EUROLAB
ep-2612-total-aerobic-microbial-count-testing
Microbiological Quality Testing AFNOR NF T73-101 Microbial Preservation Testing for CosmeticsANSM Challenge Testing of Natural Cosmetic FormulasANSM Microbiological Control of Non-Sterile Cosmetic ProductsANVISA RDC 481/2021 Microbial Control for Brazilian Cosmetic ProductsAOAC 2003.07 Challenge Test for Cosmetic CreamsAOAC 991.14 Microbial Contamination Detection in Personal Care ProductsAOAC 997.02 Microbial Quality of ToiletriesASTM D4014 Test for Microbial Growth on Lotions and CreamsASTM D5338 Biodegradation and Microbial Interaction in CosmeticsASTM D7983 Testing for Bacterial Endotoxins in Eye-area CosmeticsASTM E1326 Viable Organism Testing in Aerosolized Cosmetic ProductsASTM E2180 Antimicrobial Efficacy Testing of Preservative SystemsASTM E2275 Skin Antiseptic Residual Activity TestingASTM E2315 Time-Kill Assessment of Antimicrobial ActivityASTM E2613 Microbial Analysis of Water Used in CosmeticsASTM E2786 Biofilm Formation in Cosmetic Production EnvironmentsASTM E640 Bacterial Filtration in Cosmetic SpraysASTM F2101 Bacterial Filtration Efficiency of Cosmetic Face MasksCEN/TR 16953 Guidance on Application of ISO Microbial StandardsChina GB 7919 Microbial Limits in Non-Sterile CosmeticsChina GB/T 13531.1 Detection of E. coli in CosmeticsChina GB/T 13531.2 Detection of Pathogenic Bacteria in CosmeticsChina GB/T 13531.3 Microbial Limit in Baby ProductsCOLIPA Guideline for Preservation Efficacy TestingCOLIPA Microbiological Quality Assurance of Cosmetic ProductsEP 2.6.1 Sterility Test for Cosmetic Raw MaterialsEP 2.6.13 Detection of Designated Microorganisms in CosmeticsEP 2.6.31 Validation of Microbiological Test Methods for CosmeticsEP 5.1.3 Evaluation of Preservative EffectivenessEP 5.1.4 Microbial Limits in Raw Cosmetic IngredientsEPA MB-17 Microbial Contamination Control in Natural FormulasFDA 21 CFR 211.113 Contamination Prevention Procedures for CosmeticsFDA 21 CFR 700.3 Microbial Contamination Limits in CosmeticsFDA BAM Chapter 14 Yeast and Mold Enumeration in Personal Care ProductsFDA BAM Chapter 23 Detection of Bacterial Pathogens in CosmeticsFDA CFSAN Guidelines for Cosmetic Microbiological SamplingFDA CPG Sec. 7120.01 Microbiological Criteria for Finished CosmeticsHealth Canada Compendial Test for Pathogenic Organisms in CosmeticsHealth Canada Cosmetic Microbiological Contamination GuidelinesIndia IS 14642 Microbial Contamination in Toiletries and SkincareIndia IS 4707-2 Cosmetic Ingredients Microbial AssessmentISO 11930 Microbiological Preservation Efficacy TestingISO 11932 Method Validation for Microbial Testing in CosmeticsISO 11989 Microbial Assessment of Eye CosmeticsISO 14502-2 Microbiological Testing of Polyphenol-Rich CosmeticsISO 16212 Quantification of Yeasts and Molds in