ISO 11607 - Packaging for terminally sterilized medical devices

1. Introduction and context

1.1 Importance of medical device sterility

The sterility of medical devices is essential to ensure patient safety in healthcare facilities. Nosocomial infections, which are infections acquired in a healthcare setting, pose a significant risk to patients. These infections can lead to severe complications, prolong hospital stays, and increase healthcare costs. To minimize this risk, it is crucial that medical devices, especially those used in invasive procedures, are reliably sterilized and maintain this sterility until their use.

1.2 Overview of ISO 11607

The International Organization for Standardization (ISO) plays a crucial role in establishing international standards that ensure product quality and safety. ISO 11607 is specifically dedicated to the packaging of sterile medical devices. This standard is essential for manufacturers, healthcare professionals, and regulators as it sets clear requirements for packaging materials and validation processes, ensuring that medical devices remain sterile throughout their lifecycle. ISO 11607 does not cover all requirements for aseptically manufactured medical devices. Additional requirements are needed to ensure drug/device combinations.

ISO 11607 is divided into two complementary parts:

• ISO 11607-1 (Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems, and packaging systems) : requirements for packaging materials and systems – This part specifies the requirements for materials and packaging systems designed to maintain the sterility of medical devices.
• ISO 11607-2 (Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing, and assembly processes) : requirements for process validation – This part focuses on the validation of packaging processes to ensure that medical devices remain sterile after packaging.

By combining the requirements of these two parts, ISO 11607 provides a comprehensive approach to the packaging of sterile medical devices, covering all aspects from material selection to process validation. This standard plays a vital role in protecting patient health by ensuring that medical devices remain sterile and safe until their use.

2. Scope of ISO 11607

2.1 Division of the standard into two parts

ISO 11607 is structured into two distinct but complementary parts, each addressing specific aspects of sterile medical device packaging. Together, these two parts provide a comprehensive approach to maintaining the sterility of medical devices throughout their lifecycle.

2.1.1 ISO 11607-1: requirements for packaging materials and systems

This part of the standard specifies the requirements for materials and packaging systems intended to maintain the sterility of medical devices. It covers various essential aspects to ensure the integrity of medical devices up to the point of use:

• Characteristics of packaging materials:
  • Strength: Materials must be robust to withstand sterilization methods without degrading.
  • Permeability: Materials must provide an effective barrier against microorganisms and other contaminants.
  • Compatibility: Materials must be compatible with different sterilization methods, such as steam, ethylene oxide, radiation, etc.
• Design and development requirements:
  • Packaging must be designed to allow aseptic opening without compromising the sterility of the contents.
  • The design must consider the shape, size, and fragility of medical devices.
• Performance testing:
  • Materials must undergo rigorous testing to verify their compliance with established criteria, including mechanical strength, microbial barrier, and durability after sterilization.

2.1.2 ISO 11607-2: requirements for process validation

This part of the standard focuses on the validation of packaging processes to ensure that medical devices remain sterile after packaging. It includes requirements for:

• Equipment and sterilization process qualification:
  • Installation Qualification (IQ): Verification that the necessary equipment and environments for the process are correctly installed and functioning as intended.
  • Operational Qualification (OQ): Tests to verify that equipment operates correctly under all intended conditions.
  • Performance Qualification (PQ): Confirmation that packaging processes consistently produce compliant results.
• Continuous quality controls:
  • Maintaining stringent controls to ensure performance standards are continuously met.
  • Regular inspections and periodic audits to verify compliance with ISO 11607 requirements.

By combining the requirements of these two parts, ISO 11607 ensures a comprehensive approach to the packaging of sterile medical devices, covering all aspects from material selection to process validation. This guarantees that medical devices remain sterile and safe until the moment of use, thus protecting patient health.

3. Requirements for packaging materials (ISO 11607-1)

3.1 Performance criteria for packaging materials

ISO 11607-1 sets strict criteria for packaging materials used for sterile medical devices. Materials must meet several essential requirements to ensure their effectiveness:

• Resistance to sterilization conditions:
  • Materials must withstand sterilization methods without degrading, whether it is steam sterilization, ethylene oxide, radiation, or other processes.
  • Example: A packaging material intended for use with steam sterilization must be able to withstand high temperatures and humidity without compromising its integrity.
• Maintenance of product integrity:
  • Materials must provide an effective barrier against contaminants, ensuring that the medical device remains sterile until the point of use.
  • Example: Tyvek® pouches are often used for their excellent barrier against microorganisms while allowing permeability to air and steam.
• Aseptic opening:
  • Packaging must be designed to allow easy and aseptic opening without compromising the sterility of the contents.
  • Example: Packaging systems must include controlled tear areas that allow easy opening without the risk of contamination.

3.2 Design and development requirements

In designing and developing packaging systems, manufacturers must ensure that the products meet the following requirements:

• Adaptability:
  • Packaging systems must be adapted to different types of medical devices, considering their shape, size, and fragility.
  • Example: Packaging for fragile surgical instruments must provide protection against shocks while being easy to open aseptically.
• Reliability:
  • Materials must provide reliable protection against the risks of puncture, tearing, and contamination.
  • Example: Materials must be tested for their mechanical strength to ensure they can withstand handling and transport conditions without deteriorating.
• Compatibility with sterilization methods:
  • Packaging materials must be compatible with the intended sterilization methods without releasing harmful substances.
  • Example: Materials must be chosen based on their ability to not chemically react with the sterilant used, such as ethylene oxide or steam.

