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iso-11135-1-eo-gas-thermal-process-monitoring
Thermal Resistance and Environmental Testing ASTM D1500 Heat Aging of Insulating MaterialsASTM D1929 Thermal Ignition of PolymersASTM D2240 Hardness Testing After Thermal ExposureASTM D2765 Thermal Stability of PolymersASTM D3039 Thermal Fatigue Testing of CompositesASTM D3045 Thermal Aging of PlasticsASTM D3895 Oxygen Index and Thermal StabilityASTM D3895 Thermal Degradation of PolymersASTM D4065 Dynamic Mechanical Thermal AnalysisASTM D412 Thermal Aging of ElastomersASTM D573 Heat Resistance of RubberASTM D618 Conditioning for Thermal AnalysisASTM D618 Conditioning of Plastics under Thermal ExposureASTM D648 Heat Deflection Temperature TestingASTM D648 Heat Deflection Testing of PlasticsASTM D695 Compressive Strength After Thermal ExposureASTM D746 Brittleness Temperature TestingASTM D785 Thermal Deformation TestingASTM D7945 Thermal Stability of CompositesASTM E595 Thermal Emission TestingASTM F1278 Thermal Cycling of Medical PolymersASTM F1576 Thermal Conductivity TestingASTM F1980 Accelerated Aging of Sterilized Medical DevicesASTM F1980 Accelerated Thermal Aging of Medical DevicesASTM F1981 Thermal Compatibility of Medical AdhesivesASTM F1983 Thermal Compatibility of MaterialsASTM F1984 Thermal Cycling of Sterilized ProductsASTM F2009 Thermomechanical Testing of DevicesASTM F2461 Thermal Performance of Medical Device CoatingsASTM F2477 Thermal Aging of Silicone ElastomersASTM F2516 Thermal Conductivity of Medical Device MaterialsASTM F2621 Thermal Expansion TestingASTM F3001 Thermal Endurance of ImplantsASTM F392 Thermal Resistance of Medical TubingIEC 60068-2-1 Cold Temperature TestingIEC 60068-2-11 Salt Fog with Thermal ExposureIEC 60068-2-14 Rapid Thermal Shock TestingIEC 60068-2-14 Thermal Shock Test MethodIEC 60068-2-14 Thermal Shock TestingIEC 60068-2-2 Dry Heat TestIEC 60068-2-20 Low Temperature and Thermal CyclingIEC 60068-2-30 Damp Heat, Cyclic (12+12 hour)IEC 60068-2-38 Dry Heat, Steady StateIEC 60068-2-4 Rapid Change of TemperatureIEC 60068-2-5 Combined Environmental Testing Including ThermalIEC 60068-2-78 Damp Heat, Steady StateIEC 60529 Environmental Protection Ratings and Thermal ImpactIEC 60529 Protection Against Environmental Thermal ConditionsIEC 60529 Protection Degree and Thermal ImpactIEC 60601-1 Medical Electrical Equipment Safety at Thermal LimitsIEC 60601-1 Thermal Safety RequirementsIEC 60601-1-11 Environmental Conditions for Medical Electrical EquipmentIEC 60601-1-11 Thermal Performance in Home Healthcare DevicesIEC 60601-1-2 Electromagnetic and Thermal ImmunityIEC 60601-1-8 Temperature Alarm SystemsIEC 60601-2-4 Temperature Limits for DefibrillatorsIEC 60749-23 Thermal Shock for Semiconductor DevicesISO 10993-1 Biological Evaluation Considering Thermal EffectsISO 10993-10 Sensitization Tests under Thermal ExposureISO 10993-10 Thermal Sensitization TestingISO 10993-11 Evaluation of Thermal Effects on Medical DevicesISO 10993-12 Sample Preparation with Thermal ConsiderationsISO 10993-18 Chemical Characterization Considering Thermal ExposureISO 10993-4 Hemocompatibility Testing under Thermal StressISO 10993-5 Cytotoxicity Testing after Thermal ExposureISO 11135 Thermal Effects in Ethylene Oxide SterilizationISO 11135 Thermal Process Validation for EO SterilizationISO 11137-2 Thermal Validation of Sterilization CyclesISO 11137-3 Radiation Sterilization and Thermal EffectsISO 11607 Packaging Performance under Thermal StressISO 11607-2 Packaging System Validation under Thermal StressISO 13485 Quality Management Including Thermal ControlsISO 13485 Thermal Control in Manufacturing ProcessesISO 13485 Thermal Management in Medical Device ManufacturingISO 13485-1 Quality Systems and Thermal ControlsISO 13943 Fire Safety and Thermal Risk in DevicesISO 14644-1 Cleanroom Environmental MonitoringISO 14644-2 Thermal Stability in CleanroomsISO 14644-3 Cleanroom Testing and Thermal ConditionsISO 14644-4 Monitoring Thermal Conditions in CleanroomsISO 14698-1 Biocontamination Control Under Thermal ConditionsISO 14937 Thermal Process ValidationISO 14937 Thermal Validation of Sterilization ProcessesISO 14971 Risk Management for Thermal HazardsISO 14971 Thermal Risk ManagementISO 16750 Environmental Testing for Automotive Electrical EquipmentISO 16750 Environmental Tests Including Thermal CyclingISO 16750-4 Electrical Equipment Environmental Thermal TestingISO 16750-4 Environmental Testing for Electrical EquipmentISO 21789 Environmental Stress Testing for Medical Devices

Comprehensive Guide to ISO 11135-1 EO Gas Thermal Process Monitoring Laboratory Testing Service

ISO 11135-1 is an international standard that governs the requirements for the validation of aseptic processing of pre-filled syringes, cartridges, and other injectable products. This standard is published by the International Organization for Standardization (ISO) and is widely recognized as a benchmark for ensuring the quality and safety of pharmaceutical products.

The legal and regulatory framework surrounding this testing service is primarily governed by national and international regulations. In the European Union, for example, the Medicinal Products Directive (2001/83/EC) requires that all medicinal products comply with the principles of good manufacturing practice (GMP). Similarly, in the United States, the Food and Drug Administration (FDA) regulates pharmaceutical products under the Federal Food, Drug, and Cosmetic Act.

Internationally, ISO 11135-1 is aligned with other standards such as ASTM E2233 (Standard Guide for Aseptic Processing of Pre-Filled Syringes, Cartridges, and Other Injectable Products), EN ISO 14644 (Cleanrooms and associated controlled environments) and TSE 1479 (Cleanrooms and associated controlled environments). These standards provide a framework for ensuring the quality and safety of pharmaceutical products.

Standard development organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), Turkish Standards Institution (TSE) play a crucial role in developing and maintaining these standards. These organizations work together to ensure that standards are aligned and consistent across different regions.

Standards evolve over time as new technologies and research findings become available. This is done through periodic reviews and updates, which involve stakeholders from industry, government, and academia. The aim of this process is to maintain the relevance and effectiveness of the standard in ensuring product quality and safety.

Standard Numbers and Scope

  • ISO 11135-1:2014 - Sterilization of healthcare products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical instruments

  • ASTM E2233:2015 - Standard Guide for Aseptic Processing of Pre-Filled Syringes, Cartridges, and Other Injectable Products

  • EN ISO 14644-1:2015 - Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness

  • TSE 1479:2006 - Cleanrooms and associated controlled environments

    • These standards provide a framework for ensuring the quality and safety of pharmaceutical products. Compliance with these standards is mandatory in many countries, and failure to comply can result in product recalls, legal action, and damage to reputation.

    Standard Compliance Requirements

    Compliance with ISO 11135-1 is required by regulatory authorities worldwide. In the European Union, for example, compliance with EN ISO 14644 is mandatory for all pharmaceutical manufacturers. Similarly, in the United States, FDA requires compliance with ASTM E2233 for aseptic processing of pre-filled syringes.

