When it comes to processing, equipment must be tested for gluten-free status if it is used to process products containing gluten or other prohibited substances or allergens. Engineering parameters such as air handling systems, enclosed systems or equipment, one-way traffic, and water and pressure controls need to meet specific standards. These safeguards will prevent other areas of production from intermingling with the gluten-free environment.
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Explore This IssueDecember/January 2009
Because most of these requirements mimic other special situations such as the handling of allergens and organic products, manufacturers with this kind of experience can easily adapt to the changes. Separate lines, equipment, and processes may not be feasible for all manufacturers, but strict adherence to policies and internal guidelines can allow medium- and high-risk manufacturers to provide gluten-free products.
Manufacturers can perform cleaning procedures specific to products containing gluten. The first step is to validate the sanitation program. A good sanitation program will take into account types of gluten-containing products in order to identify hard-to-clean areas. Three consecutive cleanings should yield fewer than 20 PPM of gluten on hard-to-clean surfaces. Because each type of gluten grain is unique, this program needs to be revisited for cleaning different glutens. Even though all proteins of interest belong to the same family of prolamins and glutenins, there may be subtle differences in sanitation needs.
A sanitarian must ensure that the detergents, strengths of detergents, types of sanitizer, and water temperature are adequate. Sanitation basics teach that acid or alkaline detergents denature proteins easily. Medium- and high-risk facilities may still be able to meet standards if they adopt and validate sanitation recommendations.
Manufacturers should ensure that suppliers provide documentation showing that incoming raw materials are gluten free. A letter of guarantee and a supplier audit can reveal gaps. Manufacturers should ask the following questions:
- Are proper segregation procedures followed?
- Do all the manufacturing locations have strict guidelines for meeting the standards?
- Do suppliers have gluten-free dedicated lines?
- Do suppliers handle any prohibited grains?
- Do the distributors follow segregation policies?
In addition, ask your suppliers to go through a third-party certification process to certify gluten-free status. Certification agencies such as Gluten-Free Certification maintain lists of manufacturers, suppliers, and products that they have certified as gluten free.
Testing for gluten-free status is quick and uses the enzyme-linked immunosorbent assay (ELISA) principle. Various companies, including Neogen Corporation, ELISA Technologies, R-Biopharm Group, and Tepnel Biosystems manufacture such kits in the United States. The kits are simple to use and will satisfy regulatory needs; most are Association of Analytical Communities-approved or in final action. The testing can help to validate and verify raw materials (prior to approving a vendor), equipment (routine clean downs) or finished product (to declare gluten-free status). The sampling matrix can be varied based on need and priority.
From a quality assurance perspective, such sampling needs to represent the entire spectrum in question. Samples should be taken from a large pool of raw and finished product, and a composite sample product can be tested. Compositing can vary depending on the client requirement and the product in question. For a pre-operational purpose, multiple sample sites of hard-to-clean parts of a piece of equipment can be used to measure its gluten-free status. Hard-to-clean areas must be identified based on historic knowledge gleaned from previous micro or adenosine triphosphate bioluminescent tests.
The test result interpretation is simple, irrespective of the product or equipment analyzed or the kits used for the studies. A negative result indicates only controls appearing during visual examination, while a darker color in the test well indicates the detection of more than 20 PPM of gluten. Keep in mind that manufacturers have their own, additional testing requirements and conditions.