samedan logo
 
 
 
spacer
home > pmps > autumn 2010 > green goals
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Green Goals

Gaëlle Janssens of PRO EUROPE and consultant Attilio Caligiani explore the regulations and trends surrounding sustainable and environmentally-friendly packaging

WASTE & PACKAGING:THE CURRENT LEGISLATIVE FRAMEWORK IN THE EU

In EU legislation, the thematic strategy for the prevention and recycling of waste is one of the seven that were developed under the 6th Environmental Action Programme, which is the framework for community action in environmental affairs until 2012. This long-term strategy aims to help Europe become a recycling society that not only seeks to avoid waste, but also uses it as a resource. In this respect, it complements and draws upon the knowledge generated by the thematic strategy for resources. A major step in the implementation of this strategy for prevention and recycling of waste was the revision of the Waste Framework Directive (2008/98/EC). This new directive aims to streamline and clarify legislation, contribute to better regulation, set recycling standards, and develop national waste prevention programmes. The Waste Framework Directive is a key part of European environmental legislation; not only in terms of its direct impact, but also in the use of its definitions for recovery and recycling targets and waste shipment rules. It sets out the basic rules for the waste management industry, a significant economic sector, and has important economic implications for other industries and public authorities. Initially, the objective of the Waste Framework Directive was to provide a system of permits, registrations and inspections to ensure that waste was traceable and properly treated at every stage, both in recycling and disposal.

With regards to packaging, the EU has adopted a specific piece of legislation: the Packaging and Packaging Waste Directive (94/62/EC). This law aims to harmonise national measures in order to prevent or reduce the impact of packaging and packaging waste on the environment and to ensure the functioning of the single market. It contains provisions on the prevention of packaging waste, on the re-use of packaging, and on the recovery and recycling of packaging waste. The directive requires that a certain percentage of packaging waste produced by member states goes for recovery or incineration at waste incineration plants that incorporate energy recovery systems. It also establishes the minimum recycling targets for materials (glass, paper and board, metals, plastics and wood) contained in packaging waste. The directive also lays down essential requirements with which European countries should comply regarding the composition and the reusable and recoverable nature of packaging and packaging waste.

The European Commission’s aim is to promote the development of common standards relating to these essential requirements. In February 2005 the references to six of the packaging standards of the European Committee for Standardization appeared in the Official Journal of the EU (2005/C 44/13), as the final step in a process lasting over 10 years from the adoption of the EU directive on packaging and packaging waste in 1994. For packaging producers and packaged goods industries, this step has eliminated lingering legal uncertainty over whether or not packaging entering the single market conforms with the essential requirements laid out in the directive. Since 1998, only packaging that complies with all essential requirements defined in the directive may legally be placed in the internal market. The standards cover requirements specific to the manufacturing and composition of packaging, the reuse of packaging and the recovery methods of recycling, energy recovery and composting. The sixth standard, described as ‘the umbrella standard’, explains the management systems approach when used in the application of the other five. The management systems approach adopted in these standards provides the industry with a flexible method of demonstrating conformity, but presents some challenges for the regulatory authorities interpreting them.

GREEN PACKAGING: CURRENT TRENDS & TECHNOLOGIES

Packaging Recovery Organisation Europe (PRO EUROPE) is the umbrella organisation for the packaging and packaging waste recovery schemes, and mainly uses the ‘Green Dot’ trademark. It believes that waste and resource management is at the forefront of the new economy – an economy that is being called upon to face up to an increasingly widespread environmental awareness, notably boosted by the mainstream resonance of climate change, and the financial crisis. Although sustainability and pharmaceutical packaging seem to be at odds with one another, several manufacturers and suppliers are riding the green wave with products or packaging that help to save energy and reduce waste. Traditionally, the pharmaceutical industry has focused on effectiveness and safety rather than environmental friendliness. Today, there is a considerable opportunity within the manufacturing practices and processes for pharmaceutical packaging to become more sustainable. The United Nations Environment Programme defines ‘greening the economy’ as “the process of reconfiguring businesses and infrastructure to deliver better returns on natural, human and economic capital investments, while at the same time reducing greenhouse gas emissions, extracting and using less natural resources, creating less waste and reducing social disparities.” In other words, sustainability is about having a positive impact throughout the supply chain, not just at the raw materials stage or when the product restarts its life cycle.

Efficiency at All Stages
Sustainability requires an approach that is focused on technical, environmental and social practices. Regarding the design process, the current trend in sustainable packaging in the pharmaceutical sector is the creation of the most efficient form of packaging that maximises each step in the supply chain and minimises impact on the environment. For instance, prefilled medication packaging benefits the environment, consumers and pharmacists, as it helps to speed up pharmacist handling and provides a better timetable for consultation with the consumer, ensuring that he or she can receive accurate medication. A rigid, robust outer package also means there is no need for excessive shipping material like corrugated boxes. When the primary and secondary packaging steps are combined with the drugs into a single process at one location, it leads to energy and cost savings throughout the supply chain. In addition, well-designed packaging can be implemented to existing equipment, which can often be recalibrated or enhanced to run more efficiently and with more flexibility.

