Innovations address sustainability, serialization and supply chain issues.
From a business perspective, solid dose manufacturers are outsourcing more production to contract development and manufacturing organizations (CDMOs). Industry stakeholders are also facing dramatic increases in raw material costs and overcoming supply chain constraints.
Rising costs, limited supplies and long delivery times are not uncommon today, both for product ingredients and packaging materials. “The COVID-19 pandemic has taken its toll on solid-dose bulk manufacturing [drugs]says Pat Elvin, president of Reed-Lane, a private company specializing in contract pharmaceutical packaging. He explains, “This supply shortage is due to an inability to obtain all the ingredients and a lack of employees to operate these facilities at this time.” Cardboard and label paper were particularly scarce. “Therefore,” he says, “when we look at the private label market, we see that companies are keeping their supply chain inventory extremely tight, and packaging operators are seeing more line changes for adapt to smaller and shorter packaging cycles.” An agile supply chain approach and production schedule is required.
PCI Pharma Services focuses on supply chain tools to improve its ability to respond to market changes. Its goal is to improve productivity and provide instant feedback to all stakeholders through better resource management and material allocation. The CDMO, which offers packaging and clinical trial services, uses the pci | digital gateway to share real-time information, customizable reports and digitized workflows to ensure all factors are included in a connected digital supply chain. “We are also leveraging digital tools within our manufacturing environment to make our customers’ supply chains more agile and create supply chain efficiencies, optimized inventories and predictive analytics,” says Justin Schroeder, Global Vice President, Product Development and Commercialization, PCI Pharma Services.
To address sustainability, serialization and supply chain issues, CDMOs are expanding packaging material options; adding or upgrading equipment, lines and technologies; and optimizing operations and supply chains. Adare Pharma Solutions, for example, has increased capacity and is completing validation of a high-speed blister packaging line with integrated cartoning and palletizing. Scheduled to be operational this year, the line will handle traditional solid dose formats as well as orally disintegrating tablets. Other improvements at Adare Pharma Solutions include an expanded safe for U.S. Drug Enforcement Administration restricted products and the start of high-speed stick-pack equipment for filling powders and granules. The company is also on schedule to implement large-scale aggregation capability before the end of 2022, well ahead of the November 2023 DSCSA deadline.
On the materials side, innovations include new materials, barrier substrates and more durable substrates. ACG Films and Foils, for example, has developed high-barrier polyvinylidene chloride (PVDC) films, more durable alternatives to PVC, and five-layer cold forming foil.
Another alternative to PVC is Amcor’s AmSkythermoformblister system. Based on polyethylene (PE), the printable material does not contain vinyl or aluminum foil and is compatible with PE recycling channels. The barrier properties are said to be equivalent to a 120 gram coating of PVDC. Processability is equivalent to existing materials and structures can be childproof (1).
SÜDPACK Medica has also developed a more durable blister film which is a co-extruded polypropylene (PP) designed to replace PVC/PVDC blister materials. “PP as a raw material base naturally provides an exceptional vapor barrier,” noted Michael Hermann, Head of Research and Development at SÜDPACK Medica, in a press release. Co-extrusion technology offers the potential for improved barrier properties and closed-loop material handling (2).
With counterfeiting being an ongoing concern, Holographyx is working with Hazen Paper and Uhlmann Packaging to develop, test and launch its Holo-Blister technology. Recently issued patents in the US and Europe, Holo-Blister technology enables conventional heat-seal packaging equipment to cost-effectively apply custom holograms to the back of blister packs. Holo-Blister holograms are designed to be visible only behind each pill/capsule cavity on the back of each blister pack, allowing instant verification of authenticity, while leaving space around the recess for printing dosage and marketing information (3).
1. Amcor, “AmSky Thermoform Blister System”, AmSky Thermoformed Blister System | Soft packaging | Amcoraccessed February 11, 2022.
2. SÜDPACK Medica, “SÜDPACK Medica presents PP films”, press release, October 28, 2021.
3. Holographyx, “Holo-Blister is a new anti-counterfeiting system for pharmaceutical blister packs that has just been patented in the United States and Europe,” press release, February 23, 2022.