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Equipment and Processing Report
As demand increases, new materials and machines broaden options for blister packaging.
Demand for blister packaging will grow at a 9% compound annual growth rate from 2018 through 2022, according to a report from Technavio (1). Driving forces include low cost, patient convenience, sustainability benefits, and compatibility with anticounterfeiting, child-resistant, and senior-friendly features. According to a senior analyst at Technavio,“Blister packaging is predicted to be the most economical packaging method throughout the supply chain of a pharmaceutical product …. Additionally, blister packaging is more sustainable as it creates less landfill when compared with glass and plastic bottle manufacturing” (1).
Unit-dose blister packaging also is recognized as a potential tool to circumvent opioid abuse. In fact, unit-dose packaging is specifically mentioned as one way to reduce the over-prescription of opioids in The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, which was signed into law on Oct. 24, 2018 (2).
In an Oct. 24, 2018 statement about the passage of the act, FDA Commissioner Scott Gottlieb, MD, noted, “The convenience of this kind of packaging could encourage prescribers to opt for shorter durations of use, thereby limiting the number of opioids dispensed to patients…. It could reduce the number of 30-day prescriptions that are still too common. Ultimately, this approach could reduce the overall number of drugs in circulation and potentially lower the rate of new opioid addiction. It could also address the problem of excess supply, leading to fewer pills left in medicine cabinets that could be inappropriately accessed by family members, including children” (3).
As demand for blister packaging rises, so does the range of available material and machinery options. New material choices include high-barrier materials and materials designed to create all-film blisters on strip packaging machines. The Flexible Blister from Constantia Flexibles runs on conventional strip packaging equipment and offers barrier properties and push-through opening similar to traditional thermoform-fill-seal blister packs. The Flexible Blister can accommodate various tablet sizes and shapes, as well as incorporate anticounterfeiting measures. Push-through force can be customized for child resistance or easy access. In some cases, consumer information can be attached to or printed on the Flexible Blister, eliminating the need to carry doses in a secondary paperboard carton (4).
Strip-packaged blisters can be produced on Siebler strip packaging equipment from Romaco Group running a patent-pending multilayer polyethylene terephthalate (PET)/polyethylene (PE)/aluminum foil/PE/Surlyn laminate or a clear barrier film from Huhtamaki. A targeted perforation of the polyester layer of the four-side-sealed pack allows press-through removal of the dose. The tear-resistant material can meet child-resistant packaging requirements. The design uses less material and costs less than cold-formed aluminum blisters. The push-through strips can be supplied in the standard rectangular format or as “design strips.” A Siebler HM 1-350 heat-sealing machine equipped with a continuous die-cutter produces special formats such as round, heart, petal, or star shapes at rates of up to 800 design strips/min (5).
For conventional blister packs, Tekni-Films, a Tekni-Plex business, has introduced SBC 240 polyvinylidene chloride (PVDC)-coated PE film. Designed as a lower cost alternative to 4- and 6-mil polychlorotrifluoroethylene(PCTFE) or cold-formed foil, the clear, triplex material offers an ultra-high barrier to moisture and oxygen and a wider processing window than PCTFE and eliminates the need for stiffening ribs as well as the larger blister wells needed for cold forming. That means more doses can be arranged on the card or the card size can be reduced. The result is material costs savings throughout the supply chain and improved production efficiencies (6).
A newcomer on the machinery side, the Eagle-Omni blister machine from Maruho Hatsujyo Innovations (MHI), the US subsidiary of Maruho Co. Ltd., serves short-run production requirements (up to 20 blisters/min), as well as packaging development, prototyping, and materials testing needs. Measuring just over 2 m in length and 1.6 m tall, the compact machine offers a format area of 150 x 95 mm and a forming depth of 30 mm, with an upgrade available to 40 mm for larger dosage forms. The machine handles a wide range of forming materials (polyvinyl chloride (PVC), PVDC, PCTFE, polypropylene, PET, and foil) as well all typical lidding substrates (foil, paper, PVC, PET, and laminates) (7).
1. Technavio, “Blister Packaging Market in the US 2018-2022, Growth Analysis and Forecast, Technavio,” Press Release, Oct. 2, 2018.
2. US House of Representatives, “H.R.6 - SUPPORT for Patients and Communities Act,” www.congress.gov/bill/115th-congress/house-bill/6/text#toc-H496E9F6EA1E7428A8CE3BA236D8B27CA, accessed Feb. 1, 2019.
3. FDA, “Statement from FDA Commissioner Scott Gottlieb, M.D., on How New Regulatory Authorities Will Assist the Agency In More Forcefully Addressing Opioid Crisis; Included as Part of the Newly Enacted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act,” Press Release, Oct. 24, 2018.
4. Constantia Flexibles, “Constantia Flexibles Introduces Flexible Blister Packaging,” Press Release, Jan. 14, 2019.
5. Romaco Group, “Romaco Joins Industry Partners at CPhI Worldwide,” Press Release, Sept. 27, 2018.
6. Tekni-Films, “Tekni-Films Introduces SBC 240 Performance-Oriented Super-Barrier Coated Thermoformable Film for Pharma Blister Packs,” Press Release, Jan. 31, 2019.
7. Maruho Hatsujyo Innovations, “MHI Introduces Eagle-Omni Deep-draw Blister Packaging Machine,” Press Release, Jan. 10, 2019.