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iso-13408-3-lyophilization-for-aseptic-processing
Sterility and Microbial Limit Testing 21 CFR Part 211.113 Control of Microbiological Contamination21 CFR Part 211.165 Testing and Release for Distribution21 CFR Part 211.167 Special Testing RequirementsAOAC 2003.01 Testing for Escherichia coli and ColiformsAOAC 2003.07 Microbial Enumeration for Nutritional SupplementsAOAC 966.23 Microbial Limits in CosmeticsEN 556-1 Requirements for Medical Devices Labeled ‘Sterile’EN 556-2 Requirements for Sterile Barrier SystemsEN 868-1 Packaging Materials for Terminally Sterilized Medical DevicesEN 868-2 Sterilization WrapsEN 868-3 Paper for Use in SterilizationEN 868-4 Paper Bags for Steam SterilizationEN 868-5 Heat Sealable PouchesEN 868-6 Paper for Low Temperature SterilizationEN 868-7 Nonwoven WrapsEN 868-8 Reusable Textiles for Sterile Barrier SystemsEN ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – RequirementsEN ISO 11607-2 Packaging Validation RequirementsEP 2.6.1 Sterility Testing of Finished Dosage FormsEP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration TestsEP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified MicroorganismsFDA BAM Chapter 10 Listeria monocytogenes DetectionFDA BAM Chapter 14 Bacillus cereus TestingFDA BAM Chapter 18 Microbial Limits for CosmeticsFDA BAM Chapter 3 Aerobic Plate Count for Food and SupplementsFDA BAM Chapter 4 Enumeration of Yeast and MoldFDA BAM Chapter 5 Coliforms and E. coli DetectionFDA BAM Chapter 7 Staphylococcus aureus DetectionFDA BAM Chapter 8 Salmonella DetectionICH Q10 Pharmaceutical Quality SystemICH Q6A Specifications for New Drug SubstancesICH Q6B Specifications for Biotechnological ProductsICH Q7 GMP for Active Pharmaceutical IngredientsICH Q9 Quality Risk ManagementISO 11135 Validation of Sterilization by Ethylene OxideISO 11137-1 Sterilization of Healthcare Products – RadiationISO 11137-2 Establishing the Sterilization DoseISO 11137-3 Guidance on Dosimetric Aspects for Radiation SterilizationISO 11138-1 Biological Indicators – General RequirementsISO 11138-2 Biological Indicators for Ethylene Oxide Sterilization ProcessesISO 11138-3 Biological Indicators for Steam Sterilization ProcessesISO 11138-4 Biological Indicators for Dry Heat Sterilization ProcessesISO 11138-5 Biological Indicators for Low-Temperature Steam and FormaldehydeISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-2 Tests of Sterility Assurance for Medical DevicesISO 13408-1 Aseptic Processing of Healthcare ProductsISO 13408-2 Sterilizing FiltrationISO 13408-4 Clean-in-Place for Aseptic ProcessingISO 13408-5 Sterilization-in-PlaceISO 13408-6 Isolator Systems for Aseptic ProcessingISO 13408-7 Aseptic ConnectionsISO 14160 Sterilization of Medical Devices Using Liquid Chemical SterilantsISO 14644-1 Cleanroom Classification by Particle CountISO 14644-10 Classification of Surface Chemical CleanlinessISO 14644-2 Cleanroom Monitoring to Provide Evidence of CleanlinessISO 14644-3 Test Methods for CleanroomsISO 14644-4 Design, Construction and Start-Up of CleanroomsISO 14644-5 Operations in CleanroomsISO 14644-6 VocabularyISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.)ISO 14644-8 Airborne Molecular ContaminationISO 14644-9 Classification of Surface Particle CleanlinessISO 14698-1 Biocontamination Control in Cleanrooms and Controlled EnvironmentsISO 14698-2 Evaluation Methods for Biocontamination ControlISO 14937 General Requirements for Sterilization ProcessesISO 15883-1 Washer-Disinfectors for Medical DevicesISO 15883-2 Washer-Disinfectors for Surgical InstrumentsISO 15883-3 Washer-Disinfectors for Human Waste ContainersISO 15883-4 Washer-Disinfectors for Thermolabile EndoscopesISO 15883-5 Test Soils and Methods for Washer-DisinfectorsISO 15883-6 Washer-Disinfectors for Baby Bottles and UtensilsISO 17665-1 Moist Heat Sterilization of Healthcare ProductsISO 17665-2 Guidance on Moist Heat Sterilization ValidationISO 18362 Manufacture of Sterile Medicinal ProductsJP 4.05 Sterility Testing for Injectable ProductsJP 4.06 Microbial Limit Tests for Pharmaceutical ProductsPDA TR 1 Sterility Testing GuidelinePDA TR 27 Pharmaceutical Package IntegrityPDA TR 28 Process Simulation TestingPDA TR 36 Isolator Systems for Sterility AssurancePDA TR 69 Bioburden and Cleanroom Microbial ControlPDA TR 70 Sterilization of Drug Products by Moist HeatPh. Eur. 2.6.30 Bacterial Endotoxins – LAL TestPh. Eur. 5.1.10 Guidelines for Viral Safety of Biotechnological ProductsPh. Eur. 5.1.2 Biological Indicators for Sterilization ProcessesPh. Eur. 5.1.4 Cleanroom and Isolator Environmental MonitoringPh. Eur. 5.1.6 Container Closure Integrity for Sterile ProductsPh. Eur. 5.1.8 Microbiological Quality of Herbal PreparationsTGA TG-GMP Sterility Requirements for Medicinal ProductsUSP <1211> Sterilization and Sterility AssuranceUSP <1222> Terminally Sterilized Drug ProductsUSP <1229> Sterilization of Compendial ArticlesUSP <1231> Water for Pharmaceutical PurposesUSP <2021> Microbiological Testing of Nutritional and Dietary SupplementsUSP <2022> Microbiological Testing of Nonsterile Personal Care ProductsUSP <55> Biological Indicators – Resistance Performance TestsUSP <61.1> Microbial Limit Testing for CosmeticsUSP <61> Microbial Enumeration Test for Non-Sterile ProductsUSP <62> Test for Specified Microorganisms in Pharmaceutical ProductsUSP <71> Sterility Test for Parenteral Drug Products

