Logistics becomes the rising star in pharma as it impacts both drug integrity and revenue


Pharmaceutical product development is changing. The need to produce significantly higher potency large molecule biopharmaceutical drugs to improve efficacy and tailor drugs to the individual needs of a patient puts new pressure on transportation and shipping. Why? The reason is that these newer more complex protein based drugs are highly sensitive to temperature changes, and are often required to be shipped under strict temperature control of typically 2° to 8°C.

Recent research says that the global biopharmaceuticals market was worth US$ 136 billion in 2014 and is expected to experience a healthy growth rate in the future. In addition to higher potency, efficacy and more personalization, other key factors that will contribute to the growth of the biopharmaceuticals industry include higher approval success rates and significantly higher cost of therapy compared to traditional medications.

These biopharmaceuticals, being protein based, are highly sensitive to temperature changes, so any excursions in their ideal storage or transportation temperatures can disrupt their protein structure and make them ineffective.

Other key trends impacting the supply chain includes factors like the entry of biosimilars or generic versions of biological drugs which have already been launched in the US, Europe and other major healthcare markets; the increase in outsourcing trends of biopharmaceutical manufacturing to offshore locations; and biopharmaceutical manufacturing plants are now concentrated in a few regions, but their end-use markets diversified across the globe.

Trends point to more importance for logistics

All this amounts to placing logistics higher up in priority in the pharmaceutical business. The industry trends highlighted will create huge demand for efficient cold chain logistics services in the biopharmaceuticals industry, as well as for clinical trial materials and vaccines. Research from IMARC Group suggests that the global healthcare cold chain logistics services market will grow to almost US$13.4 billion by 2020, up from its current figure of US$8.5 billion.

With logistics becoming more important – and critical – in the supply chain, the cost of maintaining strict environmental and temperature conditions also becomes a larger element of the cost of the overall cost of supply a drug. In larger organizations, proper cold logistics might add between 30-50 percent additional cost, especially as a result of the new strict shipping conditions being required to address the new trends in drugs as mentioned above.

Hence logistics has become serious business for many pharmaceutical companies, and as a result, company boards have also responded, with logistics executives increasingly being elevated to board positions. One major Israeli pharmaceutical major has done just this.

Potential revenue loss if logistics are not in order

For people involved in logistics operations, this has become a welcome trend – especially since logistics executives have in recent times been struggling to get budgets approved as the cost of cold chain shipping and temperature control rises. In fact in many cases, the lack of proper cold chain monitoring can actually lead to loss of revenue – for example, there have been cases of countries banning companies from shipping their medicines if they are unable to prove that the temperature of the transported medicines has been properly maintained.

This is necessary because of new GDP (Good Distribution Practice) guidelines which are in fact now the law rather than just guidelines. Many board level executives are now beginning to recognize that if they don’t have their cold chain logistics and temperature monitoring in order, then there is potential loss of revenue, especially if an inspector somewhere in the process cannot see full evidence of product integrity.

So while in the past the need to prove a drug’s quality and integrity was often seen as an additional cost or overhead, this is now changing as drugs change. Pharmaceutical companies need to protect revenue, by ensuring that newer, higher cost and highly temperature sensitive drugs can be handled by their logistics in a safe environment and that they can provide proof that the products have travelled safely.

Making the business case for implementing serialization cost-effectively in the supply chain

As part of the implementation of serialization, automation of the process will become law within 10 years.  As already highlighted previously, serialization provides accountability and traceability of every item shipped in the supply chain.  The need to conform to these new requirements might at first glance look like it would require costly additional investment. But it need not be – and it might even be more cost-effective, once you take into account the additional benefits that could be obtained.

The ultimate goal is to provide complete traceability of a product to make companies accountable, and help ensure that medicines being delivered to the patient are safe to use. So the key is to collect information about products through the supply chain. For some companies, cold chain monitoring is already in place in some form, providing temperature data; so collection of additional data should be a simple incremental cost. For others, this may be a completely new area to address, and an investment in technology infrastructure might be required.

In both circumstances, the additional information provides much more value that just simply providing serialization data – and this is the key to a demonstrating that a strong return on investment is possible. The additional benefits might include, for example, stronger marketing value (to assure patients that products are safe), improved brand value, and also a more efficient network.

So what about the technology infrastructure requirement? Well, that is easy to address. The availability of ubiquitous mobile connectivity and cloud (internet) based data storage capability has made the task of collecting and storing information much easier than ever before. Many vendors now offer cold chain monitoring and track and trace facilities in what is called ‘software-as-a-service (SaaS), or the entire solution platform-as-a-service (PaaS).

