Cold chain ‘’pack’’age

Over the years, forms and characteristics of medicines have evolved continuously and so have the packaging requirements for them. The changing appearances and characteristics of medicines have kept packaging solution providers on their toes. May it be vaccines, different types of proteins or antibodies, each of these have their own set of temperature requirements. To package such temperature sensitive medicines in a manner that would preserve their integrity and make them suitable for cold chain logistics is a prime concern for pharma packaging solution providers.

Trends in cold chain packaging

“With novel therapies, like stem cells, r-protein and monoclonal antibodies coming aboard, packaging of cold chain products have received a phenomenal impetus.” Vishal Sharma Co-founder & Director, Vienni Training and Consulting LLP

Success of a cold chain is largely dependent on the way the pharma product has been packed. Cold chain environment can interfere with the properties of improperly packed medicines. Vishal Sharma, Co-founder and Director, Vienni Training and Consulting LLP, explains why the packaging of cold chain pharma products are getting increasing attention. He says, “A cold chain is a temperature controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. It is used to help extend and ensure the shelf life of drug products. Historically, cold chain is maintained by vaccine manufacturers in India, but with novel therapies, like stem cells, r- protein and monoclonal antibodies coming aboard, packaging of cold chain products have received a phenomenal impetus. Biologics and pharma companies are getting increasingly aware about the importance of cold chain maintenance and the challenges associated with it.”

While explaining recent trends in such packaging, Sharma adds, “Recently I came across a product, by an Indian company, that is for clinical trial and needs more than -1900C for storage, which is previously not thought of and the most current packaging solutions does not work. The current trends belong to investments in ultra-low temperature storages, space optimisation and ensure that there is an excellent track-and-trace mechanism. Innovation and energy saving technologies are in the pipeline with many organisations, since low volume shipments, especially in clinical trials, also need cold chain distribution.”

“Packaging requirements for the cold chain pharma products have evolved significantly from dry-ice packaging to refrigerated trucks/cars.” Sharad Dahatonde Gen. Manager – Biotechnology, Elder Pharmaceuticals

Scientific advances in the pharma industry have made cold chain pharma products not only more effective and but also complex. Fortunately, to safeguard these products their packaging has also improved over the years. Sharad Dahatonde, General Manager, Biotechnology, Elder Pharmaceuticals, says, “Packaging requirements for the cold chain pharma products have evolved significantly from dry-ice packaging to refrigerated trucks/cars. There is good availability of gel packs, insulated shipping containers, phase change materials and temperature monitors to ensure that thermal control is maintained throughout the cold chain shipping, handling and storage process.”

“Although most developments in cold-chain packaging focus on conductive systems, new high-performance convection systems are worth considering.” Suresh Ganapuram Packaging Development, Torrent Pharmaceuticals, Research Center

Cold chain pharma products are moved over land, air and sea. So approved packaging materials are necessary to ensure their safety. Suresh Ganapuram, Packaging Development, Torrent Pharmaceuticals, Research Center, talks about a few more aspects of cold chain pharma product packaging. He says, “Although most developments in cold-chain packaging focus on conductive systems, new high-performance convection systems are worth considering. One relies on polyurethane-foam insulation to keep shipments cold longer than would be possible with polystyrene foam. This higher insulation factor reduces the amount of dry ice or gel packs needed to protect the payload and may allow shippers to switch from overnight delivery to more economical two or three-day service. High durability means the foam insulation can be reused.”

Challenges

Managing cold chain pharma products was never a cake walk for the medicine manufacturers. As far as packaging solution providers are concerned they always have to engage most recent technology to ensure optimum standards of packaging.

Sharma opines, “More and more Indian pharma companies are exporting out of India, thus adding newer challenges in maintaining the cold chain. Apart from more regulated markets, Indian drug export is steadily growing in less regulated regions too. Imagine a vaccine or a drug that is delivered to sub-Saharan Africa, and which needs cold chain maintenance. The challenges with such products are not only time and temperature excursions or logistics, but also with respect to active infiltration and theft.”

Sharma adds, “Managing cold chain at clinical sites is another challenge which companies are working on. Indian clinical research market is growing and more often than not the clinical sites are at remote places from the manufacturing site, in some cases outside India too. Here packaging and logistics have to be carefully deliberated upon, the failure here is not the inventory cost, but the cost of delayed R&D, which in some cases can go up to years.”

As described earlier, technology is the key factor while developing packaging solutions for the cold chain pharma products. However, technology needs money and to keep the cost under control is also a major challenge. Sharma elaborates, “Logistics and packaging cost is of course another challenge which needs to be addressed. Often primary, secondary and tertiary packaging is designed to maintain cold chain and ‘data loggers’ are used to record and observe time and temperature during transit, long hauls etc. Cost optimisation using local hubbing and packaging, which works excellently for other cold chain products like agricultural produce may not work for drug product, thus increasing the cost.”

According to Suresh Ganapuram, for many frozen shipments, dry ice has been the refrigerant of choice. He adds, “However, it may alter the pH of some drugs, and many carriers consider it a hazardous material because it can cause burns and requires special handling during packing and unpacking. Dry ice also emits carbon dioxide.”

Manufacturing precautions

Packaging aspects are taken into consideration right from the manufacturing stage. Even more so for cold chain pharma products. Dahatonde explains, “All pharma and biotech executives are working very hard to manufacture best quality cold chain pharma products and always keep the packaging aspect in mind to provide the accurate quality for their drugs in the market. Moreover, the molecules of the drugs are becoming more complex (therefore potentially unstable), and regulatory authorities around the globe are demanding a greater degree of proof concerning drugs identity, strength, quality and purity.”

Dahatonde explains by giving an example. He says, “In case of Menaquinone manufacturing, due to product stability issue, the purification and packaging process need to have dark conditions after the fermentation process. The finished product is light sensitive and need to be packed in special quality, black plastic bags and containers to retain their efficacy.”

Technologically sound

Though maintaining cold chain is a tough task, according to Sharma, the Indian players are in a position to offer world class services in this category. He strongly feels that the Indian packaging development organisations are keeping themselves abreast to face the challenges. “There is a lot of collaboration happening between Indian organisations and multinational companies. A lot of good work is done and a lot more needs to be done, as the paradigm is shifting every day, with new challenges emerging. Parenteral Drugs Association (PDA) came up with a comprehensive guideline for cold chain maintenance in their Technical Report 39 (Revised 2007) ‘PDA Guidance for Temperature- -Controlled Medicinal Products: Maintaining the Quality of Temperature Sensitive Medicinal Products through the Transportation Environment’. With PDA chapter recently functional in India, we see a lot of knowledge sharing and learning possibilities,” informs Sharma. However, he cautions that the technology is available but, keeping up-to-date is a challenge due to lack of guidance and enforcement in the local scenario.

Innovative future

Sharma informs about some of the key developments in the pharma packaging sector. “Utilising Quality by Design (QbD) concept is gaining fast momentum in packaging development for cold chain products, and we see a lot of novel products/concepts coming in near future,” says Sharma. He expects that the innovative products that are at the top of the dosage forms pyramid will necessitate novel packaging and distribution methodologies, which in turn will turn the wheels of innovation in the cold-chain management quicker and smarter.

With the rise in number of biologics’ companies in India, the cold chain pharma products have also started becoming more visible in the medicine market. Moreover, packaging solution providers have also responded positively to these developments by offering requisite packaging solutions. It is to be expected that these moves by the packaging companies would contribute in enhancing their credibility globally and usher in more progress in the sector.

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