Due to environmental concerns about PVC-based blisters, the pharmaceutical industry proposes transitioning to alternative blister packaging materials.
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Key takeaways:
· A cross-industry workstream was established by the Pharmaceutical Manufacturing Forum to identify the technical and regulatory challenges for accelerating the transition to alternate blister packaging.
· Several pharmaceutical companies are actively assessing PVC-free alternatives, such as mono-polymer and aluminum options.
· The regulatory requirements for replacing PVC-based blister materials vary globally and depend on their potential impact on the product's quality, safety, and efficacy.
Over the last 50 years, blister packs have become the preferred packaging choice for oral solid-dose medicines across Europe and many other parts of the world. These packs are predominantly composed of combinations of Polyvinyl Chloride (PVC) and aluminum, materials that have been widely accepted due to their excellent attributes, including their ability to protect products from physical damage, compatibility, manufacturability, capability to accept film laminations/coatings or improved barrier performance, and economics.
However, from an environmental standpoint, PVC has been a cause of discussion as a plastic material of concern over the past few decades. Its lifecycle, from production and use to disposal, releases potentially concerning chemicals. Additionally, due to its composition, PVC is challenging to recycle in standard waste streams. It requires separation for effective recycling, and even small amounts can contaminate other polymer recycling streams.
There are also industry headwinds that may impact the viability of using PVC as a packaging material. This shift may lead to the discontinuation of PVC by suppliers or significant premiums for its use in pharmaceuticals. This scenario is not hypothetical; multiple examples of compounds, such as Barex* and various PFAS#, have been phased out in the food market and subsequently discontinued worldwide. As demand for PVC products decreases over time, the economic viability of PVC may diminish, risking reputational damage for those who continue to use it. Further, regulators have started introducing restrictions on PVC applications. E.g. South Korea.
In light of this situation and the pharmaceutical industry's focus on sustainability initiatives, a cross-industry workstream was established by the Pharmaceutical Manufacturing Forum (PMF) to identify the technical and regulatory challenges and opportunities for initiating and accelerating the transition to alternate blister packaging. The core aim is to optimize the costs, timeline, and efficiency to implement while mitigating technical, regulatory, financial, and reputational risks. This paper presents the findings of this workstream, focusing on the key areas: design for recycling, reduced carbon footprint, manufacturability and printing, quality, and regulatory strategy.
Design for Recycling
The pharmaceutical industry has long relied on PVC-based blisters for solid-dose form packaging, but recycling these materials has consistently posed a challenge. Current initiatives have been limited to examples of pharmacy-led schemes or pharmaceutical company-initiated take-back programs. These schemes typically utilize non-circular 'one-off recycling' pilots using specialist recyclers. However, these efforts often lead to higher costs, low take-back rates, and difficulties in upcycling.
Several pharmaceutical companies are actively assessing PVC-free alternatives, such as mono-polymer and aluminum options that are PVC-free. Mono-polymer blisters made from plastics that take advantage of established recycling streams offer the most significant potential for widespread recyclability of blister packages. Three key mono-polymer formats are being evaluated across the industry:
Polypropylene (PP)
Polyethylene (PE)
Polyethylene Terephthalate (PET)
Technically, manufacturing mono-polymer blisters is feasible with currently known machine setups and tooling. Design for recycling depends on many factors beyond just polymer type, including dimensions, inks, ink coverage, adhesives, and plastic additives. Frameworks such as RecyClass in the EU and APR in the US guide the requirements for packaging to be considered recyclable, but these are primarily aimed at the Fast-Moving Consumer Goods (FMCG) sector. A practical assessment of the sorting behavior of blisters against standardized testing methodology is required, presenting an opportunity to partner with these organizations to develop specific guidance for pharmaceutical formats. However, achieving technical recyclability does not guarantee that the components will be recycled at scale, which is essential for true circularity.
There also needs to be market demand for the recyclate to drive the circularity of the system. Take-back schemes may address collection challenges and partner with recycling facilities with more specialist capabilities. CiPPPA^ (Circularity in Primary Pharmaceutical Packaging Accelerator) and other associations, including recyclers, are evaluating blister and pharma packaging recycling options via take-back schemes. These systems need to be sustainable both from an environmental and business perspective. Residual contamination of the blister and the risk of release of APIs into the environment through wastewater from cleaning steps or risk to operators working in recycling and reprocessing should be considered.
Life Cycle Analysis
Life Cycle Assessment (LCA) is a critical tool for supporting design and material selection. ISO 14040 provides a standardized framework for holistically modeling a product's environmental footprint. One LCA impact assessment method is carbon footprint, expressed as CO2 equivalents, which assesses a material's contribution to climate change. However, a holistic decision on material choice should consider a range of environmental impacts, as exemplified by the Product Environmental Footprint (PEF).
Each LCA factor, such as GHGe, is scaled 1-10 (1 being the lowest environmental impact), and then the factors are accumulated to give the total for each material.The PMF Working Group
Graph 1: Each LCA factor, such as GHGe, is scaled 1-10 (1 being the lowest environmental impact), and then the factors are accumulated to give the total for each material.
