Sustainability is a growing ambition in the medical device industry. The changes outlined here that can be made to pack design to meet this goal will also bring other beneficial efficiencies. Options exist to increase product protection, enhance end-user convenience and improve manufacturing.
Becoming a business fundamental
Sustainability, that is, meeting the needs of the present without compromising the ability of future generations to meet their own needs,1
is a common corporate goal. Determining the practicalities of how to achieve that goal is much more challenging. Packaging and the impact it can have on promoting sustainability has long been a focus of manufacturers of consumer packaged goods. Appealing to consumers’ environmental conscience, addressing the demands of retailers such as Wal-Mart and its packaging Sustainability Scorecard, and enjoying the cost savings often associated with more sustainable packaging options have all been important drivers for that industry. The medical device industry has been much slower to adopt these corporate ambitions. Although companies such as Baxter International, Abbott Laboratories, Johnson and Johnson and Allergan have been recognised for their sustainability efforts, medical device companies, in general, are poorly represented in lists of companies that rank high in packaging social responsibility.
Certainly, designing packaging for medical devices is a complex process. Considerations such as sterilisation requirements, barrier, biocompatibility and toxicology, durability, processing, appearance, labelling and meeting the numerous regulatory requirements are all geared toward ensuring the safety and efficacy of the device. Recognising that all of this must be done in a cost-effective manner adds to the challenge. As a result, sustainability has often been an afterthought and sustainability claims have been met by simply reassigning what had begun as cost-savings initiatives.
However, the sustainability movement is maturing and companies, including medical device manufacturers and their suppliers, are making it a fundamental part of their business process. Industry recognises that the increasing trend towards disposable medical supplies, although advantageous in many ways, does have an impact on the environment and makes it more challenging to meet government initiatives such as those detailed in the United Kingdom’s 2005 Sustainable Development Strategy2 and the 2006 Renewed EU Sustainable Development Strategy.3 Companies are actively searching for ways to make their devices more environmentally friendly. Part of that effort focuses on packaging. Abbott recently announced its goal to achieve a reduction of 5% in the amount of packaging used for certain products. This programme has already achieved results. By redesigning its re-closable 0.24 litre plastic bottles, the amount of plastic used in those bottles has been reduced by 8.3 percent. The reduced-weight bottles also reduce transportation costs, which helps save an additional 1.65 million litres of petrol per year. Abbott has also developed a reusable, recyclable box that replaces a larger single-use box for shipment of doctors’ samples that require refrigeration.4
- is beneficial, safe and healthy for individuals and communities throughout its life cycle
- meets market criteria for both performance and cost
- is sourced, manufactured, transported, and recycled using renewable energy
- optimises the use of renewable or recycled source materials
- is manufactured using clean production technologies and best practices
- is made from materials healthy in all probable end-of-life scenarios
- is physically designed to optimise materials and energy
- is effectively recovered and used in biological and/or industrial closed loop cycles.5
Configuration to improve sustainability
Although the sustainable options for medical packaging may not be as broad as those for consumer packaged goods, the opportunities for packaging improvements are significant. Focusing on the sterile barrier system (primary packaging), the first area to consider is the packaging configuration. Medical devices intended for sterile use are often double-packaged: an inner package, intended for the sterile field and providing a sterile barrier, is placed inside an outer package, which is also capable of maintaining a sterile barrier. Operating room nurses prefer this approach because it allows for error and facilitates presentation into the sterile field. However, this design can more than double the amount of material needed to package the device.
The solution is to carefully design a single sterile barrier system so that it promotes aseptic delivery of the product. Successful designs
- allow the operating room nurse to hold the packaged product securely
- are easy to open even when wearing gloves
- present the device so that loose or coiled parts are secure
- promote “flipping” or “dumping,” that is, the ability to transfer the device into the sterile field without the assistance of the sterile nurse
- allow the sterile nurse to easily grip and remove the product.
Reducing the package density is an obvious way to improve sustainability. Tray configurations are inherently less desirable than pouch or form-fill-seal sterile barrier systems for achieving sustainability goals. The production of trays requires more fossil fuel; trays produce more carbon dioxide emissions during the manufacturing process and have a much higher impact on the solid waste stream. In addition, it is often overlooked that energy consumption during transportation is significantly less for flexible packaging than its alternatives.
