How to verify the allergen is CLEAN after thorough sanitation?
We need to control one of our allergen material--fish and some seafood. My question is how to verify the allergen is CLEAN after operators has done a thorough sanitation work? Can we just say follow the procedure--warm water rinse, cleaner, sanitizer applied, plus visual inspection? Or there are some test kits available for a swab test?
Thanks a lot!
Swabs are one way to validate (Neogen and 3M are both suppliers of allergen swab kits). Outside testing is another, although probably more costly.
We target a visual clean as we are a low risk facility and we communicate the fact we use other allergens (either on our packaging or to the business customer accepting our product.) We don't make anything "free from".
I calculated the "worst case" scenario for each product in terms of the % of an allergenic ingredient contained within. I just calculated this as "contains 5% milk" rather than how much milk protein it contained as that would get too complicated.
That then gave me a list at each point in my process where the product with the greatest percentage of allergenic ingredient was contained. That also gave me a real insight into where in the process the greatest risks of cross contamination were.
I then targeted mid and end of shift cleans after the most allergen filled products and swabbed them with Neogen swabs after the employees had identified the area as clean to their satisfaction. Fortunately they all passed. I wrote all of this up as part of my quality manual section on allergens and the auditor was really happy with it. The swabs were expensive, £9 each as a pack of 10 from memory but they're easy to use (like pregnancy testing kits), you get a result within 5 minutes.
Obviously from our point of view not making any "free from" products it wasn't worth us swabbing after every clean, especially at £9 a pop for each allergen type but for some facilities that might be necessary, especially if you're making an allergen claim.
I'm afraid you will struggle to get Fish validated as it is difficult to get species specific testing completed in this country. We use Neogen and they are unable to test for fish or oyster.
To get over this, we did similar to GMO and validated the clean for our worst case allegen, which is Sesame, using a recipe containing the highest levels.
In addition to swabbing points which had been risk assessed as the most difficult areas to clean, we also took samples of the sesame product and the follow-on product, whihc did not contain sesame, to a) verify that the test would identify the sesame and b) that the sesame did not carry over into the next product.
One word of caurtion, the testing of the surface swabs is very sensitive and Neogen were able to identify presence of Sesame down to very low levels. We had one reading of 40ppb on a swab, even though the sesame levels in the follow on product were below detectable limits. This makes interpretation very difficult, but all you can do in this case is to inform your customer of your findings and write this into your validation report and allergen policy.
I will tell you what we did and this is for BRC (and was accepted).
We target a visual clean as we are a low risk facility and we communicate the fact we use other allergens (either on our packaging or to the business customer accepting our product.) We don't make anything "free from".
I calculated the "worst case" scenario for each product in terms of the % of an allergenic ingredient contained within. I just calculated this as "contains 5% milk" rather than how much milk protein it contained as that would get too complicated.
That then gave me a list at each point in my process where the product with the greatest percentage of allergenic ingredient was contained. That also gave me a real insight into where in the process the greatest risks of cross contamination were.
I then targeted mid and end of shift cleans after the most allergen filled products and swabbed them with Neogen swabs after the employees had identified the area as clean to their satisfaction. Fortunately they all passed. I wrote all of this up as part of my quality manual section on allergens and the auditor was really happy with it. The swabs were expensive, £9 each as a pack of 10 from memory but they're easy to use (like pregnancy testing kits), you get a result within 5 minutes.
Obviously from our point of view not making any "free from" products it wasn't worth us swabbing after every clean, especially at £9 a pop for each allergen type but for some facilities that might be necessary, especially if you're making an allergen claim.
The approach is correct. It is what I suggest to my Clients to validate all the cleaning and sanitation procedures (using sweb and external laboratory for the first result), then I suggest them to keep under controll the operation with monthly hygienic audit and (if the process is low risk like backery production with the risk analisys) with ambient laboratory analisys one for year.
http://www.neogen.co...Handbook_10.pdf
Testing is extremely expensive. Our "internal" kits come in at 13 euro a pop and our external lab charges 145 euro per allergen (we test for presence of eggs and milk). We only use the problem flour in question at the end of the week. We've started redesigning our packaging to add a "may contain egg and milk" as a cheaper alternative, although I got a spec through yesterday from a perspective supplier in france that had 2 allergens present and "may contain" a further 12.
As per the OP, the requirement was verification (validation) for achieving allergen “absence” in line for fish and “some seafood”.
As per previous posts, neogen should work for a specific validation of shellfish and crustaceans.
So I guess it depends on what fish or other seafood is of interest ? There were certainly lab. procedures for cod and tuna in a 2002 text I found. Sensitivity I didn’t see mentioned. Maybe by now other species / families also.
Presumably the validation can be based on line samples or finished product.
It seems likely that the costs discussed in previous posts will simply be out of range for some situations despite the undoubted elegance of the methods. Particularly where one-time testing (validation?) is not a reasonable option.
I am curious if other people have submitted equally acceptable solutions (auditorially speaking) of a less hi-tech basis. The generic link below suggests basic solutions are still an acceptable routine methodology (somewhere?) although I would hv thought the use of a quantitative evaluation raises the credibility to another level. (auditor’s delight?)
http://www.foodaller...t/Cleaning.html
This 2011 compendium of GMP procedures has a (general) chapter on allergen control from a USA perspective.
