Every glass and elastomeric material used in pharmaceutical packaging or delivery systems should be safe and suitable for its intended use. Establishing the suitability of packaging systems for pharmaceutical products involves multiple tests and testing procedures, for which USP has established a number of minimum requirements. However, with many new materials and applications entering the marketplace, these requirements need to be revised regularly to make sure quality attributes are considered.
To that end, USP has started an effort to modernize its packaging standards. More specifically, USP is revising two existing General Chapters: <381> Elastomeric Closure for Injections and <660> Containers−Glass.
Part of the modernization effort also includes proposing three new chapters: <1381> Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems, <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems and <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems.
We spoke with USP’s Principal Scientific Liaison, Dr. Desmond Hunt, to get a better understanding of the scientific thinking behind these revisions and proposed new chapters.
Question: Why talk about glass and elastomeric packaging at this time?
Answer: Determining the suitability of a packaging component is very important in light of issues related to patient safety. We know that chemical compounds can migrate from packaging systems into a finished drug product and pose risks to patient safety; so choosing suitable and well characterized packaging components and systems is an important first step. Part of that is always making sure you are in compliance with compendial standards. They represent a baseline.
The reason we’re looking at revising the packaging standards now is mainly because some of these standards haven’t been modernized in a long time. We try to make our standards reflect the current industry and regulatory thinking and best practices.
Question: What are the major differences between these and the previous chapters?
Answer: With regard to the standard for glass components - Chapter <660> - the revisions will be phased. The first phase, which is currently published for public comment in Pharmacopeial Forum, is looking to address concerns from industry regarding the autoclave procedure and to give more information as to why the autoclave is critical to getting reliable test results. The second phase of the revision, which we plan to discuss at our upcoming workshop, will be to update and add more modern methods, and look at adding new tests that go beyond just identification.
For the elastomeric standards - Chapter <381> - the changes are quite significant. We currently have one Chapter that addresses elastomeric components (i.e. <381>), but we are expanding the scope to include three new chapters. The revision is aimed at not only looking at elastomeric closures for injections, but all elastomer components used in injectable packaging/delivery systems. We’re also taking out the functionality tests currently in Chapter <381> and transferring them to a separate, new chapter, <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems.
Together with the new General Chapter <382> we are proposing two informational chapters, <1381> and <1382>, which are meant to give more background and information on elastomeric materials, as well as to offer guidance on how to choose the correct functionality test.
Question: What are some of the challenges in establishing standards for these specific types of packaging?
Answer: I think the difficulty in revising these standards is that there are so many different types of materials – both glass containers and elastomeric components used in injectable packaging/delivery systems – that it is hard to develop a single standard that addresses all the possibilities. One solution we are proposing with the modernization effort is to introduce the notion of “suitable for intended use,” because an elastomeric component or glass container may be suitable for one drug product, but not another. For that to happen, we are trying to make the standards less prescriptive so that useful materials or components are not prevented from being on the market.
Question: Who do the changes in the packaging standards affect?
Answer: Anyone who sells a packaging material or a component to drug manufacturers. If you think about it, every drug product is going to be packaged in some kind of packaging system – it could be plastic, glass, metal, or some type of elastomeric material. So for manufacturers of packaging systems that include glass or elastomeric materials, these revisions will have an impact, as well as for drug product manufacturers who intend to use new components in their packaging systems.
Question: When are the changes expected to take effect?
Answer: That’s a good question. The chapters are currently published for public comment, and that period ends on July 31, 2017. While we hope those affected by the changes provide feedback for us to consider in the final publication of these standards through our official process, we wanted to provide a chance for our stakeholders to comment on the changes in our June workshop. After the workshop and the comment period, we will consider the feedback and take it from there. Depending on the nature of the comments we receive, we may revise and republish the chapter(s) once again, or we may make some changes and publish without a second comment period. So it really depends on the type of feedback we get.
Question: What are the next steps from here?
Answer: The next step is to get as much feedback as we can. That way we prevent any negative impact that the changes proposed might have on our stakeholders. By listening to their concerns, we can make the revised standards useful while keeping in mind the quality of the packaging materials and systems being used.
Question: Any other insights or final thoughts?
Answer: The only thing I would like to add is that, while people often don’t think about the impact of packaging systems, if you look at product recalls related to incompatibility of packaging systems, this is an important issue. Compendial standards have always been and will continue to be a minimum requirement, so paying attention and being a part of the discussion for the development of these standards only adds value for our stakeholders.
To register for the June 19 – 20th workshop, go here.
Desmond Hunt, Ph.D., USP’s Principal Scientific Liaison, provides insight into packaging systems for drugs and how USP standards can support quality in this field. Dr. Hunt works closely with USP’s Expert Committee on Packaging and Distribution—the volunteer experts who serve as key decision-makers in the USP standards-setting process.