It is also possible to find ways to reduce consumption by incorporating a more sustainable design at the beginning of package development. For this purpose, producers have to understand the exact need of the customers and find a solution that meets goals surrounding consumer usage, manufacturing efficiency, market relevance and branding. It is important to determine where changes can be made to make a package lighter in weight, structurally sound, and more machineready and efficient, with uncompromised product protection.

In addition to this, a new, efficient and updated transportation programme could be another way to improve sustainable packaging in the industry. This has a less noxious impact on the environment, and is generally recognised to produce a smaller carbon footprint. This ambitious goal can be reached in several different ways; for example by trying to reduce the weight of the global package and by reviewing the shipping routes and consignments of products destined for commercialisation. In terms of materials, new innovative packaging for pharmaceutical products is 100 per cent recyclable.

Social Considerations
Having said this, the concept of sustainable packaging does not involve only the environmental dimension, but also a social one. For instance, being socially sustainable in the pharmaceutical industry includes developing packaging that is effective, safe and promotes medication adherence. Industry research has highlighted that only a fraction of the drugs prescribed in Europe are taken according to physicians’ directions. Increased patient adherence results in better care, better outcomes and better health. Effective adherence packaging has a positive impact on health outcomes. We can take as an example the blister packs which are projected in order to help the patients to avoid risks as taking the wrong medication or taking the correct one in the wrong moment. This of course has a very positive impact on the treatment outcomes of the medications involved. Also, child-resistant packaging solutions reduce the number of accidental child poisonings and deaths, as well as improving the ease of use for older users.

Currently, the pharmaceutical industry continues to provide a means to secure and authenticate products. Recently, many leading pharmaceutical companies are starting to include hot-stamped brandholograms on the external part of cartons and labels, in order to protect the products in a relatively easy and economically viable way, instead of using expensive readers or scanners. Other successful solutions include special security links, RFID tags and security features in the label materials themselves, such as visible and invisible fibers, or chemical markers in the adhesive which are only detectable by forensic study. RFID makes it possible to identify drugs quickly and reliably at each point in the supply chain, from factory to consumer. Every single chip (and therefore every labelled unit dose) can have its own unique serial number providing a covert security feature which is extremely suitable for tracking and tracing.

CONCLUSION

Advancements in research and technology are creating new opportunities for more effective and sustainable solutions, such as smart packaging applications that can record and transmit real-time data, or use sound and light to communicate with the consumer. These new opportunities also explore the use of new substrates to enhance supply chain and design. These technologies better support consumers’ adherence to their medication regimen, improve patient outcomes and lead to longer-term wellness. Yet technology and standardisation are not sufficient to produce high efficiency in the pharmaceutical industry. The whole packaging process can be better harmonised and there is huge potential for improvement in this area. Within the production and packaging process, there are many operations and interfaces between process steps that are still performed manually. In the future, many of these tasks will be taken over by flexible robotics technology.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

Gaëlle Janssens has been in charge of the Environmental Affairs of PRO EUROPE since July 2010. She graduated from the Université Catholique de Louvain, Belgium in Management and Administration Sciences, Quantitative Methods, and has a postgraduate degree in Environmental Management from the Université Libre de Bruxelles, Belgium. She worked for two years at University of Louvain-La-Neuve on the implementation of the Kyoto protocol. In 2007, she became responsible for R&D, Prevention and Design for Recycling.

Attilio Caligiani recently joined Weber Shandwick as a Consultant. With four years of experience in European public affairs, he previously worked in-house on regulatory affairs for the German energy company EnBW, as well as for Honeywell’s Government Relations office. He has an in-depth understanding of European environmental and energy policy and has a strong network of contacts in the Parliament and the Commission. Attilio graduated from the Catholic University of Milan from which he holds a Master cum laude in European Affairs.

spacer
Gaëlle Janssens
spacer
spacer
spacer
Attilio Caligiani
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harbouring Exon 20 Insertion Mutations

BEERSE, BELGIUM, May 18, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 1 CHRYSALIS study evaluating amivantamab (JNJ-6372) in the treatment of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.[i] Amivantamab is an EGFR and MET-targeted bispecific antibody, which targets activating and resistance EGFR mutations, and MET pathway activation.[ii],[iii] Investigators assessed efficacy using overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), duration of response, as well as the safety profile of amivantamab,1 which were the basis of the U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation granted earlier this year.[iv]
More info >>

White Papers

Choosing the Right CMO for HPAPI Manufacturing

AMRI

Over the past few years a steady stream of contract manufacturing organizations (CMO) have added high potency active pharmaceutical ingredient (HPAPI) production capacity. The expansions give biopharma executives charged with selecting HPAPI production partners an unprecedented number of options, but all this choice creates a problem — which CMO should you pick when each is touting similar technical capabilities?
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement