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iso-21528-2-swab-testing-for-enterobacteriaceae-on-contact-surfaces
Food Contact Surface Swab Testing AOAC 2006.02 Surface Testing for Pathogenic MicroorganismsAOAC 2007.07 Microbial Enumeration on Food Contact SurfacesAOAC 2008.02 Swab Testing for Clostridium PerfringensAOAC 2009.01 Surface Swab Testing for Clostridium BotulinumAOAC 2012.05 ATP Surface Testing for Rapid Cleanliness AssessmentAOAC 960.52 Surface Testing for Spoilage MicroorganismsAOAC 961.02 ATP Bioluminescence Testing on Food Contact SurfacesAOAC 990.12 Surface Sampling for Salmonella DetectionAOAC 991.08 Surface Swabbing for Yeast and Mold DetectionAOAC 991.14 Swab Sampling for Bacillus Cereus DetectionAOAC 991.39 Surface Testing for Salmonella in Food PlantsAOAC 995.02 Surface Swab Testing for Listeria in Dairy ProcessingAOAC Official Method for Surface Swab Testing of E. coliAOAC Official Method for Surface Testing of Food Allergen ResiduesEU Commission Decision 2015/712 Surface Testing Standards EnforcementEU Directive 2004/37 Surface Testing for Hazardous Substance ResiduesEU Food Hygiene Regulation Swab Testing in Food Contact AreasEU Regulation 2019/1381 Transparency in Surface Testing ProtocolsEU Regulation 2073/2005 Swab Sampling Compliance for Food SurfacesEU Regulation 852/2004 Hygiene Monitoring via Surface SwabbingFDA 21 CFR Surface Swab Testing Protocols for Ready-to-Eat FoodsFDA 21 CFR Surface Swabbing in Meat and Poultry ProcessingFDA Bacteriological Surface Swab Testing per BAM Chapter 3FDA BAM Surface Swabbing for Pathogen Recovery EfficiencyFDA Guidance on Surface Swab Sampling ValidationFDA Surface Swab Testing for Cross-Contamination PreventionFDA Surface Testing Protocols for RTE Food Processing LinesISO 11133 Preparation of Microbial Cultures for Surface TestingISO 11290-1 Surface Swab Testing for Listeria MonocytogenesISO 11464 Sample Preparation Procedures for Surface TestingISO 11607-1 Surface Testing of Packaging Materials for ContaminantsISO 11737-1 Sterility Testing via Surface Swabs in Food FacilitiesISO 14698 Environmental Surface Testing for Cleanroom CertificationISO 14698-1 Biocontamination Control in Surface TestingISO 14698-2 Surface Bioburden Monitoring in Food ProcessingISO 15189 Surface Testing in Medical Food Handling EnvironmentsISO 15216-2 Norovirus and Hepatitis A Virus Detection via Surface SwabsISO 17025 Accredited Surface Swab Testing for Microbial ContaminationISO 17025 Validation of Swabbing Equipment and MaterialsISO 18593 Environmental Sampling by Swabbing for Hygiene MonitoringISO 18593 Sampling for Surface Hygiene in Food Industry PremisesISO 18593 Surface Swab Testing for Staphylococcus AureusISO 18593 Swabbing Methods for Surface Allergen TestingISO 18593 Swabbing Techniques for Surface Contamination ControlISO 18593 Validation of Swabbing Techniques for Surface MicrobiologyISO 21469 Surface Testing for Food Grade LubricantsISO 21528-1 Surface Swab Methods for Total ColiformsISO 22000 Incorporating Surface Testing into Food Safety ManagementISO 22196 Measurement of Antibacterial Activity on Plastic SurfacesISO 22196 Surface Testing for Antimicrobial Coatings on Food EquipmentISO 22196 Testing Antimicrobial Properties on Stainless Steel SurfacesISO 22196 Testing for Surface Disinfectant EffectivenessISO 6579 Surface Swabbing for Salmonella Detection in Food IndustryISO 9001 Hygiene Surface Testing as Part of Quality Management

ISO 21528-2 Swab Testing for Enterobacteriaceae on Contact Surfaces: Eurolabs Laboratory Testing Service

ISO 21528-2 is an international standard that specifies the requirements for swab testing for Enterobacteriaceae on contact surfaces. The standard is developed by the International Organization for Standardization (ISO) and is part of the ISO 21528 series, which deals with microbiological analysis of non-sterile products.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 21528-2 testing is governed by various international and national standards. In Europe, for example, the standard is aligned with the European Unions (EU) requirements for product safety and quality. The EUs General Product Safety Directive (GPSD) sets out the general principles for ensuring product safety, including microbiological safety.

