According to WHO, 25% of the vaccines found ineffective when reaches their final destination due to the uncontrolled temperature. 30% of scrapped pharmaceuticals can be attributed to logistics issues alone. 20% of temp-sensitive products are damaged during transport due to a broken cold chain.

This means while in transit, the temperature deviates from the specified temperature range due to one or the other factor and amount to the wastage of the vaccine/Pharmaceutical product and therefore it is extremely important that we choose the correct temperature controlled packaging for the transportation of temperature controlled pharmaceutical product.

Since the very subject of pharmaceuticals, biological products, vaccines revolve around several regulations, there are some regulations which are definitely worth giving a read and follow before taking a decision in choosing the correct packaging for the transportation of the pharmaceutical product.

There are number of guidelines available which talks about the pre-requisites for the correct selection and aspects to check but on a more practical level, here are some indicators that can come in handy:

1. Transit time: Normally some will consider the transit time as flight time or road time that the package spends while in transit but transit time really starts when the packaging has been prepared at the origin and ends when it is unpacked at the consignee’s location. Example: you prepare the package at the shipper’s location on day 1 and it takes 4-5 days to finally reach the destination, then the package that must be chosen should have the qualification time/autonomy of over 120 hours, for it to last that transit time and not having the need to replenish it.

2. Transit temperature: As for transit temperature, it is just not the temperature of the transit(journey) but it actually consist of four temperatures that we must check, temperature at the origin, where the shipment is being stored and packed, second is the ambient temperature of all the transit points it will pass through. Third is the temperature of the aircraft if it is to be transported by air or the temperature of the vehicle if it is being transported via road/via sea. Fourth is the temperature of the destination. It is to ensure that the temperature controlled packaging is able to endure the external ambient conditions of all the places it will transit through.

3. Refrigerant volume: Refrigerant is anything that helps maintain the temperature in the packaging systems. For 15-25C, 2 to 8C and -20 C, it could be done by PCMs and anything for -80C, dry ice could be used, liquid nitrogen for below -196 C. Any increase or decrease in the quantity of any refrigerant can lead to temperature deviations. Normally these packaging systems are tested to work as a system and qualified with the set quantity of refrigerant that is to be used for optimum performance. Any deviation in that calls for the deviation in the performance of the package.

4. Product size: Lets say that the box is qualified to store 100 vials in the box, in case we are transporting only 5 vials in the same box, it could be that the bigger mass of thermal energy starts working on the smaller mass of the commodity and could lead to deviation in the temperature. It could be vice versa too. So, among other things, correct size of the package must be chosen for the quantity of the product.

So practically these are some of the factors that must be considered before choosing the correct packaging for your shipment. Each Pharmaceutical company would want to qualify the packaging before they make a decision to go with a particular packaging. They call it Performance qualification(PQ). There are two ways that can be done-

1. Testing using environmental chambers
2. Actual route testing

The first thing is to freeze on the industry standard against which the qualification is needed to be done. It could be WHO PQS standard, ISTA 7D/7E standard or any other standard. After the standard is shortlisted, the decision is to be made whether a company has the expertise and resources to do it themselves or outsource the activity to the external certified lab.

In order for the testing to be completed, you will need calibrated environmental chambers, calibrated temperature loggers and the expertise to execute the testing. Normally a protocol is prepared, testing is done and the report is prepared after the execution. This is called the qualification report. Only after the receipt of the valid qualification report, the packaging must be used. This is to satisfy the compliance requirements and moreover to have the peace of mind.

Current market scenario of the temperature controlled packaging- What is available- What you could look for:

While some or the other packaging systems have always been available in the market but the advancement of technologies we are seeing now, was never seen before:-. The introduction of passive systems with Phase Change Material of different temperatures have been the talk of the town in this space, with many new players coming in the market now and introducing their technologies.

While we had been using different passive and active systems for the transportation of different products with different temperature ranges, there are packaging systems coming up which can maintain different temperatures using the same outer boxes, just with the change of inner refrigerant. While not many “small” active systems are available in the market but its not that there is no availability at all, but of course getting them to maintain different temperature ranges is still a challenge.

Another game changer now is the introduction of the integrated temperature logger in the transportation packages not only with small active packages but also with passive systems of different sizes. Separate temperature loggers have always been used but the use of integrated loggers with Real time Monitoring(RTMD) with GPS enabled technology is now a way forward.

Opinions expressed in this article are solely my own and do not express the views or opinions of my employer.