The available LCA data above on alternative materials to PVC show that PP, PET, and PE materials have a carbon footprint similar to PVC when compared to fossil fuel versions of each material. From a carbon footprint perspective, eliminating aluminum-based lidding foil in favor of plastic material can reduce at least 50% of CO2 equivalents. Moving from high-barrier, large-size Alu/Alu blisters to smaller mono-polymer blisters with an overwrap can reduce the carbon footprint further, up to 70%. This move also introduces the opportunity to use more sustainable feedstocks to produce plastic materials, such as bio-based plastics, chemically recycled polymers, or those manufactured from carbon capture utilization or other technologies, all of which can enable significant reductions in carbon footprint relative to the traditional, virgin versions of the same types of polymers.
Manufacturability and Printing
Machine Processability
Implementing sustainable packaging solutions will introduce new material combinations, impacting current equipment, tooling, and process parameters. Achieving high machine speeds will require materials that seal quickly, withstand high sealing pressures, and offer a wide process window. New tooling could include forming tools with adjusted cavity geometry and low friction coating to prevent unwanted adhesion. Packaging lines may need extra features, such as pre-heating or plug assist, to optimize performance. Films exposed to heat during forming, sealing, or pre-heating may soften on machine stops, affecting packaging integrity. Platen sealing presents additional challenges due to its intermittent process and the fragile and flexible polymer films.
Printing
According to regulatory requirements, pharmaceutical blisters must be labeled with product specific information and batch data. Thus, the lidding film must be printed either by a third-party vendor or in-line via a UV-flexo or UV-inkjet module. Digital printing technologies allow new approaches for processing and printing blisters, such as printing after sealing and punching, serialization of single units and color-coding different strengths which would eliminate the need for pre-printed stock. Replacing the reflective metallic surface of aluminum lidding with a dull white lid film enhances readability, making it easier to identify correct print images, codes and batch information. UV laser technology for marking of blisters has the potential to eliminate the need for consumables and inks and the concerns related to extractables and leachables. However, the current state of the technology does not deliver sufficient power for the required production speed.
Table 1 Compares the alternative plastic materials proposed for blisters. **. Plastics material data.The PMF Working Group
Quality
There are several considerations to note which may affect product quality and/or compliance. Sustainable blister solutions will likely be 100% polymeric and may present challenges in achieving equivalent barrier properties to existing blister packs; opportunities exist to engage with regulators to utilize simulation models and reduce the stability testing required. Although the intent is to leverage materials whose safety has already been established by the food industry, it is possible that extractable and leachable testing may be required for materials not yet established in the pharmaceutical industry. Compliance with food packaging regulations and pharmaceutical compendial standards is required.
Regulatory
Transitioning to sustainable blister packaging involves significant regulatory considerations, as changes to primary packaging materials generally require regulatory submissions. The regulatory requirements for replacing PVC-based blister materials vary globally and depend on their potential impact on the product's quality, safety, and efficacy. Factors such as the nature of the dosage form, the extent of the change, and the novelty of the packaging materials will influence the exact requirements, which may also vary by market.
Key Points:
Regulatory Submissions: Changes to primary packaging materials will require regulatory submission. The data and submission pathways for these changes can differ globally, depending on their potential impact on product quality, safety, and efficacy.
Multi-National Regulatory Strategy: A cross-business, multi-national regulatory strategy is essential for successfully implementing sustainable blister packaging. This strategy should accommodate changes to multiple products and various PVC blister packaging alternatives within the same framework.
Post-Approval Change Management Protocol (PACMP): The proposed strategy includes developing a multi-product PACMP that defines a standard set of data and commitments and establishes a simple notification pathway for post-implementation of supporting data. This protocol will exploit science, risk-based principles, and prior knowledge to streamline product-specific quality data requirements.
Regulatory Endorsement: It is crucial to gain endorsement and support from influential regulators, particularly the European Medicines Agency (EMA), which has supported industry efforts.
Due to environmental concerns about PVC-based blisters, the pharmaceutical industry proposes transitioning to alternative blister packaging materials. Alternatives like mono-polymer blisters are being explored for better recyclability, reduced carbon footprint, and elimination of PVC. This transition involves considering environmental impact, quality, regulatory compliance, manufacturing, and market demands, showcasing the importance of industry collaboration.
Evan Kamph is theSenior Manager, Packaging Technology and Industry Intelligence, Pfizer.
Sriman Banerjee is theHead of Diagnostics, Software Devices & Packaging R&D Pharma Sci, Takeda Pharmaceutical Company Limited.
The PMF Working Group on Sustainable Blisters was founded according to its statutes in February 2008, as a pre- and non-competitive Non-Profit Organisation in Basel. Bayer is one of the founding members as Novartis or Pfizer is.Individual personal members are the TechOps leaders of the top BioPharma companies. Across industry and across BioPharma, experience sharing, learning, providing solution of equal benefit to all members and also beyond the PMF, also in cooperation with earlier or later parts of the BioPharma va
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