaminants in its introduction via -

 

Contaminants that may be a potential hazard in food for human consumption

In the context of the BCAS COP, hazard is presumably interpreted as safety hazard. On this basis, some difficulties also arise IMO, eg - 

The BCAS Food Grade Compressed Air, A Code of Practice states,

"6.2 Microbiological contaminants.

HACCP shall establish the risk of contamination by microbiological contaminants. The level of viable microbiological contaminants in the compressed air shall not be detectable using the method described in clause 7.6." Clause 7.6 refers to ISO 8573-7 test method for viable microbiological contaminant content.

 

The word "detectable" suggests that any microbial species other than what is (somehow) defined as "natural"  to the specific product have zero tolerance. This seems inconsistent with basic haccp principles. Unless a list of accepably non-hazardous species exists ?

--------------------------------------------------------------------------------------------------

This post primarily focuses on micro. “B” factors, the “C, P” hazards are well over-viewed in the SQF faq (see Excel file/sheet3 below) and the Code’s Guidance documents, eg for parts 2/11.

 

I have done a little background searching regarding standards, micro.species, filters, etc and pasted some selected extracts into the attached excel book (the earlier studies in this area seem a little neglected these days, maybe justifiably ) . Most of the content will probably be (only too) familiar to you of course.

 

The source files are attached below, keyed to the excel sheet numbers.

 

 Compilation regarding Micro.Standards,etc for env. air,compressed air,filters in food plants.xls   1.48MB   1477 downloads

 

added Charles.C, 21082018 - NOTE - URL Link on Sheet 2 of Excel is broken. File is available in Post 15.

 

 sh1 - microbiological air quality.pdf   489.76KB   1895 downloads

 sh4 - Compressed-Air-in-the-Food-and-Beverage-Industry.pdf   3.82MB   1181 downloads

 sh4.1 - food industry compressed air systems,white-paper.pdf   196.81KB   806 downloads

 sh5 - compressed air in food plants,white paper,Parker Balston.pdf   522.15KB   816 downloads

 sh6 - ECFF.pdf   402.26KB   762 downloads

 sh7 - tesco standard 2014.pdf   1.15MB   927 downloads

 sh8 - air filtration systems.pdf   193.62KB   809 downloads

 

Rgds / Charles

 

PS - Two/three of the above documents are already in the thread linked in post 2 above. I re-used them to allow some convenient integration.

 

The mystery (to me) of why SQF's faq (typically) refers to 0.1micron filters whereas the guidance document specifies 0.01 micron remains. Nonetheless, if the cost/maintenance/implementation factors are comparable (?), the latter seems a logical investment for an easy audit (also see sheet5 in Excel file). For current purposes i assumed the faq is more "maintained" than the guidance and "acted accordingly".

 

PPS - the extensive collection of TA documents available via Laura's links in previous post(s) are remarkable and valuable. Highly recommended for browsees.

 

P3S – for those interested here are 5 more links, the first two look at typical air sampling devices/procedures (mainly food/cleanroom respectively), the next 3 focus on micro.aspects/standards  as applied in pharmaceutical, cleanroom, sterile work scenarios. The similarities to concepts used (borrowed?) in the food business is clear but there are also significant differences in emphasis, eg the interest in viable/non-viable particles.

 

http://www.foodquali...Monitoring.html

http://www.pharmacop...24s0_c1116.html

http://www.fda.gov/o...ug Products.htm

http://www.cemag.us/...classifications

http://www.cemag.us/...d-action-limits

Edited by Charles.C, 13 December 2022 - 01:25 PM.
added note for broken link in Excel/text colouring

[Parkz58]

Thanks so much, Charles - I appreciate it!

[rpp_k]

Thank you very much !!

[rpp_k]

Dear Laura,

 

Thank you for the detailed reply. Much appreciated. I have expanded a little on some of the comments in yr post / links.

 

Intro

 

I looked at  2 viewpoints, SQF/BCAS, on some desirable Quality characteristics of Compressed Air -

 

Strictly, use of the word “contamination”  as defined by SQF implies that  micro.standards based solely on APC limits could be regarded as safety (ie haccp) meaningless. (In a cleanroom context the situation would likely be rather different,  limits derived for sterile scenarios are in some articles recommended as not being arbitrarily transferred into the food scene without due caution).

 

Similarly to SQF, BCAS implicitly defines contaminants in its introduction via -

 

In the context of the BCAS COP, hazard is presumably interpreted as safety hazard. On this basis, some difficulties also arise IMO, eg - 

 

The word "detectable" suggests that any microbial species other than what is (somehow) defined as "natural"  to the specific product have zero tolerance. This seems inconsistent with basic haccp principles. Unless a list of accepably non-hazardous species exists ?

--------------------------------------------------------------------------------------------------

This post primarily focuses on micro. “B” factors, the “C, P” hazards are well over-viewed in the SQF faq (see Excel file/sheet3 below) and the Code’s Guidance documents, eg for parts 2/11.

 

I have done a little background searching regarding standards, micro.species, filters, etc and pasted some selected extracts into the attached excel book (the earlier studies in this area seem a little neglected these days, maybe justifiably ) . Most of the content will probably be (only too) familiar to you of course.

 

The source files are attached below, keyed to the excel sheet numbers.

 

Compilation regarding Micro.Standards,etc for env. air,compressed air,filters in food plants.xls

 

sh1 - microbiological air quality.pdf

sh4 - Compressed-Air-in-the-Food-and-Beverage-Industry.pdf

sh4.1 - food industry compressed air systems,white-paper.pdf

sh5 - compressed air in food plants,white paper,Parker Balston.pdf

sh6 - ECFF.pdf

sh7 - tesco standard 2014.pdf

sh8 - air filtration systems.pdf

 

Rgds / Charles

 

PS - Two/three of the above documents are already in the thread linked in post 2 above. I re-used them to allow some convenient integration.

 

The mystery (to me) of why SQF's faq (typically) refers to 0.1micron filters whereas the guidance document specifies 0.01 micron remains. Nonetheless, if the cost/maintenance/implementation factors are comparable (?), the latter seems a logical investment for an easy audit (also see sheet5 in Excel file). For current purposes i assumed the faq is more "maintained" than the guidance and "acted accordingly".

 

PPS - the extensive collection of TA documents available via Laura's links in previous post(s) are remarkable and valuable. Highly recommended for browsees.

 

P3S – for those interested here are 5 more links, the first two look at typical air sampling devices/procedures (mainly food/cleanroom respectively), the next 3 focus on micro.aspects/standards  as applied in pharmaceutical, cleanroom, sterile work scenarios. The similarities to concepts used (borrowed?) in the food business is clear but there are also significant differences in emphasis, eg the interest in viable/non-viable particles.

 

http://www.foodquali...Monitoring.html

http://www.pharmacop...24s0_c1116.html

http://www.fda.gov/o...ug Products.htm

http://www.cemag.us/...classifications

http://www.cemag.us/...d-action-limits

This helps me so muck.

Thank you!! (>_<)

[Assy Syofia]

Dear Laura,

 

Thank you for the detailed reply. Much appreciated. I have expanded a little on some of the comments in yr post / links.

 

Intro

 

I looked at  2 viewpoints, SQF/BCAS, on some desirable Quality characteristics of Compressed Air -

 

Strictly, use of the word “contamination”  as defined by SQF implies that  micro.standards based solely on APC limits could be regarded as safety (ie haccp) meaningless. (In a cleanroom context the situation would likely be rather different,  limits derived for sterile scenarios are in some articles recommended as not being arbitrarily transferred into the food scene without due caution).

 

Similarly to SQF, BCAS implicitly defines contaminants in its introduction via -

 

In the context of the BCAS COP, hazard is presumably interpreted as safety hazard. On this basis, some difficulties also arise IMO, eg - 

 

The word "detectable" suggests that any microbial species other than what is (somehow) defined as "natural"  to the specific product have zero tolerance. This seems inconsistent with basic haccp principles. Unless a list of accepably non-hazardous species exists ?

--------------------------------------------------------------------------------------------------

This post primarily focuses on micro. “B” factors, the “C, P” hazards are well over-viewed in the SQF faq (see Excel file/sheet3 below) and the Code’s Guidance documents, eg for parts 2/11.

 

I have done a little background searching regarding standards, micro.species, filters, etc and pasted some selected extracts into the attached excel book (the earlier studies in this area seem a little neglected these days, maybe justifiably ) . Most of the content will probably be (only too) familiar to you of course.

 

The source files are attached below, keyed to the excel sheet numbers.