    Industry sectors that require this testing include:

  • Pharmaceutical

  • Biotechnology

  • Medical device manufacturing

    • These industries rely heavily on cleanrooms and associated controlled environments to ensure product quality and safety. Failure to comply with standards can result in product recalls, legal action, and damage to reputation.

    The aseptic processing of pre-filled syringes, cartridges, and other injectable products requires careful attention to detail to prevent contamination and ensure product quality and safety. ISO 11135-1 provides a framework for ensuring the quality and safety of these products.

    Business and Technical Reasons

    Conducting ISO 11135-1 testing is essential for several reasons:

  • Ensures compliance with regulatory requirements

  • Provides assurance of product quality and safety

  • Supports business growth and reputation

  • Enhances customer confidence

    • Failure to comply with standards can result in product recalls, legal action, and damage to reputation.

    Consequences of Not Performing this Test

    Failure to conduct ISO 11135-1 testing can have severe consequences:

  • Product contamination and recalls

  • Legal action and regulatory fines

  • Damage to reputation and business growth

    • Industries and Sectors

    The following industries require ISO 11135-1 testing:

  • Pharmaceutical

  • Biotechnology

  • Medical device manufacturing

    • These industries rely heavily on cleanrooms and associated controlled environments to ensure product quality and safety.

    Risk Factors and Safety Implications

    Contamination of pre-filled syringes, cartridges, and other injectable products can have serious consequences for patients. ISO 11135-1 provides a framework for ensuring the quality and safety of these products by controlling factors that contribute to contamination.

    Quality Assurance and Control Aspects

    ISO 11135-1 requires that manufacturers develop, validate, and routine control of sterilization processes. This involves monitoring and controlling factors that affect product quality and safety.

    Standard Requirements and Needs Conclusion

    In conclusion, compliance with ISO 11135-1 is essential for ensuring the quality and safety of pre-filled syringes, cartridges, and other injectable products. Failure to comply can result in product recalls, legal action, and damage to reputation.

    The validation of aseptic processing involves demonstrating that the process is capable of producing sterile products consistently. This requires careful attention to detail and monitoring of factors that affect product quality and safety.

    Development of Validation Protocol

    The development of a validation protocol involves several steps:

  • Define the scope and objectives of the validation

  • Identify the equipment, materials, and personnel involved in the process

  • Develop a plan for sampling and analysis

  • Establish acceptance criteria

    • Validation of Aseptic Processing Equipment

    The validation of aseptic processing equipment involves demonstrating that it is capable of producing sterile products consistently. This requires careful attention to detail and monitoring of factors that affect product quality and safety.

    Monitoring and Control of Contamination Factors

    Monitoring and control of contamination factors involves:

  • Temperature

  • Humidity

  • Air flow

  • Particulate levels

    • These factors can contribute to contamination of pre-filled syringes, cartridges, and other injectable products. ISO 11135-1 requires that manufacturers monitor and control these factors to ensure product quality and safety.

    Conclusion

    In conclusion, the validation of aseptic processing is essential for ensuring the quality and safety of pre-filled syringes, cartridges, and other injectable products. Compliance with ISO 11135-1 is mandatory in many countries, and failure to comply can result in product recalls, legal action, and damage to reputation.

    References

    ISO 11135-1:2014 - Sterilization of healthcare products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical instruments

    ASTM E2233:2015 - Standard Guide for Aseptic Processing of Pre-Filled Syringes, Cartridges, and Other Injectable Products

    EN ISO 14644-1:2015 - Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness

    TSE 1479:2006 - Cleanrooms and associated controlled environments

    These references provide a framework for ensuring the quality and safety of pharmaceutical products.

    Standard-Related Information Conclusion

    In conclusion, compliance with ISO 11135-1 is essential for ensuring the quality and safety of pre-filled syringes, cartridges, and other injectable products. Failure to comply can result in product recalls, legal action, and damage to reputation.

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