So there’s no need to invest in technology infrastructure – as it’s already there, and all you have to do is subscribe to a service offering what you need, often on a monthly subscription basis based on various parameters – such as the number of points you need to measure.

The data gathered  gives companies insights into a lot more than just serialization information – it can provide complete logistics details through the whole journey of a particular product. Everything is recorded. This means that people running the logistics network can better understand their supply chain and this data might help them to make improvements and run more efficient supply chain networks. It can also help logistics managers use this data to manage shipping schedules and ultimately boost the bottom line.

To use an analogy, consider how web sites like Amazon now provide information to their customers: many now provide a complete track and trace facility for order shipments, so that customers can know at any time where their goods are located on their journey.

Now consider this same system implemented in a pharmaceutical temperature-controlled supply chain, with temperature sensors added to the network or along with the shipment.  It is possible to both pinpoint exactly where the shipment is at any time, and also overlay a temperature graph on top so that you get a complete picture of the shipment’s journey and the temperature history (see illustration).

Supply chain with temperature graph overlay

If this is integrated into existing enterprise systems or workflows, the software technology solution can then provide insights into a complete transport fleet or network of warehouses.  And because the data is available live, alerts or warnings can also be sent by email or text to responsible persons that a digression or some other problem has occurred during the shipment’s journey.

From a serialization point of view, this addresses all necessary requirements:

  • Product identification
  • Product tracing
  • Product verification
  • Detection and response
  • Notification

With details on where every box has been, the temperature, and other key parameters, this provides a complete story of the product shipment – and helps assure patients that products they receive are safe, and in the process helps add value to your brand and marketing. So when thinking about the justification for the cost of implementing serialization, it’s worth remembering the additional non-measurable benefits that can be achieved – and potentially also being able to improve your supply chain efficiency in the process.

Addressing the convergence of transport and logistics, and pharmaceutical compliance

This week, the largest transport and logistics conference for the Benelux countries, NT Dagen, will take place in Rotterdam on 10-11 June 2015.  One of the topics being discussed at this conference is pharma logistics, where the CEO of Dyzle, Rene Tjong Tjin Tai, will answer questions in a discussion forum to outline some of the industry challenges he has seen after working with many customers in pharmaceutical cold chain logistics.

He will address questions such as:

  1. What are the key recent market developments in pharmaceutical logistics?
  2. How can the transport and logistics sector maintain profitability while addressing new customer needs?
  3. What kind of cost implications are there in meeting the needs of the pharmaceutical sector?
  4. What are the things I need to put in place to serve the requirements of pharmaceutical customers?
  5. Will I be able to handle this, from a compliance and GDP (Good Distribution Practice) perspective?
  6. GDP: is it an opportunity or a threat?
  7. What exactly is the new GDP all about, and what makes it different compared to the previous compliance requirements?
  8. What’s the impact on my business if we want to work towards achieving GDP compliance?
  9. How much additional cost is involved to add GDP compliance (note: you’ll be shocked!)?
  10. Will I be able to succeed, given that logistics is cost driven, yet pharmaceutical logistics is quality driven?

These questions will be addressed in the forum, bearing in mind the convergence of logistics and pharmaceuticals, and the different business KPI’s (key performance indicators) that they come from.  If you’d like to learn more, make sure you attend the session on “Pharma Logistics, developments and compliance” starting at 13:30h on 11th June 2015 at NT Dagen.

Why serialization is vital for pharmaceutical product integrity in the cold chain

More than ever before, drug security is an important issue in ensuring the integrity of medicines and vaccines reaching patients. The industry needs to demonstrate that we care for patients, and are putting all necessary measures in place to ensure that medicines are safe to be taken.

That means knowing the entire journey of a medicine through the supply chain, and having fully automated documentation about the conditions on its journey. One of the ways in which this can be addressed in the cold supply chain is through serialization. A key driver for implementing serialization will be global compliance requirements coming into play. The USA introduced the Drug Supply Chain Security Act at the end of 2013, which will require the availability of information at individual package level about where a drug has been in the supply chain.

What is serialization?

Serialization enables product authentication and product quality monitoring, by assigning a unique traceable number to each individual package or container.  This unique number, as it is tracked through the supply chain, allows key stakeholders do several things:

  • enable verification of the legitimacy of the drug product identifier down to package level
  • enhance detection and notification of illegitimate products in the drug supply chain
  • facilitate more efficient recalls of drug products

Essentially this facilitates the prevention of and identification of counterfeit, diverted, sub-standard or adulterated drugs in the market, and provides accountability for the movement of drugs by participants in the supply chain.

