Progress Report: March 2011
Sterile Medical Device Packaging: International and European Rules
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Christelle Scliffet, Project Certification Manager, Auditor and Assessor, LNE/G-MED France
Naturally, manufacturers of sterile devices must validate their method of sterilization. However, the essential requirements also require such products to remain sterile throughout transport until their eventual use.
European (EU) and International (ISO) standards address this requirement taking into account a variety of factors.
This newsletter explores packaging for sterile medical devices, including:
- applicable European directives
- relevant international (ISO) standards
- specific testing requirements
- examples of packaging failures
Medical Devices Can Face harsh Conditions
The distribution of medical devices can involve a variety of diverse methods, each with its own potential hazards. Depending on the vehicle (plane, train, automobile, etc.) and destination, packaged devices are subjected to countless mechanical stresses, such as vibration, shock, perforation, pressure, abrasions and falls.
The packaging is also subject to the effects of temperature, humidity, air pressure variations and other stresses, such as microbiological environment. A device’s sterile barrier system must stand up to the relevant hazards, retain its integrity over time and not interact in a detrimental way with the device over time.
International Standard - ISO 11607: 2006
The applicable harmonized standard covering this requirement ISO 11607: 2006 -- Packaging for terminally sterilized medical devices -- is the best tool to methodically analyze and demonstrate the relevance of the packaging system for devices sterilized through a process after it is actually packaged (by opposition of aseptically processed). These standards specify the requirements and test methods for packaging that are intended to maintain sterility of medical devices that are sterilized at the end stage until point of use. The standard contains two parts:
- Part 1: Requirements for materials, sterile barrier systems and packaging systems
- Part 2: Validation requirements for forming, sealing and assembly processes
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Technical File Requirements
Complying with this harmonized standard (EN ISO 11607; 2 parts) gives presumption of compliance to the corresponding essential requirements of the European Medical Device Directives. (See box above.)
General requirements for the control of packaging for sterile devices include the need for a quality system. Methods used to demonstrate the compliance to this standard must be validated and be based on sound statistical approach, with documented evidence of compliance.
The elements to be addressed in the technical file are as follow:
- Choice of the material, including:
- Microbiological barrier properties
- Biocompatibility and toxicological characteristics
- Physical and chemical characteristics
- Compatibility with the forming and sealing processes
- Compatibility with the considered sterilization process
- Restraints on shelf life for warehousing, before and after sterilization
- Compatibility with the labeling
- Warehousing and transport
- Design of the packaging system, demonstrating the ability to present the product aseptically
- Performance testing of the packaging system, demonstrating the integrity of the packaging system after sterilization
- Stability testing, demonstrating by real time and accelerated studies the maintenance of the integrity of the packaging system during the shelf life of the medical device.
The validation of testing methods in the validation of the packaging will justify the choice of the tests, with regards to the packaging system, determination of the acceptance criteria, the repeatability, reproducibility and sensitivity of the testing method.
The validation of all packaging-related processes must include installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) in this order.
The EN ISO 11607 also specifies traceability requirements to consistently demonstrate the maintenance of sterility of the packaging system.
Laboratory simulation testing
Medical device packages are subject to a testing program (e.g. mechanical and climate) to simulate all of the constraints of a distribution chain.
The main test programs are described in:
- The American standard ASTM D 4169
- The technical guide of the International Safe Transit Association (ISTA; of which LNE is a member)
- The standard EN ISO 4180 (November 2010).
The choice of program depends on the particular type of package used (weight, dimensions, etc.), the mode of transport selected, the distribution chain and destination.
The following tests among others are included in these programs:
Vibration testing for road transportation, pressure testing for air transportation.
Evaluation of the microbial barrier properties, biocompatibility and toxicity, as well as the effects of sterilization on the chemical and physical properties of materials, and compatibility with systems forming and sealing.
For impervious materials, demonstration of the impermeability of the material is sufficient to demonstrate the microbial barrier properties.
For porous materials, there is no universal method to demonstrate the microbial barrier properties of materials; EN ISO 11607 standard indicates that the samples may be subjected to the action of aerosolized bacterial spores or particulates under a set of test conditions specifying the flow of air through the material, microbial resistance of the sample and the test duration.
After testing, packaging will be considered satisfactory if the product has retained its usability and if the package can still be handled by common means. Integrity testing and/or peelability will be performed to verify the integrity of the products such as the maintenance of sterility.
The documentation for this packaging process for maintaining a sterile condition until use at minimum must include performance data, specifications, test results, protocols and testing of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
