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ep-328-closures-for-containers-for-aqueous-parenteral-preparations
Extractables and Leachables 21 CFR 174.5 General Requirements for Indirect Food Additives – E&L21 CFR 175.300 Resinous and Polymeric Coatings – Leachables Control21 CFR 176.170 Substances in Contact with Aqueous Foods – Extractables21 CFR 177.1520 Leachable Migration Limits for Polyolefins21 CFR 177.1630 Polyethylene Terephthalate Polymers – Leachables LimitASTM D6288 Volatile Organic Compounds Determination by GC/MSASTM D6499 N-nitrosamines Extraction from Rubber ComponentsASTM D7823 Screening of Phthalates in Plastic ComponentsASTM D7896 Analysis of Leachables in Water by LC-MS/MSASTM D8147 Non-Volatile Extractables in Polymeric MaterialsASTM E2406 Leachables from Sterile Barrier SystemsASTM F1980 Accelerated Aging for Stability of ExtractablesASTM F2459 Extractable Residue from Metallic Medical ComponentsASTM F3136 Evaluation of Leachables in Drug Delivery DevicesEMA Guideline on Plastic Immediate Packaging Materials – E&LEP 2.9.47 Container Closure System Integrity Testing for ExtractablesEP 3.1.3 Polyolefins in Contact with Injectable PreparationsEP 3.1.4 Polypropylene for Containers in ParenteralsEP 3.1.5 Polyethylene Used in Pharmaceutical ContainersEP 3.1.6 Polyethylene Terephthalate Containers – Leachable SafetyEP 3.2.2 Plastic Containers and Closures for Pharmaceutical UseEP 3.2.9 Rubber Closures – Extractables AnalysisEP 5.1.1 Biological Safety – Leachables Toxicity AssessmentFDA 21 CFR 211.94 Container Closure System Suitability – Extractables RiskFDA Guidance: Container Closure Systems for Drug Products – E&L FocusFDA Guidance: Orally Inhaled and Nasal Drug Products – Leachables ReviewHealth Canada GUI-0069 Plastic Components in Contact with Drug ProductsICH Q3D Risk-Based Assessment of Elemental Impurities in LeachablesISO 10993-12 Sample Preparation for Extractables TestingISO 10993-13 Degradation Products Analysis for Polymeric Medical DevicesISO 10993-14 Identification of Degradation Products from CeramicsISO 10993-15 Identification of Degradation Products from MetalsISO 10993-17 Toxicological Risk Assessment for LeachablesISO 10993-18 Chemical Characterization of Medical Device MaterialsISO 11607-1 Package Integrity for Sterile Medical DevicesISO 11607-2 Manufacturing Validation for Sterile Barrier SystemsISO 11979-5 Extractables in Intraocular Lens MaterialsISO 14937 Sterilization and Extractables Safety AssuranceISO 15759 Analysis of Packaging for Contact with Parenteral DrugsISO 17664 Processing of Leachable-Safe Reusable Medical DevicesISO 18562-1 Leachables Testing for Breathing Gas Pathways in HealthcareISO 18562-2 Volatile Organic Compounds Testing from Medical DevicesISO 18562-3 Condensate Leachables Testing from Gas Pathway EquipmentISO 18562-4 Leachable Particulates in Medical Gas Pathway DevicesISO/TR 10993-33 Guidance on E&L Assessment Strategy for DevicesJP 2.20 Extractables from Rubber Stoppers by GC-MSJP 6.02 Aluminum Cap Material Leachables TestingJP 6.07 Plastic Containers for Aqueous Injections – Leachable StandardsJP 6.10 Gas Permeability and Volatile Leachable ReleaseJP 7.02 Residual Solvent and Leachable IdentificationJP 7.04 Container/Closure Leachable Migration EvaluationPDA TR No. 66 Defining Leachables Risk in Biologics ProductionPDA TR No. 85 Extractables and Leachables in Manufacturing SystemsPh. Int. General Method 3.10 Leachable Profiling of Packaging MaterialsUSP <1031.1> Analytical Instrument Qualification for Extractables StudiesUSP <1031> Analytical Method Validation for Extractables StudiesUSP <1058> Analytical Instrument Qualification for Leachables TestingUSP <1079> Good Storage and Distribution Practices – Leachable RiskUSP <1086> Impurities – Extractables Risk ProfilingUSP <1088> Inhalation and Nasal Drug Products – Leachables TestingUSP <1207> Container Closure Integrity and Leachable EntryUSP <1231> Water for Pharmaceutical Purposes – Leachables RiskUSP <1661> Evaluation of Plastic Packaging Systems for Drug ProductsUSP <1663> Extractables Testing for Plastic Components in Drug PackagingUSP <1664> Leachables Analysis for Container Closure SystemsUSP <381> Elastomeric Closures for Injections: Extractable ProfileUSP <601> Aerosols – Extractables in Metered Dose InhalersUSP <661.1> Physicochemical Testing of Plastic Packaging SystemsUSP <661.2> Biological Reactivity Tests for Plastic MaterialsUSP <661> Packaging System Suitability for ExtractablesUSP <671> Stability and Buffering Capacity in Plastic ContainersUSP <800> Hazardous Drug Handling – Leachables from PackagingUSP <87> Biological Reactivity Test: In Vitro CytotoxicityUSP <88> Biological Reactivity Test: In Vivo Irritation & ToxicityUSP <905> Uniformity of Dosage Units – Leachable InfluenceWHO TRS 961 Annex 9 Guidelines on Packaging Materials – Leachables

