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Pharmaceutical Manufacturing and Packing Sourcer

Plastic Power

Around five per cent of the current world population of 7.2 billion face an illness of some sort each year. Now consider that each one of those approximately 360 million people may rely on at least one healthcare product made from plastic. Realistically, it would probably be two, or maybe even three products. These need to deliver medication that is easy to administer, sterile and safely packaged in order be effective.

Plastic materials play an ever-increasing role in the pharmaceutical industry, offering customers the opportunity to manufacture products that meet these requirements. Examples include plastic packaging around painkillers or vitamins, cough syrup bottles with child-resistant caps, eye drop bottles with tamper-evident seals, diagnostic products, medical devices, syringes and intravenous bags and bottles. The applications for polyolefins in healthcare are endless, varying from the simplest to the most complex of products.

Polypropylene (PP) and polyethylene (PE) resins continue to replace traditional materials used in healthcare applications, such as glass. It is important to remember, however, that not all plastics are the same. For every application there are materials that will meet basic functional needs and, at the opposite end of the spectrum, there are innovative materials that will deliver new levels of functional performance. The same can be said for manufacturers of polyolefin resins.

Finding the right fit is key. For example, are you looking for guidance navigating the sometimes arduous path through pharmacopeia compliance and product stewardship, or do you simply want the raw materials? Service packages come in many shapes and sizes. From continuity of supply, to consistency of formulations and expertise in regulatory compliance, there are numerous considerations in selecting a partner to produce new resin for your healthcare application needs.

Cornerstones of Service

The cornerstones of a strong service package include much more than simply the delivery of raw materials: consistency of formulation, continuity of supply, pursuit of quality, single sourcing and regulatory compliance all need to be considered. To be effective, the service package must be a living concept that is constantly aligned with new regulatory requirements.

Whether products are manufactured in Europe, North America or anywhere around the globe, consistency of formulation must be a primary focus. This starts with the highest quality of raw materials. PP and PE resins used in healthcare applications must be produced in line with the highly demanding expectations of the pharma industry.

In the heart of every production unit, the manufacturing process is closely monitored and controlled at every stage. Before production starts, it is imperative that process parameters are checked and the ingredients prepared according to specified formulations. Manufacturers of resins going into healthcare applications need to understand that continuity is more important than an opportunity for a cost reduction or a possible increase in their output. A minimum of two years’ notice is also standard notification before a change in formulation or supply.

Quality Control

Nowhere is the pursuit of purity and high quality more important than in healthcare. In medical facilities, plastic packaging offers a proven ability to protect products against contamination and, consequently, protect patients against risk of infection. The chemical resistance and toughness of plastics enhances safety, and offers opportunities for greater efficiency with durable and lightweight materials. Production samples are continuously analysed and visually inspected inside the quality laboratories.

Samples are produced and the quality, density and consistency is checked – but quality control does not stop at the production stage. Dedicated supply chain procedures with controlled storage areas or dedicated transport vehicles are necessary to ensure that stringent control requirements and cleaning procedures continue to be met.

Regulation-Driven Market

The most fundamental component to selecting an innovative new resin is knowledge of, and compliance with, regulatory requirements. For a polyolefin producer to adopt the quality standards required to manufacture resins used in healthcare applications represents a paradigm shift in thinking. To produce a high-purity polyolefin requires special procedures for production, documentation and staff training, among others. It involves far more than simply changing a brand name; it requires significant time and resources.

Government regulations and pharmacopoeia compliance standards vary from one geographical region to another, and they grow more stringent in their requirements every year. Knowledge of these regulations, and the deviations by geographic region or by application type, can help avoid possible pitfalls in the application process. Serving this regulatory-driven market requires a team committed to continuous improvement and ever-vigilant in their awareness, change management and documentation.