Cosmetic ProductsISO 17516 Quantitative Limits of Microorganisms in Finished ProductsISO 18415 Detection of Specified and Non-Specified MicroorganismsISO 19007 Preservation Test of Microbial Resistance in Cosmetic WipesISO 21148 Detection of Anaerobic Bacteria in Cosmetic FormulationsISO 21149 Detection of Aerobic Mesophilic Bacteria in CosmeticsISO 21150 Detection of Escherichia coli in CosmeticsISO 22176 Hygiene Requirements in Cosmetic Packaging LinesISO 22716 Microbial Risk Management in GMP Cosmetic ManufacturingISO 22717 Identification of Pseudomonas aeruginosa in Cosmetic ProductsISO 22718 Identification of Staphylococcus aureus in CosmeticsISO 22719 Detection of Candida albicans in Cosmetic ProductsISO 24434 Enumeration of Aerobic Mesophilic Spores in Personal CareISO 24442 Selection Criteria for Challenge Test OrganismsISO 29621 Microbiological Risk Assessment for Low-Risk ProductsISO/TR 19838 Guidance on Risk Management for Cosmetic MicrobiologyISO/TR 24444 Comparison of Microbiological Test ProtocolsISO/TR 24475 Microbiological Assessment of Cosmetic Raw MaterialsISO/TR 24476 Test Method Selection for Cosmetic Product MicrobiologyISO/TS 29621 Categorization of Cosmetic Products Based on Microbiological RiskJIS K 5101 Preservative Efficiency in Japanese CosmeticsJIS L 1902 Evaluation of Antibacterial Activity of Cosmetic TextilesJIS Z 2801 Antimicrobial Efficacy Testing for Surfaces in Cosmetic FacilitiesKFDA Microbiological Safety Evaluation of Korean Cosmetic ProductsKFDA Testing for Microbial Contamination in Imported CosmeticsPh. Eur. 2.6.12 Total Count Test for EmulsionsPh. Eur. 2.6.13 Detection of Pathogens in Powdered CosmeticsSCCS/1564/15 Risk Assessment of Microbiological Contamination in CosmeticsSCCS/1611/19 Safety Levels of Microbial Contaminants in CosmeticsTS 13218 Total Bacteria Count in Cosmetic CreamsTS 13531 Bacterial Safety Testing of Shampoo ProductsTS EN 12353 Hygiene Control of Cosmetic Containers and ClosuresTS EN ISO 11930 Preservative Efficacy Test for Personal Care ProductsTS EN ISO 16212 Mold and Yeast Count in Cosmetic LiquidsTS EN ISO 18415 Detection of Transient Organisms in ToiletriesTS EN ISO 21148 Enumeration of Microorganisms in Cosmetic ProductsUSP <1227> Validation of Microbial Recovery in Cosmetic ProductsUSP <1231> Water Quality for Microbiological Control in Cosmetic ProductionUSP <2021> Microbial Control of Nutraceutical-Cosmetic HybridsUSP <2022> Evaluation of Cosmetic Quality Control ProtocolsUSP <51> Antimicrobial Effectiveness Testing (Preservative Challenge Test)USP <61> Microbial Enumeration Testing for Non-Sterile CosmeticsUSP <62> Testing for Specified Microorganisms in CosmeticsUSP <791> pH Control and Microbial Growth AssessmentWHO Guidelines for the Microbiological Control of Herbal Cosmetics

