Harmonizing ISO 11607 and EN 868-1 will benefit medical device manufacturers.
Don't stop reading if you've heard this before: Efforts are under way again to harmonize ISO 11607, Packaging for Terminally Sterilized Medical Devices, and EN 868-1, Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized, Part 1, General Requirements and Test Methods. In late October, a technical committee charged with revising ISO 11607 to incorporate EN 868-1 and subsequent parts, Technical Committee 198, Working Group 7, Task Group 1, met in London to start once again the laborious task of creating a draft that will satisfy the concerns of the International Organization for Standardization (ISO), the European Committee for Standardization (CEN), and FDA, as well as meet the needs of medical device manufacturers all over the world.
The committee picks up where it left off in Kyoto, Japan, where its previously harmonized draft was presented by ISO after being rewritten by an ISO representative, who eliminated all references to EN 868-1. As a result, that draft is not expected to be accepted by CEN committee members, so another revision is still needed. In this exclusive roundtable discussion with PMP News editor Daphne Allen, the following members of this technical committee explain the intent and progress of their efforts: Michael Scholla, PhD, senior consultant, DuPont Medical Packaging and DuPont Medical Fabrics; Curt Larsen, packaging consultant to DuPont Medical Packaging; Paul Fielding, consultant to DuPont; John Spitzley, associate fellow, packaging, of Medtronic Inc.; Tim Galekop, business manager, medical, Europe, Ahlstrom FiberComposites and convener of CEN working group TC 102 WG 4; and Cathy Nutter, expert microbiologist, FDA's Division of Reproductive, Abdominal, and Radiological Devices.
What is your purpose behind revising ISO 11607?
Galekop: For background, CEN publishes the 868 series 1 to 10. Part 1 is the horizontal and mandated part. All these standards are in line with the European Medical Devices Directive, and what we are trying to do is to harmonize ISO 11607 with EN 868-1 and subsequent parts to prepare one document for the future.
What happened with the effort to harmonize the two this year?
Galekop: We had rewritten ISO 11607 in a direction that referred to EN standards. Our document was then completely changed by the ISO secretary in Geneva, who took it totally out of line and deleted the references to the EN documents. Nonetheless, it was sent out for final votes. Michael Scholla met the technical editors in Geneva to express his concern. This resulted in a new final draft of the 2nd edition. This draft has been discussed at length in Kyoto and has been sent around for a two-month voting period, but I do not know the results. We are now starting over by working on another revision that will give medical device manufacturers one document that is fully in line with the European Medical Devices Directive.
Will FDA need to review this harmonized document?
Nutter: If a consensus standard is changed, then FDA needs to review the revised standard before we could recognize it. The new standard, after being balloted and approved by ISO/CEN, would have to pass through an FDA technical review committee again. If accepted, the updated standard would then be recognized by FDA's Center for Devices and Radiological Health and be formally listed in the Federal Register under Recognition of Consensus Standards.
When do you anticipate having a draft ready for balloting?
Spitzley: At the meeting in Kyoto, we established the ground rules for this effort, and we came up with a schedule. Our goal is to have a final draft for CD ballot completed by the next plenary session, which is scheduled for the fall of 2003. We don't know, at this point, whether we're going to be able to stick to that schedule. It was rather ambitious, and this can be very difficult and slow-moving work.
Galekop: As soon as we have finalized a working document in our task group, we certainly will have a joint meeting between ISO and CEN working groups to go through the document to see if both working groups can accept the proposal. We are working together so there's one standard document for the future.
Fielding: The one key point for users of the ISO document is that the plan for the new drafts will involve two standards. The current EN 868-1 covers packaging materials and the design of the final package. The current ISO 11607 covers materials, the way in which the package is formed, and the final package. Now CEN has said that it would like the standard to be a materials standard, because the way in which you arrive at that package is not relevant to requirements under the Medical Devices Directive. Therefore, the ISO document will have to be split into two separate standards. We're going to prepare one standard that covers packaging materials and the final package and a second standard that covers the way in which that package is formed, either by the converter or the device manufacturer.