Regulatory authorities recognise different classes of medical devices based on factors such as design complexity, use characteristics and potential for harm if used incorrectly. The higher the numerical classification, the greater the potential risk. Simply stated, a device is considered Class 1 if general controls are enough to assure the safety and effectiveness of the device. These are typically products such as labware, pill containers and closures, elastic bandages and surgical gowns. If reasonable assurance cannot be determined through general control measures and further special controls are necessary, a device is classified as Class 2. Examples might include intravenous bag tubing and connectors, blood specimen collection devices or syringes. In Class 3 devices, pre-market approval will be required – in addition to the controls set for Classes 1 and 2 – in order to offer reasonable assurance of its safety and effectiveness. Furthermore, some devices in Class 3 are deemed life-supporting or life-sustaining, such as implantable pacemakers or replacement heart valves.

Aiding Approval

The old adage ‘time is money’ is as true today as it ever was. New resin grades can be delayed months or even years before they are approved for use. A material that meets the requirements of European and US Pharmacopoeia can expedite the progression of approvals for a new resin and streamline the often complex validation process governing the use of products in the healthcare industry.

Some resin manufacturers also offer drug master file (DMF) listing for their healthcare products. Though filing a DMF with the Food and Drug Administration is not a regulatory requirement, it is another important tool used by the application manufacturer to show the quality, safety and effectiveness of the product.

Global Footprint

The location of the manufacturing facilities, as well as collaboration and backing from regional technical support staff, is also a crucial factor in service package value assessments. Most leading medical and pharma companies have production sites throughout the world. These strategically-located manufacturing facilities insist on uniformity of specifications, no matter where customers are located.

Customers in the healthcare industry also benefit from knowledgeable local sales and application development teams dedicated to medical and pharma applications. This business team interacts directly with manufacturing, regulatory affairs, product safety and quality control departments to ensure that any changes made to regulatory requirements can be implemented as quickly as possible.

Versatile Materials

From high- and low-density PE to PP, resins are offered in various application areas. Plastics have the potential to conform to any shape and can be used widely. New material properties have allowed manufacturers of healthcare applications to make products that can be sterilised at higher temperatures, offering additional benefits to the end customer as the sterilisation time is shorter.

The high purity of these plastics makes them perfect candidates for both the laboratory and day-to-day hospital use. Insulin manufacturers, for example, use polyolefins to produce insulin injection pens – a highly effective drug delivery system. This rapidly growing market offers numerous advantages over traditional insulin syringes, including ease of handling, dosing accuracy and more discrete self-medication. In uses such as bottles for intravenous applications and break-resistant containers, plastic packaging has proven indispensable in modern medical care. They are also an ideal material for shipping and storing intricate medical instruments.

Medical devices are one of the most varied and challenging application areas in healthcare due to the variety of applications that are classed as medical devices. Whether an implant, instrument or in vitro component, if a tool is used to treat, diagnose or prevent illness or diseases without chemical actions, it can be considered a medical device. A range of examples can be seen from simple devices such as thermometers and disposable gloves, to complex devices including diagnostic applications, inhalers and so on. Medical devices are often made up of many components, so more than one polymer type or grade is often used in one device. The design of medical devices constitutes a major segment in the healthcare market and currently amounts to nearly $300 million globally.

Conclusion

Interacting with customers, pharma companies and hospitals is key to developing new packaging products for the healthcare industry. When supplying resins used to manufacture medical devices and packaging, quality is obviously very important. With every quality check and certification received, high-purity PP and PE resins are helping to make items that improve the lives of people around the globe.

Operating in a regulatory-driven market such as healthcare requires application and regulatory expertise, reliable manufacturing and organisational dedication. All of these factors play an important role in evaluating the right resin grades and selecting of the appropriate service partner to fit your healthcare packaging needs.

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Alessandro Guidicini is an Application Development and Technical Service Engineer for LyondellBasell, a leading provider of speciality resins used in healthcare applications for over 30 years and manufacturer of the Purell resin brand. With more than 25 years of experience at LyondellBasell and predecessor companies, Alessandro’s focus on PP product development has given him an in-depth knowledge of PP properties and industrial polymerisation technologies.

Alexander Woerz is an Application Development and Technical Service Engineer for LyondellBasell. An active participant in the healthcare industry for nearly 15 years, he has spent his entire career in the cultivation and development of resins for healthcare applications. Focused on PE applications, Alexander is particularly interested in blow-fill-seal applications.
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Alessandro Guidicini
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Alexander Woerz
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