spacer
home > pmps > winter 2013 > active ingredients
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Active Ingredients


When managing risk in the safe transportation of life-saving pharmaceuticals, it is always important to consider active versus passive cooling in the distribution supply chain

The growth in demand for biologics and preventative medicines will only lead to a further increase in the amount of temperature-sensitive products moving though global supply chains. Today, 25 per cent of all healthcare products are temperature-sensitive and the requirements for high-value, life-saving healthcare products such as blood plasma, insulin, vaccines and other biological pharmaceuticals are at an all-time high. This means there is also a rising need for the safe and effective global transportation of these products. In fact, industry experts predict that the world cold chain market for healthcare products will grow by 10 per cent year on year.

Pharma Challenge

One of the most prominent challenges faced by the pharma industry in the safe transportation of temperature-controlled pharmaceutical products is to keep the temperature of the product within its required band during transit. Indeed, 20 per cent of temperature-sensitive healthcare products have to be destroyed as a result of a broken cold chain. Any weak link in the chain can compromise drug or sample integrity, breach security, delay shipments, and ultimately result in financial loss or liability.

Packaging systems, transport companies, freight forwarders and airlines all need to take the necessary measurements to ensure the product’s temperature stays within the correct range. This is not an easy task, especially when multiple handlers are active within the cold chain, or different products with different temperatures are distributed.

Due to the urgency of shipments and the value of the products, most high-value temperature-sensitive products are transported by air. Shipping across international borders adds complexities above those of domestic transport due to fragmented supply chains, extreme ambient temperatures and the infrastructure of those countries through which the product must pass.

Air freight is the most expensive mode of transportation and, for airlines to make money from its cargo, the lanes that are available for shipping are often limited. To combat this, products are often transported via multiple flights that include stopovers: this increases the route’s complexity, duration and touch points where things can go wrong.

Furthermore, each country has its own regulations, codes, policies, procedures and customs that affect international shipments and can result in delays. The infrastructure differs greatly from more mature markets to those of emerging markets. For example, Frankfurt is Europe’s busiest cargo hub. It is used to handling temperature-sensitive goods and has a thorough understanding of their requirements, whereas a county such as India has a poor modern transport infrastructure which could result in additional overland transport of up to 72 hours. In contrast, China has a great transport infrastructure, but delays are possible due to custom regulations. Regulatory requirements are only increasing, particularly in emerging markets – and then of course there is the pressure of associated cost implications.

Assessing the Options

Being able to ensure that a shipment will remain within a temperature range for an extended period of time largely comes down to the type of container that is used and the refrigeration method. Factors such as duration of transit, the size of the shipment and the ambient temperatures experienced are important in deciding what type of system is needed for each route. Options can range between small insulated boxes that require dry ice or gel packs, rolling containers, or 40 foot vehicles with their own powered refrigeration units.

For high-value products that have strict temperature requirements, such as +2°C to +8°C, the two main ways of maintaining the correct environment and temperature during transport are active solutions or passive temperature-controlled packaging. But which option provides the best and most cost-effective solution? The decision can be reached through assessing the different transport and product requirements: reviewing the market, quantity, timing, destination and cost.

Active Systems

Active systems are exactly as they say: ‘active’. Similar to a refrigerator, generally the containers maintain a thermostatically controlled environment based on two technologies: compressor cooling and electric heating or dry ice refrigeration using a compressor. Small units may use single-use chemical reactions or pressure differences to provide set periods of heating or cooling, while larger units resemble large freezers, fridges or cold rooms and include heating or cooling elements that power air through heat exchangers and circulate it around the product space.

If a product requires heating it is usually done electronically, utilising heavy battery packs or via an external power supply. If cooling is needed, dry ice or conventional refrigeration are the typical methods, using electrically driven or fuel-powered compressors.

Because active systems are reliant on external power sources, there are higher cost implications and restrictions on handling and shipping. To offset the cost, active systems are often leased to customers. They also require attention in the form of human intervention during transit to either physically replace or recharge the batteries or reice after 72 hours. In addition, units are fitted with control and data logging systems to monitor and verify events such as start and stop operations, cargo and ambient temperature, as well as door openings and alarms for temperature deviations and system failures.

Due to their high cost, active containers are generally leased on a short-term basis to customers, and there are only a certain amount in global circulation. They are positioned at various global stations, and additional costs might be incurred to deliver the system to the required point of origin. Once at its departure point, an active system often requires limited preparation and can be packed simply following a standard operating procedure. However, active systems are generally only cost-effective in large volumes, as partial loads incur similar costs to full loads. This is because the system still requires the same level of handling, and the product transported does not significantly alter the system volume and weight.

