spacer
home > pmps > winter 2014 > the pressure is off
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

The Pressure is Off

Increased demand for pharmaceutical products, driven by global megatrends, is placing pressure on supply chains for more pharma packaging and drug delivery devices. Traditional vulcanised rubber materials used in stoppers and septa, caps and closures, syringe plungers and intravenous (IV) bag connectors can slow production and increase system costs, as they require lengthy and complex processing, post-treatment and secondary operations.

Replacing rubber with specialised healthcare grades of thermoplastic elastomers (TPEs) streamlines processing and minimises secondary operations, resulting in higher productivity and lower system costs. Beyond these major manufacturing advantages, TPEs deliver a number of design and usability benefits. Today’s TPEs can make an important contribution to supply chain efficiency, enabling pharma companies to optimise the growth in demand for their products.

Driving Demand

Two healthcare market forces are accelerating demand for a wide range of pharma products, and putting intense pressure on manufacturers to produce significantly greater quantities in a shorter period, ideally at lower costs. This imperative for greater productivity extends beyond medical devices to encompass packaging components. The first trend is the ageing global population, which is leading to greater overall consumption of healthcare services and products with a particular emphasis on treatments for chronic diseases, often administered by patients or caregivers in a home setting. In turn, the rise in home care calls for packaging, device designs and materials suitable for elderly and disabled consumers, making ergonomics, aesthetics and comfort increasingly important. For example, the US Food and Drug Administration’s (FDA’s) draft guidance on design considerations for home-use devices cites sensory perception/tactile sensitivity variations among users (1).

Another factor driving greater demand for pharma products is in developing nations, where growing affluence and the rise of the middle class are leading to expanded healthcare services. In these low- to middle-income nations, increased availability of medical devices must be paired with affordability. According to a World Health Organization (WHO) bulletin from January 2013: “Radha Basu, director of Santa Clara University’s Frugal Innovation Laboratory in the US state of California, believes that one of the big drivers of change is the increased demand for effective and robust low-cost medical devices from emerging economies, notably China and India” (2).

As a result of these two sweeping changes, pharma companies will need a supply chain that can sustain major increases in demand in order to capture this growth and increase revenue for future investment and shareholder value. Key to supply chain optimisation are higher productivity and streamlined processing, which not only yield greater quantities in a shorter period but can also drive system costs down. Replacing traditional materials with innovative technologies can help manufacturers meet these goals, while also bringing other benefits to the table.

Material Improvements

Vulcanised rubber materials have been used for years in an array of pharma packaging and drug delivery devices. Although the materials themselves offer cost advantages, an examination of the production process reveals many drawbacks. The vulcanisation, or curing step, not only takes time but also requires chemicals such as sulfur and zinc. Any unreacted chemical agents must be washed away after moulding to prevent them from leaching into the pharma product and potentially interacting with a drug. This post-cure step can lengthen the process by up to three hours and requires environmentally appropriate disposal of the washing agents. In addition, rubber parts typically require de-flashing and must often be assembled using adhesives, further adding cost.

Thermoplastic elastomers combine the flexibility, low modulus and soft touch of vulcanised rubber with the processing advantages and potential for recycling. While TPEs are varied and versatile, ranging from ultra-soft to rigid and from transparent to opaque, they share three characteristics:

  • The ability to return to their original shape after being stretched
  • The ability to be processed as a melt at an elevated temperature
  • The lack of significant creep

Most TPEs can stretch repeatedly to at least twice their original length – some up to 10 times their length – without significant permanent deformation. TPEs can also be easily coloured, and can accept special visual effects for aesthetic appeal and product differentiation.

Medical grades of TPE materials offer an excellent alternative to medical rubber. The TPE materials have very low levels of leachables and extractables for safety, and are available in many different formulations to address specific processing and end product requirements. In contrast to the lengthy and complicated processing required for vulcanised rubber components, TPEs feature a faster and simpler system. Not only do TPEs require little to no compounding, they also eliminate the need to add any reinforcing agents, stabilisers or cure systems. In fact, no curing step is required because TPEs combine thermoplastic properties with their elastomeric characteristics, helping manufacturers avoid the time-consuming and environmentally challenging washing step.

Furthermore, unlike thermoset rubber, TPEs can be injection moulded or extruded using high-speed equipment, and can be overmoulded onto a substrate in a single operation, such as two-shot injection moulding or insert moulding. Overmoulding can eliminate the need for adhesives, helping to promote a seamless, secure bond and enable part consolidation. With simpler processing and the use of high-speed moulding machinery, TPEs can boost production speeds, increase productivity and lower overall system costs. An added plus is that these versatile materials also provide other, highly desirable design and usability advantages.

Self-Care Benefits

With a range of Shore A hardnesses and the ability to provide a customised feel, TPEs are ideal for medical device packaging and devices that require ergonomic design and excellent usability, particularly for self-care.

