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Pharmaceutical Manufacturing and Packing Sourcer

Trending Towards Plastic

Glass packaging has become a staple of the pharma industry, but the growing variety of drug products raises the risk of incompatibility. Plastic offers an alternative, although not without its own problems to overcome

The use of glass for primary packaging systems has long been a standard in the pharmaceutical industry. Glass vials, syringes and cartridges have all been used for container systems, thanks to a variety of characteristics that generally enable safe and efficient drug delivery. However, glass may not be compatible with newer, more sophisticated products, including biologics and cell-based therapies. In fact, there are drugs that, by their very nature, simply do not work as intended when contained in glass. As more sensitive, high-quality drug products reach the market, the risks associated with glass containers have grown apparent. Issues such as breakage, delamination, leachables, and physical and chemical compatibility can affect the safety and efficacy of a pharmaceutical product. Companies now face the challenge of ensuring that their innovative products also have an innovative packaging and delivery system.

In order to keep pace with the new treatments, technologies and growth in drug products, pharma manufacturers have begun to look closely at alternative packaging options, including cyclic olefin polymers, and are weighing the potential benefits of systems created using plastic materials with the technical challenges of implementing what many believe to be a new system. New technologies in packaging and delivery have been developed that will meet the needs of highly sensitive products by reducing breakage, increasing cleanliness, eliminating materials such as silicone and tungsten that can interact with drug products, and enhancing functionality through higher dimensional precision and design flexibility.

While the purchasing cost of the system materials may be slightly higher than glass, technologies to optimise production of plastic systems and increase quality have helped to close the gap between such systems and high-end glass. In addition, when customers evaluate the total cost of ownership and factor in quality improvements that have reduced risk, it can be demonstrated that cyclic olefin systems offer a more cost-effective solution than glass.

Pharmaceutical manufacturers now have options that will not only match the needs of their drug products, but also ensure that the packaging and delivery systems provided to the patient are the most appropriate solution.

Overcoming Resistance to Change

Glass is a traditional packaging material that has been used for many years, and any novel material presents a potentially risky change in a market that is extremely risk-adverse. However, there has been a growing trend towards the use of plastic for primary containment of pharmaceuticals and biopharmaceuticals for many years. The primary market change has been in Japan, where estimates suggest that 60-70 per cent of all prefilled syringes in the Japanese market are plastic, rather than glass. The trend has been driven by increasing demand for higher quality products that will reduce breakage and increase functionality.

Although Japan has led the way in adopting plastic as a primary container, there has also been an increased interest from Europe and the US, specifically in cyclic olefin polymer, although many other products are available in a variety of plastic materials from other manufacturers. So plastic is not a new material for drug packaging. As data supporting the benefits of plastic systems grows, the adoption of plastic as a high-quality material for delivery systems will continue.

A Growing Need for New Material

Issues with glass breakage and delamination have caused concern in the market place. Glass can break at any time – in production, in transportation/handling, when used within a device such as an auto-injector, or even when in use by the patient or caregiver. Breakage or cracking in production or after the drug has been packaged may cause loss of sterility of the drug product and hazards to patients and caregivers. With the increasing use of devices as part of a combination product, a glass container may not be visible, causing concerns about breakage when a device is dropped. For example, patient instructions may suggest an auto-injector should be discarded if dropped due to the risk of glass breakage.

The drivers behind the use of plastic vials and syringes are very different. In the case of vials, the interest in plastic has been led by breakage concerns as well as various product recalls relating to glass particles. Under certain conditions, glass particles are formed by delamination on the surface of the glass vial. In the past several years, the FDA has initiated a number of recalls due to the risk that glass particulate may enter a patient through drug products, particularly those that are administered intravenously. A recent study indicates that clinicians have concerns about the potential harmful effects of glass particles when injected into the body, especially directly into the bloodstream. Plastic vials offer an alternative because the nature of the material eliminates delamination and reduces the potential for breakage.

For prefillable syringes, the main drivers towards plastic have centred not only on glass breakage, but also on the functionality of the syringes, which must be siliconised when made of glass. It has been shown that silicone oil, when used in conjunction with certain biologic products, particularly proteins, can cause problems such as the formation of protein/silicone aggregates, which may alter the integrity of the drug product. The use of plastic syringes provides an alternative that eliminates the problems caused by residual tungsten and adhesives. In the formation of a glass syringe, a tungsten pin is used to create a hole. The needle is then bonded to the syringe using an adhesive. Residual tungsten has been shown to cause stability problems with certain biologics.