Comprehensive Guide to ISO 13408-3 Lyophilization for Aseptic Processing Laboratory Testing Service by Eurolab

ISO 13408-3 is a widely recognized international standard that specifies the requirements for lyophilization (freeze-drying) processes in aseptic processing. This standard is essential for ensuring the quality and safety of pharmaceutical, biotechnology, and other products that are sensitive to moisture and require freeze-drying as part of their manufacturing process.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 13408-3 lyophilization testing is governed by various international and national standards. These include:

  • International Organization for Standardization (ISO) standards, such as ISO 13408-3

  • American Society for Testing and Materials (ASTM) standards, such as ASTM E2531

  • European Committee for Standardization (CEN) standards, such as EN 285

  • Turkish Standards Institution (TSE) standards, such as TS 14342

    • These standards are developed by standard development organizations (SDOs), which include:

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • CEN (European Committee for Standardization)

  • TSE (Turkish Standards Institution)

    • Standard Development Organizations

    Standard development organizations play a crucial role in the development of international and national standards. They are responsible for:

  • Developing new standards

  • Reviewing and revising existing standards

  • Providing guidance on standard implementation

    • Some examples of SDOs include ISO, ASTM, CEN, and TSE.

    International and National Standards

    The following are some examples of international and national standards that apply to lyophilization testing:

  • ISO 13408-3: Freeze-drying (lyophilization) of pharmaceutical products Part 3: Aseptic processing

  • ASTM E2531: Standard Practice for Freeze-Drying of Pharmaceuticals

  • EN 285: Sterilization Steam sterilizers Large sterilizers

  • TS 14342: Freeze-dried food products Requirements

    • Standard Compliance Requirements

    Compliance with these standards is mandatory for companies operating in the pharmaceutical, biotechnology, and other industries that require lyophilization as part of their manufacturing process. Failure to comply can result in:

  • Product recall

  • Regulatory fines

  • Loss of market share

  • Damage to reputation

    • Industry-Specific Examples and Case Studies

    The following are some examples of industry-specific applications of ISO 13408-3 lyophilization testing:

  • Pharmaceutical companies: Lyophilization is used for the production of vaccines, antibodies, and other biopharmaceuticals.