 

Compilation regarding Micro.Standards,etc for env. air,compressed air,filters in food plants.xls

 

sh1 - microbiological air quality.pdf

sh4 - Compressed-Air-in-the-Food-and-Beverage-Industry.pdf

sh4.1 - food industry compressed air systems,white-paper.pdf

sh5 - compressed air in food plants,white paper,Parker Balston.pdf

sh6 - ECFF.pdf

sh7 - tesco standard 2014.pdf

sh8 - air filtration systems.pdf

 

Rgds / Charles

 

PS - Two/three of the above documents are already in the thread linked in post 2 above. I re-used them to allow some convenient integration.

 

The mystery (to me) of why SQF's faq (typically) refers to 0.1micron filters whereas the guidance document specifies 0.01 micron remains. Nonetheless, if the cost/maintenance/implementation factors are comparable (?), the latter seems a logical investment for an easy audit (also see sheet5 in Excel file). For current purposes i assumed the faq is more "maintained" than the guidance and "acted accordingly".

 

PPS - the extensive collection of TA documents available via Laura's links in previous post(s) are remarkable and valuable. Highly recommended for browsees.

 

P3S – for those interested here are 5 more links, the first two look at typical air sampling devices/procedures (mainly food/cleanroom respectively), the next 3 focus on micro.aspects/standards  as applied in pharmaceutical, cleanroom, sterile work scenarios. The similarities to concepts used (borrowed?) in the food business is clear but there are also significant differences in emphasis, eg the interest in viable/non-viable particles.

 

http://www.foodquali...Monitoring.html

http://www.pharmacop...24s0_c1116.html

http://www.fda.gov/o...ug Products.htm

http://www.cemag.us/...classifications

http://www.cemag.us/...d-action-limits

 

i just read this earlier..

and i'm very appreciate this

 

thank you Mr. Charles..

it's help me a lot..

[Charles.C]

Hi rpp_k / Assy Syofia,

 

Thks for responding and you're very welcome !

 

Good Luck !

 

PS - and continuing thanks to Laura / Trace Analytics also !

[ARROMERO]

Dear Laura,

 

Thank you for the detailed reply. Much appreciated. I have expanded a little on some of the comments in yr post / links.

 

Intro

 

I looked at  2 viewpoints, SQF/BCAS, on some desirable Quality characteristics of Compressed Air -

 

Strictly, use of the word “contamination”  as defined by SQF implies that  micro.standards based solely on APC limits could be regarded as safety (ie haccp) meaningless. (In a cleanroom context the situation would likely be rather different,  limits derived for sterile scenarios are in some articles recommended as not being arbitrarily transferred into the food scene without due caution).

 

Similarly to SQF, BCAS implicitly defines contaminants in its introduction via -

 

In the context of the BCAS COP, hazard is presumably interpreted as safety hazard. On this basis, some difficulties also arise IMO, eg - 

 

The word "detectable" suggests that any microbial species other than what is (somehow) defined as "natural"  to the specific product have zero tolerance. This seems inconsistent with basic haccp principles. Unless a list of accepably non-hazardous species exists ?

--------------------------------------------------------------------------------------------------

This post primarily focuses on micro. “B” factors, the “C, P” hazards are well over-viewed in the SQF faq (see Excel file/sheet3 below) and the Code’s Guidance documents, eg for parts 2/11.

 

I have done a little background searching regarding standards, micro.species, filters, etc and pasted some selected extracts into the attached excel book (the earlier studies in this area seem a little neglected these days, maybe justifiably ) . Most of the content will probably be (only too) familiar to you of course.

 

The source files are attached below, keyed to the excel sheet numbers.

 

Compilation regarding Micro.Standards,etc for env. air,compressed air,filters in food plants.xls

 

sh1 - microbiological air quality.pdf

sh4 - Compressed-Air-in-the-Food-and-Beverage-Industry.pdf

sh4.1 - food industry compressed air systems,white-paper.pdf

sh5 - compressed air in food plants,white paper,Parker Balston.pdf

sh6 - ECFF.pdf

sh7 - tesco standard 2014.pdf

sh8 - air filtration systems.pdf

 

Rgds / Charles

 

PS - Two/three of the above documents are already in the thread linked in post 2 above. I re-used them to allow some convenient integration.

 

The mystery (to me) of why SQF's faq (typically) refers to 0.1micron filters whereas the guidance document specifies 0.01 micron remains. Nonetheless, if the cost/maintenance/implementation factors are comparable (?), the latter seems a logical investment for an easy audit (also see sheet5 in Excel file). For current purposes i assumed the faq is more "maintained" than the guidance and "acted accordingly".

 

PPS - the extensive collection of TA documents available via Laura's links in previous post(s) are remarkable and valuable. Highly recommended for browsees.

 

P3S – for those interested here are 5 more links, the first two look at typical air sampling devices/procedures (mainly food/cleanroom respectively), the next 3 focus on micro.aspects/standards  as applied in pharmaceutical, cleanroom, sterile work scenarios. The similarities to concepts used (borrowed?) in the food business is clear but there are also significant differences in emphasis, eg the interest in viable/non-viable particles.

 

http://www.foodquali...Monitoring.html

http://www.pharmacop...24s0_c1116.html

http://www.fda.gov/o...ug Products.htm

http://www.cemag.us/...classifications

http://www.cemag.us/...d-action-limits

Thank you for the very informative information however , the  link provided on attached excel file sheet 2 doesn't open 

http://www.scientifi...-indicators.htm. I'm so interested to read the whole page to know where they get the standard limits or what is their reference on these standards.

[Charles.C]

 

Thank you for the very informative information however , the  link provided on attached excel file sheet 2 doesn't open 

http://www.scientifi...-indicators.htm. I'm so interested to read the whole page to know where they get the standard limits or what is their reference on these standards.

 

 

Hi Arromero,

 

Thanks for the feedback.

I have attached a pdf of broken link from my archives below.

 

 Scientific Air Solutions -- Air Sampling, Air Systems, Spatial Mapping.pdf   124.94KB   420 downloads

[KBMB]

Thank you

[AJL]

Hi,
Got a little confused reading it all, I am interested in a method for testing for microbiological quality of the compressed air...

[forrest]

5 um filter might keep out the bread crumbs but is too porous for any microbiological control.

 

[Charles.C]

Hi,
Got a little confused reading it all, I am interested in a method for testing for microbiological quality of the compressed air...

Unfortunately as previously illustrated Quality is potentially/invariably a multi-factor item.

 

Perhaps you could narrow the scope of yr requirement ? eg for a particular SQF situation, a Post in another thread used a single characteristic for "air" quality, namely a settle plate measurement at POU. To which you might consider adding contamination from the compressor/lines as per ISO etc.

[Trace Analytics]

Hi,
Got a little confused reading it all, I am interested in a method for testing for microbiological quality of the compressed air...

Hi AnnMou, 

 

Here at Trace Analytics we provide microbial testing of compressed air! We use an impaction sampler (per ISO 8583-7). The test are easy to perform, take about ten minutes and are both quantitative and qualitative. 

Here's an article with more information on microbial testing methods: https://www.ifsqn.co...ampling-methods

Because SQF and BRC are very vague about microbial limits, we often recommend a baselining approach. Many of our clients find it is helpful to get an idea of the quality of their compressed air as it currently stands. 

You can also perform a risk assessment to help in deciding on contamination limits for your particular facility. See our risk assessment here:  https://docsend.com/view/53pwaxw

 

Hope this helps! You can also always reach out to our team of experts who can answer any of your questions and help you get set up with testing! 
512-263-0000 ext 5
sales@arichecklab.com
AirCheckLab.com 

[Charles.C]

Hi AnnMou, 

 

Here at Trace Analytics we provide microbial testing of compressed air! We use an impaction sampler (per ISO 8583-7). The test are easy to perform, take about ten minutes and are both quantitative and qualitative. 

Here's an article with more information on microbial testing methods: https://www.ifsqn.co...ampling-methods

Because SQF and BRC are very vague about microbial limits, we often recommend a baselining approach. Many of our clients find it is helpful to get an idea of the quality of their compressed air as it currently stands. 

You can also perform a risk assessment to help in deciding on contamination limits for your particular facility. See our risk assessment here:  https://docsend.com/view/53pwaxw

 

Hope this helps! You can also always reach out to our team of experts who can answer any of your questions and help you get set up with testing! 
512-263-0000 ext 5
sales@arichecklab.com
AirCheckLab.com 

Hi Laura,

 

I agree that both BRC and SQF are silent as to their quantitative expectations. If any.

 

The simplest solution might be to install a "sterile filter" assembly. Guaranteed satisfactory.

[AJL]

Hi, yes we have a filter installed so I won't bother with testing. It's all new equipment so I can't see the risk.
Let's see how the auditor takes it 😉

[AJL]

Hi, yes we have a filter installed so I won't bother with testing. It's all new equipment so I can't see the risk.
Let's see how the auditor takes it 😉