International and National Standards

The following international and national standards apply to ISO 21528-2 testing:

  • ISO 21528-2:2017

  • ASTM E2197-13

  • EN 12098-1:2008

  • TSE (Turkish Standards Institution) TS 11429

    • Standard Development Organizations

    The standard development organizations involved in the creation and maintenance of ISO 21528-2 include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution of Standards

    Standards evolve over time to reflect changes in technology, market needs, and regulatory requirements. New versions of standards may be published to update testing methodologies, equipment, or materials.

    Specific Standard Numbers and Scope

    The following standard numbers are relevant to ISO 21528-2:

  • ISO 21528-2:2017 - Microbiological analysis of non-sterile products

  • ASTM E2197-13 - Determination of the presence of Enterobacteriaceae on contact surfaces

    • Standard Compliance Requirements for Different Industries

    Different industries have varying compliance requirements for ISO 21528-2 testing. Some examples include:

  • Medical devices: ISO 21528-2 is a mandatory requirement for medical device manufacturers.

  • Food processing: ISO 21528-2 is recommended for food processing companies to ensure product safety.

    • Why This Specific Test Is Needed

    ISO 21528-2 testing is required for several reasons:

  • Product Safety: To prevent the spread of bacterial contamination on contact surfaces.

  • Regulatory Compliance: To meet international and national regulatory requirements.

  • Quality Assurance: To ensure product quality and safety.

    • Business and Technical Reasons for Conducting ISO 21528-2 Testing

    Conducting ISO 21528-2 testing provides several benefits, including:

  • Risk Reduction: Reduces the risk of bacterial contamination on contact surfaces.

  • Compliance: Ensures compliance with regulatory requirements.

  • Quality Improvement: Enhances product quality and safety.

    • Consequences of Not Performing This Test

    Failing to perform ISO 21528-2 testing can result in:

  • Product Recalls: Mandatory recalls due to bacterial contamination.

  • Regulatory Fines: Fines imposed by regulatory authorities for non-compliance.

  • Reputation Damage: Negative impact on company reputation and customer trust.

    • Industries and Sectors That Require This Testing

    The following industries and sectors require ISO 21528-2 testing:

  • Medical devices

  • Food processing

  • Pharmaceutical manufacturing

  • Cosmetics manufacturing

    • Risk Factors and Safety Implications

    Bacterial contamination on contact surfaces poses significant risks, including:

  • Product Contamination: Transfer of bacteria to products.

  • Public Health Risks: Spread of bacterial diseases.

  • Reputational Damage: Negative impact on company reputation.

    • Quality Assurance and Quality Control Aspects

    ISO 21528-2 testing is an essential component of quality assurance and quality control programs, ensuring:

  • Consistency: Consistent testing results across different batches.

  • Accuracy: Accurate detection of bacterial contamination.

  • Reliability: Reliable testing equipment and personnel.

    • Contribution to Product Safety and Reliability

    ISO 21528-2 testing contributes significantly to product safety and reliability by:

  • Detecting Contamination: Detecting bacterial contamination on contact surfaces.

  • Preventing Recalls: Preventing mandatory recalls due to bacterial contamination.

  • Enhancing Customer Trust: Enhancing customer trust through consistent quality.

    • Competitive Advantages of Having This Testing Performed

    Conducting ISO 21528-2 testing provides several competitive advantages, including:

  • Market Differentiation: Distinguishes companies from competitors through enhanced product safety and reliability.

  • Increased Sales: Increased sales due to enhanced product safety and reliability.

  • Improved Customer Satisfaction: Improved customer satisfaction through consistent quality.

    • Eurolab offers ISO 21528-2 testing services for various industries, including medical devices, food processing, pharmaceutical manufacturing, and cosmetics manufacturing. Our laboratory is equipped with state-of-the-art equipment and follows strict quality control procedures to ensure accurate and reliable testing results.

    Our ISO 21528-2 testing service includes:

  • Sampling: Collection of contact surface samples.

  • Preparation: Preparation of samples for analysis.

  • Analysis: Analysis of samples using approved methodologies.

  • Reporting: Reporting of test results in compliance with regulatory requirements.

    • Quality Management System

    Eurolabs quality management system is based on ISO 9001:2015, ensuring consistent testing results and adherence to regulatory requirements. Our laboratory personnel are trained and certified to perform ISO 21528-2 testing, ensuring accuracy and reliability.

    Conclusion

    ISO 21528-2 testing is an essential component of product safety and quality assurance programs. Conducting ISO 21528-2 testing provides several benefits, including risk reduction, compliance with regulatory requirements, and quality improvement. Eurolab offers ISO 21528-2 testing services for various industries, ensuring accurate and reliable testing results.

    References

  • ISO 21528-2:2017 - Microbiological analysis of non-sterile products

  • ASTM E2197-13 - Determination of the presence of Enterobacteriaceae on contact surfaces

  • EN 12098-1:2008 - Non-sterile pharmaceutical products - General information and requirements for non-sterile pharmaceutical products

    • Appendices

    Appendix A: Glossary of Terms

    Appendix B: Abbreviations

    Appendix C: Bibliography

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