Medical Device Security Through Materials

Although K 2016, the world’s largest plastics industry trade show, also took place in October, it was actually at CPhI Worldwide in Barcelona on 4-6 October, that Clariant launched its latest innovation. Developed jointly with the Swiss-based security specialist SICPA, Plastiward is described “as a robust integrated protection for plastic pharmaceutical packaging or medical devices”.

Other major suppliers and compounders of plastics, notably Celanese, PolyOne and Plastics Color Corporation (PCC) have previously launched similar materials-based protection systems, but this is believed to be the first to be supplied in a joint venture, to be combined with a specific detection device and to be targeted specifically at the medical sector. Plastiward integrates four things:

  • A polymer compound or masterbatch concentrate from Clariant, which is produced under cGMP and ISO 13485 protocols for tight control and full traceability of raw materials. The polymers used include all those generally used in medical devices, such as polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene-styrene (ABS) and PC-ABS blends
  • A proprietary and unique taggant or tracer, a microscopic particle produced by SICPA using complex manufacturing processes to ISO 9001 standards and added to the resin during the compounding process to give it a unique identification signal
  • A proprietary hand-held detection device for instant authentication, making the combination with the taggant “virtually impossible to reverse engineer,” according to Clariant
  • A secure inspection platform, developed by SICPA for monitoring and tracking field auditing activities and processes, thus enabling pharmaceutical companies to monitor their products from factory to pharmacy in real time

Growing Market

The driver for developing Plastiward was obvious enough: the medical device market is growing rapidly because of the increased incidence of chronic health conditions in an ageing population that can be treated with devices offering targeted drug delivery. Estimates of the market’s actual size vary enormously, but MarketsandMarkets projects that it will grow by 6.5% per year from 2014 to 2020.1

Medical devices are made with basic materials but command a high market value. This inevitably makes them attractive to counterfeiters. Indeed, the World Health Organization estimates that 6-8% of the medical devices in circulation are counterfeits.2 This poses a threat not only to patients’ well-being but also to the livelihood and reputations of legitimate suppliers.

There have been numerous incidents in recent years, involving such diverse products as blood glucose monitors, surgical sutures, insulin pen needles, heart valves, catheters and cardiovascular and orthopaedic product lines. As well as outright fakes, issues have included refurbished single-use goods and modifications to incorporate counterfeit consumables.

These counterfeits are often quite sophisticated. Moreover, they are hard to detect until something has gone seriously wrong. In any case, purely reactive responses like this are not the solution, either in terms of the patient or of the supplier. Medical device manufacturers recognize the need to address the problem at a much earlier stage of the supply chain.

Safety Responsibilities

Whilst the plastics used may be basic commodities, they are often integral to the safety of the device, as PCC pointed out in 2015.3 For instance, injectable medicines in pre-filled syringes or vials can be tainted if the wrong resin is used or if they contain contaminated regrind or recycled material that might react negatively with the drug.

In response, suppliers have developed many different overt, covert and forensic authentication technologies. These include inks and dyes, labels, holograms, serialization and radio frequency ID- and chip-based systems, plus combinations of them. Plastiward which combines covert and forensic technologies  falls into the class sometimes referred to as ‘integrated polymer-based solutions’.

These are often targeted at applications where durability matters and/or authenticity needs to be verified after sales. These technologies, PolyOne says, “embed unique identification into the polymer the product is made from. So it is indelibly linked to the item and cannot be removed or altered without mechanically altering the item itself, which is an advantage in combatting grey market goods as well as counterfeit ones.”4

PolyOne launched its Percept Authentication Technologies at K 2013. Percept combines all three types of detection technology with masterbatch or compounding tailored to the specific application. Like Plastiward, it has been sold alongside expert services. Being targeted at markets beyond medical devices, the range of polymers on which the masterbatches are based include PVC, polyamides, polyacetal, polyethylene terephthalate, polybutylene terephthalate and thermoplastic elastomers and urethanes, as well as PP, PE, PC, ABS, and PC-ABS.

Also launched for K 2013 was PCC’s MiBatch line of taggants. PCC is another US-based provider of colorants, compounds, additive masterbatches and custom polymer technologies. It developed MiBatch using a patented spray pyrolysis process in which spherical particles are made over a wide range of compositions to give homogeneous composition control.

The taggants are said to be compatible with a wide variety of plastic resins and to give an extremely high level of security and verification, being easy to authenticate via X-ray fluorescence and laser detection devices at any stage of the supply chain but “very difficult to detect and replicate”, according to Tim Workman, PCC’s VP of Business Development. Like Percept, they were targeted at a wide range of potential industries as well as medical devices and packaging.

References

1. Global Pharmaceutical Packaging Market: Forecasts till 2020, 2016 MarketsandMarkets Web
2."Over 8% of Medical Devices in Circulation Are Counterfeit: WHO." News-Medical.net. 06 Jan. 2013. Web. 
3."Securing the Medical Supply Chain: How to Prevent Counterfeit Plastic Parts and Products." Medical Design Technology. 17 Sept. 2015. Web. 
4."Counterfeiting: How to Fight Back." PolyOne  Web.

 

Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.