Food Safety
search
cart
facebook twitter linkedin
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Food Safety
  • NEWS
    • Latest News
    • White Papers
  • PRODUCTS
  • TOPICS
    • Contamination Control
    • Food Types
    • Management
    • Process Control
    • Regulatory
    • Sanitation
    • Supply Chain
    • Testing and Analysis
  • PODCAST
  • EXCLUSIVES
    • Food Safety Five Newsreel
    • eBooks
    • FSM Distinguished Service Award
    • Interactive Product Spotlights
    • Videos
  • BUYER'S GUIDE
  • MORE
    • ENEWSLETTER >
      • Archive Issues
      • Subscribe to eNews
    • Store
    • Sponsor Insights
  • WEBINARS
  • FOOD SAFETY SUMMIT
  • EMAG
    • eMagazine
    • Archive Issues
    • Editorial Advisory Board
    • Contact
    • Advertise
  • SIGN UP!
White Papers

Cost-Effective Cleaning Validation for Allergens

February 21, 2013

Effective cleaning is usually identified as a prerequisite for most Good Manufacturing Practices (GMPs) and Hazard Analysis and Critical Control Points (HAACP) plans in the food industry, and cleaning is often considered a CCP for allergen control. Cleaning is designed to remove food residues that contain many common components, such as adenosine triphosphate (ATP), protein and sugars, and some foods may contain allergens. The more effective the cleaning procedure, the lower the amount of food residues and the lower the risk. Using the most sensitive detection methods gives the greatest assurance of cleaning efficacy.

The principle of broad-spectrum monitoring methods together with indicators and specific detection methods is well established in monitoring and managing risk, for example, in microbiology, total bacteria counts, coliforms and Listeria spp. are used as indicators and then specific tests for specific pathogens are used as required. Here we describe a similar combined approach of prevalidation and monitoring of cleaning for allergen management using a combination of three high sensitivity detection methods.

Detection Methods
ATP bioluminescence provides a direct objective test of cleaning efficacy that has been well established for more than 30 years and detects a very broad range of foodstuffs. Recent developments in ATP bioluminescence have improved detection capabilities and sensitivity and at this level, it is capable of detecting food residues below the limit of detection of specific allergen tests.

Comparative Sensitivity of New ATP SystemsThe new EnSURE instrument and SuperSnap reagent swab from Hygiena both provide additional sensitivity with low background noise and low variation for precise accurate and consistent results. This means that this system is 10 times more sensitive than Hygiena SystemSURE Plus with UltraSnap swabs and 100 times more sensitive than other ATP systems (Table 1). The results are quantitative and give a linear response to increasing amounts of food residue. SuperSnap is also more robust and tolerant of harsh materials at extremes of pH; in the presence of sanitizer, it is unaffected by 1000 ppm hypochlorite.

Allergens are glycoproteins that can be detected by simple protein test (e.g., the biuret method, AllerSnap); however, this non-specific protein test cannot differentiate non-allergen protein from allergens. This protein test can detect allergenic foodstuffs, but for maximum sensitive (1–3 μg protein), the test must be run at elevated time and temperature combinations such as  37 °C for 30 min. The results are semi-quantitative and the scope and sensitivity of the protein test is limited to 10–100 ppm for certain allergenic foods.

Specific allergen tests such as lateral flow dipstick formats were originally designed to detect the presence of the allergens in foodstuffs, and certain extraction procedures are required for optimal performance. This technology has been extended for surface hygiene testing for cleaning validation where the limit of detection is claimed to be 1–20 μg or ppm; however, studies have shown that they only achieve 4–27% recovery and give a qualitative presence/absence result.

Cleaning Assurance for Allergen Control using three High Sensitivity Detection MethodsTable 2 demonstrates shows results from a factory trial where high sensitivity ATP and protein tests provided effective monitoring tools as part of the allergen management program. Before cleaning, all test results were positive; after cleaning, most tests were negative. The ATP test detects residues below that of protein tests and allergen were not detected, thus confirming the highest level of cleaning has been achieved and allergens were absent.

Detecting Allergens in a Ready Meal Factory
A production facility manufacturing ready meals and vegetable dishes for major supermarket retailers but also makes a nut product on a less frequent basis. The site needs to ensure that its cleaning has been effective to remove nut allergens after the manufacturing of nut products and before releasing the production area back to general manufacturing. The products contained three different tree nuts, but for the sake of completeness, nine nut allergens were tested in the cleaning validation exercise, and all nine nut allergens need to be shown to be absent before release of the lines and equipment.

