Medical Device Packaging Validation: What, Why, & How?

In this blog, we have discussed what is medical device packaging validation and how to perform it. Additionally, we have highlighted the need for performing packaging validation for medical devices.

What is medical device packaging validation?

Medical device packaging validation is a comprehensive evaluation of packaging equipment, materials, and designs. It ensures the packaging system effectively protects the medical device, maintains sterility, and complies with regulatory standards. Additionally, it assesses other processing variables that may impact the ability of the packaged device to meet its acceptance requirements. Hence, medical device packaging validation is vital for maintaining the sterility of medical devices, protecting their functionality, and ensuring their biological safety. In short, it ensures the medical device reaches the end-user in an uncompromised condition and the packaging system is effective. ISO 11607-1:2009 is the internationally recognised standard for packaging validation for medical devices.

The main goal of medical device packaging validation is verifying whether the material and method used for the packaging of the device are appropriate. Moreover, it also checks whether the packaging material is compatible with the sterilization process. Additionally, it also evaluates whether the packaging system complies with the necessary packaging regulatory guidelines.

Types of medical device packaging

Different layers of packaging are used for packaging medical devices. Moreover, a variety of packaging materials and methods is used.

• Primary packaging: The primary packing material remains in direct contact with the medical devices.
• Secondary packing: The secondary packing material comes into contact with the primary pack. Often paper or cardboard box is used as secondary packing material.
• Tertiary packing: A carton box is usually used as the tertiary packing system. The tertiary packing is required for bulk storage and transportation.

Regulatory requirements for medical device packaging

1. The medical device packaging must maintain the sterile condition of the device until it is opened.
2. For non-sterile medical devices, the packaging system should maintain the integrity and cleanliness of the device.
3. The medical device must be packaged in a manner that its characteristics and performance are not adversely affected during storage and transport.
4. The packaging system should be designed to minimize the effect of any risk posed by contaminants and residues on patients.

How to perform medical device packaging validation?

We have highlighted the 5 key steps of the medical device packaging validation process.

1. Plan the packaging validation process

It is important to properly plan the medical device packaging validation process. The comprehensive packaging validation plan should cover the following:

• Materials to be used for packaging the medical devices
• The equipment to be used for packaging the medical devices
• A detailed explanation of the medical device packaging process
• The sterilization process to be used
• The roles and responsibilities of the staff involved in the medical device packaging process

2. Medical device packaging material selection

Medical device packaging materials must be carefully selected. They should be able to provide the necessary protection and comply with regulatory requirements. Medical device packaging validation will assess whether the packaging materials can maintain integrity under different conditions. Additionally, they will be tested for compatibility with the product and overall performance. Notably, proper selection and testing of packaging materials are pivotal for maintaining the integrity and safety of the packaged medical device. 

3. Conducting the packaging validation process

Each stage of the packaging validation process involves specific tests verifying whether the packaging process consistently produce medical device packages that meet the required specifications. Additionally, it checks whether the equipment is installed correctly and operate as intended. Furthermore, during packaging validation, rigorous assessments are performed to check whether the medical device packaging can withstand various environmental conditions. The packaging validation process stages include the following:

• Installation Qualification (IQ): This stage verifies the equipment has been correctly installed according to the specific requirements.
• Operational Qualification (OQ): This stage verifies the equipment operates within predetermined parameters, such as sealing temperature, speed, and contact pressure. Additionally, the sterile barrier system is evaluated for compliance with quality standards. Quality properties are also assessed. This includes checking for absence of punctures or tears, no open seals, no material delamination, and intact seals. Thus, it validates the packaging process yields satisfactory and consistent results.
• Performance Qualification (PQ): This stage is used to confirm the packaging process consistently produces optimally sealed and sterile barrier systems under actual working conditions. This is usually evaluated using a seal strength test. Packaging quality properties, such as absence of punctures or tears, visible damage, and material irregularities, are verified and tested.