Current Food Industry GMP 2011.pdf 824.68KB 350 downloads
Rgds / Charles.C
This may help...
http://www.neogen.co...Handbook_10.pdf
Testing is extremely expensive. Our "internal" kits come in at 13 euro a pop and our external lab charges 145 euro per allergen (we test for presence of eggs and milk). We only use the problem flour in question at the end of the week. We've started redesigning our packaging to add a "may contain egg and milk" as a cheaper alternative, although I got a spec through yesterday from a perspective supplier in france that had 2 allergens present and "may contain" a further 12.
Just be wary. "May contain" is not widely accepted by people with allergies (there was some recent FSA research on this). Basically there is so much a*** covering by manufacturers that people with allergies would be eating from their own veggie patches and nothing else so "may contain" may not be worth the paper it's written on.
WOW! That food allergen website link you posted is a wealth of information! Thanks for sharing it. I am always looking for new training ideas and that had some good ones, as well as just thorough allergen info.
The GMP file also has a lot of good info.
Thanks! vkh
The following is a snapshot from a UK retailer CoP on verifying cleaning:
'The finished cleaning standard should be ‘no visible debris remaining’, for cleaning in connection with allergenic ingredients. This applies to product changeover and deep cleaning.
The effectiveness of removing traces of allergenic ingredient must be assessed through specific testing for the target allergen where a test method is available. Where a test method is not available, traditional microbiological and rapid test methods (eg ATP measurement) must be used to verify cleaning effectiveness. Tests should be carried at an appropriate frequency based on:
- Food and non food contact surfaces
- Track record of results.
In addition, equipment must be risk assessed to identify any areas where removing allergen traces might be difficult, and where such areas are identified, positive release systems should be used based on inspection and surface testing for allergen traces. Evidence of risk assessment and the results of inspection and testing should be retained eg. mixers, filters, ovens, fryers, spiral chillers, vacuum cooling.'
Possible alternative method knowing specific allergen test kits are expensive.
Regards
I will tell you what we did and this is for BRC (and was accepted).
We target a visual clean as we are a low risk facility and we communicate the fact we use other allergens (either on our packaging or to the business customer accepting our product.) We don't make anything "free from".
I calculated the "worst case" scenario for each product in terms of the % of an allergenic ingredient contained within. I just calculated this as "contains 5% milk" rather than how much milk protein it contained as that would get too complicated.
That then gave me a list at each point in my process where the product with the greatest percentage of allergenic ingredient was contained. That also gave me a real insight into where in the process the greatest risks of cross contamination were.
I then targeted mid and end of shift cleans after the most allergen filled products and swabbed them with Neogen swabs after the employees had identified the area as clean to their satisfaction. Fortunately they all passed. I wrote all of this up as part of my quality manual section on allergens and the auditor was really happy with it. The swabs were expensive, £9 each as a pack of 10 from memory but they're easy to use (like pregnancy testing kits), you get a result within 5 minutes.
Obviously from our point of view not making any "free from" products it wasn't worth us swabbing after every clean, especially at £9 a pop for each allergen type but for some facilities that might be necessary, especially if you're making an allergen claim.
Great information. We are currently this situation for BRC v6.
I will tell you what we did and this is for BRC (and was accepted).
We target a visual clean as we are a low risk facility and we communicate the fact we use other allergens (either on our packaging or to the business customer accepting our product.) We don't make anything "free from".
I calculated the "worst case" scenario for each product in terms of the % of an allergenic ingredient contained within. I just calculated this as "contains 5% milk" rather than how much milk protein it contained as that would get too complicated.
That then gave me a list at each point in my process where the product with the greatest percentage of allergenic ingredient was contained. That also gave me a real insight into where in the process the greatest risks of cross contamination were.
I then targeted mid and end of shift cleans after the most allergen filled products and swabbed them with Neogen swabs after the employees had identified the area as clean to their satisfaction. Fortunately they all passed. I wrote all of this up as part of my quality manual section on allergens and the auditor was really happy with it. The swabs were expensive, £9 each as a pack of 10 from memory but they're easy to use (like pregnancy testing kits), you get a result within 5 minutes.
Obviously from our point of view not making any "free from" products it wasn't worth us swabbing after every clean, especially at £9 a pop for each allergen type but for some facilities that might be necessary, especially if you're making an allergen claim.
We have packing contract manufacturer. They packing in bags our non- allergen containing candy. However, they pack candy containing milk and soy on the same equipment. QA manager prepared validation/verification protocol that requires visual assessment and post -cleaning allergen swabbing (Soy and Milk allergen test on swab - quantitative ELISA). Swabs will be analysed by external accredited lab (detection limit 0.5 micrograms/g).Results will be reviewed by the QA manager, target soy and milk no detected.
Do we have to still declare may contain soy and milk?
We have packing contract manufacturer. They packing in bags our non- allergen containing candy. However, they pack candy containing milk and soy on the same equipment. QA manager prepared validation/verification protocol that requires visual assessment and post -cleaning allergen swabbing (Soy and Milk allergen test on swab - quantitative ELISA). Swabs will be analysed by external accredited lab (detection limit 0.5 micrograms/g).Results will be reviewed by the QA manager, target soy and milk no detected.
Do we have to still declare may contain soy and milk?
Dear tery,
It may minimally depend on factors like (a) yr location, (b) local legislation, © the degree of risk you wish to take regarding yr product's allergenic safety, ie yr RA.
Not necessarily prioritized in above order.
Rgds / Charles.C
We use the AccuPoint from Neogen. Very reliable, and SQF auditors have had no issues with this.