ISO 11607-2 Packaging System Validation under Thermal Stress Laboratory Testing Service
Eurolabs Expertise and Capabilities
Standard-Related Information
The packaging of pharmaceutical products is a critical aspect of the supply chain, ensuring that products are delivered safely and effectively. To ensure compliance with regulatory requirements and industry standards, manufacturers must validate their packaging systems under various stress conditions. ISO 11607-2 Packaging System Validation under Thermal Stress testing is a laboratory testing service designed to evaluate the performance of packaging systems under thermal stress.
The relevant international standards governing this testing service include:
ISO 11607-1:2016: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and testing of sterilization barriers and packaging systems ASTM F1980-18: Standard Practice for Validation of Medical Devices - Packaging SystemsThese standards provide a comprehensive framework for ensuring the safety and efficacy of pharmaceutical products. Manufacturers must comply with these regulations to ensure product quality and regulatory compliance.
Standard Development Organizations
The development of international standards is overseen by organizations such as:
International Organization for Standardization (ISO): A non-governmental organization responsible for promoting worldwide proprietary, industrial, and commercial standards. American Society for Testing and Materials (ASTM): A non-profit organization that develops and publishes voluntary consensus standards.These organizations work together to develop and update standards to ensure industry relevance and effectiveness.
Standard Requirements and Needs
This specific test is necessary because packaging systems must be validated under various stress conditions, including thermal stress. The consequences of not performing this test can include:
Product failure: Packaging systems that fail to meet regulatory requirements may lead to product recall or failure. Regulatory non-compliance: Manufacturers who do not comply with regulations may face fines and penalties.The industries that require this testing include:
Pharmaceuticals: Manufacturers of pharmaceutical products must ensure that packaging systems meet regulatory requirements. Medical devices: Manufacturers of medical devices, including sterile barrier systems and packaging systems, must be validated under thermal stress conditions.Test Conditions and Methodology
The test is conducted using the following equipment and instruments:
Thermal shock testing chamber: A controlled environment for subjecting samples to extreme temperature fluctuations. Thermocouples: Devices used to measure temperature changes during the testing process. Data acquisition software: Software used to record and analyze data collected during the test.The testing environment requirements include:
Temperature range: The thermal shock testing chamber must be capable of maintaining temperatures between -40C and 150C. Humidity control: The testing environment should maintain a relative humidity level between 30 and 70.The sample preparation procedures involve preparing samples according to the relevant standard requirements.
Test Reporting and Documentation
The test results are documented and reported in accordance with the following standards:
ISO 13485:2016: Medical devices - Quality management systems EN ISO 9001:2015: Quality management systemsThe report format and structure include:
Summary of findings: A concise summary of test results, including any deviations or non-compliances. Test data: Raw data collected during the testing process.Why This Test Should Be Performed
Performing this test is essential because it ensures regulatory compliance, product safety, and quality assurance. The benefits of performing this test include:
Regulatory compliance: Manufacturers who comply with regulations reduce the risk of fines and penalties. Product safety: Validating packaging systems under thermal stress conditions ensures that products are delivered safely and effectively. Quality assurance: Performing this test ensures that manufacturers meet quality standards.Why Eurolab Should Provide This Service
Eurolab provides this service because it has:
Expertise and experience: Eurolabs staff have extensive knowledge and expertise in laboratory testing services, including packaging system validation under thermal stress. State-of-the-art equipment: Eurolabs facilities are equipped with the latest technology, ensuring accurate and reliable test results. Accreditation and certification: Eurolab is accredited by relevant national and international organizations.Eurolab provides a comprehensive laboratory testing service for packaging system validation under thermal stress. The benefits of choosing Eurolab include:
Quality management systems: Eurolabs quality management system ensures that all testing services meet industry standards. Customer service and support capabilities: Eurolabs staff provide exceptional customer service and support throughout the testing process. Turnaround time and efficiency advantages: Eurolab offers fast turnaround times, ensuring that manufacturers receive test results promptly.In conclusion, ISO 11607-2 Packaging System Validation under Thermal Stress testing is a critical laboratory testing service for manufacturers who want to ensure regulatory compliance, product safety, and quality assurance. By choosing Eurolabs expert services, manufacturers can rest assured that their packaging systems meet industry standards.