An off-site contract laboratory was used to conduct specific enzyme-linked immunosorbent assay (ELISA)-based allergen tests with a turnaround time of 10 working days during which the production facility could not be used thus losing valuable production time. A minimum of 10 different samples were taken at various points of the production facility and each sample was test for nine tree nut allergens at considerable cost.

Previous cleaning validation exercises using only the specific allergen tests had not always passed first time, thus requiring repeat testing and the production line out of use for further 10 days. This was an extremely costly exercise, and the facility needed a faster, more reliable and cost-effective way to validate the cleaning.

The EnSURE luminometer with SuperSnap gives a high sensitivity ATP test to a sensitivity level of 0.1 fmol ATP, and results were obtained in 15 seconds to give immediate feedback and corrective action. Surfaces that failed at greater than 10 relative light units were cleaned again and retested.

When all surfaces passed with SuperSnap, the surfaces were then swabbed with AllerSnap protein detection swabs and incubated in a portable incubator for 30 minutes. When the protein test gave negative results, the more expensive specific allergen tests were employed. Subsequently all the specific allergen tests were shown to be negative and the line was released back to production.

The staff felt extremely confident that the specific allergen tests would come back negative following the initial prevalidation using the SuperSnap and AllerSnap tests.

Prevalidation screening enabled the site to make significant savings by avoiding repeat testing and further lost production. The hygiene manager commented that the combined method approach was very beneficial in releasing the nut production are back into general production and that  “This process gave me confidence that we would get it right first time with the allergen swabs. This not only saved on cost but more importantly guaranteed food safety. All our allergen swabs came back clear and the area was released back to general production on plan. I would definitely employ this process again.”

The regular use of high sensitivity ATP and protein tests enable high standards of cleaning to be maintained that can be supplemented with specific allergen tests less frequently and as required.

Summary
Cleaning is one the CCPs for allergen control, and a variety of detection methods are available to validate the cleaning processes. Specific allergen tests have their limitations and are expensive whereas met other methods have sensitivity but lack specificity.

A combination of three high sensitivity detection methods (ATP, protein and specific allergen tests) provides a more comprehensive, sensitive and rapid result to deliver a timely and cost-effective solution.

Martin Easter, Hygiena. For more information visit www.hygiena.net


Author(s): Martin Easter, Hygiena

Share This Story

Looking for a reprint of this article?
From high-res PDFs to custom plaques, order your copy today!

Recommended Content

JOIN TODAY
to unlock your recommendations.

Already have an account? Sign In

  • people holding baby chicks

    Serovar Differences Matter: Utility of Deep Serotyping in Broiler Production and Processing

    This article discusses the significance of Salmonella in...
    Microbiological
    By: Nikki Shariat Ph.D.
  • woman washing hands

    Building a Culture of Hygiene in the Food Processing Plant

    Everyone entering a food processing facility needs to...
    Personal Hygiene/Handwashing
    By: Richard F. Stier, M.S.
  • graphical representation of earth over dirt

    Climate Change and Emerging Risks to Food Safety: Building Climate Resilience

    This article examines the multifaceted threats to food...
    Best Practices
    By: Maria Cristina Tirado Ph.D., D.V.M. and Shamini Albert Raj M.A.
Manage My Account
  • eMagazine Subscription
  • Subscribe to eNewsletter
  • Manage My Preferences
  • Website Registration
  • Subscription Customer Service

More Videos

Sponsored Content

Sponsored Content is a special paid section where industry companies provide high quality, objective, non-commercial content around topics of interest to the Food Safety Magazine audience. All Sponsored Content is supplied by the advertising company and any opinions expressed in this article are those of the author and not necessarily reflect the views of Food Safety Magazine or its parent company, BNP Media. Interested in participating in our Sponsored Content section? Contact your local rep!

close
  • mold
    Sponsored byIFC

    Tackling Mold Remediation in Food Processing Plants

  • a worker in a food processing plant
    Sponsored byLPS® DETEX®

    How a Beverage Facility Improved Food Safety and Compliance with Detectable Packaging Solutions

