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iso-15759-analysis-of-packaging-for-contact-with-parenteral-drugs
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 3.2.8 Closures for Containers for Aqueous Parenteral PreparationsEP 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 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 ISO 15759 Analysis of Packaging for Contact with Parenteral Drugs Laboratory Testing Service

The ISO 15759 standard is a widely accepted international standard that governs the analysis of packaging for contact with parenteral drugs. The standard provides guidelines and requirements for testing the compatibility of packaging materials with parenteral drugs, ensuring their safety and efficacy.

Legal and Regulatory Framework

ISO 15759 is developed by the International Organization for Standardization (ISO) in collaboration with the International Council on Systems Engineering (INCOSE). The standard is based on various international and national standards, including:

  • ISO 11607-1:2016

  • ISO 11607-2:2016

  • ASTM F1980/F1980M-16a

  • EN 16803-2:2017

  • TSE 1609:2020

    • The standard is applicable to the pharmaceutical, medical device, and packaging industries worldwide. Compliance with this standard is mandatory for manufacturers of parenteral drugs and their packaging materials.

    Standard Development Organizations and Their Role

    ISO and INCOSE are the primary standard development organizations responsible for developing ISO 15759. These organizations work together to ensure that the standard meets the needs of stakeholders from various industries and countries.

    Evolution and Updates

    Standards evolve over time to reflect changes in technology, regulations, and industry practices. The ISO 15759 standard is subject to periodic review and update to maintain its relevance and effectiveness.

    Standard Numbers and Scope

    ISO 15759-1:2017 and ISO 15759-2:2020 are the current versions of the standard. These standards provide detailed guidelines for testing the compatibility of packaging materials with parenteral drugs, including:

  • Testing methods for extractables and leachables

  • Testing methods for chemical and physical properties

  • Sampling and sample preparation procedures

    • Standard Compliance Requirements

    Compliance with ISO 15759 is required for manufacturers of parenteral drugs and their packaging materials. Manufacturers must demonstrate compliance through testing and certification by an accredited laboratory.

    ISO 15759 Analysis of Packaging for Contact with Parenteral Drugs testing is necessary to ensure the safety and efficacy of parenteral drugs. The test helps manufacturers to:

  • Evaluate the compatibility of packaging materials with parenteral drugs

  • Ensure the quality and reliability of packaging materials

  • Meet regulatory requirements and industry standards

    • Business and Technical Reasons for Conducting ISO 15759 Testing

    Conducting ISO 15759 testing provides several business and technical benefits, including:

  • Ensuring product safety and efficacy

  • Meeting regulatory requirements and industry standards

  • Improving product quality and reliability

  • Enhancing customer confidence and trust

  • Supporting innovation and research development

    • Consequences of Not Performing ISO 15759 Testing

    Failure to conduct ISO 15759 testing can lead to:

  • Product recalls and withdrawals

  • Loss of market share and revenue

  • Damage to brand reputation and customer confidence

  • Non-compliance with regulatory requirements and industry standards

    • ISO 15759 Analysis of Packaging for Contact with Parenteral Drugs testing involves the following steps:

    1. Sample Preparation: Samples are prepared according to the standard, including cleaning, cutting, and weighing.

    2. Testing Equipment and Instruments: Testing is conducted using specialized equipment and instruments, such as GC-MS, HPLC, and ICP-MS.

    3. Testing Environment Requirements: The testing environment must meet specific requirements for temperature, humidity, pressure, and other parameters.

    4. Measurement and Analysis Methods: Extractables and leachables are measured and analyzed using various methods, including chromatography and mass spectrometry.

    5. Calibration and Validation Procedures: Equipment is calibrated and validated according to the standard.

    Quality Control Measures During Testing

    Quality control measures are essential during ISO 15759 testing to ensure accuracy and reliability of results. These measures include:

  • Regular calibration and maintenance of equipment

  • Use of certified reference materials

  • Implementation of quality control charts and procedures

    • ISO 15759 test results are documented and reported according to the standard, including:

    1. Report Format and Structure: Reports must follow a specific format and structure.

    2. Interpretation of Test Results: Results are interpreted according to the standard, including limits and tolerances.

    3. Certification and Accreditation Aspects: Certificates of compliance are issued by accredited laboratories.

    Certification and Accreditation

    ISO 15759 certification is required for manufacturers of parenteral drugs and their packaging materials. Laboratories must be accredited by a recognized accreditation body to perform ISO 15759 testing.

    Conducting ISO 15759 Analysis of Packaging for Contact with Parenteral Drugs testing provides numerous benefits, including:

  • Ensuring product safety and efficacy

  • Meeting regulatory requirements and industry standards

  • Improving product quality and reliability

  • Enhancing customer confidence and trust

  • Supporting innovation and research development

    • Why Choose Our Laboratory

    Our laboratory is accredited by Accreditation Body to perform ISO 15759 testing. We offer:

  • State-of-the-art equipment and instruments

  • Experienced and skilled personnel

  • Efficient and timely testing services

  • Competitive pricing and flexible payment options

    • I hope this comprehensive guide meets your requirements!

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

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