One example of the ergonomic value of TPEs is a prefilled syringe designed by OXO, a New York-based consumer products brand, for UCB, a global biopharma company. This innovative syringe system for home use was developed to help patients suffering with rheumatoid arthritis, and takes into account specific dexterity challenges some patients may face when self-administering their medication. Features include a non-slip finger grip and an overmoulded ergonomic thumb pad, both moulded from VersaflexTM TPE: a soft, flexible, non-slip material designed for ease of use and comfort.

Creative Design


Another beneficial aspect of TPE usage is added design freedom, which can drive innovation and prove a competitive advantage for pharma manufacturers. To improve the precision of dosing for liquid medicines, Andwin Scientific, a manufacturer and brand owner of medical and laboratory supplies, came up with a concept for the SealSafe® bottle dosing adapter for oral liquid medicines, based on a self-sealing septum. Using a dosing syringe equipped with a bottle adapter allows the user to completely invert the bottle when orally dosing, improving accuracy and enabling every drop of medication to be used. The dosing adapter consists of a cylindrical, polymer shell with the septum at its core. To create the membrane, a custom-formulated TPE is overmoulded onto the shell, which also includes flexible fins.

Andwin’s application demonstrates one of the major design features of TPEs: overmoulding onto a plastic substrate. Overmoulding can replace adhesives – and their associated assembly steps – with a tough, seamless bond that can be stronger than the two materials themselves. This approach also helps to prevent leaks in medical devices, such as the connection between tubing and an IV bag. In one case, a manufacturer of a polypropylene (PP) hose for medical applications, including laser surgery, respiratory care and sleep apnoea equipment, selected a thermoplastic vulcanisate (TPV) – a type of thermoplastic elastomer with a vulcanised dispersed phase – to overmould a cuff on the end of its hoses, providing a quality seal.

Another overmoulding example is a vial stopper for medical applications from a major pharma manufacturer. The original part consisted of a PP sleeve that positioned a separate thermoset elastomer button over the vial. Engineers developed a single, two-shot part where the TPE is overmoulded and fuse-bonded to PP via two-shot injection moulding. In addition to halving the number of parts, the fuse bonding cuts down on the potential for leakage failures.

TPEs can also be engineered for other barrier applications such as dynamicseal gaskets, and can even be extruded for waste management bags, as the material provides an odour barrier.

Conclusion

Global demand for healthcare products is increasing due to an ageing population and the rise of the middle class in China, India and Brazil, among other nations. New legislation broadening healthcare access – such as the US Affordable Care Act – together with continued economic improvements, promise to accelerate this growth. Pharma and medical device companies need new strategies for optimising supplies of their products so they can easily capitalise on this demand and scale up for the future.

One solution is to replace traditional vulcanised rubber with versatile thermoplastic elastomers. This upgrade can have a far-reaching positive effect, beginning with a simplified and accelerated production process that increases volume and drives down costs. High-speed injection moulding and extrusion, in addition to avoidance of toxic materials, multiple secondary operations and complex assembly steps, are just the beginning. TPEs open the door to new, integrated designs that reduce supply chain complexity. These materials also offer enhanced ergonomics, ease of use and safety, as well as improved aesthetics for consumer acceptance and brand differentiation.


Reference:
1. Visit: www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm331675.htm
2. Visit: www.who.int/bulletin/volumes/91/1/13-020113/en

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
John Voyce is the Marketing Manager in Europe for PolyOne GLS Thermoplastic Elastomers. He has worked at PolyOne for eight years in a variety of roles, including Area Sales Manager, Key Account Manager and Business Development Manager. Prior to joining PolyOne, John served as a product development technologist for rigid poly(vinyl chloride) (PVC) for injection moulding and extrusion, as well as PVC plastisols. He has also spent several years in sales for rigid and flexible PVCs and TPEs.
spacer
John Voyce
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

3P Biopharmaceuticals renews its “Credit Impôt Recherche” (CIR) by the French Ministry of Higher Education and Research

[Noáin, April 22, 2020] 3P Biopharmaceuticals, a European leading Contract Development and Manufacturing Organization (CDMO) specialized in process development and cGMP manufacturing of biologics, has successfully extended its French CIR certificate for another four-year period: 2020-2024.
More info >>

White Papers

Device Develop for Combo Products

Phillips-Medisize

Combination products are defined as therapeutics combining two or more products (drug/device, biologics/device, biologics/drugs or drug/device/biologics), regulated and sold as a single unit. As these pharmaceutical and biological therapies and treatments have evolved, so has the need to develop appropriate delivery mechanisms for these applications. When developing a combination product, there are many things that need to be considered – the critical relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding ‘user’ needs, determining product requirements, as well as, device manufacturing variation.
More info >>

 
Industry Events

INTERPHEX 2020

15-17 July 2020, Javits Center NYC


More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement