It’s a long-established fact that healthcare supply chains are incredibly complex. Add to that the personalised nature of the growing field of cell therapy — wherein you could be dealing with your father’s or child’s cells — and maintaining sample integrity throughout the process becomes critical.
Time- and temperature-sensitive drugs involve extra layers of intricacy and potential problems in terms of product quality. Some of these challenges centre around scalability and patient demand, which can be hard to forecast. Additionally, multiple data collection systems must integrate as data integrity and tracking are key.
Delivering cell therapies can be tricky … as they come in smaller batches (as little as one). Labelling and chain of identity are critical and getting approval can be time-consuming and tricky. So, when a company does get approved, it may have to scale quickly and add machines in a hurry, which has its own challenges.
Customised e-commerce solutions
The nutraceutical market includes vitamins and supplements, as well as functional foods and beverages. According to the Nutraceuticals Market Assessment from PMMI, The Association for Packaging and Processing Technologies, consumers around the world are seeking alternatives to better health.1
However, they are also suffering from pill fatigue and looking for more innovative foods and drinks that supply all their nutritional needs for exercise, weight management, digestive health and general well-being. They are seeking a custom or semi-custom formula to fit their individual needs, creating challenges for manufacturers.
Online vitamin and supplement purchases have been increasing quickly; the category is moving 12% faster than overall e-commerce sales. When selling online, the product must be intact, look good and be as appealing in real life as it did in the online photo. E-commerce is necessitating a movement away from rigid plastic and glass containers toward portable stickpacks and flexible pouches.
A large amount of e-commerce packaging is done robotically and may not be able to pack glass bottles of nutraceutical products safely and effectively. Amazon is helping to dictate the move towards more easily packable trays and pouches. These pouches and trays also help to lessen shipping costs with lower weight packaging and more easily packable nutraceutical products.
Track, trace and RFID
Data storage, product tracking and the use of RFID are all having a more significant impact on pharmaceutical packaging as manufacturers are working to get a handle on inventory management and operational efficiency. And, with all the data, comes management and storage issues.
Whether through unique device identifier (UDI) adoption, RFID tracking or other barcode scanning methods, those struggling with inventory management and having the right products ready at the right time are looking to traceability systems. RFID tracking offers promise in terms of tracing specific items through the facility down to the room, preventing expired products from being used on patients and locating recalled products quickly.
Hospitals still experience challenges with multiple barcode formats on the packaging and IT systems that lack accurate device data. One group, Advancing Healthcare Through Supply Chain Excellence (AHRMM), made up of a coalition of healthcare leaders across sectors is hard at work developing a common understanding and approach to UDI adoption within the healthcare setting.
Aggregation to meet DSCSA requirements
Aggregation impacts serialisation projects on packaging lines throughout manufacturing operations and the overall supply chain. It provides companies involved in pharmaceutical packaging with the ability to build a serialised relationship between unique identifiers assigned to packaging containers.
Not only does this ease the mind of pharmaceutical companies, it also meets the requirements of the Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive (FMD).
If you have a case with a serial number and saleable units (cartons, bottles) with unique serial numbers within that case, aggregation associates the multiple serial numbers of the individual units (child) with their case (parent). This establishes a “parent–child” relationship as product moves through the packaging stages of the supply chain.
Aggregation lets you scan the case’s barcode to determine the identity of all the contents within the case, removing the need to open the case and examine all of the individual saleable units. Aggregation can thus facilitate the material handling aspects of serialisation projects in warehouse environments and create efficiencies across the entire supply chain.
In the past, the pharmaceutical industry has tended to shy away from sustainability. But, a mix of internal factors, such as corporate responsibility reporting and external issues, has driven the industry to take a closer look.
External factors playing into the decision include healthcare strategies to reduce carbon footprints, regulatory requirements, retailer packaging requirements, increased demand in benchmarking and performing lifecycle analyses, consumer expectations and the ability to show that you’ve optimised your design and used the least materials possible.
Pharmaceutical companies range from reactive to mature on the sustainability spectrum, but it’s an area wherein pharmaceutical packagers are looking to make significant advances.
Impact of IoT
Industry 4.0, of course, is the fourth industrial revolution, a transformation now under way in which sensors, machines and IT systems will be tightly integrated all along the value chain. These connected systems can interact with one another, thanks to standardised Internet-based communications protocols.
And by interacting with one another, they can analyse data to predict failure, reconfigure themselves and adapt to changes. Industry 4.0, sometimes called the Internet of Things (IoT), will make it possible to gather and analyse data across machines, resulting in faster, more flexible and more efficient manufacturing processes to produce higher-quality goods at a reduced cost.
Predictably enough, the pharmaceutical industry is anything but immune to the impact of IoT and Industry 4.0, trends that are transforming pharma manufacturing at a rapid pace. Why the emphasis on digitisation? There are two primary reasons.
First, it means that information in a variety of formats can be collected and processed with the same efficiency. The second benefit of digitisation is that once processes are digitised, it opens the door to other exciting possibilities such as machine learning, condition monitoring, remote-access monitoring and, ultimately, the smart factory.
There has never been more of a demand for packaging solutions for the fragmented and divisive cannabis market. Comprising two major components, the market contains tetrahydrocannabinol (THC)-based products promising some kind of buzz, and non-THC products based on extracted cannabidiol (CBD) processed from hemp.
THC remains controversial, despite a growing number of US states allowing both medicinal and recreational use. Edible cannabis poses particular problems with dosing, plus child-resistant reclosable options are hard to find, prohibitively expensive or don’t align with sustainability goals.
CBD, often misunderstood, comes in a variety of sophisticated, branded packaging and takes cues from beauty, health and food markets. Like the vitamin and nutritional supplement market, CBD oil can make broad claims about overall health … but must be careful not to make specific claims about outcomes.
The uncertain regulatory landscape has thwarted large operations from scaling-up in multiple geographies. It’s clear, however, that automation will be needed for any producer to supply a major retailer. General trends in nutrition, driven by both millennials and boomers, see people taking their health into their own hands with diet, exercise and mindfulness, which bodes well for the cannabis market.
Making drug delivery easier and more convenient for patients is a trend that is not going away — but these delivery devices add complexity and compliance risk to the packaging process. Packaging drugs into delivery devices further complicates both supply chain and delivery systems … and it reduces margins because of the increased cost of goods sold.
Although many drug makers would like to avoid this added complexity, increased competition is making this situation the new normal. Pharmaceutical companies must ease preparation and dosing, enable self-injection and improve patient compliance (drugs don’t work in patients that don’t use them).
Biologics are growing exponentially and self-injection is the driver. With insulin and human growth hormone leading the way in self-injection, there are more and more injection devices found in mature and competitive markets these days, including fertility therapy, rheumatoid arthritis, migraine drugs and more. Drug delivery has moved with time from the vial/syringe option to prefilled syringes and cartridges to pen injectors and autoinjectors.
Owing to the complexity of this endeavour, pharmaceutical manufacturers are looking to partner with original equipment manufacturers (OEMs), contract packaging organisations, packaging suppliers and others to put together a system that will work.
The perfect place to explore these partnerships and all industry trends is the PMMI-produced PACK EXPO East 2020 (3–5 March, Pennsylvania Convention Center, Philadelphia, PA, US).
With more than 100,000 square feet of exhibition space, this three-day event will bring together 7000 attendees and 400 companies showcasing new technologies. PACK EXPO East attendees will enjoy all the educational and networking opportunities traditionally offered at PACK EXPO while allowing for more face-to-face time with exhibitors to find applicable answers.