The principle guidance for validating terminally sterilized medical device packaging is ISO 11607. ISO 11607 is divided into two parts – Part 1, “Requirements for Materials, Sterile Barrier Systems and Packaging Systems” and Part 2, “Validation for Forming, Sealing, and Assembly Processes.” ISO 11607 improved the flow of package qualification and process validation by defining/harmonizing four key terms used throughout both parts of the standard.
For sterile barrier packaging systems, ISO 11607 Part 1 Design and Development outlines four key requirements as follows.
ISO 11607 Stability Testing: Real Time Aging and Accelerated Aging (ASTM F1980) to demonstrate the sterile barrier system maintains integrity over time for the anticipated shelf life of the product. ISO 11607 Performance Testing: ISTA and ASTM distribution simulation to demonstrate that the packaging system provides protection though the hazards of handling, distribution and storage. ISO 11607 Package Strength Testing: Physical tests to demonstrate the mechanical performance of the sterile barrier system.
ISO 11607 Package Integrity Testing: Physical tests to demonstrate the sterility and integrity of the sterile barrier system.
ISO 11607 requires medical device manufacturers to demonstrate the efficacy of their proposed sterile barrier packaging . Environmental conditioning, accelerated aging and distribution simulation provide a controlled means to expose a packaging system to the anticipated environmental and dynamic stresses that the packaging system may encounter in field. Package strength testing and package integrity testing provide the means to evaluate the packaging after such exposure.
ISO 11607 Package Validation Tests
Visual Inspection: ASTM F1886, Determining integrity of seals for medical packaging by visual inspection
Internal Pressurization: ASTM F2096, Detecting gross leaks in porous medical packaging by internal pressurization (Bubble test)
Vacuum Leak: ASTM D3078, Determination of leaks in lexible packaging by bubble emission
Integrity/Dye Penetration: ASTM F1929, Detecting seal leaks in porous medical packaging by dye penetration
Integrity/Dye Penetration: ASTM F3039, Detecting seal leaks in nonporous medical packaging by dye penetration
Seal Strength: ASTM F88, Seal strength of flexible Barrier materials
Seal Strength: ASTM F1140, Failure resistance of unrestrained and non-rigid packages for medical application
Seal Strength: ASTM F2054, Burst testing of flexible package seals using internal air pressurization within restraining plates
Tensile Properties: ASTM D882, Tensile properties of thin plastic sheeting
Tear Resistance: ASTM D1922, Propagation tear resistance of plastic film and thin sheeting by pendulum method
Puncture: ASTM D3420, Pendulum impact resistance of plastic film
Puncture: ASTM F1306, Slow rate penetration resistanceof flexible barrier films and laminates
Puncture: ASTM D1709, Impact resistance of plastic film by free-falling dart method
Performance: ASTM D4169, Standard Practice for Performance Testing of Shipping Containers and Systems
Performance: ISTA 1, 2 and 3 Series Distribution Tests
Aging: ASTM F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Medical Device Package Testing
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ISO 11607 Package Validation for Medical Devices
ISO 11607 is the principal guidance document for validating terminally sterilized medical device packaging systems. Packaging must comply with ISO 11607 in order to satisfy European regulations and obtain a CE Mark. ISO 11607 is also a FDA Recognized Consensus Standard. Fulfilling the requirements within ISO 11607 ensures that a medical device packaging system allows sterilization, provides physical protection and maintains sterility up to the point of use.
Testing can be performed as part of product development testing or to show conformance with appropriate standard requirements and/or demonstrate that the functional performance of the product satisfies specific design requirements.
Devices and accessories tested include, Metered dose inhalers (MDIs), Needle-base injection systems (NISs), Pump dispensers, Syringes, Prefilled syringes, Small bore connectors for liquids and gases, Transfusion and IV sets.
Product testing services include ease of assembly, actuation assessment, simulated use and ease of use, dose accuracy, tamper evidence assessment, test method design and validation, verifications of product claims, visual inspections, dimensions, connection compatibility.
Packaging testing services include ISO 11607 package validation testing, integrity testing, seal strength testing, sterile barrier system testing, shelf life studies, transport simulation, medical device shelf-life and package testing to ISO 11607
Effective packaging and packaging materials are essential to preserving the sterility of medical devices. However, the integrity of packaging material can degrade over time due to environmental exposure, or be compromised between the time it leaves the production line and the day it gets used. Packaging can be damaged during packing, transportation, distribution, storage, or end user handling. As a result, rigorous testing of medical device shelf-life and packaging systems is mandatory in most major jurisdictions around the world.
Types of tests to verify medical device packaging compliance and sterility
The ISO 11607 standard requires that specific properties of medical devices as well as their packaging remain stable for the duration of their shelf life. To back up claims of compliance to ISO 11607, manufactures should conduct appropriate validation studies on their devices’ shelf life and transport stability.
The ISO 11607 series includes two testing standards for medical devices:
ISO 11607-1 covers requirements for materials, sterile barriers, and packaging of sterilized medical devices.
ISO 11607-2 covers requirements for validation of sterile medical device packaging processes.