Why it is needed

Serialization and security technologies are a vital part of addressing counterfeiting and theft of drugs – according to some estimates global drug counterfeiting is a $200 billion market.  Counterfeit drugs can result in financial loss, but for patients it could mean the difference between life and death, especially if the fake medicines are manufactured with sub-standard materials or have diluted dosages.

According to this article, ‘How technology can protect consumers and pharma companies from fake drugs’, Interpol estimates that 10 percent to 30 percent of all pharmaceutical drugs in circulation in the world are counterfeit and that up to one million people will die annually from counterfeit pharmaceuticals.

How serialization helps – providing absolute traceability

Serialization provides absolute traceability, sometimes down to individual packs; by providing this level of detail for the entire supply chain, it makes companies accountable, and enables them to act with confidence and speed should a recall be required. It also ensures that a pharmacy or distribution point can be identified and informed quickly and effectively if any problems occur, reducing the level of risk in the supply chain.

The USA introduced the Drug Supply Chain Security Act at the end of 2013, which by 2023 is expected to have in place, in different phases, the following requirements for drug traceability and accountability on the part of the supply chain involving manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies):

  • Product identification: manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.
  • Product tracing: all stakeholders in the drug supply chain to provide information about a drug and who handled it each time it is sold in the US market.
  • Product verification: all stakeholders to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.
  • Detection and response: all stakeholders to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.
  • Notification: all stakeholders to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.
  • Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database.
  • Third-party logistics provider licensing: Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license.

Other countries are also in different phases of discussion about introduction of regulations requiring serialization, to ensure accountability and traceability – for example China, India, Mexico, Saudi Arabia, Brazil and Europe. This was discussed at the recent Pharmaceutical Traceability Forum, which looked at topics such as global compliance architecture, forthcoming regulatory deadlines, visibility between manufacturers, wholesalers and retailers, and the technology aspects – such as data standards and interoperability for product IDs.

From the technology platform perspective, Dyzle has for a while been providing a solution helping customers go some way towards tracking and documenting a drug product’s journey. Its real time monitoring solution transmits temperature and other critical cold chain data from a package or container to the web via mobile and wireless networks, and its traffic light system provides instant alerts of any digression.

From a serialization point of view, it also enables key stakeholders to get instant access at any time to the data via the web about the product and its journey, with its ability to identify the location as well as its temperature profile.

With the implementation of serialization, the process is also required to be automated within 10 years, and not paper based. Technology will be an important element in ensuring this automated assurance, providing the accountability and the traceability that various regulations around the world will require over coming years. Without proper integration, this could end up requiring significant investment.

In the next article, we will demonstrate how serialization can actually be implemented cost-effectively in the cold chain, so that full visibility of the entire journey of a product is available. As outlined in this article, it will help the industry demonstrate that we care for patients, and are putting all necessary measures in place to ensure that medicines are safe to be taken.

Top five trends move the cold chain industry to the next level: capacity, last mile, and security become important

by Rene Tjong Tjin Tai, CEO, Dyzle

There is now a good deal of awareness of the need for proper cold chain management in the storage and transportation of temperature-sensitive products in the pharmaceutical and food industry. In particular, there is now increasing pressure on manufacturers and logistics providers alike to ensure that regulatory requirements are met, and safety or integrity of products is not compromised – especially so when the lives of patients are at stake.

According to market research firm TechNavio, the global cold chain market is set to grow at a CAGR of 15.75 percent and 10.53 percent in terms of revenue and volume, respectively, over the period 2014-2019.  If defines ‘cold chain’ as supply chain management that involves storage and transportation of temperature-sensitive goods, using thermal and refrigerated packaging methods to help with the transportation and storage of those goods, and utilizing extensive logistics planning to ensure the integrity of these goods.

In order to demonstrate integrity and comply with GDP (Good Distribution Practice) guidelines, there are both monitoring and reporting requirements in the cold chain. This is provided by a variety of means – including data loggers, temperature monitors, sensors, track and trace systems and so on. Much of this reporting is provided on a historical basis (ie: at the end of a journey or on delivery), but there is also a growing trend for real time monitoring, providing alerts when a parameter such as temperature has digressed beyond a safe range.

Good Distribution Practice (GDP) and Good Automated Manufacturing Practice (GAMP) guidelines also require mandatory reports in a standard format to demonstrate compliance. Systems are now available that automatically create these reports from real time data sent to the cloud (see image).

Dyzle 3 - ROI Computer screen_web

So what is next for the cold chain industry in 2015? Here is what we consider the top five trends to watch out for this year.

  • Creation of additional capacity and capability of handling for cold chain products; there is a shortage of both at warehouses as well as 3PLs (third party logistics providers)
  • Proper last mile delivery and storage; this is still an issue in many emerging economies that don’t have proper end to end cold chain infrastructure, and this also needs to include return of products.
  • In air / at sea temperature monitoring; temperatures can already be monitored in the air but cannot currently be transmitted in real time as the wireless radio connection has to be switched off in air.
  • GDP ‘like’ inspections by the regulators in the last-mile – for example, at pharmacies.
  • Maximizing the benefits of investments in serialization, security, GS1 and temperature monitoring by integrating solutions

The last point on this list of trends to watch out for in this year, serialization, is an important one in the battle against counterfeit drugs, and ensuring supply chain security. Legislation will come on board in a number of countries, forcing multinational companies to look at effective ways of coding individual products around the world, and enabling individual item level serialization. The ability to track and record each item’s movement across borders will mean pharmaceutical companies face new challenges and requirements, and have to implement serialization standards.

In summary, we are coming to a new phase in the cold chain industry, where issues like capacity, last mile delivery, and product security become as important as the capabilities that we are currently seeing to monitor the cold chain.

As cold chain logistics demands grow, technology becomes critical

Increased demand for generic pharmaceutical products and consumption of perishable foods in developing economies is going to drive significant growth in the cold chain logistics market in the next few years.  With this demand for better visibility of products in the logistics networks, to minimize wastage, and to ensure product integrity, technology that enables better monitoring and analytics in real time will play a major part in many cold chain logistics networks.

It is not just developing markets that are seeing growth in the cold chain.  North America is the largest market for the cold chain, according to Persistence Market Research. It says that increasing demand of daily products, vegetables and fruits, along with more exports of these products has boosted the cold chain market.

In the Asia-Pacific region, various government initiatives are also impacting the market – for example, the Indian government is opening mega food parks, which require temperature controlled vehicles and temperature-controlled warehouses. There, the government has also allowed 100 percent FDI (foreign direct investment) in the cold chain industry. The report also says that in Europe, Germany is one of the largest markets due to the increased consumption of frozen foods.

In terms of potential size in relation to the refrigerated storage and refrigerated transport part of the global cold chain market, it is expected to reach a value of US$ 233,476.7 million by 2019, at a CAGR of 15.6 percent from 2014 to 2019, according to Research and Markets. It also suggests that North America accounted for the largest share – 40 percent – of the cold chain market in 2013. The market is mature in regions such as North America and Europe due to the technologically advanced systems for refrigerated storage & refrigerated transport, the rise in demand for perishable foods, and government initiatives that encourage the export and import of these foods in these regions.

Healthcare logistics cold chain requirement grows too

Healthcare products such as vaccines and blood plasma products, frozen pharmaceuticals and insulin require specific temperatures to be maintained throughout storage and transportation.  The increased demand in developing economies for these and other pharmaceutical products has created a pressing need for temperature-sensitive healthcare transportation with the use of temperature tags on products.

Recognizing this, research firm TechNavio, says that the global healthcare cold chain logistics market is expected to grow at a CAGR of 13.31 percent from 2014-2019. In its report, it says increased investment in cost-effective technologies in developing markets, especially India, is motivating vendors to enter this region.

Technology becomes critical in enhancing and assuring product integrity

In order to meet these requirements, both in food and pharmaceuticals, there’s growing investment in healthcare infrastructure and technologies.  In the cold chain in particular, there is an emergence of transport vehicles equipped with event logging and electronic monitoring systems, to enhance the effectiveness of supply chain.

In fact, this will be a key area of discussion at the forthcoming Cool Chain & Controlled Room Temperature Logistics Conference in Frankfurt, Germany on 26-29 January 2015. Among the discussions planned for supply chain integrity, there will be a look at how temperature data can be used to improve and better control the cold chain.

It will also look at what to do with the data – how implementing a centralized global database can enable an overview of all excursions and provide complete insight into the cold chain, and overcoming fears of using ‘cloud’ storage.

This will be important as big data analytics becomes an integral part of many business processes in the coming years. The growing use of machine to machine (M2M) communications, which allows sensors to send real-time data via mobile and wireless communications networks, will generate lots of data – this data might be continuous readings of temperature or other key business critical parameters that need to be monitored.

Systems like Dyzle’s cold chain monitoring platform send the huge volumes of data generated by these sensors to secure storage in the cloud, which makes it accessible for real-time monitoring and for reporting. This data is often used both for historic recording processes, as well as to produce automated reports to demonstrate GDP compliance for example; in addition, it also helps to assure customers and consumers that the products are safe to use.

hardware - sensors

Wireless sensors like those shown here send data from temperature measurements to secure storage the cloud, making the information accessible for real-time monitoring and reporting

Technology such as this will therefore become critical in reporting key business performance indicators (KPIs), and will become an integral part of the logistics as well as business management process.

This will be especially significant as the volume of temperature-sensitive products that are shipped around the world grows; hence the demand for proper cold chain logistics with the ability to prove integrity with will become more important, since pharmaceutical companies will need the proof to be able to sell their products. The only way this can be solved is to have sensors and be able to make measurements, to handle lots of data, and to be able to record and interpret that data according to the market requirements.

Why data visualization is important for the cold chain

The proliferation of sensors to monitor almost anything and everything, plus the ability to store the information they collect in the ‘cloud’ is resulting in managers becoming inundated with data. Obviously the data is collected with a purpose – for example in the cold chain, sensors measure temperature and other critical variables so that management and operators know what is going on in the supply chain, to improve visibility, and to ensure the highest quality and safety as products move through the various parts of the logistics chain from warehouse to consumer.

With conventional data loggers, these measure temperature at pre-defined intervals and store that data for reading at a later point in time. However, with the increased use of real-time monitoring, not only do you have the ability to take corrective action almost as soon as a temperature excursion outside a pre-defined safe range takes place,  but you also end up with significant amounts of data being measured and stored.

So it’s no surprise that at the recent Big Data & Analytics for Pharma Summit in Philadelphia, USA, attendees were concerned about how to interpret the masses of data becoming available. Some of the observations were as follows:

“It doesn’t matter if your reports have all of the information.  If people can’t read and understand it it’s meaningless and you’ve wasted your time.  Busy executives need pictures that display patterns and insights.” George Koumakis, Roche

“Without the right framework for visualization, good data and actionable insights will slip away.” George Koumakis, Roche

“Tailor visualization for the business persona you’re serving and create actionable outcomes.” Sara Rottunda, Medtronic

These comments suggest that data visualization is important, and any tools that help to see it at a glance in a meaningful way for a particular business process or operation would certainly improve the ability of management and logistics operators to better understand and manage their operations. In addition, ‘actionable insights’ is also important, in that data should be presented in a way that makes it easy to take corrective actions if required. One such system might be a traffic light method (see picture), which can show the status of each element of the cold chain. In the picture, a red light means action needs to be taken.

Overview diagram connecting to cloud red-green signals

Alternatively, a map might show the status of any one of the fleet of trucks as well as warehouses or fixed locations, with a green, amber and red traffic light system to show the status of each point:

One view Europe map

It is not just about locations and status though. ‘Dashboards’ can be personalized so that the visual tool shows status of critical business process parameters, according to the key performance indicators of a business. The dashboard might even be tailored differently for different stakeholders.

For example, a CEO or a CFO might simply want a dashboard that indicates financial values of any potential loss that could result from a temperature excursion. On the other hand, the logistics manager might want to pinpoint the exact location of a truck or warehouse in the network to isolate it or take action (for example to instruct the driver to close the truck door). Or a QA manager might simply want reports just to prove to their customer that the product travelled safely throughout the distribution network.

While the data visualization assists the management process with tools like simple dashboards, it doesn’t take away from the fact that all the raw data is still available for integration into other systems – such as ERP, CRM and business intelligence. This supports wider information management systems within an organization.

Ultimately, data has now become abundant, and this is why sectors like the cold chain industry need good data visualization capability in order to quickly analyze the status within a logistics network, and take appropriate action as and when required.

A buyer’s guide to cold chain temperature monitoring systems

One of the great aspects of the modern world is that technology underpins everything, yet we don’t need to know anything about the technology. The majority of us would not know how the chips in our smartphones work, but we know how to make calls, take photos or browse the internet. What we usually look for is features that enable us to do the things we need in our daily lives – whether it is for taking photos, sending emails, internet usage or other capability; and then we look at features like battery life and size to see if it suits our needs.

Using this analogy, the main concern of the cold chain logistics industry is ensuring reliability, accuracy, and security. They need assurance that the products being shipped or stored, whether in the pharmaceutical or food industry, are maintained under the right conditions for them to be safe to use or consume when they reach the customer (see ‘How cold chain monitoring assures product safety’).

For the logistics manager, he needs to know where the products or shipments are and if there have been any temperature digressions so that immediate corrective action can be taken. For the quality manager, he needs to be re-assured that product quality has been maintained and have proof of product integrity. For the senior management team, whether they are CEO or CFO, they need to know the value of the shipment lost if there has been a digression, whether it is an isolated case, and where in their network of warehouses or the transport fleet the digression is occurring.

Ultimately, at the various levels of management in the cold chain logistics industry, they are looking for the temperature monitoring solution as a means to prove quality to their customer, and in turn enhance their relationships with customers and therefore enhance business.

What are the key factors to look for in a cold chain monitoring solution?

Many technologies are now available to monitor these various parameters of temperature, humidity, energy, location, and whether a door is open or closed.  There are RFID trackers, track and trace, cold chain monitoring, temperature monitoring, wireless monitoring and many more types of technology solution being offered to the cold chain logistics industry.

So how do you choose? Here are some of the obvious factors you should look for:

  • What parameters does it measure? Is it just temperature, or will it tell me about the humidity or whether a door is open or closed?
  • Can the sensors used in the system be used just in the entire logistics network – in the controlled room temperature warehouses, and in the fleet of trucks? Will this give me complete visibility in the entire cold chain, or are there gaps?
  • How does it send the information – is it via local wireless network, or a globally connected mobile network? If it uses mobile (GPRS or UMTS networks), then there would be global coverage.
  • Will it send me a real-time alert if the temperature rises above or falls below pre-defined temperature values that define the integrity of the product?
  • Can the system also use data from my legacy products – such as existing barcode scanners, RFID tags, ERP systems, so that I can get a complete picture of my cold chain?
  • Can the system overlay location data so that I can see the exact status of all my fleet and warehouses in one geographic map?
  • How is the data stored and can I have access to it at any time? If the data is continuously monitored and sent to the cloud for storage, then you know you will have access to it in case you need to provide full reporting history to your customers.
  • Do I need to provide any extra training to my operators? Ideally the system should provide automatic monitoring and data recording and reporting, removing the task of measuring from your operations staff, leaving them to get on with their main job function.
  • Does the recording and reporting of data fit into a GDP validated environment? This is important for GDP/GAMP regulatory requirements.

Solutions that address all of these factors can help to provide complete visibility in the cold chain and proof of product quality and integrity. Solutions that can address fundamental questions such as ‘what is the status of my shipment?’ and ‘where is my shipment?’, and help provide a rapid response upon failure by automated alerts (such as SMS, email, phone, as provided by Dyzle’s cold chain monitoring solution) are very much likely to meet your needs, if you are concerned about total product quality and integrity. The ability to see the whole system in one view on a map with all necessary details adds to the value of that system.

Overview of entire system

A hardware and software platform solution like Dyzle’s can provide the visualization of both fixed and mobile locations in a cold chain, and store the data in a centralized database in the cloud.

Automated registration and reporting, for proof of compliance with GDP, GAMP and HACCP requirements should then take away the additional task of manual recording and reporting that is often used by logistics and quality managers.

A hardware and software platform solution like Dyzle’s can provide the visualization of both fixed and mobile locations in a cold chain, and store the data in a centralized database in the cloud. This database can be enriched with cold chain data from other parties and sources; with the combined data, it is possible to create visibility and control of products throughout the cold chain.

An additional benefit of this temperature monitoring is that energy consumption can also be reduced or optimized. In a controlled room temperature environment, if the cooling equipment is observed to be running colder than necessary, this can be corrected to reduce the energy usage – a one degree Celsius increase can lead to a four percent reduction in energy consumption.

A final piece of the factors to look for is validation. A monitoring solution that fits seamlessly in a GDP validated environment (meaning the computerized system is validated), means that:

  • user requirements have been defined
  • risk assessment has been performed
  • system impact has been determined

Such validation is an integral part of Dyzle’s solution. The importance of this is that there is no need for additional training of internal resources, and no additional investment is required in validation expertise.  When product integrity is becoming increasingly essential, this capability in a cold chain monitoring solution is vital.

In fact, GDP compliance or GAMP takes care of most of the factors mentioned above for pharmaceutical companies. GAMP is a methodology that has asked all these questions according to the guidelines/standards for the pharmaceutical industry.  Technology solutions like the Dyzle hardware/software cloud-based platform ensure that by working in a validated environment, all these requirements are fulfilled – which means that logistics industry managers responsible for the cold chain do not need to know anything about the detail of the monitoring solutions, since the solution has already done all of that homework, in terms of risk analysis, IQ, OQ, etc.

