9 replies to this topic

[regina.huffman]

This is my first post on IFSQN.  We are a dry powder manufacturer of a product that does not contain any allergens.  We are in the first negotiations to produce a product with an allergen and have to write an allergen program, which will include segregation and cleaning procedures.  Some questions that have arose are;

1) Do we have to have dedicated fork lifts to move the allergen containing materials versus non-allergen containing materials?

2) Does segregation from allergenic to non-allergenic materials have to have a physical barrier? 

3) If technical data exists that the allergen is easily removed with our cleaning agents, can we use a flush of a bulking agent to further mediate the possibility of cross contamination?

 

Allergen control is new to our company and would appreciate any help.

[Charles.C]

Hi Regina,

 

Welcome to the Forum !

 

Pls inform whether any specific FS Standard is involved and possibly, if SQF, which Module/Level. (some have specific allergen requirements, some have implied).

 

The generic answer to yr queries is that it depends on (your) Risk Analysis but FS Standards can vary in Prescriptive content.

[regina.huffman]

Thank you, Charles, for the reply.  We are a dry powder artificial sweetener co-packing manufacturer that is  level 2 SQF certified to modules 2 and 11 in the food category 19, Food Ingredient Manufacturer.  We blend, fill and package no-calorie sweeteners.  Currently we are an allergen free facility.  We have the possibility of gaining new business form a customer with a product that does contain one allergen, so dealing with this aspect is new to us.  We will not use dedicated blenders, filling or packaging equipment. We are in the process of performing our risk assessment, and that is when the question on the transport equipment was brought up.  Any additional thoughts?

[Charles.C]

Hi Regina,

 

As you probably know the SQF Allergen requirements are not exactly simple and particularly involve clause 2.8.2. The SQF Guidance / Appendix1 offers substantial advice on yr queries.

From memory similar queries to those you list in the OP have appeared here before but not too easy to find.

 

I have added 5 SQF links below which may help although they don't answer yr exact queries (there may be others that do) -

 

http://www.ifsqn.com...-contamination/

 

http://www.ifsqn.com...isk-assessment/

 

http://www.ifsqn.com...-documentation/

 

http://www.ifsqn.com...-for-allergens/

 

http://www.ifsqn.com...pre-requisites/

 

I’m not a SQF user myself but I deduce that in clause 2.8.2, yr queries relate mainly to paras (ix, v, vii).

 

IMO the SQF expectation will heavily rely on risk assessment and validatable cleaning efficiency/absence of allergenic cross-contamination.

 

The conservative answers to queries (1,2) are obviously yes/yes. But IIRC, the auditorial responses can be  No/No, if satisfactorily based on risk assessment.

Similarly the auditorial response to (3) IIRC can be Yes with same caveat as for (1,2).

 

Hopefully there are some SQF users in a similar situation as yourself who can practically verify my opinions/memories.

[Tony-C]

Hi Regina,



The answers to your questions need to be based on risk of cross-contamination.

1) Normally dedicated fork lifts are not necessary if allergens are kept in sealed containers. Although you will need to consider spillages/damage.

2) Segregation of allergenic to non-allergenic materials can be by segregation in the same store especially if sealed. Again you will need to consider spillages.

3) If technical data exists that the allergen is easily removed with our cleaning agents, you can use a flush of a bulking agent to further mediate the possibility of cross contamination but you will need to validate and verify the process.

As per Charles's has indicated there is some very good advice in the SQF Code Guidance:

Appendix 1: Allergen Cleaning and Sanitation Guide
CLEANING VALIDATION AND VERIFICATION
Validation
The purpose of validation is to prove that the cleaning process employed is effective in removing the allergen of concern. This proof requires evidence that the specific allergen was in fact removed, or reduced to an acceptable level by the cleaning procedure. Therefore, only an allergen specific test will provide that evidence.Both the ELISA tests and lateral flow test kits have been accepted by recognized allergen research scientists and meet the requirements for sanitation validation of the SQF Code.

Verification
Once a validated cleaning method has been shown to remove the allergenic material of concern, the facility must verify that the validated procedures were used each time.There are also sensitive ATP test swabs available however the presence of ATP does not indicate the presence of protein which is the allergenic material. The use of these total protein swabs or the ATP sensitive swabs must be calibrated with the validated cleaning procedure by using them immediately after the validated method is used and recording the results of both the allergen specific test and the protein or ATP swab test.

 

I have quoted a couple of extracts but recommend reading through and following the full guidance.

 

Kind regards,

 

Tony

[regina.huffman]

_{Thank you all for the help.  The information helps me tie up any holes I may have on my draft for our allergen policy.} 

[ncwingnut]

Hi Regina!

 

We are an ingredient manufacturer - both powder and liquid - and we do the following for allergen control:

 

1.  Allergens are labeled with an identifying label different from non-allergens - all allergens are labeled with a blue label, to make it very visible.

2.  Warehouse storage - bottom shelf or like over like only. No mixed allergens on pallets.  We do have specific racks for allergens, also.

3.  We use a quick test kit specific to that allergen (milk, soy, etc) after cleaning to ensure all proteins have been removed (I use the results as part of my validation program for sanitation)

[regina.huffman]

Thanks.  Everywhere I looked recommended using ELISA for validation or lateral flow swabs that has a low enough LOD for the allergen. For verification, I was thinking about comparing the results to total protein swabs so we can use them as our cleaning verification method. 

[Charles.C]

Thanks.  Everywhere I looked recommended using ELISA for validation or lateral flow swabs that has a low enough LOD for the allergen. For verification, I was thinking about comparing the results to total protein swabs so we can use them as our cleaning verification method. 

 

Hi Regina,

 

Based on the quirky interpretations of Va/Ve by SQF auditors as illustrated on this Forum, yr above idea for establishing Ve may be (SQF) regarded as Va.

[Tony-C]

That is fine Regina, but don't forget that 'The use of these total protein swabs or the ATP sensitive swabs must be calibrated with the validated cleaning procedure by using them immediately after the validated method is used and recording the results of both the allergen specific test and the protein or ATP swab test.'

 

Kind regards,

 

Tony