In the past, the pharmaceutical industry has paid little attention to the environmental impact of the containers and packaging that encases its life-saving drugs. The urgency of getting these drugs to market, their precise storage requirements, and the strict regulatory controls that maintain the industry’s quality assurance have pushed sustainability in packaging out from the priority list of the corporate agenda—a regulatory headache not worth pursuing.

But times are changing, and so are expectations from investors, consumers, and regulatory bodies. Environmental, Social, and Governance (ESG) investing is now a top concern for the pharmaceutical industry, which has found itself in a race to net zero. Regulatory agencies and financial institutions are asking for greater transparency around environmental risk exposure and impact. Governments worldwide are setting high-level net zero targets and instituting sustainability requirements across different industries and sectors. For example, the European Union’s Directive for Fit for 55 and the relevant legislation on Packaging and Packaging Waste under discussion will require a minimum quantity of recyclable or reusable material in pharma packaging by 2035.

Pharmaceutical companies are setting science-based climate emissions reduction targets for Scope 1 and 2 greenhouse emissions (owned and purchased emissions), and many are turning their attention to Scope 3: the emissions produced along their value chains. As more pharmaceutical brands and their suppliers identify packaging as a potential source of emissions, the question on the industry’s mind is: Is “sustainable” pharmaceutical packaging a pipe dream?

New data reveals sustainable packaging exceeds quality standards

New data from Stantec and research laboratory Technopole Mario Veronesi (TPM) demonstrates that sustainable, pharma-grade plastic packaging is possible—and, in fact, is able to fulfill the strictest quality and safety requirements of the industry, including FDA, EMA, and Pharmacopeia requirements. This represents a breakthrough for the pharma industry and should give confidence to quality assurance professionals about the viability of recycled plastics for this application.

Sustainable materials reduce environmental impact

A cradle-to-gate lifecycle assessment (LCA) conducted by Stantec investigated the differences in environmental impact between primary or “virgin” PET and carbon capture PET (PET made from captured atmospheric carbon). Stantec, a consultancy company with robust competencies in ESG, determined that a 15 ml carbon capture PET bottle offers a 21.9% reduction in environmental impact when compared with primary or “virgin” PET, while recycled PET (RPET) reduces environmental impact by 37.2%.

Sustainable materials exceed quality standards

Sustainable materials don’t just reduce environmental impact; they also perform better on quality standards. A toxicology assessment commissioned by Bormioli Pharma on recycled PET (RPET) and carbon capture PET was conducted by TPM. The assessment revealed that for RPET, the aggregate amount of PET fragments is approximately 50% less than that extracted from a virgin PET bottle (which is already 90% less than EU Pharmacopeia limits), both in number and quantity of fragments. In fact, the total amount of any detected compound measures almost 150 times below the safety risk index.

The same toxicology assessments performed on carbon capture PET reveal that PET fragments total almost 40% less than that of virgin PET bottles and measure almost 200 times below the safety risk index.

So sustainable packaging can improve environmental footprints while meeting—or even exceeding—industry quality standards. This is promising data and, hopefully, the first of many studies to reveal the potential of a wide variety of sustainable materials.

What sustainable packaging looks   like for biopharma

A number of sustainable materials are available to the pharma industry today. Bormioli Pharma is currently working with or investigating the use of:

•  Pharma-grade glass produced using post-consumer recycled glass
•  Recycled PET from chemically recycled post-consumer water bottles
•  Carbon capture PET produced using components made from captured atmospheric carbon
•  Recycled PET from chemically recycled polymers
•  Bio HDPE for pill bottles, using ethylene made from sugar cane crop waste
•  Recycled HDPE made from post-consumer recycled milk bottles
•  Recycled PP made from post-industrial recycling of plastic film for the food industry
•  Recycled LDPE sourced from off-cuts of ophthalmic blow-fill-seal (BFS) production

Bormioli Pharma’s objective is to improve dramatically the ESG impact of our production by achieving the ambitious goal of 50% of sustainable raw materials in use in our productions by 2025, including recycled, renewable, or bio-based sources. We are currently working with four major pharma companies (including two of the top 10) on sustainable packaging initiatives. These initiatives focus on three types of sustainable materials: those made from recycled materials, those made from bio-based materials, and those obtained by processing and re-using waste elements such as captured carbon emissions.