Comprehensive Guide to EP 2.6.12 Total Aerobic Microbial Count Testing Laboratory Testing Service Provided by Eurolab

EP 2.6.12 Total Aerobic Microbial Count Testing is a laboratory testing service that measures the total aerobic microbial count in various products and environments. This testing service is governed by several international and national standards, which are outlined below.

International Standards

  • ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories

  • ISO 5725-1:1994 - Accuracy (trueness and precision) of measurement methods and results

  • ISO 17065:2012 - Conformity assessment -- Requirements for assessing conformity to specifications

    • National Standards

  • ASTM E2273-13 - Standard Practice for Air Sampling for the Presence of Mycoplasma fermentans

  • EN ISO 11133:2006 - Microbiology of food and animal feeding stuffs Preparation, production, storage and performance testing of culture media

  • TSE (Turkish Standards Institution) L 1213-2015 - Microbiological examination of water

    • Standard Development Organizations

    The development and maintenance of standards for EP 2.6.12 Total Aerobic Microbial Count Testing are primarily the responsibility of the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and European Committee for Standardization (CEN).

    These organizations collaborate with industry experts, researchers, and regulatory bodies to develop and update standards that reflect current technologies, practices, and regulations.

    Legal and Regulatory Framework

    The legal and regulatory framework surrounding EP 2.6.12 Total Aerobic Microbial Count Testing varies depending on the country or region. However, most countries have implemented laws and regulations that require manufacturers to ensure their products meet specific microbiological standards.

    For example, in the European Union, Regulation (EU) No 2023/2003 sets out requirements for the quality of water intended for human consumption, including microbiological parameters such as total aerobic microbial count.

    Similarly, in the United States, the Food and Drug Administration (FDA) regulates the safety of food products, including those related to microbiology.

    Standard Compliance Requirements

    Different industries have varying standard compliance requirements for EP 2.6.12 Total Aerobic Microbial Count Testing. Some examples include:

  • Pharmaceuticals: EU GMP Annex 1 (Microbiological control)

  • Food and Beverage: FDA 21 CFR Part 110 (Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs)

  • Cosmetics: EU Cosmetics Regulation (1223/2009) - Microbiological requirements

    • Manufacturers must ensure their products meet these standards to avoid regulatory non-compliance and potential recalls.

    EP 2.6.12 Total Aerobic Microbial Count Testing is a critical testing service that helps manufacturers ensure the quality, safety, and reliability of their products. This section explains why this test is needed and required.

    Business and Technical Reasons

    Manufacturers must conduct EP 2.6.12 Total Aerobic Microbial Count Testing for several reasons:

  • To meet regulatory requirements: As mentioned earlier, various laws and regulations require manufacturers to ensure their products meet specific microbiological standards.

  • To prevent product contamination: Total aerobic microbial count testing helps identify potential contaminants that can impact product quality, safety, and shelf life.

  • To maintain customer trust: Manufacturers must demonstrate their commitment to producing high-quality products that meet customer expectations.

    • Consequences of Not Performing This Test

    Not conducting EP 2.6.12 Total Aerobic Microbial Count Testing can have serious consequences for manufacturers:

  • Regulatory non-compliance

  • Product recalls and loss of sales

  • Damage to reputation and brand image

  • Potential health risks to consumers

    • Industries and Sectors Requiring This Testing

    EP 2.6.12 Total Aerobic Microbial Count Testing is required in various industries, including:

  • Pharmaceuticals

  • Food and Beverage

  • Cosmetics

  • Water Treatment

    • These industries must ensure their products meet specific microbiological standards to maintain customer trust, prevent regulatory non-compliance, and protect public health.

    Risk Factors and Safety Implications

    Manufacturers must be aware of the risk factors associated with EP 2.6.12 Total Aerobic Microbial Count Testing:

  • Product contamination: Total aerobic microbial count testing helps identify potential contaminants that can impact product quality, safety, and shelf life.

  • Regulatory non-compliance: Failure to meet microbiological standards can result in regulatory fines, product recalls, and loss of sales.

    • Quality Assurance and Control Aspects

    Manufacturers must implement effective quality assurance and control measures to ensure their products meet microbiological standards:

  • Good Manufacturing Practice (GMP)

  • Hazard Analysis Critical Control Point (HACCP)

  • Total Productive Maintenance (TPM)

    • Standard Requirements for EP 2.6.12 Total Aerobic Microbial Count Testing

    Manufacturers must follow specific standard requirements for EP 2.6.12 Total Aerobic Microbial Count Testing:

  • ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories

  • ASTM E2273-13 - Standard Practice for Air Sampling for the Presence of Mycoplasma fermentans

    • Quality Control Measures

    Manufacturers must implement effective quality control measures to ensure their products meet microbiological standards:

  • Use of validated methods and equipment

  • Regular calibration and maintenance of equipment

  • Training and qualification of personnel

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

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