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Manufacture Packaging

Com(PET)ing with the Conventional

The risk of a planet overwhelmed by plastic is a fast-approaching reality. The blame cannot be placed firmly at anyone’s door as we have all contributed to the problem. In our daily lives, we consume more plastic than ever before. In fact, plastic production has increased by a staggering 60 percent since the 1960s and while its production is continually falling in Europe, the global landscape is still very bleak (1). In 2015 alone, 322 million tons of plastic were produced, with packaging accounting for 59 percent of all waste in the EU. This amount is set to double over the next two decades – so action is required now.

Pharmaceutical packaging accounts for a very small proportion of waste, but we can still take action in order to have a positive impact on the environment.

Fabio Silvestri, Head of Product Strategy and Planning at Bormioli Pharma.

As plastics enter both marine and terrestrial ecosystems, the threat to human health increases in turn. One avenue that has not yet been tapped into in a meaningful way is recycling. In the EU, less than 30 percent of plastic waste is collected for recycling each year, with a large proportion of it shipped to other regions where the environmental standards may not necessarily reflect those held and adhered to by EU nations (1).

As the EU pushes for a more circular economy focused on reducing waste and making the most of the available resources, such measures must be given much greater consideration. After all, the EU has pledged its commitment to ensuring that all plastic packaging is recyclable by 2030. We, as an industry, cannot remain passive in sight of such a significant challenge. Ensuring that the packaging we provide is of a high standard, yet recyclable is imperative if we aim to uphold the reputation of the industry in a world where green thinking is growing in popularity.

PET Peeves

It would be nonsensical to envision foregoing pharmaceutical packaging because it ensures the integrity of drugs and helps the commercialization process. Though glass and aluminium are commonly used, plastic, particularly polyethylene terephthalate (PET), is also an essential component for packaging, prized for its strength and light weight. As PET is non-leaching and non-extractable in nature, it meets the safety and quality standards set by the FDA and is a suitable choice for oral liquid dosage forms.

While the growth in the use of this type of packaging has increased rapidly in recent years, it should be noted that PET is a non-biodegradable material that can be recycled. When PET is cleaned and shredded into pellets, it can then be crushed and made into new products. In the past, issues related to the features of recycled PET have prevented its adoption by mainstream pharma. Some of the major challenges were related to the mechanical strength, hardness and toughness of the recycled material, as well as regulatory red tape and requirements in place to safeguard drug stability and prevent contaminants from entering drug products. The FDA stipulated in 1999 that “post-consumer recycled plastic should not be used in the manufacture of a primary packaging component. If used for a secondary or associated component, then the safety and compatibility of the material for its intended use should be addressed appropriately,” (2). However, in 2018 , the same authority publicly issued a letter of no objection confirming the capability of a producer’s secondary recycling process to clean and produce post-consumer recycled PCR-PET suitable for food contact (3).

We believe that it is possible to develop recycled and sustainable solutions that are appropriate for the pharma industry. As a first step, we have recently developed recycled PET packaging that complies with the European Pharmacopoeia. We now have bio-based polyethylene containers and BioPET bottles, containing, respectively, up to 100 percent for polyethylene and up to 30 percent for PET of raw materials from renewable sources. Being sustainable by no means results in a compromise on quality. In fact, the physical and mechanical properties of our recycled PET product line are comparable to virgin PET. We’ve also been developing measuring cups and spoons in food-grade PLA that are fully degradable within 60 days in industrial compost facilities – small solutions that still can make a big difference. We are confident that these materials would be compliant and approved by FDA. 

We also have sustainable solutions for the food and cosmetics industries, but these have not yet received pharma certification. We are working to gain approval by 2023 to meet our own corporate and sustainability targets for developing greener plastic solutions.

The pharmaceutical industry must be highly regulated and though regulators are certainly strict, they are not rigid in their ideas or approach to innovation and are open to suggestions to improve the industry’s sustainable packaging practices. We are not the only packaging company pushing for greener solutions in pharma, but more action is required. We must speak with the same voice and ensure that all the solutions we create are compliant with current pharmaceutical regulation if we truly want to affect change. The road to a sustainable future is long and winding and must be implemented in small, achievable steps. When speaking to pharma companies, I am filled with optimism by the willingness of the industry to undertake this journey. And though it may start slowly, its environmental impact will be huge.

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  1. European Commission, “Communication from The Commission to The European Parliament, The Council, The European Economic and Social Committee and The Committee of Regions: A European Strategy for Plastics in a Circular Economy”. Available at: Last accessed July 7, 2019.
  2. FDA, “Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics Chemistry, Manufacturing and Controls Documentation”. Available at: Last accessed July 24, 2019.
  3. FDA, “Prenotifcation Consultation PNC 2236”. Available at: Last accessed October 4, 2019.
About the Author
Fabio Silvestri

Fabio Silvestri is Head of Product Strategy and Planning at Bormioli Pharma.

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