Angela Morris, CEO, The Wool Packaging Company Ltd talks about challenging pharmaceutical cold chain packaging convention
It’s time to break down credibility barriers, challenge conventional regulatory standards, blow away the smoke and mirrors data claimed for man-made packaging materials and raise the global performance bar for insulated pharmaceutical packaging by using ‘smart’ materials such as pure wool – a natural technical fibre.
Why is change needed?
Incredibly, up to 50% of certain vaccines delivered globally still arrive unfit for use due to failings in cold chain distribution and insulated packaging, despite The World Health Organization (WHO) having published a paper in 2005 drawing attention to the fact and by inference, the inevitable loss of human life.
This is an unacceptable situation. What has been done to address it?
Nothing much until 2013, when the European Commission recognised this serious challenge and published revised ‘Guidelines on Good Distribution Practice of Medicinal Products for Human Use’, to ensure stricter procedures and greater accountability throughout the supply chain.
The new GDP regulations have turned the global pharmaceutical distribution sector on its head. No longer can ‘pre-validated’ temperature control performance data be relied upon for insulated packaging.
Packaging validation trials conducted in real-time summer and winter conditions, with real product on real journeys to real customers must now prove the tight cold chain temperature controls for chilled medicines, such as vaccines (2°C to 8°C), and controlled room temperature (CRT) products, (e.g. 15°C to 25°C). The latter often being those everyday items found on the chemist’s shelf, such as cough medicines or paracetamol.
Put simply, the temperature control range (e.g. 2°C to 8°C) shown on the product label must be maintained throughout the cold chain journey from dispatch to eventual destination, which may take 72 hours and longer.
Only if the packaging passes these stringent tests, will licenses to distribute medicines for human and veterinary use be issued by the Medical & Healthcare Regulatory Authority (MHRA) in the UK or Food & Drug Administration (FDA) in the USA.
Concentrates the mind, doesn’t it?
How enthusiastically is the pharmaceutical and healthcare sector embracing this regulatory change?
It varies. At the positive end, responsible pharmaceutical manufacturers, wholesale distributors and logistics companies are actively re-examining cold chain distribution practice and insulated packaging performance to ensure compliance with the new GDP guidelines.
In the middle sit many companies and organisations that do not actually understand what the new GDP regulations require, or indeed where to begin to implement changes. This category can also include our NHS hospitals, doctor’s surgeries and pharmacies. Many also fail to appreciate the whole company training required for personnel to understand their personal responsibility for maintaining cold chain integrity.
At the negative end, beyond the confused category, sit those cynical organisations for whom it is just ‘business as usual’ – simply waiting until the MHRA or FDA turns up on their doorstep, and they are forced to comply.
Astonishingly, we meet many companies in this latter category, where the priority is to avoid on-cost associated with regulatory compliance and the potential impact on margin for as long as possible. CEO’s that promote this short-term thinking are putting their businesses and stakeholders at risk. Non-compliance ultimately means no license to distribute. That should be pretty clear shouldn’t it?
What insulated packaging solutions are responsible companies considering to achieve GDP compliance?
Quite wrongly, a common perception is that if conventional passive plastic insulated packaging is not cutting the mustard, then the only solution to GDP compliance must be to make greater use of more expensive temperature controlled transport and/or active packaging solutions. (Active packaging frequently relies on integral and/or external power sources for refrigeration control)
This strategy continues to fail to recognise the weak link in cold chain – damage caused by exposure to uncontrolled temperature excursions during transit.
Damage often occurs when goods are trans-shipped from one mode of transport to another. Perhaps from temperature controlled truck to airplane hold, where pallets might sit on the runway for several hours, exposed to extreme heat or cold, depending on time of day, season and geography.
Even active packaging is vulnerable. Keynote speakers at the January 2016 Cold Chain Conference in Frankfurt, recently described how difficult it is for sea and air freight companies to guarantee no interruptions to power sources for active packaging containers during transit.
Can conventional plastic passive packaging be made more effective?
Passive packaging is often described as a system typically insulated with polystyrene, polyurethane or vacuum insulated panels. Many have been ‘pre-qualified’ to hold temperature for a certain payload capacity for a specified period of time: 24, 72 or 96 hours, and more. With these types of configurations, gel packs or other types of phase change materials (PCM’s) are used to help maintain desired temperatures.
To further improve temperature control performance, the only option for conventional plastic passive packaging is to ‘go large’ – with bigger, heavier cartons and more PCM’s, making the unit cost of shipment more expensive.
What disruptive design innovation is needed in the packaging sector to deliver GDP compliance?
In our view, the lowest common denominator in the whole cold chain equation is passive packaging.
Since 2012 Woolcool has been quietly innovating. With £1.5m funding support from UK Government via Innovate UK and close scientific collaboration with leading UK universities such as Cambridge, Bangor and Leeds, Woolcool has gained a deep understanding of how wool works at the molecular level and successfully translated natural insulative properties that have evolved over millennia into a disruptive, groundbreaking solution for passive insulated pharmaceutical packaging – ‘LifeGUARDIAN’.
Exceeding all internationally recognised standards, Woolcool brings superior performance and cost savings to the party. Better insulation means fewer ice-packs, meaning smaller packs, meaning in turn lower weight, lower logistics costs – the list of ‘no-brainers’ goes on.
What is our vision for the future?
The Woolcool passive packaging solution for pharmaceuticals isn’t just for today; it’s a genuinely sustainable, economically viable game changer that will contribute to improvement in the health of future generations and potentially save lives.
Angela Morris BA Hons, MA, MinstPkg, FRSA
The Wool Packaging Company Ltd
+44 (0)1785 262030
+44 (0)7773 613676
Please note: this is a commercial profile