ISO standards for green packaging keep the medical device manufacturing industry on its toes in terms of delivering environmentally responsible and sustainable products. Ticking all the right boxes guarantees a clear conscience, but ensuring that products are wrapped and delivered in the most environmentally conscious way, efficiently and to budget is a constant challenge for manufacturers.

Specifications such ISO 13485:2003 are designed to help. This edict demands a quality management system by which an organisation can demonstrate its ability to provide medical devices and related services that consistently meet customer requirements, as well as conforming to any applicable regulations.

Manufacturers should also be aware of several other standards. ISO 11607-1, for example, states that medical device packaging should be made of known and traceable materials that are non-toxic; non-leaching and odourless; free of holes, cracks, tears, creases and localised thinning; and be intended solely for use in medicine. ISOs such as this concern safety, but are often used to improve sustainability and are helping to create a more conscientious, waste-averse mindset.

Al Iannuzzi, Johnson & Johnson’s senior director of environment, health, safety and sustainability, led the design for the firm’s Earthwards environment and is serious about the application of standards.

“Today, consumers and shareholders expect us to incorporate sustainability in everything we do,” he explains, revealing that large medical device manufacturers must invest in green packaging initiatives. “Johnson & Johnson’s approach to sustainability is a commitment to product stewardship, and this defines how the company addresses the environmental and social impacts of its endeavours.”

The programme is intended to encourage development teams to design new products that are as sustainable as possible throughout their life cycle.

“One of our key sustainability goals is to use fewer resources and also to integrate sustainable designs into product innovation processes,” says Iannuzzi.

Sustainable products are now worth $9.3 billion to Johnson & Johnson, and the firm hopes they will account for a fifth of its revenue by 2020. Such lofty goals prove that medical device companies are making the right sort of efforts, but trying and succeeding are two different things. Many organisations often forget their worthy ideals when they bump up against budgetary constraints, for example.

“One of the principles that drives Johnson & Johnson’s process is listening to its customers in order to understand their sustainability needs,” Iannuzzi says. “The focus is on making the improvements that are required by customers and the end users of the products. Medical device companies encourage transparency in order to drive improvements for the industry to be sustainable.”

Greening your production line

Iannuzzi argues that there are many ways to maximise productivity without sacrificing any environmental goals. “One way to ‘green’ your device-manufacturing production line is to create frameworks that can be easily adopted by employees,” he suggests. “Johnson & Johnson uses a single, uniform approach to guide employee teams as they work.”

“This framework creates a system that encourages the adoption of greater sustainability, including making packaging systems more efficient and using more recycled content,” he continues, citing examples of packaging that use completely recycled fibre paper with an average of 35% post-consumer content.

This translates to substantial reductions in materials and major increases in shipping efficiency. Just as importantly, these kinds of improvements foster the development of more sustainable products in the broader medical device marketplace. 

Other developments include an ultrasonic surgical device used by surgeons for precise dissection, sealing and transaction that uses about a fifth of the packaging required by existing devices.

“Reducing packaging translates into greater efficiency right through the entire supply chain. For example, it led to a reduction in CO2 production during shipping of approximately 2,800lb a year.”

Iannuzzi believes that team spirit and making sure employees know why sustainability is important in packaging is a great way of maintaining compliance and building cultures. “Johnson & Johnson drives adoption of sustainable product development through employee recognition,” he says. “Teams behind products that receive recognition are publicly congratulated on the firm’s websites and are rewarded through established employee recognition programmes.”

Navigating environmental concerns to optimise sustainability in all materials can be tricky. Iannuzzi believes that all pharma practices should be reviewed every year by an independent accreditation organisation to ensure that standards are being upheld. “This keeps everyone accountable and drives recommendations that improve sustainable product development,” he says.

It’s important to remember that, while ISO and green initiatives were originally mandatory, companies now voluntarily come up with their own strategies. This may hint at an awareness of the need for good PR in front of a public that is increasingly suspicious of waste in industry.

“Accreditation is a four-part process that requires new products and packaging first to meet product stewardship requirements, and then be reviewed for life cycle impacts,” Iannuzzi says. “These initial steps ensure teams are focusing on areas with meaningful sustainability impact potential and that they are evaluating all materials in a product and its packaging. Johnson & Johnson then invites each product team to identify, implement and validate sustainability and social improvements. The company listens to its customers to understand their sustainability needs, while also focusing on improvements that address high-impact areas identified in the review.”

As well as taking into account customers’ views, compliance and regulatory obligations should always be at the forefront of manufacturers’ minds, and new considerations on legality are always having to be made.“The first step of the process is to ensure every item satisfies product stewardship compliance,” reveals Iannuzzi. “Johnson & Johnson also requires that its teams are able to source all materials and have a proper understanding of what happens to products after they have reached the end of their life cycles.”

Educating your staff, not just about rules, but also about the potential impact of products, could be a great way of showing them how they can help save their company money by reducing waste and the unnecessary use of packaging materials, as well as by building on basic regulations to help ISOs become a naturally ingrained part of their working environment.

“Product stewardship compliance is a complex landscape: new regulations are being introduced at a rapid pace, and Johnson & Johnson is continuously working to enhance its processes to ensure all applicable global standards are being met,” Iannuzzi says.

The future of packaging

Healthcare is one of the fastest-growing industries in the world, with a large, costly environmental footprint, and there are many paths it could pursue towards greener packaging.

“Customer demand for more sustainable products is increasing, which is a good sign of the changes that need to come,” Iannuzzi says, referring to a global survey of Johnson & Johnson’s customers in which packaging emerged as one of four major concerns, with 85% of respondents describing sustainability as “essential” or “very important”.

As demand escalates, Iannuzzi predicts an increased focus on recyclable packaging that uses less material. “I see the industry collaborating to facilitate the recycling of more packaging, which hopefully will result in lowered environmental impact and lower costs for disposal by our customers,” he says.

A context for a greener future was set in 2010 with the establishment of an industry-wide effort called the Healthcare Plastics Recycling Council (HPRC). This is a private, technical consortium of representatives in the medical device
and healthcare, recycling and waste-management industries that seeks to improve the recyclability of plastic products and packaging in the US and UK.

Describing itself as “made up of globally recognised members, HPRC engages in projects designed to help boost plastics recycling efforts in clinical settings of hospitals,” and its mission is to “collaborate across the value chain to inspire and enable the healthcare community to implement viable, safe and cost-effective recycling solutions for plastics products and packaging used in the delivery of healthcare.”

The industry itself wants wider changes and would like more processes to develop. “Johnson & Johnson hopes to design more sustainable products and have environmentally preferred purchasing (EPP) be part of all procurement programmes,” Iannuzzi says. “It would be great to see further industry alignment and support for sustainability, along with efficacy and price.”

With so much packaging and so many wasteful processes still in the industry, it seems there are mountains to be climbed. One of the most common mistakes made by people in the industry is to increase the use of disposable products that are contributing to hospital waste and not having properly administered processes and infrastructure to develop take-back programmes. Another is to use products and packaging that are stackable and returnable, thereby effectively cancelling out any sustainable advantages.

ISO regulations may be seen as a bureaucratic burden by some but they can be a great way of opening doors to a more PR-friendly environment. Device manufacturers can prove they are taking customer concerns seriously, and show that the industry is respectful and takes action. They may be a headache to enact, but properly implemented standards could change the world.