4. Documenting the whole process

The results of all the tests performed should be properly recorded. Proper documentation is required to evidence the effectiveness of the packaging validation process and demonstrate regulatory compliance. The documents should maintain records of the following:

• Formal approval of the packaging validation process
• Evidence of the validation process, including the results of IQ, OQ, and PQ stages
• Process control and monitoring measures
• Evaluation of the results obtained from each of the stages
• Plans for process changes and re-validation in case of changes

5. Regulatory compliance

Medical devices have to be packaged as per regulatory guidelines and international industry standards. Medical device packaging validation has a vital role in ensuring regulatory compliance. It verifies whether the medical device has been packaged per regulatory guidelines and industry quality benchmarks. Packaging validation checks the following:

• Adherence to international standards, such as ISO 11607, which provides guidelines for medical device packaging.
• Adherence to quality systems defined in Good Manufacturing Practices (GMP).
• Compliance with medical device regulatory body directives for packaging medical devices.
• Non-conformity management system in place for implementation of effective measures to identify, report, and rectify non-conformities.
• Revalidation system in place for conducting regular checks to ensure the packaging process remains compliant with current standards.

Medical device packaging validation test methods

Medical device packaging is subjected to various test systems to evaluate its stability and performance, aseptic preparation, and microbial barrier properties. Additionally, the ability of the packaging material to maintain the performance, functionality, and biocompatibility of the contained medical device is evaluated. Moreover, ISO 11607 requires the specific properties of medical devices and their packaging systems to remain stable during their shelf-life. Hence, the medical device packaging system is subjected to the following tests:

1. Determination of seal strength (ASTM F88/F88M, EN 868-5 Annex D)
2. Determination of air permeance (ISO 5636-5, ISO 11607-1 Annex C)
3. Validation of the forming, sealing, and assembly processes of packaging for terminally sterilized medical devices
4. Validation of final packaging systems for sterile medical devices
5. Evaluation of the shelf-life of the sterile-packed medical device
6. Visual inspection (ATM F11886/F1886M)
7. Dye penetration testing (ASTM F1929, ASTM F3039, Ph.Eur. 3.2.9)
8. Peel characteristics and seal width measurement (EN 868-5 Annex E)
9. Burst test (ASTM F1140) and bubble test (ASTM F2096)
10. Microbial ranking (ASTM F1608) and testing for germ-proofness (DIN 58953-6)
11. Accelerated and real-time aging (ASTM F1980)
12. Transport simulation (ASTM D4169, D7386 and ISTA)
13. Qualification of packaging materials

Importance of medical device packaging validation

Medical device packaging validation aims to maintain the sterility of medical devices and safeguard them from physical damage, biological contamination, and external disturbances.

1. Integrity of packaged medical devices: Packaging validation plays an important role in verifying whether the packaging materials, structure, and closure integrity are sufficient to protect the device during storage and transportation. Basically, it ensures the medical device remains uncompromised until it reaches its destination. 
2. Medical device sterility maintenance: For sterile medical devices, maintenance of sterility while it is packaged is of utmost importance. Hence, validation is essential to ensure the medical device packaging maintains its barrier properties and prevents contamination during storage and transit. 
3. Patient safety: Packaging validation is vital for maintaining the sterility and protecting the functionality of medical devices. Hence, it plays a crucial role in ensuring patient safety. 
4. Regulatory compliance: Regulatory bodies have formulated a regulatory framework for effective packaging of medical devices. Hence, packaging validation is necessary for ensuring regulatory compliance and compliance with industry standards, such as ISO 11607.

Medical device packaging systems protect medical devices and maintain their sterility during transportation and storage. Hence, medical device packaging validation assesses the effectiveness of these packaging systems and ensures regulatory compliance. Navigating the medical device regulatory guidelines can be a tricky task. Email at [email protected] or call/Whatsapp on 9996859227 to have a smooth regulatory journey and easily establish your medical device business.