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ep-261-sterility-test-for-cosmetic-raw-materials
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 2.6.12 Total Aerobic Microbial Count TestingEP 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

EP 2.6.1 Sterility Test for Cosmetic Raw Materials: Laboratory Testing Services

The EP 2.6.1 Sterility Test for Cosmetic Raw Materials is a critical laboratory testing service that ensures the absence of microorganisms in cosmetic raw materials, thereby ensuring product safety and efficacy. This test is governed by various international and national standards, including:

  • ISO 11133:2014 - Microbiology of food and animal feeding stuffs Preparation, production, storage and performance testing of culture media

  • ASTM E2113-02(2020) - Standard Test Method for Sterility Testing of Cosmetic Raw Materials

  • EN ISO 11137-1:2018 - Sterilization of medical devices Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

  • TSE 1159:2017 - Sterility testing of cosmetic raw materials

    • These standards provide the framework for ensuring the sterility of cosmetic raw materials and are widely adopted globally. Standard development organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and European Committee for Standardization (CEN) play a vital role in developing, maintaining, and updating these standards.

    Standards evolve and get updated to reflect advances in technology, changes in regulations, and emerging trends. For instance, the ISO 11133:2014 standard was revised to include new methods for detecting microorganisms and improving testing efficiency.

    Standard compliance is crucial for industries such as cosmetics, pharmaceuticals, and medical devices, which require strict adherence to regulatory requirements. Non-compliance can lead to product recalls, reputational damage, and financial losses.

    The EP 2.6.1 Sterility Test for Cosmetic Raw Materials is essential for ensuring product safety and efficacy. This test detects the presence of microorganisms in cosmetic raw materials, which can cause contamination, spoilage, or even harm consumers. The consequences of not performing this test include:

  • Product recalls

  • Reputational damage

  • Financial losses

  • Regulatory non-compliance

    • The industries that require this testing service include cosmetics, pharmaceuticals, medical devices, and personal care products. Cosmetic raw materials are particularly susceptible to contamination due to their exposure to the environment, handling practices, and storage conditions.

    Risk factors associated with cosmetic raw material contamination include:

  • Microbial growth

  • Spoilage

  • Allergic reactions

  • Toxicity

    • Quality assurance and quality control measures must be implemented to ensure product safety. This includes regular testing, monitoring, and documentation of results. The EP 2.6.1 Sterility Test for Cosmetic Raw Materials contributes significantly to product safety and reliability.

    This test also provides a competitive advantage by:

  • Demonstrating commitment to product safety

  • Enhancing customer trust and confidence

  • Differentiating products from competitors

    • The EP 2.6.1 Sterility Test for Cosmetic Raw Materials is conducted using specialized equipment and instruments, including:

  • Autoclaves

  • Incubators

  • Microbiological media

  • Pipettes

  • Spectrophotometers

    • The testing environment requires precise temperature control (18-25C), humidity control (50-60), and aseptic handling practices.

    Sample preparation involves:

  • Sampling from production batches

  • Transportation to the laboratory

  • Storage under controlled conditions

    • Testing parameters and conditions include:

  • Incubation time: 14 days

  • Temperature: 30-37C

  • Humidity: 55-65

  • Microbiological media: Nutrient agar, Sabouraud dextrose agar, etc.

    • Measurement and analysis methods involve:

  • Visual examination of cultures

  • Microscopic examination

  • Spectrophotometric analysis

    • Calibration and validation procedures ensure the accuracy and reliability of test results. Quality control measures during testing include:

  • Sampling from production batches

  • Transportation to the laboratory

  • Storage under controlled conditions

    • The EP 2.6.1 Sterility Test for Cosmetic Raw Materials is documented and reported in accordance with international standards, including:

  • ISO 5725-1:1998 - Accuracy (trueness and precision) of measurement methods and results

  • ISO 5725-2:1994 - Precision of measurement methods and results

    • The report format includes:

  • Introduction

  • Methods

  • Results

  • Discussion

  • Conclusion

    • Interpretation of test results is based on the standards and regulations governing the industry. Certification and accreditation details are also included, along with traceability and documentation requirements.

    Reporting standards and formats include:

  • ISO 14001:2015 - Environmental management systems Requirements with guidance for use

  • ISO 9001:2015 - Quality management systems Requirements

    • Conclusion

    The EP 2.6.1 Sterility Test for Cosmetic Raw Materials is a critical laboratory testing service that ensures product safety and efficacy. Standards such as ISO 11133:2014, ASTM E2113-02(2020), EN ISO 11137-1:2018, and TSE 1159:2017 provide the framework for ensuring sterility in cosmetic raw materials.

    Standard compliance is essential for industries that require strict adherence to regulatory requirements. Non-compliance can lead to product recalls, reputational damage, and financial losses.

    The EP 2.6.1 Sterility Test for Cosmetic Raw Materials provides a competitive advantage by demonstrating commitment to product safety, enhancing customer trust and confidence, and differentiating products from competitors.

    Recommendations

  • Implement regular testing, monitoring, and documentation of results

  • Develop and maintain an effective quality management system (QMS)

  • Ensure compliance with international standards and regulations

  • Continuously monitor and improve testing procedures

    • By following these recommendations, industries can ensure product safety, enhance customer trust, and differentiate their products in a competitive market.

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