Passive Packaging

Although ‘less intelligent’ than an active system, passive, by nature, means that once the system is 'packed up’ it is then not interfered with at any point during its journey. Passive temperature-controlled packaging works by combining components usually manufactured from a variety of commonly found insulation materials such as polystyrene, polyurethane or vacuum insulated panels to provide good insulation without significantly increasing temperature.

Systems are packed with temperature stabilisers such as ice, gel, cool packs or other phase-change materials to provide a fixed amount of thermal protection for its mapped-out journey. The combination of this blend of components acts to keep the temperature of the payload area within a certain temperature range for a specific time up to 120 hours. The use of different component configurations enables the system to cope with a wide range of ambient temperatures.

range of ambient temperatures. The passive packing system requires components to be prepared before being packed around the product. This preparation requires the phase change materials to be preconditioned and maintained at specified temperatures 24-48 hours before packing, until the systems are ready to be assembled.

Packages can range from single vials to multiple pallets and, once assembled for shipping, they can be sealed and despatched without the need for power supply or the requirement for additional attention from highly trained personnel, who will need to be educated in temperature-sensitive product transportation handling. The only changes to the state of the package are due to physical processes caused by the flow of heat through the components, such as the melting of ice. With this greater flexibility comes the increased option of transporting a passive shipment via more carriers and routes.

Prior to shipment, each passive package goes through a qualification process where an in-depth understanding of typical and extreme temperatures a package may encounter is achieved. Compared to active systems, passive packaging has considerably lower capital costs and is available for a range of budgets and performance capabilities. They can provide frozen protection below -20°C by using either the dry ice sublimation phase change at -78°C, or the melting phase change of tailored materials to keep temperatures above -40°C. There are also passive systems that can maintain +2°C to +25°C or +15°C to +25°C, using both water and specialised phase change materials. However, their main use is for the maintenance of refrigerated products between +2°C and +8°C, while active systems can be tailored to an exact temperature range required, providing it is between -20°C and +20°C

International Transportation

When using an active system, a logistics service provider and airline carrier are required to have a hands-on monitoring role during transit. Indeed, each cog in the supply chain is responsible for helping to combat extremes of temperature exposure on the route. This demands monitoring of the temperatures upon acceptance, in transit, upon collection and during dwell time, as well as re-icing or replacing batteries as required.

Air transport can involve the product being left on airport tarmac prior to loading, and this is where some of the most common risks occur due to exposure to the ambient temperatures on the day. Active solutions are fitted with control and data logging systems to monitor and verify events, such as start and stop operations as well as cargo and ambient temperatures. These register outside temperatures in order to maintain the required conditions inside the container. By contrast, passive packaging’s basic construction means that it can be shipped without considerable handling restrictions, which in turn offers greater flexibility in terms of having more potential carriers and routes available. However, because of its simplicity, there is a general misconception that passive packaging does not perform as well as an active solution.

Conclusion

Ultimately, active systems can react to changes in the environment, whereas passive packaging resists external temperatures for as long as there is energy available from the coolant within the shipper. The decision on whether to use an active system or passive packaging to transport temperature-sensitive products is largely determined by the product's requirements, the owner’s approach and attitude to risk, and the destination and budget. One solution does not necessarily fit all, but the best system for each shipping requirement can be found if you have a comprehensive understanding of the options available.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Kavita Somaroo is Marketing Manager at DS Smith Plastics Cool Logistics. She has over eight years’ experience in the packaging sector, beginning her career in the DG packaging industry and moving to cosmetics, before finding her niche in pharma/cold chain when she joined the company in 2009. During her time at DS Smith Cool Logistics, Kavita has experienced success through being able to adapt quickly and effectively to the changing market conditions and enjoys working with many of the leading pharma, biotech and clinical research sector companies to provide solutions that enable the movement of high-value products. Kavita holds a BA in French and Hispanic Studies and an MA in Marketing.
spacer
Kavita Somaroo
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Specialized expertise that gives you an inside edge

Tap into the knowledge of specialists with decades of experience identifying and solving difficult challenges. From technical obstacles such as siliconization and lyophilization to strategic issues such as life cycle planning, Vetter’s integrated team approach brings together the right experts for your compound’s precise requirements.
More info >>

White Papers

Future-proofing serialization solutions: the importance of strong level 3 capabilities

Adents

The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now. Around the world – in Europe and Asia in particular – disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly, be more stringent than today’s differing benchmarks. How can companies manage this transformation with the greatest degree of success while also minimizing business disruption? The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology. It’s also important to choose a solution that enables multi-phase implementation
More info >>

 
Industry Events

INTERPHEX 2020

15-17 July 2020, Javits Center NYC


More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement