Recent changes introduced in the packaging chapters within the U.S. Pharmacopeia (USP) have a direct impact on requirements for plastic packaging systems and, consequently, will affect suppliers of packaging materials of construction (MOC). To get an understanding of the scope of these changes and how they might affect the supply chain, PlasticsToday spoke with Dwain Sparks, who recently retired from Eli Lilly and Company after 39 years and has been a member of the USP Packaging and Storage Expert Committee and a key contributor to USP standards on container-closure performance testing. He will be a speaker and moderate a panel discussion exploring this and related topics during a conference at EastPack, co-located with PLASTEC East and MD&M East at the Javits in New York on June 14 to 16.

USP chapter <661>, “Container-Plastics,” and chapters <661.1>, “Plastic Materials of Construction,” and <661.2>, “Testing of Drug Products in Their Final Packaging System,” became effective this month. The revisions are extensive, says Sparks. “Many users described testing according to the prior version of <661> as a box-checking exercise. The tests were very basic and did not tell one much about the quality of the plastics that were being used,” says Sparks. That has changed.

Using the solid oral blister packaging system as an example, there may be a three-tiered supply chain, which is typical in the pharma sector. There are one or more suppliers of the materials of construction, companies that laminate the materials of construction into a blister film, for example, and contract manufacturers or pharmaceutical companies that combine the film with lidding to package drug products, explains Sparks. “The old version of USP <661> did not give the users much information about MOCs, but quality 'assurance' was achieved in part by strong relationships with the supplier, knowing how the material was made, and familiarity with supplier manufacturing facilities. MoC information is confidential and is in the supplier's Type III Drug Master File, so it was not passed along to the pharma company,” says Sparks. “As plastics were introduced for use in injection products, pharma companies needed more information about the MoC for extractables and leachables studies.”

As testing for leachables and extractables became standard practice, the old USP <661> proved to be inadequate. Now with the new <661> the implications of doing extractables and leachables studies are in place, says Sparks. “These new requirements reveal more information about the materials of construction.”

Although a reading of the USP <661> suite of chapters indicates that pharmaceutical companies are ultimately responsible for compliance, Sparks doubts very much that they will take on the full burden of testing. “There is a provision that if you do full testing on the finished container-closure system, then you don’t have to do testing on the raw materials. But I don’t think that pharma companies will take the full responsibility because there’s too much risk,” says Sparks, adding that some of the tests are new and waiting to do them until the container-closure system is in place is too late in the process. “I believe that pharma companies will ask for testing to be done on the materials of construction to have some assurances about their suitability as they head into clinical trials,” says Sparks.

Sparks is aiming to shed some clarity on issues related to the new testing during the conference session on June 16, where Desmond Hunt, PhD, Senior Scientific Liaison, U.S. Pharmacopeial Convention, will be speaking.

It’s a bit concerning that some companies may be unprepared for these changes, adds Sparks. “The revisions came out in the USP Pharmacopeial Forum (PF), a free-access online journal in which USP published proposed revisions for public review and comment, at least two years ago.” Hunt and other experts will be on hand at EastPack to help in understanding the changes in USP <661>. “The session will provide attendees with the tools and a pathway to get the answers they need to their questions,” hopes Sparks.

On a related note and to help users break the procrastination habit, Sparks encourgages readers to log into the PF to read the in-process revision for <661.3>, “Plastic Components and Systems Used in Pharmaceutical Manufacturing,” and related revisions to <1661>, “Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User Safety Impact,” which are open for comments until July 31, 2016. The steps to access the online documents are outlined below. If all of that makes your head spin, though, no worries—USP <661.3> will almost certainly be dissected in future PlasticsToday articles and EastPack conferences.

To register and access the PF:

If you have any comments, e-mail them to Desmond Hunt at [email protected].