) redesign of the package for its stylet kits is an excellent example of what can be achieved. In the original package, the device was placed into a poly(vinyl chloride) (PVC) tray with a coated Tyvek (DuPont, www.dupont.com
) lid. That tray was placed into a secondary PVC tray, also with a Tyvek lid. The entire tray combination was then packaged in a carton for shipping and distribution.
The redesigned package is radically different. Instead of two trays, the stylets are now loaded into a chevron pouch. After sterilisation, the pouch is put into a DVD case for shipping and distribution, which eliminates the need for a carton. The new package is 80% smaller than the previous design and packaging waste is reduced by 54%. In addition, PVC has been eliminated from the package. Not surprisingly, the cost savings are also impressive.6
When trays are necessary for the protection of the product, downgauging (that is, weight reduction) can be achieved by using the geometry of the tray to improve its rigidity. Clever placement of flutes and ridges can have a dramatic impact on the stability of the package.
Material technology continues to advance. There are a great number of new resin combinations and blends that can be used to improve the durability and toughness of packaging materials. There are significant opportunities for downgauging materials, particularly flexible packaging materials. Thermoformable form-fill-seal applications are a prime example of this. New material offerings allow thickness reductions on the forming bottom web of 25 percent or more and as much as 20 percent on the top web.
Unlike other market segments, bio-degradable polymers are not an appropriate choice for medical device packaging. ISO 11607-1:2006 Packaging for Terminally Sterilised Medical Devices, requires the packaging system to provide physical protection and maintain its integrity (sterility) until the point of use or until the expiry date.7 This must be supported by stability testing. Most device companies include climatic stressing as part of their testing protocol. Unless the distribution and storage of the device is extremely well understood and tightly controlled, biodegradable options are simply an unacceptable risk.
Biopolymers have received significant attention. These materials are made from biomass such as corn and sugar cane, which are renewable resources. Initially, this seems appealing. However, biopolymers typically require more energy to produce than traditional polymers. Not surprisingly, they are also more expensive. Performance is sacrificed particularly with regard to heat and moisture resistance. In fact, biopolymers are generally classified as compostable, meaning that they require more heat and moisture to decompose than biodegradable materials. Biopolymers such as polylactic acid (PLA) have been used for implants, because they will safely decompose within the body.8 Unfortunately, currently, they do not provide a packaging solution.
Biocompatibility concerns generally exclude the use of recycled materials in the sterile barrier system. Some companies have explored sandwiching recycled material between virgin materials. This requires a carefully controlled recycling stream that avoids the introduction of unwanted or unknown materials. In general, the risk–reward equation does not favour the use of waste for the sterile barrier system. However, protective packaging such as cartons are an excellent place to consider the use of recycled material.
Although companies may not want to use recycled materials in their sterile barrier systems, material choices that can be recycled provide many advantages. All-polyester peelable lidding for a polyester or a polyethylene terephthalate glycol (PETG) tray can allow the manufacturing waste and the finished product to be recycled in a single waste stream. Similarly, pairing a high density polyethylene (HDPE) tray with a peelable HDPE lid allows for easy recycling in the HDPE waste stream.
Materials chosen for thermoformable form-fill-seal applications can aid in improving recyclability options. Nylon–polyethylene coextrusions are a popular thermoforming bottom web. However, they are by design a commingled plastic that limits recycling options. Although there are some applications that may need the puncture resistance that nylon can provide, new polymer technologies offer equivalent performance with the advantage of a single waste stream.
When considering protective (secondary) packaging, moving from a carton, even when made from recycled paperboard, to a flexible pouch can offer significant gains. One study found that a flexible pouch consumed one third the energy, generated half the carbon dioxide, and required one eighth the amount of packaging per 100 g of product shipped compared with a paperboard envelope.9 In addition the paperboard envelope produced seven times more landfill waste by weight than the pouch. However, to make a significant move in this area will require the reconfiguration of central supply room layouts.
More value, less waste
Options exist to increase product protection, enhance end-user convenience and improve manufacturing efficiencies all while using less packaging, consuming fewer natural resources and creating less waste. Through the use of technology and thoughtful design, medical design manufacturers can achieve successful solutions for sustainable packaging.
7. ISO11607-1:2006 “Packaging for Terminally Sterilised Medical Devices,” Part 1.
8. US Patent 5, 674, 286 Bioabsorbable Medical Implants.
9. Flexible Packaging Association, Packaging Solutions for Sustainability.