Tag: cold chain

Active cooling becomes more important in cold chain logistics

Does Nelumbox cover all relevant temperatures for cold chain required pharmaceuticals?

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Yes, Nelumbox covers all common and for cold chain required pharmaceuticals relevant temperatures, such as 2 – 8°C / 35,6°F – 46,4°F and 15 – 25°C / 59°F – 77°F, but Nelumbox is capable of more:

Nelumbox covers the temperature ranges for most cold chain relevant concerns: 2 – 8°C / 35,6°F – 46,4°F and 15 – 25°C / 59°F – 77°F, but is not limited to cooling. Nelumbox is able to heat as well. This unique advantage is most useful in times the outer temperature drops far below 0°C / 32°F, in which case Nelumbox will heat energy efficiently and keep the temperature inside between the required 2 – 8°C / 35,6°F – 46,4°F or more. This way we can assure that your valuable content is save even if you are travelling to Germany, Siberia, North- or South Pole.

Because of this technology Nelumbox is capable of incubating at a temperature of 37°C / 98,6°F and can even heat up to a maximum of 55°C / 131°F. Furthermore, Nelumbox can be set on a custom temperature range from 2°C – 55°C / 35,6°F – 131°F. If held stationary even smallest temperature ranges are possible.

Here you will find the next FAQ blog article.

If you have any questions, please do not hesitate and send us an email: info@tec4med.com

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cold chain monitoring pharma logistics, Überwachung der Kühlkette Pharmalogistik

Cold Chain Monitoring in Pharma Logistics

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By 2020, the global cold chain monitoring and tracking market is expected to reach $ 426 billion. Back in 2015 it was only $ 148 billion. The most lucrative segment is the healthcare sector. The Cold Chain Sourcebook by Pharmaceutical Commerce projects that by 2021, pharma cold-chain logistics will be worth $ 16.6 billion. Cold chain monitoring and tracking refers to controlling devices equipped with sensors that ensure the transportation of temperature-sensitive medication at a given temperature-range.

Why is cold chain monitoring and tracking a growing business?

There are three major drivers behind the growing demand for cold chain monitoring and tracking in pharmaceutical cold chain logistics. The first being the transition towards bio-engineered, temperature-sensitive products. The second being tightening regulations for pharma shipments and the last being the growing internationalization of the pharmaceutical supply chain.

  • The turn towards biologically-based products:

The number of bioengineered drugs is steadily increasingBy 2020, 27 of the 50 top selling drugs will be temperature-sensitive biologics, requiring cold chain storage and handling between 2-8 °C. Bioengineered drugs are on the rise due to their high specificity and complexity that matches the natural biological processes in the human body and therefore lowers the risk of adverse effects.

Biologically-based medication is produced in lengthy and cost-intensive biotechnological processes in living, genetically modified organisms or cells. That makes these drugs cost-intensive in their production and expensive for buyers. Bioengineered drugs range between several hundred to several thousand dollars for a set of syringes or pens.

The gained bioengineered protein drugs are highly sensitive towards temperature excursions. If the temperature exceeds or falls below a certain temperature range, the medication´s delicate tertiary structure is being destroyed and the drug gets ineffective. This is why biologically-based drugs demand for special cold chain packaging in logistics procedures, such as insulated packaging, refrigerants and temperature monitoring devices.

  • Tightening regulations for pharma shipments:

In the past few years, regulatory requirements on the pharmaceutical supply chain have become ever stricter to mitigate risks during cold chain transportation, to ensure patient safety and to assign clear responsibilities for handling the cold chain. Key international regulatory guidance concerning cold chain management are: The EU Guide to Good Manufacturing Practice (Annex 13), the Guidelines on Good Distribution Practice (GDP) of Medicinal Products, CDC Guidelines for Maintaining and Managing the Vaccine Cold Chain, WHO Guidelines on the international packaging and shipping of vaccines, the US Code of Federal Regulations, US and European Pharmacopoeia. The amended GDP guideline of 2013, chapter 9.2 on transportation for instance stipulates that:

The required storage conditions for medicinal products should

be maintained during transportation within the defined limits as

described by the manufacturers or on the outer packaging. (…)

 It is the responsibility of the wholesale distributor to ensure that

vehicles and equipment used to distribute, store or handle

medicinal products are suitable for their use and appropriately

equipped to prevent exposure of the products to conditions that

could affect their quality and packaging integrity

To ensure the required conditions, tracking and monitoring systems have to be in place that constantly measure the product´s condition.

