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Could combination products recharge Puerto Rico's pharmaceutical industry?
A cloud of uncertainty hangs over the pharmaceutical industry in Puerto Rico following the expiration of tax incentives from Section 936 of the U.S. Internal Revenue Code. Could emerging combinations of biopharmaceuticals and medical devices provide a silver lining?
By Don Neumeister, Associate Publisher
Attendance at the 2008 Interphex show in Puerto Rico was strong, despite the fact that the event's first day fell on Valentine's Day, an unofficial national holiday. Much of the talk at the San Juan event centered around the health of the pharmaceutical industry on the island as pharmaceutical giants such as GlaxoSmithKline have already departed while others are consolidating and closing plants. In fact, one pharmaceutical plant closed shortly after a new multimillion-dollar line was installed.
Some in the pharmaceutical community blame the local government for lack of action, but the industry on the island reflects the worldwide changes taking place in the pharmaceutical industry. The future could depend on how local companies convert from high-volume pharmaceutical packaging lines to shorter-run, high-tech biopharmaceutical product lines.
Overall comments concerning the emerging medical device sector in Puerto Rico were positive. A few medical device companies are adding new lines, with more firms expected to relocate to the island soon.
Neftali Tosado, senior engineer, process development, Amgen, a human therapeutics company in the biotechnology industry, delivered a presentation entitled, "Technical Overview of Packaging Lines and Product Inspection for Biopharmaceutical Products." He stressed the importance of early understanding of drug-to-package compatibility to lower costs. Packaging provides the first line of defense for all formulated pharmaceuticals, protecting the product from the outside world and vice versa. At the same time, the package must be fully compatible with the product, whether it is in a liquid solution or lyophilized.
Dr. Michael Drues' presentation on combination products drew a small but very interested crowd. "Almost every type of medical device would benefit from the addition of a drug," Drues stated. When asked what division of the Food and Drug Administration regulates combination products, he responded, "That depends on how you define your product. If it's a device, you'll work with one area, if it's a drug, it's another. The Office of Combination Products was established to help these different agencies work together."
An interesting by-product of Interphex Puerto Rico was the attendance of non-pharmaceutical/medical device companies. For example, there was a conveyor exhibitor visited by Coke, Pepsi, and BASF representatives. This may be the only opportunity for some of these companies to see packaging developments on the island.
The lack of innovation in packaging and product protection in the pharmaceutical industry was also discussed buy one materials-producing company. An innovative, thermoformable film used for blister-packs that incorporates anti-counterfeiting features never saw the light of day in the U.S. But it will be adapted shortly by a pharmaceutical company in South America.
Accelerated aging test tips
There exists "a great deal of misinformation" when it comes to accelerated aging of medical device packaging, said Curt Larsen of Spartan Design Group, LLC (952/380-1458), at the January 28 MD&M (Medical Design & Manufacturing) West Medical Device Packaging Conference in Anaheim, CA.
He said, "One sample can't be used for both the sterile barrier system aging and design performance qualification testing, and expect consistent success. One of the objectives of the sterile barrier is to make sure it will maintain the sterility of the contents for the package's stated shelf life. To support those dating claims, you do an aging study to see what happens over time. We look at what happens to the materials and the seals between those two materials after they have been sterilized; that is all that needs to be done. You can use the same information on aging that others have, including details from suppliers that can provide data on the aging of their material combinations sterilized in different ways."
Larsen recommended that device manufacturers pay attention to materials and adhesives, and keep samples below 55 degrees C for their accelerated temperature. He added, "Humidity has nothing to do with aging—it confounds the entire process and can cause reaction between materials that would normally never happen. If there's a need for humidity in testing, the selection of the correct materials is critical." He recommended referencing the F1980-07's new revision for guidance on humidity. Other Larsen tips:
- Understand that seals may get stronger over time. Most of the packaging materials used today are very robust, and can readily maintain package integrity for many years.
- Know your distribution environment. Canned tests may be more severe than the actual distribution environment.
- Inspect your sample during testing if possible—before and after sterilization—to learn where a failure happened.
- Consider that sample sizes may open a can of worms. Ten boxes of one dozen are not 120 samples, they are 10 samples. A sample is what goes out the door, what is introduced into interstate commerce. If a single device is sold as one, or in a quantity of one dozen, as a 24-pack, as a gross, as a pallet, you have five different products and five different packaging systems. If you choose one of those as a "worst-case" design to test and not test the others, you must justify why.
- Understand what stresses your sample will be subjected to during distribution. A pallet doesn't withstand nearly the beating as one package going through small-parcel distribution on its own. A multipack package system has different stresses on the contents than that of a one-each.
- Realize that sample sizes are a business decision because they can be quite expensive and tough to get. In general, 30 is a number that the FDA finds acceptable for accelerated aging, but if you sell 150 high-priced items a year, 12 might be a reasonable amount to sample in accelerated aging tests. Whatever your sample size is, you must document the rationale you used in selecting it.
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