ISO 11607 is the defining standard for medical package testing and validation. As the consensus standard for the Food & Drug Administration (FDA), no device can expect to find its way to market without an in-depth understanding of the standard and how to meet the requirements it spells out.
Yet for as comprehensive and detailed as ISO 11607 is, some parts of the standard are open for interpretation. The difference between “should” and “shall” could have significant implications for your process and your end product. Navigating those grey areas takes a close attention to detail and benefits from an experienced partner who’s been through the process before.
Life Science Outsourcing has an in-depth understanding of ISO 11607 and all the regulatory requirements that come with successfully developing and validating medical package testing as part of the broader manufacturing process. Here are five questions we often hear from clients and partners.
1. What’s covered in the ISO 11607 standard?
The standard details requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. Essentially, it’s intended to ensure the packaging of a medical device is safe and adequate and enables the device to perform efficiently, safely, and adequately in the end-user’s hands.
2. What are the two parts to ISO 11607?
The standard is broken down into two parts – ISO 11607-1 and ISO 11607-2.
ISO 11607-1:2019 details the elemental attributes demanded of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices. It takes into consideration the vast array of potential materials, medical devices, packaging system designs, and sterilization methods. It’s typically a focus earlier in the development process when packaging decisions and designs are being developed.
ISO 11607-2:2019 describes the validation requirements for forming, sealing, and assembly processes. The development and validation of packaging processes are crucial to ensure that sterile barrier system integrity is maintained until opened by the users of sterile medical devices.
As these descriptions show, -2 is really what covers the testing and validation requirements. Typically, there are four tests that fall under these validation requirements:
- Heat seal validation tests
- Distribution simulation testing
- Accelerated aging
- Real-time aging
3. Do I need to perform all of these tests?
One of the most common questions our team gets asked is how much testing and validation is required. The answer? It depends. For a brand new product working toward a 510K FDA submission, it will be necessary to conduct a full ISO submission and ensure that you’re dotting every “I” and crossing every “t”.
But for updates to existing products with existing 510K approvals, sometimes only specific tests are warranted. Often, this validation can focus on proving the product update does not alter the product and packaging’s form, fit, function, or efficacy. In many instances, there are supporting industry standards that can help bolster testing results. Working with a partner that has navigated these partial submissions can help streamline the process and reduce the amount of validation work required.
4. What sample size is needed for validation?
Here’s another question we hear a lot where the answer is: it depends. The standard does not spell out how many samples are required to validate. And that’s for good reason. The number of samples will vary depending on the level of risk. Experienced manufacturing partners can help organizations calculate their risk and come up with a meaningful sample size, but it really must be addressed on a case-by-case basis.
5. Will the standard be updated soon?
All ISO standards are updated every five years or so – sometimes those updates are significant, sometimes not. Given the cycle for ISO 11607, it’s most important to make sure any partners have made the necessary adjustments based on the 2019 updates.
Navigate Standards with a Proven Partner
Life Science Outsourcing has decades of experience helping device manufacturers navigate medical package testing requirements and related standards – including ISO 11607. That includes incorporating established best practices and recommended timing into real-time and accelerated aging processes.