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Pharmaceutical Manufacturing and Packing Sourcer

Freeze Frame

PMPS: Regulations aside, how can products benefit from being kept at precise temperatures?

Laetitia Perche:
I think pharmaceutical laboratories are in a better position to answer this question than packaging producers – ultimately, all we do is respond to their requirements. Having said that, we have worked hand-in-hand with pharma labs for years and do understand something of the impact our packaging has.

Before going on the market, medicines undergo numerous trials that establish, among other things, the optimal temperature conditions to preserve their effectiveness. In certain cases, the more stable the temperature, the more effective the medicine. For example, we know that if a product needs to be kept between 2-8°C it can become harmful to the patient if it freezes, and loses its effectiveness if it gets above 8°C. At the end of the day, the patient’s health is paramount.

What are the challenges involved in maintaining temperature?

Clients are increasingly demanding with their product specifications, while expecting to pay only the very minimum. The challenge is to respect the client’s specifications and provide value for money, without compromising on product safety.

What options are available for temperature-sensitive products?

That depends on the cold chain logistics and equipment. To transport a temperature-sensitive product from A to B, you have three solutions: active, passive or a combination of both.

Which is better: active or passive temperature control?

There is no better solution – again, it depends on the cold chain logistics. One thing we can say is that they are complementary. The active solution offers a stable internal temperature, whereas the passive solution will be more lightweight, keep a temperature-sensitive product at the right temperature, and assure that there is no break in the cold chain.

Refrigerated vehicles are used for national distribution, in the form of grouped transport or transport of batches. Insulated boxes refrigerated by eutectic gel packs or other phase change materials, or by dry ice for very low temperatures, are used for international shipping, for national distribution requiring air transport, and also in the case of various product quantities. Both means can be used in conjunction in certain cases to avoid breaking the cold chain during transfer and delivery, for temperature profiles containing cold and warm segments, or during extreme conditions.

What additional measures can be taken once a product has been shipped to ensure it reaches its destination safely?

The only extra measure should be to ensure all suppliers adhere to their contractual obligations. For the pharma lab, this means realistic expectations – the logistics teams need to deliver products accurately, in terms of both their timing and condition, and the packaging supplier needs to produce a refrigerant pack that meets the requirements. Ideally, a data logger should be included to verify that everything is under control, in line with the risk analysis.

How do regulations impact upon the cold chain?

If we base our analysis on the last Good Distribution Practice guidelines, for example, regulations are focused on cold chain security. Products developed by big pharma labs are increasingly coming from biotechnology and need to respect strict temperature limits, so this is good news – we should never forget that patients’ lives are at stake.

Do you agree with every regulation or do you fi nd them restricting?

The purpose of every regulation is to secure health products and to keep their integrity and quality. It would be good to bring all regulatory requirements and standards into line because the pharma industry operates on a global level and would therefore benefit from globally coherent, streamlined regulations.

Does cold chain packaging have an environmental impact?

Of course, just like any kind of activity. But it does not arise purely from the packaging: the whole process is implicated. As a refrigerant packaging supplier we work with an environmental specialist to analyse the lifespan of our product. We also manage our client specifications to be sure they are realistic and do not impose too many restrictions, which would obstruct their environmental objectives. The more constraints we face, the more we are forced to develop a complex solution.

Which part of your role are you most passionate about?

We are passionate about developing new solutions to meet needs that are not being met by existing products.

Are there any gaps in the cold chain process which you believe should be developed?

A number of improvements are needed. Firstly, the temperature profi les must be representative of the logistics steps, by making a distinction between open segments (tarmac, delivery area) and closed segments (storage area, vehicle compartment). Secondly, better training for all stakeholders in the distribution process of temperature-sensitive products is necessary. And finally, it is important to secure the last link between the pharmacy and the patient.

What innovations will the industry start to introduce over the next few years?

There are three main areas: the use of various phase change materials; the use of super insulation such as vacuum insulation panels; and the combination of static and dynamic solutions (refrigerated boxes and temperaturecontrolled vehicles).

Where is the cold chain market headed over the coming decade?

The cold chain market will continue to grow as temperature-sensitive products are becoming more frequent, particularly biotech ones. New temperature ranges may appear, such as 32-38°C.

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Laetitia Perche joined Sofrigam – cold chain and insulated packaging specialists – as Director of Marketing and Communications in 2008. She is responsible for the delivery of product offers and services to pharma clients around the world, while remaining true to the company’s core values: innovation, sustainable development and continual improvement in meeting clients’ needs.
Laetitia Perche
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