  • Two men standing in a produce storage facility having a discussion.
    Sponsored byOrkin Commercial

    Staying Compliant With FSMA

Popular Stories

sunflower oil

Louisiana Passes ‘MAHA’ Bill Targeting More Than 40 Ingredients, Including Seed Oils, Dyes, Sweeteners

smoked salmon in oil

Study Shows Food Type Significantly Affects Listeria’s Ability to Survive Digestion, Cause Sickness

Justin Ransom and Denise Eblen

USDA-FSIS Announces Dr. Justin Ransom as New Administrator

Events

July 15, 2025

Hygienic Design Risk Management: Industry Challenges and Global Insights

Live: July 15, 2025 at 11:00 am EDT: From this webinar, attendees will learn the importance of hygienic design to ensure food safety and sanitation effectiveness.

July 22, 2025

Beyond the Binder: Digital Management of Food Safety

Live: July 22, 2025 at 3:00 pm EDT: During this webinar, attendees will learn best practices for the use of digital food safety management systems across industry and regulatory agencies.

August 7, 2025

Achieve Active Managerial Control of Major Risk Factors Using a Food Safety Management System

Live: August 7, 2025 at 2:00 pm EDT: From this webinar, attendees will learn about changes to the FDA Food Code, which now includes a requirement for FSMS. 

View All

Products

Global Food Safety Microbial Interventions and Molecular Advancements

Global Food Safety Microbial Interventions and Molecular Advancements

See More Products
Environmental Monitoring Excellence eBook

Related Articles

  • Managed Cleaning Program Facilitates Cost Reductions for Food Processing Facilities

    See More
  • Developing a Cost-effective Sanitation Plan for Small-to-medium Processors

    See More
  • New Inlabtec Serial Diluter UA: A Cost Effective, Greener Upgrade for Serial Dilutions

    See More

Related Products

See More Products
  • 1118396308.jpg

    High Throughput Analysis for Food Safety

  • 1119053595.jpg

    Food Safety for the 21st Century: Managing HACCP and Food Safety throughout the Global Supply Chain, 2E

  • 1119160553.jpg

    Food Safety: Innovative Analytical Tools for Safety Assessment

See More Products

Events

View AllSubmit An Event
  • March 11, 2025

    Change Management of Food Safety Culture: Effective Strategies for Achieving Greatness

    On Demand: During this webinar, attendees will gain practical knowledge on successful food safety culture change programs and transformation journeys from real-world experiences, enabling attendees to navigate challenges and achieve lasting improvements in their FSC initiatives.
View AllSubmit An Event

Related Directories

  • Air Cleaning Blowers LLC

    Air Cleaning Blowers™ (ACBs) blow and clean air in the world’s toughest conditions without filter elements. Without filter media to clog or maintain, ACBs qualify as first truly-sustainable air-filtration systems. The multi-patented technology has proven its worth in powdered-food packaging, air compressors, HVAC and production lines globally. ACBs attain full effectiveness immediately, unlike media filters that must first partially clog to reach rated effectiveness.
  • ELISA Technologies Inc.

    Since 1991, we’ve been committed to reliable and cost-effective testing solutions. Our facility is certified to ISO 9001 for manufacturing, including the first PTM certified gluten test kit (EZ Gluten) and the USDA recommended meat speciation kits. We are accredited to ISO 17025 for allergen testing and meat speciation.
×

Never miss the latest news and trends driving the food safety industry

eNewsletter | Website | eMagazine

JOIN TODAY!
  • RESOURCES
    • Advertise
    • Contact Us
    • Directories
    • Store
    • Want More
  • SIGN UP TODAY
    • Create Account
    • eMagazine
    • eNewsletter
    • Customer Service
    • Manage Preferences
  • SERVICES
    • Marketing Services
    • Reprints
    • Market Research
    • List Rental
    • Survey/Respondent Access
  • STAY CONNECTED
    • LinkedIn
    • Facebook
    • Instagram
    • X (Twitter)
  • PRIVACY
    • PRIVACY POLICY
    • TERMS & CONDITIONS
    • DO NOT SELL MY PERSONAL INFORMATION
    • PRIVACY REQUEST
    • ACCESSIBILITY

Copyright ©2025. All Rights Reserved BNP Media.

Design, CMS, Hosting & Web Development :: ePublishing