Thermal Blankets 101: Opportunities in CRT Pharmaceutical Logistics

As thermal blankets increase in popularity, Peter Lockett, Director of TP3 Global Ltd, speaks to Andrea Charles from Cold Chain IQ, about opportunities for thermal blanket use in controlled ambient pharmaceutical logistics, why controlled ambient shipments are getting more attention from regulators and shares his insights on 8 recommendations we can expect with respect to thermal blankets.

Cold Chain IQ: Controlled ambient shipments are getting more attention from regulators, why is this?

P Lockett: Many ambient pharmaceutical products have been designed to be stable between defined temperatures but are at risk of damage at more extreme conditions. Liquids tend to start chrystalising approaching freezing point, capsules are designed to melt at body temperature so heat is an obvious threat. As most freight routes don’t expose product to extreme temperatures they have largely been shipped under normal freight conditions. When product is shipped through the heat of Dubai, or the cold of Canada, damage can occur if not properly protected. The regulators have recognized this and applying more focus to ambient products, insisting on temperature monitoring in some countries such as Saudi Arabia for example.

The challenge with established pharmaceutical product is that much of the stability data revolves around storage rather than shipping conditions. Storage tends to be set between 15-25C, and without any shipping and distribution data, it’s normal to revert to the safety of storage limitations.

Newer products coming to market are likely to come with separate guides for storage and distribution.

Cold Chain IQ: When are thermal blankest appropriate for use?

P Lockett: Thermal blankets and covers are ideal where the majority of the transit route is through safe temperatures, but with risk of short temperature spikes (a few hours) either side of the air journey, or between warehousing etc.

Where the temperature threat is occasional and potentially short, shippers are reluctant to invest in the more expensive temperature control products. Instead they tend to seek out low cost options that will slow down temperature exchange rather than control it.

Thermal covers will either be used on the skid pallets for the whole journey, or larger units placed on air cargo pallets just for the ramp duration, or aircraft journey.

Blankets / covers are also well suited where there is a wide temperature zone of safety e.g. 2-40C. Professional covers should be able to slow down any temperature exchange enough t provide a few hours of safety before the product approaches limits.

Covers are also being used widely on generics where no requirement for protection was previously anticipated, and thus now budget allocated accordingly. Covers give at least some protection at entry level cost.

Cold Chain IQ: What are the opportunities for thermal blanket use in controlled ambient pharmaceutical logistics?

P Lockett: Budget is the big driver. Where shippers can afford equipment with more robust performance, they will generally do so. Thermal covers/blankets are regarded as ‘entry level’ for protection, also the lowest cost point. Where shippers have no, or very limited budget, and where the product requiring protection is low risk with relatively wide temperature limits, thermal covers would appear to be a sensible option.

Where the temperature limits are narrower, with little latitude for excursions (or limited stability data), or the product more critical or expensive, shippers will tend to look towards more thermally robust EPS solutions.

Mostly for finished generic products as well as raw ingredients where temperature is not critical but where there are limits to be kept to (usually quite wide – e.g. 2-25).

Mostly for products being shipped by air – protection required for short temperature spikes, or land where longer duration protection is required.

Blankets/covers are also being adopted by more airline and ground logistics companies looking to support their 3PL and shipper customers.

Pharmaceutical QA and operations more often take the lead in specifying protection equipment, followed by 3PL’s who either support shippers by purchasing equipment, or making their own selection. Cold Chain IQ: What is the difference between thermal "covers" and thermal "blankets"?

P Lockett: Covers – tend to be low cost, single skin or bubble wrap material suitable for one way trips.

Blankets – tend to be higher cost multi layer units designed for reusability. Usually a stronger fabric or PVC outer, with thicker insulation.

Cold Chain IQ: What would be your top tips for assessing blanket thermal performance for CRT cargo?

P Lockett: Thermal cover performance can vary hugely depending on the product type (liquid, power, pills etc), packaging, mass, volume, external ambient threats anticipated etc. Although it is reassuring to see initial data, it should only be taken as a very rough guide / indication of likely performance.

It’s also difficult (if not impossible to compare covers from separate suppliers by just looking at manufactures data. Positioning of temperature monitors may be different, load, test conditions can vary etc.

Test covers / blankets with product that as closely resembles the real product and package configeration as possible. If this varies, test the worst and best case scenario to provide an expected bandwidth of performance.

Test the above firstly in a chamber at worst expected ambient temperatures.

Secondly, carry out live testing outdoors, through anticipated routes if possible.

Cold Chain IQ: What guidance / recommendations do you think we can expect with respect to thermal blankets?

P Lockett:

Blankets and covers do NOT control temperature - they slow down the temperature exchange process to allow passage through breaks in the protected supply chain with relative safety (within time and temperature limits). The normal criteria applicable to qualified packaging does not apply to covers/blankets. For example, a 72 or 120hr system. The key criterial is what happens within the temperature spikes. QA / Performance guidelines and advice on when/ when not to use the covers / performance limitations etc would be expected. Deciding whether single use covers or reusable blankets suit operations is a key decision. Providing basic performance data followed up with live testing support would normally be expected. However, it is probably beyond the capabilities of most supplies to provide extensive in-house testing with a wide variety of dummy product and temperatures. Advice on disposal and/or recycling would be normal. Availability and stock locations are critical for product selection. Operational support training for managers and warehouse operators should be well supported via documents, video, face to face (if possible). This would normally include fitting and removal instructions.

Interview conducted by Andrea Charles.

As thermal covers are becoming more popular, a short anonymous survey has been set up on line to gauge design requirements for thermal covers in the pharmaceutical supply chain.

The survey has been set up by Peter Lockett, Director of TP3 Global Ltd, the new company set up to design and manufacture thermal covers specifically for pharmaceutical and perishable logistics. The results will be published in a white paper designed to help give the industry a deeper understanding of thermal cover use in the market. http://www.surveymonkey.com/s/TW7NXHW