Will it be called an ISO document, or will it be an ISO/EN? Will it be one standard or two?
Fielding: It will be an ISO/EN document. Whether it's a two-part standard or two parallel standards remains to be seen. That's an ISO editorial decision. They will be separate documents to some extent.
Spitzley: The advantage to this format is that it's going to align more with the real world of medical device packaging, more so than the current standard. That's the order of events: material selection, package design and testing, and then manufacturing. The current standard changes the order. It focuses on materials, then forming and sealing, and then the final package.
Will there be any new test methods mentioned?
Spitzley: Our intent is to include those documented methods that we are aware of and use those as references in the standard. We hope to reference some of the work that's been done at ASTM over the past four or five years, as well as any referenced ISO standards that may have been developed that we didn't include in the previous document. We'll try to make it as up-to-date as possible, making those test methods as references.
Will you name a method by ASTM number?
Spitzley: If the group agrees to it. We'll discuss a method, whether it's an ASTM, ISO, or CEN method, and if it's appropriate for our document, we'll include it as a reference. We won't make it a requirement.
What about a method for nondestructive package testing?
Larsen: There are some new tests under development at ASTM that are nondestructive package-integrity tests, and we will look to include them, if they're available during this whole review and cycle. But there aren't that many methods out there. There's only one or two that I can think of. So, if and when they're available, and if the timing is right and it's agreed upon by the membership of this committee, we'll submit them to ISO and CEN for review and approval.
What about microbial barrier testing, in light of the efforts of the Barrier Test Consortium?
Scholla: BTC is developing a non-microbiological, physical test method that correlates with the microbiological method for testing the microbial barrier properties of a material. The rationale in the ISO document that exists today, as well as in terms of FDA requirements, is that if you have a porous component in your package, it should be evaluated by a microbial barrier methodology. Everything else should be looked at generally from a physical-test-method perspective. Hopefully the BTC test will enable you to look at microbial barrier properties without having to employ a bug checker like me.
The consortium is trying to develop a physical test that correlates with the microbiological test. How people use such a test is up to them. But there's always been a need for a physical test. The consortium did two things. First, it funded the basic scientific research, which established the mechanism by which porous packaging materials act as microbial barriers. Then it developed a physical test. Today, it is trying to take the scientific research that was generated at Air Dispersions Ltd. and turn it into a usable test method that is inexpensive enough to be widely adopted.
Adopted by material manufacturers and converters, or medical device manufacturers?
Scholla: By anybody who wants to use it.
Will this test be mentioned in this revision of ISO 11607?
Scholla: Sure. There's a paper that was published in the PDA Journal of Pharmaceutical Science and Technologyauthored by Colin Sinclair and Alan Tallentire that will be referenced. I don't know that we'll have an ASTM test method ready for this revision.
In general, how sensitive does a test method need to be?
Scholla: People are trying to take a very complex issue, which is, "What's an appropriate tortuous path?" and turn it into a question that's very simple. Anybody would love to give you a simple answer, but it doesn't work that way. What's appropriate and what's not appropriate will be influenced by package material, pressure differential, and airflow. If you have a package that's very porous, like something wrapped with CSR wrap, and there's a tiny hole in the CSR wrap, the probability that you're going to see a significant increase in airflow through that hole is relatively small. So it's a more complex problem than just what size hole is too small.
Galekop: For the last 30 or 40 years, we've been trying to develop a barrier test method, and we still don't have one accepted by everyone.
Spitzley: And improvements in test methods aren't just centered around increased sensitivity levels. There are other things that are improving, such as reliability and reproducibility. Many are taking the human element out of tests.
Scholla: If we look back 10 years ago, there were several company- or laboratory-specific test methods being used. Often without control, validation, or reproducibility. It wasn't a controlled situation, because these methods were not standardized and published. When you start subjecting test methods to peer review and round-robin testing to determine their inter- and intralaboratory reproducibility, what you find is people become more aware of their product's performance, because they have a test that's more reliable.