samedan logo
 
 
spacer
home > pmps > summer 2011 > thinking outside the box
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Thinking Outside the Box


When transporting clinical trial material around the globe, two factors are of the upmost importance – the transport infrastructure and the ambient temperature experienced by the products in question.The western world seems almost privileged with its logistics infrastructure, its well-maintained transport links and its sympathetic climate, where the ambient temperatures encountered are not too sporadic.These factors result in a testing but consistent and stable environment to deliver clinical trial materials in a timely and safe manner.

However, in the Middle East and North Africa (MENA) it is a very different story. Less qualified infrastructure leads to longer lead times, using up the precious Supply chain partners, specialising in the safe and effective transportation of clinical trial materials around the globe, are continuing to expand into the Middle East to support client demand. Consequently, a host of technical challenges are being encountered by the cool chain sector during its journey into this relatively uncharted territory time permitted to get a product from A to B, while ambient temperatures soar. In some areas of the MENA region, temperatures have been known to reach up to 50ºC.

Still the pharmaceutical industry is increasingly undertaking clinical trials in this part of the globe – in fact, there has been a distinct rise in the demand for this type of service over the last five years as trade flows more easily within the region. Service providers are constantly looking for ways to overcome the challenges presented to them, striving to deliver support for their clients.

The Sporadic Transport Hubs Challenge

Nothing beats having a base central to the area you are operating in, in order to control, support and be a landing base for clinical trials making their way through the region. By being strategically placed, global service providers have the distinct advantage of having a retreat to either break up a journey or act as a warehouse to send out and return reusable packaging to. These supply chain partners are able to reduce lead times associated with the supply of high quality temperature-controlled packaging, an essential part of a successful clinical trial shipment.

Providing packaging that can minimise the risk of keeping product maintained between certain temperatures is crucial in the pharmaceutical supply chain strategy. By having the additional advantage of being strategically placed in the Middle East, you can have more control over what could be seen as an otherwise uncontrollable environment.

Supply chain partners are striving to do all they can to reduce the lead times associated with the supply of high quality temperaturecontrolled packaging. Time is of the essence, and anything that can be done to reduce the duration of a journey is welcomed with open arms.Temperaturecontrolled packaging providers who are based in the Middle East are more able to give timely expert technical support and troubleshoot if any discrepancies do occur, which would be a difficult task if based on the other side of the world.

However, the challenge here is the shortage of hubs through the Middle East. The vast geographical scale presented by the region means the hubs available are sparse, and few and far between. There has been a growth of pioneering third party logistics (3PLs) hubs in the Middle East, which occurred in response to an increase in foreign direct investment from the big pharmaceutical players. Back in 2007, 3PLs such as DHL started spreading their wings, and have since set up hubs in the Middle East to act as stepping stones for transporting goods – a move which was welcomed by the cool chain sector.

The Unpredictable External Environment Challenge

Cool chain suppliers rely on trusted real-world data of ambient transport temperature history, and profiles for certain routes around the globe have been analysed and perfected over the years. However, with the move to the Middle East, which in profile terms can be seen as unchartered territory, there is a lack of data support. Routes across this area have been rarely undertaken, meaning there is a lack of knowledge of potential ambient temperatures the product will need to travel through before arriving at its destination.

Temperature-controlled packaging companies are able to undertake a performance qualification, which can help anticipate the environment of certain routes, known as real-world temperature monitoring. Data loggers are used – small electronic devices that travel on the packaging during test runs to the client’s chosen destination, which can track exposed ambient temperatures in real-time. Every five to 10 minutes the data loggers will track the external ambient temperatures it is being exposed to. Data is collected and slowly the cool chain become experts in these new remits, building up a databases for this area of the globe, which are currently unexplored.

The Unknown Supply Chain Infrastructure Challenge

As well as the unknown temperatures that the product will tackle, there is also the unknown in the infrastructure of the Middle East. Airports, motorways, border crossings, main roads and trade zones all make up inefficient distribution channels which can affect consistent trip profiles thus increasing system performance risk.

Different countries have vastly different logistics risks. For example, a product potentially worth millions might randomly get left on the shelf for a few weeks at customs. Because of these unknowns, two factors are vital for providing a quality service to customers. The first is building the knowledge of how different markets work across the Middle East, to be able to pre-empt and advise customers on the best routes and approaches. The second is to offer intelligent packaging that can react to these situations on our behalf, therefore protecting the product regardless of the environment it encounters.

The Product Stability Data Challenge

In our experience, regulatory bodies are not receptive to drug stability data in relation to system qualification. Previous experience in this field has enabled cool chain providers to utilise drug stability data to support any small excursions seen during the qualification of packaging. In recent months, it has been noted that having access to this data has declined, making it harder to forecast the journey ahead.When qualifying standard packaging, the customer – whether it is a big pharmaceutical or individual clinical trials – has detailed knowledge surrounding the product being shipped and its reaction in environments outside of the normal +2°C to +8°C. It is this information that can enable the qualification of the packaging to be completed quickly to get to the completed result. The lack of data about the Middle East adds complexity, which needs to be built into the qualification, increasing the time and costs associated with the project.

Conclusion

The Middle East is certainly a complicated area of the globe to operate in, but a requirement for those who want to stay ahead of the game.The attraction of this area is increasing by the day, and cool chain suppliers must invest energy and resources to keep up with the ever-growing demand in what often feels like uncharted territory.

In the long run, improved infrastructure and the arrival of more strategically based hubs will help to ensure a smooth ride across the Middle East. However, in the shorter term, supply chain partners are investing heavily in the right research to gain trusted temperature profiles and achieve knowledge of how the new market operates. In addition to this, temperature-controlled packaging manufacturers are coming into their own, offering intelligent systems that can react to the unpredictable. This winning combination will separate the wheat from the chaff, allowing those who are prepared to invest in tackling the technical challenge presented by the Middle East to prevail.




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
Joining in 2010, Roland Nicholas is Product Manager for the company, and is responsible for SCA Cool Logistics’ product portfolio management. He also has previous experience in the pharmaceutical industry that includes roles within both medical devices and consumer products sectors. Roland holds a BSc in Mechanical Engineering (new product development), an MSc in Industrial Design (packaging design) and a Masters of Business Administration in Innovation Management. Email:roland.nichlas@sca.com

As Senior Product Development Engineer, Karen Adams is responsible for all aspects of new product development within SCA Cool Logistics. Karen joined SCA Cool Logistics three years ago, with several years of experience in both the pharmaceutical and FMCG sectors. Karen is a time-served, indentured apprentice and has a Bachelor of Engineering (BEng) in Mechanical Engineering Design. Email: karen.adams@sca.com
spacer
Roland Nicholas
spacer
spacer
spacer
Karen Adams
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Syntegon and Vetter win PDA Drug Delivery Innovation Award for Versynta microBatch

Waiblingen/Germany, October 6, 2021. Together with Vetter, an international pharmaceutical service provider for injectables, Syntegon (formerly Bosch Packaging Technology) has won the PDA Drug Delivery Innovation Award. In the "Partnership Innovation" category, the Parental Drug Association (PDA) honors development projects by pharmaceutical and machine manufacturers that advance the production of (bio)pharmaceuticals. The collaboration between Vetter and Syntegon resulted in Versynta microBatch, a highly flexible and fully automated production cell with a gloveless isolator, the smallest possible dimensions and a complete batch-to-batch changeover of less than two hours.
More info >>

White Papers

Environmental Factors in Data Centres

Dycem

In addition to temperature and humidity, there are many more constraints in the environment that increase failure rates, explains Emilio Sapiña of Secure Techincal Rooms.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement