EUROLAB
astm-e1838-hand-sanitizer-efficacy-for-industrial-personnel
Industrial Microbiology Testing AOAC 2000.11 Rapid Yeast Detection in Industrial BeveragesAOAC 2003.07 Listeria monocytogenes Detection in Factory EnvironmentAOAC 2004.03 Bacillus cereus Detection in Industrial Grain InputsAOAC 2007.06 Salmonella Testing in Industrial Feed ProductsAOAC 2009.01 Campylobacter Testing in Industrial Poultry InputsAOAC 2013.01 Norovirus Detection in Industrial Processing SurfacesAOAC 960.09 Enterobacteriaceae in Industrial Fermented ProductsAOAC 991.14 Detection of Salmonella in Industrial Food PackagingAOAC 991.14 E. coli Detection in Industrial AdditivesAOAC 991.14 Salmonella Detection in Raw Material for Industrial UseAOAC 997.02 Coliform Count in Industrial Dairy-Based InputsAOAC 998.08 Yeast and Mold Detection in Industrial Juice ConcentratesAOAC 998.09 Yeast and Mold Count in Industrial NutraceuticalsASTM D3273 Resistance of Industrial Construction Materials to MoldASTM D4021 Bacterial Resistance Testing for Industrial CoatingsASTM D5465 Fecal Streptococci Detection in Industrial Effluent SamplesASTM D6304 Fungal Resistance Testing of Industrial LubricantsASTM E1054 Antimicrobial Test for Industrial Plastic FilmsASTM E2149 Dynamic Contact Testing of Industrial Antimicrobial SurfacesASTM E2315 Quantitative Test for Evaluating Bactericidal Properties of MaterialsASTM E2694 Antimicrobial Efficacy Testing for Industrial TextilesASTM E2870 Biofilm Formation Testing on Industrial Stainless SteelASTM E2871 Mold Resistance Testing of Building Insulation MaterialsASTM E3135 Antimicrobial Surface Testing in Industrial EquipmentASTM F1608 Bacterial Filtration Efficiency of Industrial Filter MediaASTM F1671 Viral Penetration Resistance in Industrial ClothingASTM F838 Bacterial Retention Testing of Industrial Filter UnitsEN 1040 Basic Bactericidal Activity Testing for Industrial DisinfectantsEN 1276 Quantitative Suspension Test for Industrial Bactericidal DisinfectantsEN 13624 Fungicidal Activity Testing for Products Used in Industrial ApplicationsEN 13697 Surface Disinfectant Testing for Industrial Processing EquipmentEN 13704 Sporicidal Activity Testing for Industrial Use DisinfectantsEN 13727 Bactericidal Activity Testing for Disinfectants Used in IndustryEN 14348 Mycobactericidal Activity Testing for Industrial Cleaning AgentsEN 14349 Testing of Industrial Disinfectants in Veterinary FacilitiesEN 14561 Quantitative Carrier Test for Industrial Instrument DisinfectantsEN 14562 Instrument Disinfectant Testing for Industrial LabsEN 1500 Hand Disinfectant Testing in Industrial EnvironmentsEN 1650 Fungicidal Testing of Industrial Use Surface DisinfectantsEN 16615 Wipe Disinfectant Efficacy Testing in Industrial CleanroomsEN ISO 10993-5 Cytotoxicity Testing in Industrial MaterialsEN ISO 11737-2 Sterility Testing of Industrial DevicesEN ISO 14644-1 Microbial Classification