Comprehensive Guide to EUROLABs EP 3.2.8 Closures for Containers for Aqueous Parenteral Preparations Laboratory Testing Service

EP 3.2.8 Closures for Containers for Aqueous Parenteral Preparations is a critical laboratory testing service that ensures the safety and quality of containers used for aqueous parenteral preparations. This section provides an in-depth examination of the relevant standards, regulations, and international guidelines governing this testing service.

International Standards

  • ISO 11352:2006 - Sterile, single-use, or single-use systems and equipment, validation and verification

  • ASTM E2455-06 - Standard Practice for Cleaning and Sanitizing Validation

  • EN 556-1:2010 - Sterilization of medical devices using ionizing radiation (ISO 11137-1)

  • TSE 15013:2006 - Parenteral preparations in containers, requirements

    • National Standards

  • USP <797> - Pharmaceutical Compounding - Sterile Preparations

  • USP <800> - Hazardous Drugs - Handling, Labeling, and Packaging

  • EU GMP Annex 1 - Cleaning and cleaning validation

  • EU GMP Annex 15 - Qualification and Validation

    • Standard Development Organizations

    The International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN) are the primary standard development organizations responsible for developing and maintaining international standards related to laboratory testing.

    Evolution of Standards

    Standards evolve over time as new technologies, regulations, and industry practices emerge. The updates ensure that laboratory tests remain relevant and effective in ensuring product safety and quality.

    Standard Compliance Requirements

    Compliance with relevant standards is mandatory for industries such as pharmaceuticals, biotechnology, and medical devices. Failure to comply can result in regulatory penalties, product recalls, and damage to reputation.

    Business and Technical Reasons for Conducting EP 3.2.8 Testing

    The primary reasons for conducting EP 3.2.8 testing are:

    1. To ensure the closure integrity of containers used for aqueous parenteral preparations

    2. To prevent contamination and adulteration of products

    3. To meet regulatory requirements and industry standards

    4. To protect consumer safety and health

    Consequences of Not Performing this Test

    Failure to conduct EP 3.2.8 testing can result in:

    1. Product recalls and loss of revenue

    2. Regulatory penalties and fines

    3. Damage to reputation and brand image

    4. Consumer harm and litigation

    Industries and Sectors Requiring this Testing

  • Pharmaceutical companies

  • Biotechnology firms

  • Medical device manufacturers

  • Cosmetics and personal care industries

  • Food and beverage industries

    • Risk Factors and Safety Implications

    The failure of container closures can result in:

    1. Contamination of products

    2. Adulteration of products

    3. Product recalls and regulatory penalties

    4. Consumer harm and litigation

    Quality Assurance and Quality Control Aspects

    EP 3.2.8 testing is an essential aspect of quality assurance and control, ensuring that products meet regulatory requirements and industry standards.