In addition, prefillable syringe and cartridge systems are often used in conjunction with a device, such as an auto-injector, pen or a needle safety system. The inherent variability in the dimensions of glass can lead to design challenges because many devices put stress on glass products, particularly in the flange area, where breakage can occur.

Design Flexibility

One of the many benefits of plastic is that it offers design flexibility and increased dimensional precision. When developing more sophisticated devices such as auto-injectors, pump systems and patch injectors, the use of a plastic container may offer significant advantages by providing a consistent functionality for the system.

Design flexibility also offers the opportunity to create more innovative syringes/containers, and to integrate these containers within devices tailored for the needs of patients. An alternative system may be needed for certain new biologic materials where the dose volume may be higher than is typical in a standard 1ml syringe. Plastic containers can be moulded in sizes above 1ml, so creating a system designed for a larger volume is much easier with a plastic primary container.

The reverse is also true; the ability to make a more precise, lower-dose volume in a plastic system can be particularly interesting for a customer who wants to deliver a very small dose of biologic material. Therapeutic injections to the eye, for example, require the absence of glass particles and silicone in order to be safe for the patient. Often, the dose volume for such injections must be small and extremely precise, which can be done by creating a smaller volume plastic syringe system.

As the containment system is only one part of an integrated solution, the advantages of certain polymers will lead to more novel syringe/container designs. By working closely with a packaging system manufacturer well-versed in manufacturing excellence and who has cultivated partnerships with companies such as assembly equipment manufacturers, filling companies, human factors experts and design companies, pharmaceutical manufacturers can select, design and develop an appropriate system that maximises the chances of moving product to market quickly with an optimal drug and packaging combination that will be easy to use for patients or caregivers in the home or clinical setting.

Partnerships Create High-Tech Solutions

Despite its many benefits, hurdles to adoption of polymer-based delivery systems and containment solutions still exist. While some barriers are inherent to the material – for example, oxygen permeability of polymers is typically inferior to glass – manufacturers must evaluate packaging options on a drug-by-drug basis to ensure appropriate packaging for oxygen-sensitive products. Other issues, such as the perceived higher cost of plastic and filling/ handling concerns, can also be overcome.

When choosing proper packaging for drug products, in all cases it is important to understand the needs of the integrated drug delivery system and evaluate appropriate solutions. When working with a company on high-value or sophisticated biologic products, cyclic olefin polymers should be evaluated alongside glass. As glass has many limitations, it is important to evaluate alternatives based on the drug product, including whether it will be used in a vial or syringe, or whether the primary container will be used within a device. A decision can then be made on the most appropriate system for that particular application.

Another issue often associated with the switch to plastic is optimising filling lines. Providing an optimum solution to the challenges of packaging and delivering today’s sensitive and complex biopharmaceutical products requires not only a unique syringe system, but also the assurance that this system can be filled, handled, validated and approved in accordance with all appropriate current good manufacturing practices (cGMPs) and pharmaceutical practices.

Finally, polymers have long been perceived as a more costly alternative to glass. However, as the market demands higher and higher quality from the pharmaceutical industry, technologies have begun to optimise polymer production, which in turn has closed the gap between the cost of high-end glass and plastic.

An Evolving Future

Glass has been around for many years and will continue to be a suitable material for drug containment for many years to come. However, as newer and more sophisticated drug products and delivery technologies are developed, containment systems must evolve. Containment systems must be developed specifically for the needs of today’s sophisticated drug products and offer significant benefits to the end user in terms of increased security and safety. This trend toward high quality, safety and efficacy will only increase.

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Graham Reynolds joined West Pharmaceutical Services Inc in 1980 as a Polymer Technologist, and throughout his long career with the company has held a range of positions with increasing responsibility. In his current role, as Vice President of Marketing and Innovation, Graham leads initiatives to market novel delivery systems and develop strategies for future growth, including the acquisition and development of new technologies to enhance the West Pharmaceutical Services Inc portfolio. His activities include work on key strategic areas involving injection devices, safety and administration systems, auto-injectors and prefillable syringes. 

Graham Reynolds
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