Flexible packaging suppliers continue to evolve their product offerings to meet industry demands.

Just by their very nature, both over-the-counter and ethical pharmaceutical products place heavy requirements on the packaging that contains and protects them. Flexible packaging suppliers continue to evolve their product offerings to meet ever increasing demands from manufacturers and consumers.

Here are some of the material and processing developments that are likely to impact go-to-market strategies in the near and mid-term.

Alternatives to Polyvinyl Chloride Structures

Eliminating polyvinyl chloride (PVC) from packaging structures has been an ongoing initiative for many years. More recently there has been an even bigger push to reduce carbon footprint and eliminate chlorine from the waste stream. However, PVC is a relatively inexpensive material, so packaging suppliers are working on developing alternatives that deliver the same performance attributes in a cost-effective manner, while also positively impacting the environment. 

Other materials, such as polyesters, copolyesters, and cyclic olefin polymers and copolymers, have had success in specific applications. But higher material costs, and in some instances, narrower thermoforming process windows and lower outputs, have limited conversions. The goal is to move toward PVC replacement materials with similar or enhanced processing attributes so that the process impact is negated.

The other issue is that PVC alternatives frequently require different heat-seal formulations to maintain seal integrity. This is driving packaging suppliers to develop better sealing and opening performance technology focusing on both a combination of material chemistry and processing modifications.

Consumer, Healthcare Demands

As a parallel to what suppliers are developing, packaging decisions made by pharmaceutical manufacturers continue to be informed by what consumers and healthcare professionals are asking for. These include:

• Blister accessibility. The ongoing challenge of using lidding with the appropriate seal strength, protection, barrier, etc., while at the same time offering consumers-easy access. With a population that is aging, this will continue to grow in importance.
• Converting from pouches to trays for medical applications. Ease-of-use is a frequent complaint amongst operating room nurses. In pressure-filled situations, nurses want to quickly see the package contents and access just as fast. Trays typically deliver that faster than pouches.
• Over packaging. Operating room nurses have voiced complaints about products which are over packaged. One example given at a recent conference included a lidded tray, which held another lidded tray. That assembly was placed in a paperboard sleeve. The multiple components significantly slowed down the nurse’s ability to examine and access the contents.
• Lack of standardization. An example includes the location of information, such as date code. Not knowing where to look is perceived as a time waster.

Pharma Company Expectations

Although the exact material requirements will vary by product, there are five main packaging deliverable areas that are demanded by all pharmaceutical manufacturers. Those are: business continuity, compliance, integrity, product safety, and sustainability. Here are the expectations.

Business Continuity

Due to supply disruptions that have happened in the past five years, pharmaceutical companies are asking suppliers to provide detailed redundancy information. The goal is obvious. Pharma companies want to put in place as many mechanisms as possible so that their production is not shut down should something happen to the packaging vendor’s primary supply chain and production process.

Pharma companies want to see proof of a backup plan that can be immediately deployed should a serious disruption occur. Some even require a detailed matrix that covers everything from backup manufacturing locations, down to alternate power sources, such as generators, should electrical supply be disrupted. In addition to items directly under the supplier’s control, upstream supply chain details, such as resin supply redundancies, are also part of this matrix.

Compliance

This is a wide-reaching area that can include everything from mandatory material compliance with regulatory standards, to (in some cases) optional ISO compliance.

Each packaging supplier has to meet individual pharma company standards that have been set forth in the supply agreement. Understandably, the supply agreements cater to specific product needs. For example, the specification might call for virgin resin only. Another might mandate a percentage of recycled content. Companies may also request a copy of the supplier’s Hazard Analysis Critical Control Point (HACCP) plan to make sure it is aligned with their quality requirements.

Many pharmaceutical companies are moving away from Certificates of Conformance, which state that compliance parameters have been met, and going toward Certificate of Analysis which provide specific data points which specify performance attributes. These typically include water vapor transmission and oxygen transmission rates which are necessary to understand the flexible material’s impact on product shelf life, and therefore, efficacy.

Integrity

One of packaging’s primary roles is to protect product integrity. This area includes multiple attributes such as safety, potency, efficacy, shelf life, and more.

The objective is to use the latest processing technology and polymer chemistry to create flexible materials with the desired performance attributes at the lowest possible cost. Rigorous testing is required to make sure barrier and other mandatory performance criteria are met.

Safety

Increasingly, pharmaceutical manufacturers are turning toward their packaging suppliers to help them address safety issues ranging from counterfeiting deterrents to track-and-trace methodologies.

With counterfeiting representing multi-billion dollar losses for pharmaceutical companies, everyone in the supply chain continues to work toward creating methodologies to reduce occurrences.  

There are a myriad of approaches that are being experimented with, including incorporating “chemistry” to various materials to reduce their ability to be counterfeited. There are also various printing techniques/ink options (holograms, invisible inks, etc.) being deployed as well as bar codes, RFID chips, and more.

There are multiple challenges to a sweeping adopting of these technologies. At the forefront is cost and consumer education. For example, the best technology in the world will not have an impact if the consumer doesn’t know to look for it on the package.

Another issue is that incorporating these anti-counterfeiting devices are not mandated by law—therefore, any initiatives being considered are done so voluntarily and without specific guidelines.

Sustainability

Raw material source reduction, carbon footprint decreases, and new material alternatives all have been part of the packaging decision-making landscape for a considerable amount of time now. In more recent years, these attributes have gone from “nice to have,” to being mandated by retailers, such as big box stores and non-government organizations (NGOs).

Increasingly, pharmaceutical manufacturers are asking suppliers to provide details on how they are managing these initiatives.

One of the more commonly-deployed tactics is the use of a percentage of regrind in creating materials. Another is sourced post-consumer recycled material. The latter is largely dependent on geography (which frequently determines supply availability) and cost.

In addition to wanting to be good environmental stewards, many of the environmental initiatives are being driven by cost-reduction objectives. For pharma companies, better use of raw materials typically results in packaging cost savings. For retailers, environmentally-driven packaging reductions can mean more product per square foot and less waste (such as corrugated shippers) that have to be handled and recycled at the store level.

Not only is this driven by material quantity, but also packaging material composition, as well. There is a critical eye by constituents (such as NGOs) for what base resin is being used in the packaging material. Certain resins types are not considered to be environmentally and socially accepted.

Another area that is growing in importance is the ability for a supply to move toward “zero trash plants.” At the manufacturing site, a holistic approach is taken. The goal is to reduce, reuse, and recycle materials so that as little as possible is delivered to the landfill. These initiatives extend well beyond the plant floor and into offices and cafeterias, as well.

Pharma Companies’ Role in Improving the Process

From the packaging supplier’s perspective, one of the most frequent challenges are the long timetables involved in getting new material qualified. Sometimes materials are specified so early in the process, that the requirements are going to change multiple times along the way.

The other issue is unwillingness to consider converting to a different material.

Packaging material manufacturers need to know that their development dollars are being put to good use, so that innovation can continue.

This article can also be found in the March 2016 edition. 

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