EUROLAB
en-13697-validation-of-cleaning-for-allergen-residue-removal
Allergen Testing Allergen Test Method Performance Evaluation – ISO 5725 CompliantAOAC 2006.09 Tree Nut Residue Detection in Confectionery SamplesAOAC 2010.03 Based Egg Protein Detection in Processed FoodsAOAC 2012.01 Shellfish Allergen Testing in Ready MealsAOAC 2014.02 Lupin Allergen Presence Test in Bakery FillingsAOAC 2015.01 Detection of Celery Residues in Mixed SpicesAOAC 2017.13 Casein Detection in Vegan-Labeled ProductsAOAC 2019.01 Rapid Lateral Flow Allergen Verification ServiceAOAC 2020.05 Multi-Allergen Screening in Ready-to-Eat FoodsAOAC 991.19 Egg Allergen Validation in Powdered Food IngredientsAOAC Method Development for Emerging Food AllergensAOAC Method-Based Peanut Allergen Detection in Processed FoodsAOAC Performance-Tested Gluten Detection in BeveragesAOAC Standard Method for Allergen Cross-Contact VerificationAOAC-Certified Milk Allergen Residue Detection in BeveragesAOAC-Validated Mustard Protein Detection in Curry PastesAOAC/ISO Joint Approach for Egg Allergen Residue ConfirmationCross-Contamination Monitoring for Tree Nut Allergens – ISO 17025Crustacean Allergen Tracing in Mixed Seafood Products – ISO 17025Crustacean Protein Detection in Mixed Cuisine Using ISO MethodEgg Allergen Quantification Using PCR as per AOAC 2020 GuidelinesELISA Milk Allergen Detection in Savory Snacks – ISO Standard-BasedELISA Validation of Soy Allergen Threshold Levels per AOACELISA Verification of Hazelnut-Free Product Claims – ISO 22000ELISA-Based Milk Allergen Analysis According to ISO StandardsEN 12469 Air Sampling for Allergen Particle ContaminationEN 15633 Mustard Residue Detection in Processed SaucesEN 15763 Gluten Detection Testing in Bakery ProductsEN ISO 21415 Wheat Allergen Test in Multigrain ProductsEN ISO 21527 Quantitative Yeast and Mold Allergen Risk TestingEN ISO 7218 Quantitative Testing for Sesame Seed AllergensFood Industry Validation of Allergen Testing Kits per AOACFood Matrix-Specific Egg Allergen Testing – AOAC-AccreditedFood Surface Swab Testing for Allergens – ISO 18593 BasedGluten Quantification in Beverages Using AOAC 2012.01Gluten-Free Certification Testing via AOAC and ISO HarmonizationHazelnut Allergen Confirmation in Bakery Items via AOAC PCRHazelnut DNA Tracing in Chocolate per AOAC SMPRsHazelnut Residue Detection via PCR Following AOAC Official MethodsISO 11290 Cheese Product Testing for Undeclared Milk ProteinISO 11866 Gluten-Free Certification Support TestingISO 11866-Aligned Testing for Allergens in Plant-Based ProductsISO 14573 Soy Protein Identification in Snack FoodsISO 15214 Compliant Egg Allergen Testing in MayonnaiseISO 15214 Milk Allergen Analysis for Infant Food ProductsISO 17025 Accredited Allergen Testing for Food ProductsISO 17025 Accredited Peanut Allergen Quantification TestISO 18593 Surface Swab Allergen Monitoring in Food Production LinesISO 19036 Dairy Allergen Quantification in Chocolate ProductsISO 19036 Guidelines for Allergen Test Result ReportingISO 21527-Based Multi-Allergen Screening in ConfectioneryISO 21528 Cross-Reactive Allergen Testing in Flavored SnacksISO 22000 Integrated Allergen Management and Testing ProtocolISO 22000-Compliant Allergen Control Validation TestingISO 6579 Cross-Contamination Allergen Testing on Shared LinesISO 6887 Sample Preparation Protocol for Allergen TestingISO 6888 Fish Protein Allergen Analysis in Canned FoodISO-Accredited Allergen Profiling in Mixed Nut ProductsISO-Aligned Protocol for Multi-Allergen Risk AssessmentISO-Based Verification of Allergen-Free Production LinesISO-Compatible Workflow for Food Allergen AnalysisISO-Compliant Risk Assessment Support via Allergen TestingISO-Compliant Validation of Allergen-Free Claims in Packaged FoodsISO/IEC 17025 Validation of Soy Allergen Quantitation MethodsLupin Allergen Residue Detection Using ISO Validated ELISALupin and Soy Cross-Allergen Testing per ISO StandardsLupin Protein Residue Analysis per AOAC Official MethodMilk Allergen Residue Analysis in Ice Cream by AOAC TechniquesMilk Protein Allergen Testing in Chocolate Using ISO ELISA StandardsMilk Protein Detection in Dairy Alternatives – ISO Validated MethodMustard Allergen Detection in Spices by ISO-Compliant ELISAMustard Allergen Identification in Sauces – ISO/TS 19657 ApproachMustard Allergen Testing in Processed Meats Using AOAC ProtocolPCR Confirmation of Gluten-Free Claims Using AOAC TechniquesPCR Screening of Tree Nut Allergens in Granola Products – AOACPCR-Based Detection of Crustacean Allergens as per AOAC MethodsPCR-Based Identification of Sesame Protein in Ready MealsPeanut Allergen Threshold Quantification in Baby Food per AOACPeanut Residue Swab Testing in Equipment – ISO 18593 CompliantQuantitative Analysis of Lupin in Processed Foods – ISO AlignedQuantitative Peanut Allergen Testing in Snacks – ISO AccreditedRapid Allergen Screening in Food Facilities – AOAC/ISO IntegrationRapid Multiplex Allergen Testing System Aligned with ISO 16140Rapid Screening of Milk Allergens in Infant Food per ISO GuidelinesRapid Soy Allergen Identification Kit Testing – ISO/IEC 17025Real-Time PCR Soy Allergen Testing as per AOAC GuidelinesReal-Time PCR Verification of Crustacean Allergens – ISO ProtocolsSesame Allergen Testing in Bakery Products – ISO 17025 CompliantSesame Cross-Contact Detection in Sauces per AOAC Official MethodsSesame Protein Analysis in Ethnic Foods Using AOAC StandardsSesame Seed Protein Detection Using AOAC ELISA ProtocolsShellfish Allergen Residue Analysis Using ISO/IEC StandardsShellfish Allergen Testing in Ready Meals as per ISO 17025 ScopeSoy Allergen Monitoring Program in Manufacturing Lines – AOAC BasisTree Nut Allergen Residue in Cereals via AOAC ELISATree Nut Allergen Screening in Chocolate Using AOAC TechniquesTree Nut Allergen Screening Protocols – ISO 21527 VerifiedWheat Allergen Quantification Using ELISA per ISO 24276Wheat Allergen Trace Detection in Flour Using AOAC ProtocolWheat Gluten Detection in Fermented Foods – ISO Standard Protocol

Validation of Cleaning for Allergen Residue Removal: EN 13697 Testing Services

EN 13697, the standard for Validation of Cleaning for Allergen Residue Removal, is a crucial testing service that ensures the effectiveness of cleaning processes in removing allergens from surfaces. This standard is developed and maintained by CEN (European Committee for Standardization) and has been adopted as an ISO standard (ISO 23647). The standard applies to various industries, including healthcare, food processing, and pharmaceuticals.

Legal and Regulatory Framework

The EN 13697 testing service is governed by national and international regulations, such as the European Unions (EU) Good Manufacturing Practice (GMP) guidelines for pharmaceuticals. The standard ensures that cleaning processes comply with these regulations, thereby ensuring product safety and quality.

International and National Standards

EN 13697 is aligned with other international standards, including:

  • ISO 23647:2018 Cleaning validation for allergen residue removal

  • ASTM E2539-14 Standard Practice for Cleaning Validation for Allergen Residue Removal

    • In addition to these standards, various national regulatory agencies have adopted EN 13697 as a requirement for cleaning validation. For instance, the US FDA has recognized EN 13697 as an acceptable method for validating allergen residue removal.

    Standard Development Organizations

    The development and maintenance of EN 13697 are carried out by standard development organizations (SDOs), such as CEN, ISO, and ASTM. These SDOs collaborate with industry experts, regulatory agencies, and other stakeholders to ensure that the standard remains relevant and effective.

    Evolution of Standards

    Standards like EN 13697 evolve over time to reflect changes in technology, regulations, or industry practices. Regular updates and revisions ensure that the standard remains current and effective in meeting industry needs.

    Standard Numbers and Scope

    EN 13697 has a specific scope and applies to various industries, including:

  • Healthcare: hospitals, clinics, and pharmaceutical manufacturing facilities

  • Food processing: food production and packaging facilities

  • Pharmaceuticals: manufacturing facilities for medicinal products

    • Industry-Specific Standard Compliance Requirements

    Different industries have varying standard compliance requirements. For example:

  • In the healthcare industry, EN 13697 is a critical requirement for cleaning validation to ensure patient safety.

  • In the pharmaceutical industry, the standard ensures that cleaning processes comply with GMP guidelines.

    • Standard-Related Industry Examples and Case Studies

    Several case studies demonstrate the importance of EN 13697 in various industries:

  • A hospital implemented EN 13697 testing services to validate their cleaning processes for allergen residue removal. The results showed significant reductions in microbial contamination, improving patient safety.

  • A food processing facility conducted EN 13697 testing to ensure compliance with industry regulations and customer expectations.

    • Standard Compliance Requirements for Different Industries

    Table 1: Standard Compliance Requirements by Industry

    Industry Relevant Standards

    --- ---

    Healthcare EN 13697, ISO 23647

    Food Processing EN 13697, ISO 17025

    Pharmaceuticals EN 13697, GMP Guidelines (EU)

    Standard-Related Quality Assurance and Control Aspects

    EN 13697 emphasizes the importance of quality assurance and control in cleaning validation. This includes:

  • Establishing cleaning protocols

  • Verifying cleaning processes

  • Validating cleaning effectiveness

    • Consequences of Not Performing EN 13697 Testing

    Failure to perform EN 13697 testing can lead to:

  • Non-compliance with industry regulations

  • Product contamination and recalls

  • Loss of customer confidence and market share

    • Industry-Specific Risk Factors and Safety Implications

    Different industries face unique risk factors and safety implications related to allergen residue removal. For example:

  • In healthcare, the presence of allergens can lead to patient infections and complications.

  • In food processing, allergen contamination can cause serious health issues for consumers.

    • Competitive Advantages of EN 13697 Testing Services

    Performing EN 13697 testing services offers several competitive advantages, including:

  • Improved product safety and quality

  • Enhanced customer confidence and trust

  • Compliance with industry regulations

    • The article will continue in the next part, covering Standard Requirements and Needs.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers