Medical device packaging validation is an important part of preparing a sterile medical device for market. However, it is often addressed too late in the product development process.
Selecting the right validation lab involves more than comparing prices or finding the earliest available start date. The lab should have the accreditation, testing capabilities, quality systems, documentation practices, and technical experience required to support your specific device and packaging system.
Before requesting a quote, medical device manufacturers should understand what to look for in a packaging validation partner and what information the lab will need to build an accurate proposal.
When Should Packaging Design and Validation Begin?
Packaging discussions should begin as early as possible in the product development process.
Too often, manufacturers wait until the device design is nearly complete before considering the packaging system. They may then discover that packaging design, material selection, prototype development, test method development, and validation require more time than anticipated.
Waiting can delay the product launch, affect the project budget, or require design changes after other decisions have already been made. Early planning also gives the team more time to consider the device’s size, weight, geometry, sterile barrier requirements, sterilization method, distribution environment, and end-user needs.
The earlier a packaging partner becomes involved, the more opportunity there is to identify potential risks before they affect the validation timeline.
1. Review the Lab’s Accreditation
ISO 17025 Accreditation
ISO 17025 is an internationally recognized standard that establishes requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories.
Accreditation provides confidence that a lab’s quality management system, personnel, equipment, processes, and test methods have been evaluated by an independent accrediting body. However, a lab is not automatically accredited for every test it performs. Accreditation applies to the methods listed on its scope of accreditation.
The Role of an Accrediting Body
Organizations such as A2LA assess laboratories against ISO 17025 and other applicable requirements. During an assessment, the accrediting body reviews areas such as the laboratory’s quality management system, employee competency, equipment calibration, recordkeeping, and ability to perform specific test methods.
The name of the accrediting body is important, but manufacturers should also look closely at what the accreditation covers. A current certificate and scope provide more useful information than an accreditation logo alone.
Key questions to ask:
- Is the laboratory currently accredited to ISO 17025?
- Which accrediting body issued the accreditation?
- When does the accreditation expire?
- Are the methods required for this project included on the accredited scope?
- Will any testing be performed outside the lab’s accredited scope?
2. Review the Scope of Accreditation
A laboratory’s scope of accreditation identifies the specific test methods for which the lab has demonstrated competency. Confirm that the scope includes the standards and methods required for your packaging system, which may include distribution simulation, accelerated aging, environmental conditioning, package integrity testing, seal strength testing, or other specialized evaluations.
It is also important to determine whether the lab regularly supports medical device manufacturers. A general packaging lab may offer some of the same tests, but medical device packaging projects typically require a higher level of documentation, traceability, and quality oversight.
Key questions to ask:
- Which required methods are included on the accredited scope?
- Which methods are performed regularly for medical device projects?
- Are there limitations related to package size, weight, materials, or configuration?
- Does the lab perform all testing in-house?
3. Confirm the Lab Has the Right Capabilities
Before requesting a quote, provide as much information as possible about the device, packaging system, sterilization method, distribution environment, and anticipated test plan. This allows the lab to determine whether its equipment, facility, and technical team can support the work.
Equipment availability is only one part of the evaluation. Ask whether the lab has experience with products similar in size, weight, packaging format, sterilization method, and distribution requirements. Relevant experience can help identify potential concerns earlier in the process.
4. Discuss the Expected Timeline
Validation timelines can vary significantly depending on the project. Rather than asking only when testing can begin, request a complete projected timeline that accounts for protocol development, sample coordination, sterilization, aging, conditioning, testing, data review, and final reporting.
Key questions to ask:
- What is the current lead time for protocol development?
- What must be completed before the project is placed on the schedule?
- How long will each phase of testing take?
- How quickly are reports issued after testing is complete?
- What could cause the schedule to change?
- How will delays be communicated?
- Can the lab support an expedited timeline if necessary?
5. Understand the Documentation You Will Receive
The final report may be used to support design history files, regulatory submissions, audits, and future investigations. Before selecting a lab, ask what documentation is included in the quote and request sample documents when possible.
The protocol should define the samples, configurations, methods, acceptance criteria, conditioning requirements, test sequence, and responsibilities of each party. The final report should make it clear what was tested, how it was tested, what results were observed, and whether any deviations occurred.
Key questions to ask:
- What documents are included in the quoted price?
- Will we receive raw data and photographs?
- How are deviations documented and approved?
- Can the report format support our quality and regulatory requirements?
- How long are project records retained?
- Are document revisions included or billed separately?
6. Evaluate the Lab’s Communication Process
Packaging validation often involves engineering, quality, regulatory, manufacturing, sterilization providers, and the testing laboratory. When responsibilities are unclear or updates are inconsistent, small issues can quickly affect the schedule.
Key questions to ask:
- Who will manage the project and serve as the primary contact?
- How frequently will project updates be provided?
- How are questions and approvals documented?
- Who will contact us if a sample fails?
- Will testing pause if an unexpected condition is observed?
- Can our quality or engineering teams speak directly with the personnel performing or reviewing the testing?
7. Determine What Happens if a Package Fails
A failed test result does not always explain why the failure occurred. Some laboratories may document the result and return the samples to the manufacturer. A lab with in-house packaging engineers may also be able to evaluate the failure, identify potential contributing factors, and recommend next steps.
Key questions to ask:
- How are failures documented?
- Will testing stop after a failure is identified?
- Are failed samples preserved and returned?
- Can the lab support root cause analysis?
- Are packaging engineers available to review the results?
- Can the lab help develop a confirmation or retest plan?
- Are investigations included in the quote or billed separately?
8. Consider the People and Facility Behind the Testing
Ask about the qualifications and training of the technicians who will perform the testing. The lab should be able to explain how employees are trained, how competency is evaluated, and how authorization to perform specific methods is documented.
An in-person or virtual facility tour can also provide insight into how equipment, projects, and samples are managed day to day.
9. Prepare the Right Information Before Requesting a Quote
A complete request for quote allows the laboratory to provide a more accurate scope, cost, and timeline. Incomplete information may lead to assumptions, revisions, or change orders later in the project.
If some information has not yet been determined, identify those gaps for the lab. An experienced partner may be able to help develop the validation strategy, but that work should be clearly included in the project scope.
Choosing the Right Medical Device Packaging Validation Partner
The right packaging validation lab should do more than perform a series of tests. It should help your team understand the project requirements, establish a realistic timeline, maintain clear documentation, and address potential problems as they arise.
Reviewing accreditation, capabilities, timelines, documentation, communication practices, and technical support before selecting a lab can help reduce uncertainty throughout the validation process.
Whether your device is still in development or approaching validation, early conversations with a packaging partner can help identify the information, samples, and testing needed to move the project forward.