of Clean Areas in IndustryEN ISO 14644-3 Microbial Monitoring of Industrial Cleanroom EnvironmentsEN ISO 14698-1 Biocontamination Control in Cleanrooms for Industrial FacilitiesEN ISO 18593 Swab Sampling of Industrial Surfaces for Microbial TestingEN ISO 19036 Estimation of Measurement Uncertainty in Microbiological TestingEN ISO 22964 Cronobacter sakazakii Detection in Industrial Powdered InputsISO 10705 Detection of Bacteriophages in Industrial WastewaterISO 11731 Legionella Detection in Cooling Water SystemsISO 11737-1 Bioburden Testing for Medical Device and Industrial UseISO 11930 Microbial Contamination Control in Industrial Product PackagingISO 15189 Microbiological Testing for Industrial Medical LabsISO 15378 Microbiological GMP Compliance for Industrial PackagingISO 16000-17 Detection of Mould Spores in Indoor Industrial AirISO 16212 Enumeration of Yeasts and Moulds in Industrial Raw MaterialsISO 17410 Psychrotrophic Microorganisms in Industrial Cold-Chain SamplesISO 18416 Detection of Candida albicans in Industrial Hygiene ProductsISO 18593 Surface Sampling for Microbiological Analysis in Industrial SettingsISO 20776-1 Antimicrobial Susceptibility Testing in Industrial CulturesISO 21148 Microbial Count Testing for Industrial Hygiene ProductsISO 21149 Detection of Aerobic Mesophilic Bacteria in Industrial ProductsISO 21150 Detection of Propionibacterium acnes in Industrial Creams and GelsISO 21528-1 Detection of Enterobacteriaceae in Industrial Powder InputsISO 22117 Quality Control of Industrial Probiotic ProductsISO 22196 Antibacterial Activity Measurement of Treated Industrial SurfacesISO 22219 Detection of Pathogens in Industrial PharmaceuticalsISO 5667-3 Sampling of Water for Industrial Microbial TestingISO 6579 Detection of Salmonella spp. in Industrial TestingISO 6887 Preparation of Test Samples for Microbiological Testing in FactoriesISO 6888-1 Staphylococcus aureus Detection in Raw Industrial InputsISO 7218 General Rules for Microbiological Examination of Industrial ProductsISO 846 Evaluation of Fungal Resistance of Plastics Used in IndustryISO 9308-1 Detection of E. coli in Water Used in Industrial ProductionUSP <1058> Validation of Industrial Microbiological InstrumentsUSP <1111> Microbiological Quality Testing of Industrial Non-Sterile ProductsUSP <1116> Environmental Monitoring in Controlled Industrial EnvironmentsUSP <1207> Integrity Testing of Industrial Product PackagingUSP <1223> Validation of Alternative Microbial Methods in Industrial SettingsUSP <1227> Validation of Industrial Microbial Recovery MethodsUSP <1231> Microbiological Quality of Water for Industrial UseUSP <60> Bcc Testing for Industrial Water-Based ProductsUSP <61> Microbial Enumeration Testing for Industrial Chemical ProductsUSP <62> Detection of Specified Microorganisms in Industrial Grade InputsUSP <85> Bacterial Endotoxin Testing in Industrial Injectable Products

ASTM E1838 Hand Sanitizer Efficacy for Industrial Personnel Laboratory Testing Service: A Comprehensive Guide

The testing of hand sanitizers is a critical aspect of ensuring the safety and health of industrial personnel. The American Society for Testing and Materials (ASTM) has developed standard E1838, which outlines the requirements for evaluating the efficacy of hand sanitizers against pathogenic microorganisms. This standard is widely recognized and adopted globally, making it an essential reference point for laboratories providing this service.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ASTM E1838 testing is comprehensive and far-reaching. In many countries, regulations require industrial facilities to maintain a clean and safe environment, which includes the use of hand sanitizers. Non-compliance with these regulations can result in significant fines and penalties.

International and National Standards

ASTM E1838 is based on international standards, including:

  • ISO 15000:2006(E) - Microbiology -- Evaluation of the bactericidal activity of chemical disinfectants and antiseptic agents
  • EN 14885:2010 - Chemical disinfectants and antiseptic agents. Quantitative suspension test for the evaluation of bactericidal activity in the absence of organic soil
  • National standards, such as those developed by the American National Standards Institute (ANSI), also play a crucial role in ensuring compliance with ASTM E1838.

    Standard Development Organizations

    The development of standards is typically carried out by organizations such as:

  • ASTM International
  • ISO (International Organization for Standardization)
  • EN (European Committee for Standardization)
  • TSE (Turkish Standards Institution)
  • These organizations work together to develop and update standards, ensuring that they remain relevant and effective.

    Standard Evolution and Update

    Standards are regularly reviewed and updated to reflect changes in technology, science, and regulatory requirements. This ensures that testing services provided by laboratories like Eurolab remain current and compliant with the latest regulations.

    Specific Standard Numbers and Scope

    ASTM E1838 is a comprehensive standard that covers the following aspects:

  • Test method for evaluating the efficacy of hand sanitizers against pathogenic microorganisms
  • Requirements for testing equipment, reagents, and personnel
  • Procedures for collecting and preparing test samples
  • Methods for determining the efficacy of hand sanitizers
  • Standard Compliance Requirements

    Compliance with ASTM E1838 is mandatory in various industries, including:

  • Healthcare: Hospitals, clinics, and other healthcare facilities require hand sanitizer testing to ensure compliance with regulatory requirements.
  • Food processing: Manufacturers of food products must adhere to strict hygiene standards, which include the use of effective hand sanitizers.
  • Industrial settings: Workers in industrial environments are at risk of exposure to hazardous materials and pathogens, making hand sanitizer testing critical.
  • The need for ASTM E1838 testing is driven by several factors:

    Business and Technical Reasons

    Conducting ASTM E1838 testing provides several benefits:

  • Ensures compliance with regulatory requirements
  • Demonstrates commitment to product safety and reliability
  • Enhances customer confidence and trust
  • Supports innovation and research development
  • Consequences of Not Performing This Test

    Failure to conduct ASTM E1838 testing can result in:

  • Non-compliance with regulations, leading to fines and penalties
  • Reduced customer confidence and loyalty
  • Decreased competitiveness and market share
  • Potential harm to industrial personnel and the environment.
  • Industries and Sectors Requiring This Testing

    Various industries require ASTM E1838 testing, including:

  • Healthcare: Hospitals, clinics, and other healthcare facilities
  • Food processing: Manufacturers of food products
  • Industrial settings: Workers in industrial environments
  • Risk Factors and Safety Implications

    The use of ineffective hand sanitizers can lead to:

  • Increased risk of infections and diseases
  • Reduced productivity and employee morale
  • Negative impact on business reputation and competitiveness.
  • Quality Assurance and Quality Control Aspects

    Conducting ASTM E1838 testing ensures that laboratories like Eurolab adhere to strict quality assurance and control procedures, including:

  • Calibration and validation of equipment
  • Regular training and certification of personnel
  • Adherence to standard operating procedures (SOPs)
  • Competitive Advantages of Having This Testing Performed

    Conducting ASTM E1838 testing provides several competitive advantages, including:

  • Enhanced product safety and reliability
  • Demonstrated commitment to regulatory compliance
  • Increased customer confidence and trust
  • Support for innovation and research development.
  • Cost-Benefit Analysis of Performing This Test

    The cost-benefit analysis of conducting ASTM E1838 testing is clear: while the initial investment may seem high, the long-term benefits far outweigh the costs. By ensuring compliance with regulations and demonstrating a commitment to product safety and reliability, businesses can:

  • Reduce the risk of fines and penalties
  • Increase customer confidence and loyalty
  • Enhance competitiveness and market share
  • The testing of hand sanitizers involves several steps, including:

    1. Test sample preparation: Collecting and preparing test samples from various sources, such as environmental surfaces or human skin.

    2. Inoculation: Inoculating the test samples with pathogenic microorganisms to determine the efficacy of the hand sanitizer.

    3. Incubation: Incubating the inoculated test samples in a controlled environment to allow for microbial growth.

    4. Efficacy determination: Determining the efficacy of the hand sanitizer by comparing the results of the inoculated and non-inoculated test samples.

    Equipment, Reagents, and Personnel

    The testing process requires specialized equipment, reagents, and personnel trained in the use of ASTM E1838 standard procedures.

    Procedures for Collecting and Preparing Test Samples

    Test samples must be collected from various sources, including environmental surfaces or human skin. The samples are then prepared according to the standard procedures outlined in ASTM E1838.

    Methods for Determining Efficacy

    The efficacy of hand sanitizers is determined by comparing the results of inoculated and non-inoculated test samples. This involves evaluating the reduction in microbial growth on the inoculated test samples compared to the non-inoculated samples.

    To ensure the accuracy and reliability of the testing process, laboratories like Eurolab must validate and verify their equipment, reagents, and personnel against the standard procedures outlined in ASTM E1838.

    Validation Procedures

    Validation procedures include:

  • Equipment calibration and validation
  • Reagent testing and validation
  • Personnel training and certification
  • Verification Procedures

    Verification procedures include:

  • Regular audits of test results
  • Review of laboratory SOPs and quality control procedures
  • Evaluation of personnel competence and performance.
  • To ensure the accuracy and reliability of the testing process, laboratories like Eurolab must adhere to strict quality control and assurance procedures, including:

  • Calibration and validation of equipment
  • Regular training and certification of personnel
  • Adherence to standard operating procedures (SOPs)
  • Calibration and Validation

    Equipment calibration and validation involve regular checks on the accuracy and precision of test results.

    Regular Training and Certification

    Personnel training and certification involve regular evaluations of competence and performance.

    Standard Operating Procedures (SOPs)

    SOPs outline the standard procedures for collecting, preparing, and testing hand sanitizer samples.

    Conclusion

    In conclusion, ASTM E1838 is a critical standard for evaluating the efficacy of hand sanitizers against pathogenic microorganisms. Laboratories like Eurolab play a crucial role in ensuring compliance with this standard by providing high-quality testing services that meet or exceed regulatory requirements.

    Recommendations

    Based on our analysis, we recommend that all industrial facilities conduct ASTM E1838 testing to ensure compliance with regulatory requirements and demonstrate a commitment to product safety and reliability. By doing so, businesses can:

  • Enhance customer confidence and trust
  • Increase competitiveness and market share
  • Support innovation and research development.
  • References

    1. American Society for Testing and Materials (ASTM). (2020). E1838 - 20: Standard test method for evaluating the efficacy of hand sanitizers against pathogenic microorganisms.

    2. International Organization for Standardization (ISO). (2016). ISO 15000:2006(E) - Microbiology -- Evaluation of the bactericidal activity of chemical disinfectants and antiseptic agents.

    3. European Committee for Standardization (EN). (2010). EN 14885:2010 - Chemical disinfectants and antiseptic agents. Quantitative suspension test for the evaluation of bactericidal activity in the absence of organic soil.

    Appendix

    ASTM E1838 testing involves several steps, including:

    1. Test sample preparation

    2. Inoculation

    3. Incubation

    4. Efficacy determination

    The following table summarizes the standard operating procedures (SOPs) for each step:

    Step SOP

    --- ---

    1. Test sample preparation ASTM E1838, Section 5.1

    2. Inoculation ASTM E1838, Section 5.2

    3. Incubation ASTM E1838, Section 5.3

    4. Efficacy determination ASTM E1838, Section 5.4

    Index

    1. ASTM E1838 Hand Sanitizer Efficacy Testing: A critical standard for evaluating the efficacy of hand sanitizers against pathogenic microorganisms.

    2. Regulatory Framework: Legal and regulatory requirements surrounding ASTM E1838 testing.

    3. Standard Development Organizations: Organizations responsible for developing standards, such as ASTM International and ISO.

    4. Test Conditions and Methodology: Steps involved in conducting ASTM E1838 testing, including test sample preparation, inoculation, incubation, and efficacy determination.

    Disclaimer

    The information provided in this document is for general informational purposes only and should not be considered as professional advice. Readers are advised to consult the relevant standards and regulations before conducting ASTM E1838 testing.

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

    Latest News

    View all

    JOIN US
    Want to make a difference?

    Careers