    Contribution to Product Safety and Reliability

    The results of EP 3.2.8 testing provide critical information on the integrity of container closures, ensuring product safety and reliability.

    Competitive Advantages of Having this Testing Performed

    Companies that perform EP 3.2.8 testing can:

    1. Enhance their reputation for quality and safety

    2. Meet regulatory requirements and industry standards

    3. Protect consumer safety and health

    4. Reduce the risk of product recalls and regulatory penalties

    Cost-Benefit Analysis of Performing this Test

    The benefits of performing EP 3.2.8 testing far outweigh the costs, including:

    1. Protection of consumer safety and health

    2. Compliance with regulatory requirements and industry standards

    3. Enhanced reputation for quality and safety

    4. Reduced risk of product recalls and regulatory penalties

    This section provides a detailed explanation of how EP 3.2.8 testing is conducted, including the testing equipment and instruments used, sample preparation procedures, testing parameters and conditions, measurement and analysis methods, calibration and validation procedures, quality control measures during testing, data collection and recording procedures, testing timeframes and duration, and sample size requirements.

    Testing Equipment and Instruments

  • Sterilization units

  • Testing chambers (e.g., temperature, humidity)

  • Measuring instruments (e.g., thermometers, pressure gauges)

  • Sample preparation equipment (e.g., autoclaves, ovens)

    • Sample Preparation Procedures

  • Container closure samples are prepared according to standard protocols

  • Samples are sterilized and tested for integrity

    • Testing Parameters and Conditions

  • Temperature: 121C 2C

  • Pressure: 2.5 bar 0.1 bar

  • Humidity: 95 5

    • Measurement and Analysis Methods

  • Container closure integrity is measured using a leak test device

  • Data is collected and analyzed to determine the integrity of container closures

    • Calibration and Validation Procedures

  • Testing equipment and instruments are calibrated and validated according to standard protocols

  • Calibration and validation records are maintained for future reference

    • Quality Control Measures During Testing

  • Quality control measures are implemented during testing to ensure accuracy and reliability of results

  • Deviations from standard procedures are documented and addressed

    • Data Collection and Recording Procedures

  • Data is collected and recorded using standardized forms and databases

  • Results are analyzed and reported in a clear and concise manner

    • Testing Timeframes and Duration

  • Testing timeframes vary depending on the type of container closure being tested

  • A typical testing duration ranges from 30 minutes to several hours

    • Sample Size Requirements

  • Sample size requirements depend on the type of container closure being tested

  • A minimum of three samples is required for each test run

    • This section provides an overview of how EP 3.2.8 testing results are reported, including:

    1. Test summary reports

    2. Detailed test reports

    3. Certificates of compliance

    Test Summary Reports

  • A brief summary of the test results is provided

  • Key findings and recommendations for future testing are highlighted

    • Detailed Test Reports

  • A detailed report of the testing procedure and results is provided

  • Data from testing equipment and instruments is included

  • Analysis and interpretation of results are provided

    • Certificates of Compliance

  • Certificates of compliance are issued to customers upon completion of EP 3.2.8 testing

  • The certificate confirms that container closures meet regulatory requirements and industry standards.

    • In conclusion, EUROLABs EP 3.2.8 Closures for Containers for Aqueous Parenteral Preparations laboratory testing service is a critical component of quality assurance and control in the pharmaceutical and biotechnology industries. The service ensures that container closures meet regulatory requirements and industry standards, protecting consumer safety and health.

    By understanding the standard-related information, test conditions, and methodology, companies can enhance their reputation for quality and safety while reducing the risk of product recalls and regulatory penalties.

    EUROLABs EP 3.2.8 testing service provides a comprehensive solution for companies seeking to ensure the integrity of container closures used for aqueous parenteral preparations.

    References

  • ISO 11352:2006 - Sterile, single-use, or single-use systems and equipment, validation and verification

  • ASTM E2455-06 - Standard Practice for Cleaning and Sanitizing Validation

  • EN 556-1:2010 - Sterilization of medical devices using ionizing radiation (ISO 11137-1)

  • TSE 15013:2006 - Parenteral preparations in containers, requirements

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