Helping pharma meet exacting regulatory standards for packaging

Josie Morris. Insulated Packaging. Naturally.

Woolcool® was launched in 2008 and the innovative, sustainable design has scooped an impressive haul of awards in the packaging, business and environmental arenas.

March, 2024

At Woolcool®, we understand that transporting and distributing pharmaceutical items is often a matter of life and death.

Whether it’s drugs, medicines, serums or apparatus, the importance of issues such as sterility, robustness and temperature control are of paramount concern when it comes to choosing packaging options within the pharma sector.

It’s no wonder that Good Distribution Practice (GDP) is enshrined in law around the world. In Europe, GDP describes the minimum standards that a distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.

Under the EU’s European Medicines Agency (EMA), companies that distribute medical and pharmaceutical items are not only authorised in accordance with European Union (EU) legislation, but are also required to ensure that goods are stored in the right conditions at all times, including during transportation. At stake are vital GDP and GMP (Good Manufacturing Practice) certificates, with inspections (including distant assessments) liable to be carried out at any time. In case of serious non-compliance, appropriate regulatory actions are triggered.

As a market leader and innovator in the field of temperature-controlled pharmaceutical packaging, Woolcool® provides clients with peace of mind that their products are in the best possible hands when it comes to meeting these exacting needs.

Let’s look at the Agency’s GDP requirements. They expect packaging to ensure that contamination by or of other products is avoided, that an adequate turnover of stored medicines takes place, and that the right products reach the right addressee within a satisfactory time period.

Our carefully-designed range of components ensure our packaging is highly flexible. We have the expertise and data to develop the correct combination to fit the requirements of the contents.

Josie Morris MBE

Managing Director, Woolcool®

At Woolcool®, our years of research and testing have built a solid science-based approach to how we help clients create the right packaging solutions to meet these needs.

Rightly, the pharmaceutical sector expects exacting standards of its temperature-controlled packaging solutions, backed up by hard, tested data and scientific research.

First and foremost, key to the success of our packaging are the remarkable properties of 100% pure sheep’s wool, an insulator which far outperforms manmade alternatives such as polystyrene. Selecting the correct combination of wool liner for your packaging – balancing factors such as required internal temperature, likely external temperature, length of journey, and likely idle periods and delays in the delivery process – will ensure your products arrive at their destination at the right temperature. Crucially, wool is an effective insulator as part of a refrigerated delivery chain or as passive packaging.

Temperature-sensitive deliveries typically, although not exclusively, fall within two ranges – 2-8°C and 15-25°C – and wool utilised across our range of solutions, as a temperature regulator developed by nature through millions of years of evolution, consistently performs to maintain the challenging demands of both. Wool also performs exceptionally for products requiring regulation at CRT (Controlled Room Temperature). That means when refrigeration is not available to keep a delivery cool – such as a vaccine delivery to a remote area – wool-based insulated packaging provides both the protective and insulative security required.

Next, there is selecting the best method of temperature control within the packing – such as ice packs, gel packs or frozen blocks.

Then there is the build of the packaging. Our carefully-designed range of components ensure our packaging is highly flexible. We have the expertise and data to develop the correct combination to fit the requirements of the contents.

That means ensuring the robustness of the outer packaging to avoid damage to the contents, whether that is through natural impacts during transit or the effects of weather. Our work has also shown how the smart fibre attributes of wool also make it a protective packaging component at the same time – wool absorbs impact, while allowing a level of flexibility not found in more rigid manmade insulators. Within the packaging there is also a science to getting the right combination, with dividers providing extra strength and separating content from ice packs.

Finally, we understand the value of quality research to help pharma partners meet the requirements of GDP and GMP regulations.

That’s why research, testing and data collection are the key drivers behind Woolcool’s range of Pharma products. For more than a decade, our innovative approach to harnessing the properties of wool has resulted in millions of pounds worth of Government-backed research and development, in partnerships with scientists at Cambridge University and other respected seats of learning. The result of this research work is scientific data that proves the superior insulating benefits of sheep’s wool – and how it is a practical and reliable material for use in pharma packaging.

Regulations place pharmaceutical packaging under tremendous scrutiny, putting in place vital safety standards that the sector embraces. We ensure our pharma clients can meet these demanding standards.

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