  • Biotechnology companies: Freeze-drying is used for the preservation of enzymes, proteins, and other biological materials.

  • Food industry: Freeze-drying is used for the production of instant coffee, tea, and other food products.

    • Consequences of Not Performing This Test

    Failure to perform ISO 13408-3 lyophilization testing can result in:

  • Product contamination

  • Loss of product potency

  • Reduced shelf life

  • Inability to meet regulatory requirements

    • Business and Technical Reasons for Conducting the Test

    The business and technical reasons for conducting ISO 13408-3 lyophilization testing include:

  • Ensuring product quality and safety

  • Meeting regulatory requirements

  • Reducing production costs

  • Increasing product shelf life

    • Risk Factors and Safety Implications

    The risk factors associated with freeze-drying include:

  • Product contamination

  • Equipment failure

  • Human error

  • Inadequate training

    • These risks can be mitigated through proper testing and validation of lyophilization processes.

    Quality Assurance and Quality Control Aspects

    ISO 13408-3 lyophilization testing is an essential part of quality assurance (QA) and quality control (QC) programs. This includes:

  • Validation of freeze-drying equipment

  • Calibration of temperature and pressure controls

  • Monitoring of product moisture levels

    • Competitive Advantages and Market Positioning

    Companies that conduct ISO 13408-3 lyophilization testing can enjoy competitive advantages, including:

  • Improved product quality and safety

  • Enhanced regulatory compliance

  • Increased market share

  • Reduced production costs

    • Cost-Benefit Analysis

    The cost-benefit analysis of performing ISO 13408-3 lyophilization testing includes:

  • Initial investment in equipment and personnel

  • Ongoing costs for maintenance and calibration

  • Benefits of improved product quality, safety, and regulatory compliance

    • ISO 13408-3 lyophilization testing involves a series of steps that ensure the accurate measurement of freeze-drying processes. These include:

    1. Sample Preparation: Preparing samples for testing by removing any packaging or labeling.

    2. Freeze-Drying Equipment Calibration: Calibrating freeze-drying equipment to ensure accurate temperature and pressure controls.

    3. Monitoring Product Moisture Levels: Monitoring product moisture levels during freeze-drying to ensure optimal conditions.

    4. Temperature Control: Maintaining precise temperature control during the freeze-drying process.

    5. Pressure Control: Controlling pressure during the freeze-drying process to prevent product collapse or distortion.

    Equipment and Instrumentation

    The following equipment and instrumentation are used for ISO 13408-3 lyophilization testing:

  • Freeze-dryers

  • Thermocouples

  • Pressure gauges

  • Moisture analyzers

    • Testing Procedures

    The following testing procedures are used for ISO 13408-3 lyophilization testing:

    1. Initial Testing: Conducting initial testing to determine optimal freeze-drying conditions.

    2. Revalidation Testing: Revalidating freeze-drying processes on a regular basis (e.g., every 6 months).

    3. Monitoring and Recording: Monitoring and recording product moisture levels, temperature, and pressure controls.

    Data Analysis

    The data collected during ISO 13408-3 lyophilization testing is analyzed to:

  • Determine optimal freeze-drying conditions

  • Validate freeze-drying equipment

  • Monitor product quality and safety

    • Test Report

    A comprehensive test report is generated after each testing procedure. This includes:

  • Summary of results

  • Recommendations for improvements

  • Documentation of testing procedures and equipment used

    • Conclusion

    ISO 13408-3 lyophilization testing is an essential part of ensuring the quality and safety of pharmaceutical, biotechnology, and other products that require freeze-drying as part of their manufacturing process. Companies that conduct this testing can enjoy competitive advantages, including improved product quality and safety, enhanced regulatory compliance, increased market share, and reduced production costs.

    Appendix

    The following is a list of additional resources related to ISO 13408-3 lyophilization testing:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

  • Freeze-drying equipment manufacturers

  • Lyophilization consultants

    • Glossary

    The following is a list of key terms related to ISO 13408-3 lyophilization testing:

  • Freeze-Drying: The process of removing moisture from products using a combination of freezing and vacuum.

  • Lyophilization: A synonym for freeze-drying.

  • Aseptic Processing: The process of handling and processing products in a sterile environment to prevent contamination.

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