Sustainability has become mainstream, and European standards may influence the development of global standards. But there could be some unintended consequences to sustainability that medical device manufacturers should be wary of when redesigning packaging.
For packaging professionals, designing the optimal package has always been the objective. For years the packaging industry has been obligated to provide “sustainable” packaging through state and local legislation (Green Laws, Packaging Waste Directives, ‘Reduce/Reuse/Recycle initiatives); economics (increased margins on products and lower product costs to the consumer); reduced damage claims (engineering, design, testing); and new technologies. Packaging engineers have been designing packaging with these criteria in mind since the first packaging engineer graduated from Michigan State University. The first Earth Day heightened the challenge for packaging engineers. More recently, the rapid industrial growth of countries such as India and China has heightened the awareness of the environmental impact of industrialization.
And so, for many corporations, sustainability is one of their goals. Designing sustainable packaging and minimizing packaging’s impact on the environment fall into that scope. They view (packaging) sustainability as just as important as what is produced, how it is produced, and where it is delivered. These initiatives are spreading among corporations, organizations, regulatory bodies, and governments.
However, in the medical industry, there are many challenges to implementing truly sustainable packaging initiatives. Considerations include the regulatory requirements; preserving the efficacy of the product at end use; ensuring material compatibility with manufacturing processes, sterilization processes, and transportation; and guaranteeing that package designs do not cause unintended consequences within the sustainability continuum that impacts economic, environmental, or social responsibilities.
What is Sustainability?
One of the major dilemmas facing the industry is determining just what sustainability means. “Sustainable development” is a term that grew out of the conservation/environmental movement of the 1970s. While the conservation/environmental movement asked questions about preserving the Earth’s resources, sustainable development includes questions about how human decisions affect the Earth’s environment.
Sustainable development is a process of developing (land, cities, business, communities, etc.) that “meets the needs of the present without compromising the ability of future generations to meet their own needs,” according to the Brundtland Report, a 1987 report from the United Nations. The precise meaning of sustainable development has been widely debated. For example, two years after the Brundtland Commission’s term, more than 140 definitions of sustainable development had been catalogued,” according to ENO Online.
There have been many more definitions for sustainability cataloged since then. The table below illustrates how three other organizations define sustainability.
A significant move is afoot over the past ten years to develop metrics, standards and certifications for proving that packaging is biodegradable or compostable. These standardization efforts are beginning to converge on standard test methods and metrics that will level the playing field and provide some trust and integrity to the marketplace. There is a guideline published by the Sustainable Packaging Coalition (SPC) that helps define packaging design criteria that is modeled after their definition. Another guidance document is available called “Greener Package Guidelines to Sustainability Claims” from Greener Package.com with the objective of combating greenwashing. Governments such as California are entering this cause as well by passing legislation to eliminate claims regarding products and/or packaging being “Environmental Friendly” without qualifying text and data.
It is imperative that standards be developed early on to avoid duplicative systems that could neutralize the value of sustainability. This is being done at a global level through the development of international standards that can be used to determine when efforts towards sustainable design and manufacturing options are being employed. There is more detail on this later in the article. Corporately, companies are developing programs, such as the Walmart Scorecard and a new system recently published by Procter & Gamble.
Scorecards, however, may present a challenge to the development of global standardization. It will not exactly be ‘sustainable’ for product manufacturers and packaging supplier to have to comply with a different ‘scorecard’ for each retailer or customer to whom they want to sell, just as it would be unsustainable for companies to have to follow different laws from every government entity that chooses to regulate and respond to the ‘green’ movement. So global standardization is critical. Can standardized metrics, criteria, and goals be developed in order to provide some universal measure of packaging sustainability? If so, how do we create and design sustainable packaging in an industry like the life sciences industries that has its first priority to transport sterile products to the end-user?
Global Standards Development
ISO, ASTM, and other standards development organizations will play an integral part in developing standard test methods, practices, and specifications for sustainable packaging materials.
Global sustainable packaging standards are being developed that will give guidance on effective packaging design. The work planned will be performed by a new Technical Committee formed within the International Organization for Standardization (ISO), ISO/TC 122/SC 4, “Packaging and environment.”
The global standards development initiative is based on the existing EN standards that support the EU Directive 94/62/EC, “Packaging and Packaging Waste Directive” (PPWD). This EU Directive states in Article 9 that “Member states shall ensure that…packaging may be placed on the market only if it complies with all of the Essential Requirements defined by the Directive including Annex II.” As this directive is only enforceable for packaging imported into Member States, the goal then will be to harmonize EU and Asian country standards and gain global consensus on standards for designing environmentally friendly packaging and enforcing similar requirements globally. Compliance to these standards will be imperative for medical device manufacturers in order to obtain approval for market entry into these countries. The global harmonization effort is being conducted through the structure of the ISO. The goal is to use global standards that will govern how packaging is developed from cradle to grave, or cradle to cradle.
The SC4 has conducted two international meetings within 9 months (in Stockholm and Beijing) and is well on its way to harmonizing the EN and other existing standards. The goal is to publish ISO standards in 2012. When these standards are published, regulatory agencies will be free to cite them as requirements in local regulations and rules.
A series of five standards and two reports have been developed to establish a common basis for assessing conformity with the Essential Requirements and to support compliance with the directive. Following are the basic EN (European Norm) standards and how a medical device company could be impacted. This analysis is based on the current EN standards as published and used in support of the EU directive. The final published ISO standards will require a reanalysis of their impact on medical device packaging.
EN 13427, General requirement for use of ISO standards in the field of packaging and the environment. This is the umbrella standard that provides a framework within which the individual standards are unified to provide a conformity assessment to the directive and later to the global series of standards within ISO. The introduction of the standard states that “although the essential requirements of the directive are focused on the effects of packaging after use, it is necessary that these individual but associated Reports and Standards be addressed prior to placing the packaging and packaged products on the market. Account should be taken of the potential change in releases to the environment that will result from introducing the used packaging and packaging waste to the recovery processes.” The standard’s objective is to “establish the overall methodology for a set of measures that will enable those responsible for the placing of packaging or packed products on the European (or global) market to do so with a presumption of compliance with the essential requirements of the Directive.”
EN 13428, Packaging—Requirements specific to manufacturing and composition—Prevention by source reduction. The objective of this standard is to define requirements for the manufacturing and composition of packaging. The introduction of the standard states that “this document amplifies these requirements with respect to reduction of packaging at (the) source and the minimsation of dangerous substances or preparations as they may arise from waste management operations.” It continues to state that “reduction of packaging at the source is one of several options for reducing the amount of used packaging for final disposal. In order to save resources and minimize waste, the whole system in which the packaging takes part should be optimized.”
For the medical device packager, prevention (or reduction of materials) by source reduction must be achieved (and proven) while still meeting the necessary requirements of the packaging functions. So a procedure is provided (Annex A) for assessment of packaging to ensure that the weight and/or volume of the material content is at the minimum commensurate with the maintenance of:
•Functionality throughout the supply chain.
•Safety and hygiene for both product and user/consumer.
•Acceptability of the product to the user/consumer.
So in order to comply with the EU Packaging and Packaging Waste Directive and show conformity, medical device packaging engineers must “demonstrate (and document) by the determination of a critical area that the minimum adequate amount of weight and/or volume of the packaging have been reached (optimized) taking into account all the (required) “performance criteria” (e.g., functions) of the package.” It’s not a matter simply of reducing the gauge thickness of a thermoform tray or a poly pouch as the packaging “shall be suitable for the expected logistics, transport and handling systems and maintain adequate protection of the product.”
The method for demonstrating this aspect of the packaging is to use test standards like the ASTM D4169 Practice for Performance of Shipping Containers and Systems. This standard uses a uniform basis for evaluating in the laboratory the affects of the dynamic inputs of shock and vibration inherent in the logistics and transport environment on the performance of packaging and packaging systems. It will effectively assess what the impact of reducing gauge thickness of packaging materials might have on the protective capability of the package. For example, the potential for breach of the sterile barrier of the medical device packaging and product sterility and functionality. This is ultimately determined by performing the strength and integrity tests commonly used for package validation: ASTM F88 for seal strength and ASTM F2096 for package seal and material integrity.
This particular standard has the most relevance for medical device packagers as this is the most fruitful area for contributions toward packaging sustainability in the medical device industry.
EN 13429, Packaging, Reuse. This standard identifies and defines tests that will demonstrate that a packaging is in compliance with the Packaging and Packaging Waste Directive (PPWD). The PPWD requires specific attributes of the packaging to allow it to be classified as reusable. The standard defines reusable packaging as “packaging or packaging component which has been conceived and designed to accomplish within its life cycle a minimum number of trips or rotations in a system for reuse.” This definition of reuse does not include the recovery and subsequent reuse of materials to reform or manufacture new packaging. Owing to the risks in reusing sterile barrier systems used as medical device packaging, it is not common for manufacturers to design these packaging systems to be reusable. However, there may be other packaging systems that lend themselves to reusability. It will be those systems that must be compliant to this standard through conformity assessment. The overall requirements of reusable packaging are determined by a combination of the demands placed on the packaging itself and the requirements of the reuse system. The conformity assessment requires documentation and the recording of the results of the assessment process. This document requires that this be done in a formal manner by a statement recording the fulfillment of all the conditions identified as enabling reuse.
The initial conditions for classifying packaging as reusable include:
• Confirmation that the packaging is capable of reuse for the application intended in normally predictable conditions of use. This may require that testing be performed on the reusable packaging to establish the number of trips that might be expected in its life cycle.
• Confirmation of the trading/unloading/retailing companies’ intention to place the packaging into a reuse circuit when the packaging is unloaded.
• Confirm that an organized system exists to provide return facilities for packaging that is emptied by consumers
• Confirm that reconditioning systems are available for that packaging.
The verification procedure to establish and record conformity to this standard includes nine conditions that further detail the reusable packaging system.
EN 13430, Packaging—Requirements for packaging recoverable by material recycling. This standard has more significance to medical device packagers than does the reusable standard as most medical packaging is recycled or recovered by some means. The standard specifies the requirements for packaging to be classified as recoverable in the form of material recycling. Recycling is defined as “reprocessing in a production process of the waste materials for the original purpose or for other purposes including organic recycling but excluding energy recovery.” The primary requirement is that the packaging supplier shall be able to demonstrate that the criteria set forth in the standard has been followed when arriving at the final design of the finished packaging such that a certain percentage of the packaging materials can be claimed to be recyclable. The packager shall declare the percentage by weight of the functional unit of packaging available for recycling. Medical device packaging engineers will have to consider the following:
• Control of packaging construction/composition and processing.
• Suitability for available recycling technology.
• Releases to the environment caused by recycling of the packaging after use.
Medical device packaging engineers will need to be mindful of the types and composition of materials that are being used for designing their packaging. The packaging engineer will not only need to consider the design criteria but also:
• Production criteria: raw material and material composition in production, conversion, and filling; and control of changes during processing.
• Utilization criteria: nonprejudice to essential requirements, criteria for emptying by the end user, and criteria for sorting by the end user.
• Criteria for collecting/sorting: requirements for the expected and relevant collection and sorting process are identified and communicated.
The following two standards, although important in evaluating the conformity of the packaging system to the essential requirements, may not impact medical device packaging design as much as other forms of packaging reduction, reuse, or recovery.
EN 13431, Packaging–Requirements for packaging recoverable in the form of energy recovery, including specification of minimum inferior calorific value. The introduction of this standard explains that “Since packaging waste used for energy recovery substitutes for other fuels, total system optimization includes production of heat and/or power. This document defines and specifies the thermodynamic requirements for packaging to allow the incineration with energy recovery of packaging waste, but does not consider the transformation and use of the produced energy.”
EN 13432, Packaging—Requirements for packaging recoverable through composting and biodegradation. The introduction of this standard explains that “Organic recovery of packaging and packaging materials, which includes aerobic composting and anaerobic biogasification of packaging in municipal or industrial biological waste treatment facilities, is an option for reducing and recycling packaging waste.
The following reports define the requirements for heavy metals and dangerous substances:
• CR 13695-1, Packaging—Requirements for measuring and verifying the four heavy metals and other dangerous substances present in packaging, and their release into the environment.
• CR 13695-2, Packaging—Requirements for measuring and verifying the four heavy metals and other dangerous substances present in packaging and their release into the environment.
The United States has not been active in developing national standards on packaging sustainability and has instead allowed local and state governments to regulate material composition, reuse, recycling, and recovery of packaging through legislation and ordinance. There is some activity in the ASTM International to develop standards: a new activity within ASTM International Committee D20 on Plastics includes a proposed standard for, “Practice for Marking Plastic Products for Identification in Reuse and Recycling.” The objective is to develop an updated resin coding system so that everyone can more easily identify, reuse, and recycle all types of plastics. In addition, ASTM Committee D10 on Packaging has begun to help define ‘sustainable packaging’ through its activity in subcommittee D10.19 on Sustainability. Other more broad ASTM International activity on sustainability is taking place within Committee E60 on Sustainability.
Unintended Consequences of Sustainable Design
When anyone speaks about or works towards sustainability, it must be in the context of the cradle-to-cradle or cradle-to-grave continuum. Along the continuum are an almost infinite number of inputs, factors, effects, and influences that will determine the ultimate sustainability of the process or product as it relates to the economics, social responsibility, and environment. So to optimize sustainability, one must also consider the unintended consequences, or cause and effect of changing anything on the continuum.
The Law of Unintended Consequences warns that an intervention in a complex system invariably creates unanticipated and often undesirable outcomes.
Designing packaging for optimum sustainability can not be done in a vacuum. Reducing packaging by 15% by weight or volume is a laudable but not sustainable goal if reaching that goal results in medical devices that have a higher risk of being non-sterile at their point of use. The unintended consequence of reducing packaging may result in increased damage (loss of product), an unusable product (waste), delayed procedure (poor quality healthcare), non-sterile product (infection), or death of a patient. Any one of these consequences influences the economic, social, and environmental goals of sustainability.
When applying sustainability principles to the medical device packaging industry, there are limited opportunities. As will be the case when global standards on packaging and environment are published and implemented by governmental entities, package designers will be forced to consider all the strategies for developing sustainable production. The most likely areas for medical packaging are source reduction and recycling.
For many MDMs, the focus is on reducing or removing materials, reusability, recycling, and the ability to use renewable materials. However, the primary focus across the board is on source reduction. When reducing materials at the source, it is important to evaluate whether minor changes could be made to eliminate the package all together to or eliminate unnecessary components. However, it is imperative that these changes do not cause unintended consequences such as an increase in transit damage, loss of convenience to the end user, increase in shipping costs, or other consequences within the life cycle of the package. Thorough testing and analysis of the whole life cycle must be completed before implementing a source reduction program on a packaging design.
Key Considerations for Medical Packaging
Medical device packaging poses a unique challenge to the packaging engineer who is responsible for package sustainability initiatives in his/her company.
• There are limited options in materials that are compatible with manufacturing, sterilization, and transportation processes and inputs.
• The package must maintain the efficacy of the product at the point of use as its primary objective.
• Regulations and compliance to standards trumps efforts to make packaging more sustainable.
Perhaps the most promising route to applying sustainability practices in medical packaging is in development of biomaterials. Since the medical device industry uses a high percent of packages that are made from plastics and are predominately pouches and thermoform trays, these are areas that packaging engineers should be concentrating on in developing sustainable packaging designs.
Films are being developed from polylactic acid (PLA), a corn starch– or sugarcane–based product, which could have some applications as laminated films, making traditional materials somewhat more sustainable. Using biodegradable tie layers and adhesives could further enhance these materials’ sustainability quotient.
PLA is also being considered for thermoforming applications. However due to the extreme physical and environmental requirements placed on medical packaging, PLA’s thermal stability, impact resistance, and destacking performance characteristics need to be improved. But, research and development of this material is improving these physical characteristics so that it is comparable in many respects with PP (polypropylene) and ABS (Acrylonitrile butadiene styrene).
Medical device companies are becoming more interested in sustainable packaging solutions. Medical packaging contributions are expected to be minimal due to the regulatory and risk management considerations that must be balanced with the economic, social, and environmental responsibilities. However, regulatory burdens created by the movement to sustainability and environmental consciousness are forcing hard decisions on the medical device industry between conformity to regulations, cost, and general moral stewardship of the environment.
ASTM Committee D10 on Packaging will continue to be stewards of our environment by developing responsible standards and specifications for earth friendly packaging and packaging systems. If you’d like to get involved in shaping the future of packaging and the environment, join a packaging organization like ASTM or get involved in the ISO TC122 SC4 activity. In addition, NGOs like the Sustainable Packaging Coalition are doing great work to help packaging engineers design more sustainable packaging.
Author Patrick Nolan is President of DDL Inc.
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Perfecseal has released a whitepaper discussing package redesign that can reduce package costs and improve sustainability. Written by Paul Steger, marketing manager, roll stock products, the paper includes a case history on a syringe manufacturer’s switch to one of Perfecseal’s high-performance coextrusion films. The new 10-mil film provided equivalent or better performance compared with the previously used 12-mil film, reducing material consumed by 17%. “Additional savings were also realized in the operations and logistics areas,” he writes. Specific data are included. Another case history on a package redesign for two urinary incontinence products is also included, outlining the 50% material reduction for each product. --Daphne Allen
Also see articles Packaging Suppliers Step Up and What Do Hospital Buyers Think about Packaging Waste?