Alastair Cook, ULMA Packaging UK, explores the specific legislative packaging challenges faced by the medical industry and how processors can simultaneously reduce pack waste.
Reducing materials waste and creating more sustainable medical packaging is now more pressing than ever, says ULMA Packaging
With McKinsey calculating that the demand for plastic packaging will double in the next 20 years, in addition to increased demand from consumers to reduce plastic packaging, there has been more efforts made in recent years to redouble sustainability efforts. For the medical industry, where product integrity and consumer safety are paramount, reducing the overall environmental impact of plastic packaging, all while ensuring that strict legislative requirements are met, will require no small amount of innovation from packaging machinery providers.
Strict legislation
Though contamination remains a concern regardless of industry, ensuring a contaminant-free packaging process and hygienic hermetic seal, to keep medicines safe, is especially important in the medical sector. For this reason, strict regulations exist to ensure product safety is always prioritised.
When choosing a packaging machinery provider, it is important to check that any machinery can meet the regulations required. The main standard for packaging equipment in the medical sector is ISO 11607, which governs packaging requirements for terminally sterilised medical devices, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility until the point of use.
As well as ISO 11607, further legislation has been introduced to tighten product safety throughout the entire supply chain. The new Falsified Medicines Directive (FMD), introduced by the European Union in February 2019, is designed to improve product protection and preserve the tough sterilisation conditions in the healthcare sector. For packaging, the FMD establishes two mandatory safety demands on packs of medical products. This includes a unique identifier barcode to ensure full traceability, and tamper-evident features so patients have peace of mind that their medicines have not been interfered with.
Indeed, many medical products manufacturers actually go beyond even the heightened scrutiny specified in current legislation to provide quality control assurance, achieving compliance with regulations such as Part 11 of Title 21 of the Code of Federal Regulations, otherwise known as Title 21 CFR Part 11, or Part 11 for short.
Though part of the USA’s Food and Drug Administration (FDA) regulations, a number of UK organisations have implemented practices set down in Part 11. Its criteria look to ensure electronic records in the healthcare, biotech and biologic fields can be considered as trustworthy as equivalent paper records. Put into practice, this translates into implementing controls such as audits, system validations, audit trails, electronic signatures and the documentation for software and systems involved in processing electronic data.
Knowing the risks
The risks of contamination in medical packaging cannot be overstated, as it can impair the packaging process, and any adverse effects could lead to potential fines, reputational damage, and, most seriously, jeopardise consumer health.
Only by choosing a reputable packaging machinery provider can any healthcare product be trusted once it leaves the factory floor. With the right packaging machinery equipment design however, medical products can meet the discerning standards required and even be sustainable too.
Packaging solutions
A number of packaging solution providers can and have taken steps to improve sustainability in the medical packaging industry. For example, ULMA Packaging UK has traysealing and thermoforming packaging machinery solutions that can be used with medical-grade paper or Tyvek flash spun high-density polyethylene; porous materials, gas and steam can pass through for sterilisation purposes. Certain substrates of this paper can be recycled and, in the case of Tyvek, discarded packaging can be absorbed back into the broader circular economy to minimise waste. These materials can then be repurposed into construction, protective garments, graphics, tags and labels, or even back into medical packaging again.
Further avenues for improving sustainability include using thinner gauge materials in rigid medical packs, such as pre-formed trays in traysealing applications. Certain thermoforming packaging methods like positive forming can also allow medical device manufacturers to save on material. This is because in contrast to traditional negative forming, where the packaging shape is formed by a vacuum under the mould sheet, the formed cavity achieved by positive forming is more robust. As a result, it is possible to securely package certain items on a case-by-case basis using less materials.
Finding efficiencies
Even when using materials like film and plastics, there are ways to reduce waste when sustainable materials can’t be used. It can make a great difference given that even a small amount of lost raw material over time can become a significant amount of waste in the long run. This situation is compounded when the logistics and costs of waste removal are factored in too.
ULMA Packaging UK’s thermoforming solutions are also compatible with reduced scrap solutions developed by Sealed Air, which can help manufacturers markedly reduce material waste and disposal costs. These machines use a narrower reel of film than standard, allowing for pronounced waste reduction, and, when combined with machine automation capabilities, enhanced productivity.
Furthermore, because of the design of thermoformer machinery, a finished package arrives fully-formed having been created on-demand from a roll of stock materials. As a result, manufacturers opting for such a solution can make efficiency gains and cost savings while improving the sustainability of their operations.
By offering a one-stop packaging solution, with no further transportation of products to the manufacturing facility required, companies like ULMA Packaging UK can help manufacturers avoid the logistical challenges associated with transporting materials, reducing overall carbon footprint. Furthermore, situating all packaging processes in one place gives these manufacturers the chance to use lighter gauge materials, providing excellent product protection alongside further material savings.
In conclusion, reducing materials waste and creating more sustainable medical packaging is now more pressing than ever. The ‘Blue Planet’ effect has rightly put packaging under the spotlight, and medical manufacturers installing new packaging lines will need to be mindful of the potential for future sustainability measures on packaging. Indeed, with consumers attitudes shifting and the packaging industry accounting for 40% of plastic processed every year, it is clear that, if possible, sustainable solutions that minimise waste should be implemented.