The biggest challenges for sustainable packaging

Despite recent progress, the pharma industry faces several obstacles on its journey to more sustainable packaging.

Securing quality supply
Going forward, the biggest challenge in sustainable pharma packaging will be securing a reliable supply of recycled materials. With a supply consistent in volume and quality, packaging providers can build strong and sustainable business models. The quality needs of the pharmaceutical industry are far more rigorous than most industries, so suppliers must be able to reliably meet industry quality standards to avoid compromising drug efficacy or patient safety.

Currently, there are very few suppliers for sustainable packaging materials. To supply the global pharma market, we need to secure recycled and bio-based materials from a wider range of suppliers. For example, Bormioli Pharma is currently working with hospitals and healthcare institutions to establish greater supplies of recycled materials and create circularity within the industry.

Quality and consistency concerns make it imperative that companies not just seek out sustainable suppliers based on price. Companies should seek to establish long-lasting relationships with a wide variety of suppliers to ensure consistent supply and long-term results.

Material-specific concerns
Other challenges the industry faces are specific to the various materials employed. For example, the glass recycling process requires extremely high temperatures, which traditionally results in a high greenhouse gas profile. Bormioli Pharma is currently working on solutions to reduce energy requirements and by using energy produced by natural sources. Other materials, such as Type 1 glass, are not yet permitted by regulations to contain recycled components. However, Bormioli Pharma is confident that a series of scientific studies we are submitting to regulatory bodies will change this law to allow for wider use of recycling materials.

Quality control and industry acceptance

Beyond material-specific concerns, there is an ongoing need to ensure that sustainable packaging meets relevant quality standards. When quality has been assured and regulatory bodies endorse the use of sustainable materials in packaging, we can begin to shift the industry as a whole toward acceptance. This may prove the biggest hurdle to overcome, but the outlook is positive — this is an industry that responds well to scientific innovation and data-driven conclusions. What is needed for industry-wide buy-in is more fact-based, scientifically supported evidence, such as the studies commissioned by Bormioli Pharma that demonstrate the safety and efficacy of alternative materials.

The opportunities for packaging innovation are endless

Technology exists today to truly revolutionize pharma packaging to make it better for both patients and the planet. Take, for example, traceability — a key concern in recycling programs. A combination of QR coding and blockchain tracing could ensure end-to-end traceability and this is something Bormioli Pharma is currently investigating and for which functional proof of concepts (PoC) have been developed. Full digital traceability would ensure the veracity of recycling efforts and enable closed-loop circularity of materials, but it would also be instrumental in combatting the counterfeit drug market, improving patient safety around the world.

Behind Bormioli Pharma’s long-standing push for recyclability and sustainability is the realization that, with a rapidly growing planet, current extraction rates may soon see us running low on raw materials to work with or dealing with surging prices as environmental regulations restrict the supply of newly extracted resources. Yet delivering life-saving drugs to more and more people must remain viable. The solution lies in a more sustainable use of our natural resources. And with science and technology driving innovation, there is potential for pharmaceutical packaging to combat multiple problems at once, and even represent not just a neutral source of emissions but in fact a negative source of emissions through materials like carbon capture PET.

Though our economies have traditionally prioritized growth, and we are living on a planet with limited stock of natural resources, this will urge for change in coming decades. Until we can source our raw materials from Mars, we’ll need to find solutions here on Earth. The good news is that, for the pharma industry, options abound. 

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Andrea Sentimenti is a member of the executive leadership team at Bormioli Pharma, where he leads the corporate marketing and innovation organization. He oversees all the innovation, R&D and technology programs, the global product portfolio strategy and developments, M&A initiatives and partnerships, strategic development projects, and sustainability agenda. He is also supervising the global branding and communication activities.