11 replies to this topic

[Ferdi1982]

Hi everybody. We are machinery manufacturers of industrial equipment for thermal processing of food. I've been asked whether our equipment is FDA approved. Anyone can explain me what is the procedure, who should take care and when it is necessary? Please indicate the FDA web-site page covering this topic.

 

Thanks in advance for your kind reply

 

Best regards

Ferdinando 

[Sandima]

What type of equipment?  Retorts, controls?  I am not aware of a requirement for FDA to approve equipment.  The USDA used to approve equipment for meat production but stopped many years ago.  Canada lags behind always but equipment approvals stopped here 4 years ago.  The burden is on the manufacture to certify that it meets the appropriate regulations and be able to demonstrate that.  

[Charles.C]

Hi everybody. We are machinery manufacturers of industrial equipment for thermal processing of food. I've been asked whether our equipment is FDA approved. Anyone can explain me what is the procedure, who should take care and when it is necessary? Please indicate the FDA web-site page covering this topic.

 

Thanks in advance for your kind reply

 if

Best regards

Ferdinando 

 

I'm not in USA but if you are referring to canning, AFAIK, for certain products the process thermal conditions have to be FDA approved (in USA presumably). This may involve the equipment capabilities i guess, eg instrumentation.

AFAIK, there is a specific FDA "form" to be filled in for above (saw a copy in a textbook).

 

Or did you mean the Italian FDA ?

 

Rgds / Charles.C

[Ferdi1982]

Dear Charles,

 

Thank you very much for your explanation. Yes I was referring to U.S. FDA regulations. I had the idea that it was the food manufacturer having to prove compliance with FDA regulations for the process, not the machine manufacturer having to apply for a generic approval from FDA. Please correct me if I'm wrong in this.

 

Best regards

Ferdinando

[Charles.C]

Dear Charles,

 

Thank you very much for your explanation. Yes I was referring to U.S. FDA regulations. I had the idea that it was the food manufacturer having to prove compliance with FDA regulations for the process, not the machine manufacturer having to apply for a generic approval from FDA. Please correct me if I'm wrong in this.

 

Best regards

Ferdinando

Dear Ferdi,

 

Posters in USA / relevant business will be more definitive than I but i think (from long memory) that you are in principle correct albeit with local caveats such as i mentioned in my post.

 

Nonetheless documentation from the equipment manufacturer asserting adequacy to certain process-related requirents (eg relating to F0 criteria) could also be involved within an overall (submitted) scheme for compliance by a processor. Seems reasonable.

 

From memory, the edehg organisation is a primary equipment "approver" in Europe but I'm not sure regarding the scope of their involvement, maybe focused more on the hygenic aspects / guidelines.

 

It may obviously depend on yr specific process, eg low-acid canning or ?. i think there are some US posters here who may work in this business and will hopefully respond.

 

Rgds / Charles.C

 

PS - it is a rather general requirement IMEX that, generically, the actual processor is "responsible" for his product.

Nonetheless the aspect of "due diligence" is also legally relevant in  UK (Europe?). USA no idea.

[fgjuadi]

Depends on the system - NSF certifies equipment for ANSI standards and has a really great search tool by manufacturer -

 

http://www.nsf.org/c...roducts-systems

 

Fro ex if you made Meats & polutry and used a Kemco water heater, they have this -

 

http://info.nsf.org/...tandard=14159-1

 

I really like that you don't have to go the to manufacturer to get it, it's right there on their website.

 

One time, I had a supplier who stole the NSF logo and just slapped it on their product, and when I searched the database it wasn't there, so we disqualifed their shady ass. 

 

A lot of thrid party companies will certify equipment per ANSI standards

http://www.ansi.org/...n.aspx?menuid=1

 

 

[Ferdi1982]

Dear Charles/Magenta,

 

Thank you very much for your support. It seems to me that this NSF certification is a good procedure to certify compliance with ANSI and therefore the safety and quality of the equipment installed in the U.S. What is still not clear from my side is whether this type of certification is mandatory also for equipment installed outside U.S., for the production of food&bev to be exported in the U.S. In other words, I would like to know if FDA in order to permit the import of the finished product in the U.S., would ask the food processor to provide this NSF certification for each equipment employed in the production process. I'm asking this because I'm in the process of selling a pasteurizer for mango pulp in Asia, and the fruit processor is asking me this "FDA approval", not very clear to me...

 

Best regards

Ferdi

[Charles.C]

Dear Charles/Magenta,

 

Thank you very much for your support. It seems to me that this NSF certification is a good procedure to certify compliance with ANSI and therefore the safety and quality of the equipment installed in the U.S. What is still not clear from my side is whether this type of certification is mandatory also for equipment installed outside U.S., for the production of food&bev to be exported in the U.S. In other words, I would like to know if FDA in order to permit the import of the finished product in the U.S., would ask the food processor to provide this NSF certification for each equipment employed in the production process. I'm asking this because I'm in the process of selling a pasteurizer for mango pulp in Asia, and the fruit processor is asking me this "FDA approval", not very clear to me...

 

Best regards

Ferdi

Dear Ferdi,

 

IMEX, the USFDA have zero interest in food production outside USA unless certain characteristics apply.

 

For example -

 

(1) some countries have MOUs (memorandi of understanding) with USA, ie mutual acceptance of standards as officially implemented in the non-US location. Equipment requirements might be included within such documention.

 

(2) some US-imported products are required to be harvested in US-approved environmental situations.

 

(3) some products / producers / locations have an automatic import  detention status.

 

I daresay other special conditions exist across the vast scope of food products / producing areas.

 

Personally, i believe yr potential customer is simply trying to cover his back. I assume the specific process requirements / capabilities have already been mutually agreed, ie a COC type of documentation will be available.

 

IMEX of buying 2nd-hand (?) equipment, the company always asked for a 3rd party inspection as to "functionality". Obviously not a process capability guarantee but prevented gross fraud.

 

Regarding NSF, seems unlikely their "guarantees" would apply to non-US-located items. They also validate sanitisers for USDA but i do believe they (initially) require samples ?.

 

Rgds / Charles.C

[matthewcc]

I would say that to "demonstrate that utilities and equipment are suitable for their intended use and perform properly" would be a key phrase in this type of assessment with respect to US FDA. 

 

This (http://www.fda.gov/f...e/ucm188064.htm) talks about food equipment requirements in general.

 

Although it is written for drugs, it's possible that much of the following document would be general enough to apply to food as well.  http://www.fda.gov/d...s/UCM070336.pdf

[Charles.C]

I would say that to "demonstrate that utilities and equipment are suitable for their intended use and perform properly" would be a key phrase in this type of assessment with respect to US FDA. 

 

This (http://www.fda.gov/f...e/ucm188064.htm) talks about food equipment requirements in general.

 

Although it is written for drugs, it's possible that much of the following document would be general enough to apply to food as well.  http://www.fda.gov/d...s/UCM070336.pdf

 

Dear matthewcc,

 

Thks for the input.

 

This is rather OT but since you are in the USA, may i pose a specific query ?

 

Suppose you are purchasing a system for canning product X, what kind of equipment documentation do you "officially" require from the equipment supplier to then be able to propose your intended process to USFDA for further approval (I believe this is the basic procedure required).

 

I suspect the answer will simply be a document from equipment suppplier (or perhaps a link to NSF specific approved model) couched in the general, ie non-binding, terms of yr first paragraph. However the  possible requirements are in theory wider, eg this example discussing differences between COC/COA -

In terms of SAP there is none.  The terms refer to the content provided in a certificate that is delivered to yoru company by a vendor for a product or a certificate that you send out when you sell a product.

 

A COC or Certificate of Compliance is usually very simple and contains minimal information.  It usually has header info about the product or batch and maybe some delivery info.  That  is usually followed by a statement that says something like "This product meets all requirements of specifcation XYZ and is approved for import use as a xxxxxxxx to the EU".  Or whatever the heck your product complies with.  It may be provided with non-batch managed material or batch managed material, or serial numbered product.

 

The COA or Certificate of Analysis is more complicated and while it may also have similar statement as the COC, it also usually contains specific analytical data that is specific to a batch or serial numbered product. It may list multiple batches each with their own set of data. The headers of a COA and a COC can be virtually identical.

 

In SAP, you can create as many certificate types as needed, some might be COC's, some might be COA;s.  Your company might receive in both COA's and COC's and your company might send out both COAs and COC's.

http://scn.sap.com/thread/1548455

 

I noted (to my surprise) that above example text does imply that documents guaranteeing "blanket" import capabilities (eg to EU) are apparently in common usage/available so the OP may not be so unexpected in reality. I guess business is business.

 

Rgds / Charles.C

 

PS - just to further illustrate the semantic opportunities, i noticed these 2 definitions while browsing -

 

Certificate of Analysis (COA) is a record of quality control testing performed for the product/ material which indicates whether the product or material conforms or not.

The Certificate of Compliance (COC) is a record that everything which was performed as a part of manufacturing that material or product has been verified and was found to be in compliance to all its written procedures (batch instructions, written procedures).

 

Welcome to the World of Gobbledegook, aka Business !

[matthewcc]

Dear matthewcc,

 

Thks for the input.

 

This is rather OT but since you are in the USA, may i pose a specific query ?

 

Suppose you are purchasing a system for canning product X, what kind of equipment documentation do you "officially" require from the equipment supplier to then be able to propose your intended process to USFDA for further approval (I believe this is the basic procedure required).

 

I suspect the answer will simply be a document from equipment suppplier (or perhaps a link to NSF specific approved model) couched in the general, ie non-binding, terms of yr first paragraph. However the  possible requirements are in theory wider, eg this example discussing differences between COC/COA -

 

I noted (to my surprise) that above example text does imply that documents guaranteeing "blanket" import capabilities (eg to EU) are apparently in common usage/available so the OP may not be so unexpected in reality. I guess business is business.

 

Rgds / Charles.C

 

PS - just to further illustrate the semantic opportunities, i noticed these 2 definitions while browsing -

 

Certificate of Analysis (COA) is a record of quality control testing performed for the product/ material which indicates whether the product or material conforms or not.

The Certificate of Compliance (COC) is a record that everything which was performed as a part of manufacturing that material or product has been verified and was found to be in compliance to all its written procedures (batch instructions, written procedures).

 

Welcome to the World of Gobbledegook, aka Business !

 

I'm not an expert on this, but it sounds like IQ/OQ/PQ (installation qualification/operation qualification/performance qualification) is the answer.  I would summarize in the following way:

 

Did the equipment arrive intact and was it installed according to manufacturer recommendations?

Does the equipment, when started up, run as expected?

Does the equipment produce products that are within specifications?

 

If you do an internet search for "IQ OQ PQ" you might come up with something like http://www.grantinst...-documentation/ which gives you an idea of how it works in practice.  Clearly there are examples out there that are more pertinent to food, especially US FDA.

 

If you can get the equipment supplier to document that, that is ideal.  Otherwise, I think you should do these yourself to make sure that the products made using the equipment will be within specifications.  Regardless, specification conformance should be verified.

 

Best wishes,

 

Matthew

[Charles.C]

Dear matthewcc,

 

Thks for yr reply.

It seems to me that the crucial aspect in present case is the 3^rd part of yr set. The question then is  what does the agreed specification actually state as referenced in the COC/COA. In the current case the customer appears to believe that the documentation is required to include a statement that the equipment (hygiene?, performance?,material?) satisfies USFDA import regulations.

 

I have also done a little more digging. Have assumed a canning process is involved.

 

In fact the USFDA offer substantial guidance for intending producers of canned foods (presumably for US market), eg –

 

http://www.fda.gov/F.../ucm2007436.htm

 

Basically the details of the intended thermal process must be submitted and approved unless the specific conditions fulfil those for an exception to be made (as discussed in above link). The requirements  (eg see the linked forms) are complex and may require considerable information regarding the specific equipment and its functional capabilities. My guess this is why the purchaser was seeking a blanket assurance of FDA acceptability although such a statement seems to not remove the purchaser’s liability to themselves obtain process approval from FDA. A purely import -only activity might be a different issue of course.

 

An (external) pictorial overview of  process approval sequence is given in this document –

 FDA canning facility, process registration,2012.pdf   1.22MB   48 downloads

 

Rgds / Charles.C