Temperature-Controlled Packaging for Pharmaceutical Market

The article is written by Preeti Saluja, Cold Chain Expert, Global Leader, Speaker IATA Trainer

If we need to travel from one place to another, we carry our stuff in the packaging which will keep our stuff safe during the transportation.

How about transporting a lifesaving drug? And the drug which will only work on a human body if it is kept at the right temperature at all the time even during transportation? Can we take a risk with the choice of our package?

Apparently, those who are involved in the supply chain of the temperature-controlled pharma products understands the importance of it. Not only the choice of the package must be based on the certain regulated parameters but also the very fact that if the package fails, the drug will be useless, not only it will not work but can adversely affect the health of the patient.

Since the subject is very sensitive, government bodies and other voluntary bodies have played their part by highlighting the kind of packaging system that must be used while transporting temperature sensitive pharmaceutical products.

Some guidelines may be checked from WHO guidelines, European GDP guidelines, FDA, PIC/S etc. But if you read them point by point, they are not very different from each other and stresses on the importance of making the required procedures which enables the safe transportation of pharmaceutical products. Because of the sensitivity, this has become the huge market for pharmaceutical logistic segment.

The role of the temperature-controlled packaging is to keep the product safe from external ambient conditions. The future demand of temperature-controlled packaging is projected to remain promising owing to the rising manufacturing output and global research and development initiatives from the pharmaceutical industry.

The requirement for cold chain packaging systems has also increased because of the growing development of innovative medications and therapies such as r-proteins, stem cells, monoclonal antibodies, and pharmaceutical materials at various stages of product development.

The significant shift in customer opinion in favor of eco-friendly packaging solutions over the past few years has been one of the key industry developments.

When we try to find the market research report on internet to see the size of the market and the CAGR, unfortunately we don’t get the common result in different reports but in order to get the idea on the market size, here is an example : Temperature-Controlled Packaging For Pharmaceutical Market Worth USD 20,235.2 Million by 2030 witnessing a CAGR of 9.2% – as per the report by Market Research Future (MRFR).

It is a huge market with regional, local, multinational players in the market. While it will be safe to believe that all players have their own market share but obviously the multinational ones with superior quality, have their global presence and thus a bigger market share. Each one of them are competing on quality, cost, technology, reliability and now even sustainability. It is a highly competitive market environment.

In the broader sense, the temperature control packaging industry is divided by many parameters.

By Type: 1. Type of Packaging- Active and Passive: They are two different technologies. Active technology needs an external energy source like batteries or electricity to work. Passive does not need an external source of energy.

Active systems may provide heating, cooling or both. If a system provides heating, it is almost always done by electrical means – with some relying on heavy battery packs and others on a supply of external power. If cooling is supplied, it is either by use of a cold reservoir – typically dry ice – or by conventional refrigeration using electrically driven or fuel-powered compressors.

The use of passive temperature-controlled systems allows the shipment size to determine the solution used, from single small doses to multiple pallets. The systems comprise the payload material surrounded by thermal media, which is prepared to specific temperatures and encapsulated within an insulation material. Different refrigerants may be used to keep the material cool inside like ice pack, gel pack, phase change material etc.

2. By use
Usage type Single Use/Multiple use
Single use: As the name suggests the single use boxes are one time use packages, they are mostly preferred when the user wants to avoid the reverse logistics of the packaging systems due to several reasons like high logistics costs, usage of the same package during different legs of storage and distribution, etc. Obviously this approach may not be sustainable approach as the usage of the same box is being limited.
Multi use packages: As the name suggests the same box may be used for several trips over the years is multi use packaging systems. These kinds of systems are used where it is possible to manage the reverse logistics and the user is looking at sustainable cost effective solutions.

3. By temperature range
Temperature ranges:
The common temperature ranges are 2 to 8, 15 to 25, -25 to -15, -80, -196.
Not only limited to the below products but 2C to 8C temperature may be used to transport vaccines and medicines. Investigational drugs in tablet forms may be transported in 15C to 25C.

Biological products/samples may be transported in -80 to -20 temperature. The temperature of dry ice is -78.5C and hence it is an apt refrigerant for samples needing temperature of -80 temperature. Embryos, semen and stem cells may be sent at the temperature below -120. This can be sent using liquid nitrogen as the refrigerant. The temperature of liquid nitrogen is -196C which makes it the suitable refrigerant for this temperature range. For transportation of such samples, dry shippers are normally a preferred choice.

4. By Size
Size of the boxes: Parcel size/Pallet size
Depending on the use case, size of the box may be determined. Single use or multi use packages which are mostly parcel size, may be used to transport biological samples, clinical trial materials, R and D samples. For commercial/bulk shipment, pallet size shipment are preferred because of the size and weight of the shipments.

When it comes to packaging solution, while the normal qualification of the active or passive solution currently may be anything between 24- 48 hours or 48 hours to 96 hours or 96 to 120 hours the idea is to get the most qualification time in the extreme of the ambient conditions.

While India could be 44 C in summers and Germany in winters can be -6 C, package must be able to perform in both conditions and hence they need to undergo special testing which are being talked about in various compliance documents. The industry has started talking about the need of the qualification time of 240 hours now.

What does future looks like when it comes to innovations in temperature controlled packaging solutions. Sustainable and smart packaging solutions are the talk of the town now.

With rising environmental concerns and implementation of stringent regulations regarding the use of plastic across the globe, a substantial rise in the adoption of sustainable packaging solutions is experienced across various end use industries.

In accordance to this, numerous packaging companies are shifting their focusing of manufacturing sustainable packaging using 100% recycled plastics, biodegradable plastics, and plastic alternatives such as paper. Hence, introduction of novel sustainable packaging solutions is expected to create lucrative demand opportunities in the market.

Also, emergence of intelligent packaging with the integration of artificial intelligence (AI), internet of things (IoT), and data science have improved the demand for Temperature Controlled Pharma Packaging Market. Hence, key players are incorporating novel technologies such as AI and IoT to increase their revenues, propelling the sales.

“The opinions expressed in the article are solely author’s own and do not express the views or the opinions of her employer

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