3.3 Performance testing

The standard imposes several performance tests to verify the compliance of materials:

• Microbial barrier tests:
  • These tests ensure that materials prevent the penetration of microorganisms, thus ensuring the sterility of the contents.
  • Example: Materials must pass bacterial filtration tests to confirm their effectiveness as a barrier against microorganisms.
• Mechanical resistance tests:
  • These tests assess the durability of materials against physical stresses such as puncture and tear.
  • Example: Materials must undergo tensile and tear tests to ensure they can withstand handling during packaging, transport, and use.
• Aging tests:
  • These tests ensure that materials maintain their performance throughout their intended lifespan, even after prolonged exposure to sterilization and storage conditions.
  • Example: Materials must be exposed to accelerated aging conditions to verify they do not deteriorate before the expiration date.

By meeting these requirements, manufacturers can ensure that their medical devices will remain sterile and safe until their use. This contributes to reducing the risk of nosocomial infections and improving patient safety.

4. Validation of packaging processes (ISO 11607-2)

4.1 Validation steps

The validation of packaging processes is crucial to ensure that medical devices remain sterile after packaging. ISO 11607-2 details the necessary validation steps to ensure the compliance and performance of packaging systems. These steps include Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

4.1.1 Installation Qualification (IQ)

Installation Qualification (IQ) is the first step of validation. It aims to verify that all equipment and systems necessary for the packaging process are correctly installed and functioning according to the manufacturer's specifications.

• Documentation of specifications:
  • Gather and review technical specifications of packaging equipment.
  • Example: A manufacturer must verify that the technical characteristics of the sealing machine match the required specifications for packaging medical devices.
• Equipment installation:
  • Ensure that equipment is installed according to specifications and installation plans.
  • Example: A sealing machine must be installed according to the manufacturer's guidelines, including verifying electrical and pneumatic connections.
• Environmental verification:
  • Check environmental conditions (temperature, humidity, etc.) to ensure they are appropriate for the packaging process.
  • Example: The packaging room environment must be maintained under specific temperature and humidity conditions to ensure the integrity of packaging materials.
• Functionality tests:
  • Conduct tests to verify that each component of the equipment functions correctly.
  • Example: Perform operational tests on the sealing machine to ensure it operates without malfunction.

4.1.2 Operational Qualification (OQ)

Operational Qualification (OQ) involves testing equipment and processes under operational conditions to verify that they function correctly and consistently.

• Definition of critical parameters:
  • Identify and define critical process parameters (sealing temperature, cycle time, pressure, etc.).
  • Example: Determine optimal temperature and pressure parameters for sealing packaging.
• Tests under normal and extreme conditions:
  • Conduct tests to verify that equipment functions correctly under normal and extreme conditions.
  • Example: Test the sealing machine at different temperatures to ensure it can maintain hermetic seals under all intended conditions.
• Data collection:
  • Collect and analyze performance data to ensure critical parameters are controlled and stable.
  • Example: Record temperature and pressure data during tests to verify the consistency of results.

4.1.3 Performance Qualification (PQ)

Performance Qualification (PQ) is the final step of validation, aiming to confirm that the packaging process consistently produces compliant results.

• Pilot production:
  • Conduct a pilot production using the parameters defined during OQ.
  • Example: Produce a pilot batch of packaging to verify the quality of sealing and the sterility of medical devices.
• Conformity tests:
  • Perform tests to verify that finished products meet specifications and performance requirements.
  • Example: Test packaging to ensure they maintain sterility and mechanical strength after pilot production.
• Statistical analysis:
  • Use statistical methods to analyze results and ensure the process is under control and capable of producing compliant results consistently.
  • Example: Analyze performance data to verify that the packaging process is stable and capable of producing compliant packaging repeatedly.

4.2 Quality controls and documentation

Once the processes are validated, it is essential to maintain rigorous quality controls to ensure consistent performance. ISO 11607-2 stipulates that manufacturers must implement continuous quality control systems and comprehensive documentation to ensure compliance.

• Regular inspections:
  • Conduct periodic inspections of packaging systems to detect any potential failures.
  • Example: Regularly inspect sealing machines to ensure they operate correctly and without failure.
• Records and documentation:
  • Maintain documents detailing each step of the validation process, as well as the results of continuous quality controls.
  • Example: Keep comprehensive records of performance tests, inspections, and audits to ensure traceability and regulatory compliance (FDA, EMA, ANSM, etc.).
• Audits and reviews:
  • Conduct regular audits to ensure that validation practices remain in compliance with ISO 11607.
  • Example: Perform internal and external audits to verify that packaging processes continue to meet the standard's requirements.

By adhering to these validation and quality control requirements, manufacturers can ensure that their medical devices remain sterile and safe until their final use. This contributes to protecting patient health and reducing the risk of nosocomial infections.