In this article, we’ve looked at the key factors that one should consider when looking to implement a complete cold chain monitoring solution. As illustrated, it is not necessary to know about the technology platform – but it is important to know that they can do certain things, like measure data automatically, tell you the data in the right format, and help you provide proof of product integrity and compliance.

The Internet of Things is not a future vision: it’s already here in the cold chain

Everyone is talking about the “The Internet of Things”, or IoT.  To the uninitiated, this might sound like science fiction, depicting a world of smart and intelligent refrigerators, appliances, smart homes and ‘smart’ everything.  But what does the IoT actually mean for the cold chain industry? In this article, we’ll look at the reality of IoT in the food cold chain, and how it can and is already enhancing food safety.

The IoT has been evolving over many years, and you could say it goes as far back as the bar code was conceived in 1949; or to 1995 when Siemens introduced its first remote monitoring module for tracking and tracking applications (see ‘A very short history of the Internet of Things’). The IoT market has grown over the years, and despite the buzz and futuristic vision it may present, it is very much here already. According to market research firm International Data Corporation (IDC), a transformation is underway that will see the worldwide market for IoT solutions grow from US$1.9 trillion in 2013 to US$7.1 trillion in 2020 (see announcement here).

For several years, Ericsson and Cisco have been forecasting that there will be about 50 billion connected devices by 2020, and now ZTE predicts that there will be 100 billion connected devices by 2020, of which 50 billion will be connected sensors making up the IoT.

IDC defines the Internet of Things as a network of networks of uniquely identifiable endpoints (or ‘things’) that communicate without human interaction using IP (internet protocol) connectivity – be it locally or globally.

In the food cold chain, the ‘things’ could be trucks or warehouses. The ‘IoT’ enables sensor networks to be deployed in all parts of the cold chain – in production, in shipping and in storage. Using a mobile connection, data from the sensors can be transferred in real-time to the cloud, where it can monitored and analyzed.

The benefit of such an IoT sensor network connected to the cloud is that it helps in monitoring parameters like temperature, humidity, and whether a door is open or closed. If there are temperature excursions, or a door is open, then the connected sensors in the trucks or in storage act as part of the IoT network to provide ‘real-time visibility’ of the status of the food products.

In the case of the platform available from Dyzle, the sensors are connected via a local wireless gateway to the mobile phone (GPRS or UMTS) network so that they can constantly send temperature and other data to a central data collection point or hub. In Dyzle’s platform, it is sent to the cloud (internet), and the data is interpreted and presented to the user in a ‘personal dashboard’ format that shows the parameters important for that customer.

Such a platform provides logistics managers, quality managers, and other responsible persons for the cold chain with the user interface that provides a visual display of key parameters, and provides real-time alerts. These alerts might warn a responsible person that the temperature of the shipment has exceeded a pre-defined safe temperature range, or that a door is open causing the temperature to rise above the safe temperature range for the food. By providing the alert, it is possible that corrective action, either manual or automated, can be taken instantly so that food safety can be ensured.

An additional benefit of an IoT system like Dyzle’s is that data is stored in the cloud, and therefore the system has the ability to provide automated compliance reporting of the entire history of the temperature and other parameters.

To demonstrate the latter, one food retail chain in Europe that uses Dyzle’s network has multiple outlets, and in order to provide proof of its compliance to HACCP (Hazard Analysis and Critical Control Points) requirements, must record temperatures across its chain. This involves completing 28 pages of reports – which can be very time consuming.

However, with the Dyzle platform, the food retail chain is able to automatically register the data in the cloud (internet) for all its stores, since measurements are sent directly from the sensors in each outlet via the mobile network to the cloud. The data is recorded and stored in a pre-defined format as required by the compliance reporting procedure. This completely removes the burden of manually completing the paper records of temperature and other parameters.

This is just one example of IoT as applied to the food cold chain. As the example illustrates, the IoT is already here in the form of trucks and storage connected with sensors that provide monitoring of key cold chain parameters that must be monitored to maintain the safety of temperature-sensitive food products. The sensor network provides complete real-time visibility of the cold chain by constantly providing relevant data from all critical points in the supply chain. This in turn helps logistics and quality managers to assure their customers and management of the safety of their products.

The IoT is hence not a future vision, but is here and in use now. In the future, there will be even more connected networks monitoring all parts of the cold chain, which will generate significantly more data. The key issue then will not be about real-time monitoring, since that will be a given. The more important issue will be in analysing and interpreting the data, and ensuring traceability and compliance to provide assurance of food safety. This is the real future of IoT in the cold chain.

The importance of cold chain in healthcare, and how technology is enhancing patient safety

The recent investment of US$1.4 million by the Bill & Melinda Gates Foundation in innovative refrigeration technology to bring a life-saving vaccine cooler to market is an important development. It shows that even if you give away expensive drugs for free to help save human lives, you still need to be able to guarantee that the drug will make an impact and not lose its effect.

Immunisation helps protect individuals and communities from infectious disease. However, to remain effective, vaccines need to be stored within the temperature range recommended by manufacturers – usually in the range +2˚C to +8˚C.  Incorrect storage of vaccines can be wasteful and costly, and can also reduce or nullify the potency of the vaccine.

Many healthcare delivery organisations that provide vaccinations have strict guidelines to ensure the effectiveness of the vaccines is maintained, and that all parts of the cold chain, including independent contractors:

  • ensure there is a relevant policy on safe storage of vaccines, including having a designated person responsible for receipt and storage of vaccines.
  • have procedures in place to assure themselves that that all relevant departments and providers adhere to the policy for vaccine cold chain storage
  • review storage temperature readings in a manner that will identify if vaccines have been stored correctly or encountered any temperature excursions outside manufacturers’ recommended temperature ranges before they are administered to patients
  • have procedures in place for remedial action in case of temperature excursions

The need for vaccine storage at correct temperatures demonstrates the importance of the cold chain in healthcare. Whether they are using vaccines or expensive medication that can deteriorate outside a manufacturer’s recommended temperature or humidity range, places like hospitals and healthcare service providers cannot do without refrigeration. From the point of view of ensuring patient safety, monitoring these facilities is extremely important, and being able to take remedial action in case of some failure is equally critical.

Many hospitals are utilizing technology platforms to provide actionable real-time monitoring and reporting. One example is a hospital in Nieuwegein/Utrecht, The Netherlands, which has more than forty cold stores and freezers distributed among its three campuses. The contents of these fridges and freezers are very expensive and if anything is lost, patient safety is put at risk. Quick action is therefore essential if temperature excursions occur.

The hospital equipped a total of 43 cold stores and freezers with a wireless monitoring solution (from Dyzle) for temperature and other parameters, and if anything goes wrong with a cold store, the personnel of the department in question are notified instantly with real-time email and text alerts. It provides operational staff 24-hours a day assurance, and instant indication of anything that goes wrong. If a door is ajar, for example, it can quickly be closed.

The hospital not only gets a real-time monitoring solution, but also reports of the vaccine’s temperature history presented in an easy-to-read format. The data stored on the cloud-based server is shown at the hospital as a dashboard via the Internet. If a cold store exceeds its temperature limits this is visible on the dashboard, and the person responsible at the hospital is notified by means of a text message, via email or by telephone. It enables immediate action to be taken.

Immediate action is particularly important in the case of stored human-derived materials like tissue, blood or viruses, which shouldn’t fluctuate too much. In another hospital wireless temperature sensors monitor the blood storage facilities, cold cases and freezers. From a patient safety point of view, it is absolutely unacceptable if temperatures fluctuate beyond specified temperature ranges.

Real-time measurement enables instant feedback and this is the difference between this type of solution and data loggers. Prior to the wireless sensors, the hospital would put data loggers in their cold cases and freezers and read them once a week. This never allowed the performance to be viewed in in real-time.

The monitoring of key parameters in the cold chain is just one part of the story. The other elements of the system include relevant reporting and analytics, and automatic provision of records for regulatory reporting purposes.

We are hearing a lot about machine-to-machine communications (M2M), big data, and the cloud. The solutions described above bring together all of this emerging technology into real world relevance for the cold chain in healthcare: wireless monitoring (M2M), reporting with appropriate dashboards (big data), and temperature history through the entire cold chain for regulatory requirements (via the cloud).

The impact of this combination on technology solutions to deliver a platform enabling full cold chain visibility to ensure product integrity in the pharmaceutical industry will be a key debate at the 12th Annual Cold Chain GDP & Temperature Management Logistics Global Forum in Boston (29th September 2014 – 3 October 2014), in which Dyzle in will demonstrate and discuss examples like the hospital examples given above.  There will be various discussions including a follow up to last year’s panel run by the CTO of Dyzle on the value real-time data, and how to integrate and interpret various sets of data to influence real-time decisions in temperature controlled logistics.