Master Allergen Control Validation & Verification

Webinar Summary: Fundamentals of Allergen Validation and Verification

Host & Sponsor:
Shannon Kerber, Global Product Management Leader at Hygiena, welcomed attendees to a webinar focused on allergen validation and verification. Hygiena, a provider of diagnostic testing solutions, sponsored the event to support food safety efforts by detecting, quantifying, and mitigating allergen risks.

Featured Speakers:

• Dr. Joe Baumert – Director of the Food Allergy Research and Resource Program (FARRP) and Professor at the University of Nebraska-Lincoln, specializing in food allergen research and detection methods.
• Janine K. – Global Product Manager at Hygiena, showcasing innovative allergen management solutions.

Key Topics Covered

1. Importance of Allergen Validation & Verification

• Validation and verification are essential parts of an effective allergen control program.
• Validation ensures cleaning procedures effectively remove allergens, while verification ensures they are consistently followed.
• The Food Safety Modernization Act (FSMA) does not require analytical validation for allergens but encourages it for risk mitigation.
• A holistic allergen management program includes hazard identification, supplier controls, facility design, staff training, and sanitation procedures.

2. Best Practices for Allergen Control

• Understanding Allergens & Their Forms:
  • Assess protein load in different ingredients (e.g., peanut paste vs. soy lecithin).
  • Consider allergen form (powders, pastes, particulates) to determine difficulty in removal.
• Developing & Validating Standard Sanitation Operating Procedures (SSOPs):
  • SSOPs should be specific to different allergens, food matrices, and production lines.
  • The hardest-to-remove allergen should be used as the benchmark for cleaning validation.
  • Validation should include environmental swabbing, visual inspection, and analytical testing.
• Revalidation Considerations:
  • SSOPs should be revalidated periodically, especially after changes in formulation, equipment, or cleaning methods.

3. Allergen Testing Methods

• Lateral Flow Devices (LFDs):
  • Provide rapid (10-minute) qualitative results.
  • Used for environmental swabbing and product testing.
• ELISA Tests:
  • More sensitive and quantitative, used for validation.
  • Typically performed in a laboratory setting.
• General Protein & ATP Tests:
  • Used as initial indicators of contamination before allergen-specific tests.
  • Suitable for general hygiene monitoring.
• PCR Testing:
  • Detects allergen DNA for high specificity.
  • Useful for distinguishing wheat allergens from gluten-containing grains like rye and barley.

4. Data Management for Allergen Control

• SureTrend Software:
  • Tracks and trends allergen test results, improving food safety monitoring.
  • Allows real-time visualization of food safety risks using environmental mapping.

5. Industry Challenges & Q&A Highlights

• Zone Swabbing for Allergen Detection:
  • Focus primarily on Zone 1 (product contact surfaces) but include Zone 2 (adjacent surfaces) for risk assessment.
• Validation Using Qualitative vs. Quantitative Methods:
  • LFDs can be sufficient for validation, but ELISA or PCR may be needed for deeper analysis.
• Distinguishing Wheat Allergens from Gluten:
  • Gluten tests detect wheat, barley, and rye proteins, while PCR can specifically identify wheat allergens.

Conclusion & Next Steps

The webinar emphasized a holistic approach to allergen validation, combining testing, training, and sanitation protocols to enhance food safety. Hygiena provides comprehensive allergen detection solutions, including LFDs, ELISA, ATP, and PCR testing. Attendees were encouraged to integrate best practices, proper documentation, and continuous monitoring into their allergen control programs.

For further inquiries, Hygiena will follow up on unanswered questions.