  • Growing internationalization of the pharmaceutical market:

The pharmaceutical supply chain demands for a global approach as manufacturers and distributors work in different regions of the world. They need to transport medication from the US to Russia, from Europe to China. Thus, they are faced with differences in environmental conditions, like temperature variations, that present a potential risk for temperature-sensitive medication. Tracking the drug´s temperature during transportation is hence an essential part of today’s globalized pharma supply chain.

It seems unlikely that the growth in the cold chain monitoring and tracking market is a short-lived one. This transition requires cost-efficient, reliable tracking devices that match the customer´s needs in a flexible manner.


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Cold Chain Temperature Monitoring

Cold Chain Temperature Monitoring in Pharma

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Cold chain temperature monitoring in pharma Download Infographic

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medication delivery

Hi, parcel service here! Your medication.

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As an Amazon Prime customer, I can now receive my painkillers just as electronics, clothing or books within an hour after ordering at my front door. At least if I live in Munich, since here Prime Now for medicinesAmazon´s new medication delivery service was launched last week.

Amazon´s tentative steps into the pharma market

This new Prime Now service is made possible by Michael Grintz, owner of the „Bienen-Apotheken“ – a pharmacy chain in Munich. Prime customers can order medication of his pharmacies via the site primenow. In doing so, the customer enters symptoms and disease history into a form. This data is checked by a pharmacist prior to releasing a delivery. The customers receive the medicines of either within one hour (extra charge 6.99 EUR) or in a two-hour time window from Monday to Saturday of the customer´s choice. Prime Now for drugs is not just launched in Germany. In Japan, too, this service is being tested.

Prescription and cold chain requiring drugs are not (yet) available via Prime Now. Cold chain logistics are currently still too complex for Amazon. As for now the drug´s integrity could not be adequately ensured during transportation, and patient health would be compromised. In addition, the visit to the doctor is unavoidable for issuing a prescription and the latter cannot be forwarded without effort to a medication mail-order. However, with the introduction of the e-prescription envisaged for 2019 in Germany, the last-named hurdle could fall. Moreover, the complexity of the cold chain certainly does not stand forever in Amazon´s way. Just as little as does the German pharmacy law. It prohibits Amazon to appear as a drug provider – which Amazon does not do. It is enough, when mail-order pharmacies integrate their online shops into Amazon. Likewise, the online retailer cleverly worked its way around legal shoals through its cooperation with the “Bienen-Apotheken”. Again, the company does not make an appearance as a provider but as deliverer and as a shop.

The future of Prime Now for medication

Even if the shipping of prescription drugs is publicly heatedly discussed, it is possible. So it could only be a matter of time until I can order insulin, multiple sclerosis drugs etc. via Prime Now. Then a completely different, much more urgent question arises: is it ethically justifiable that the limited number of Prime Now customers are better provided with medication than patients who are in the same need but have not subscribed to membership? For years, Amazon has been thinking about entering the pharma market. Now the company seems to take the gloves off. More than 20 years ago, Amazon started out as a small online bookstore and is now the world’s most famous online retailer with a worldwide sales of roughly 44 USD in the fourth quarter of 2016. Amazon has big plans.

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Internet of Things in the pharmaceutical cold chain

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IoT – the buzzword

Buzzwords share a common fate. They are used ubiquitously, but their meaning gets blurred underway and at some point no one knows where they came from. To start off, I did some digging: The term “Internet of Things” was coined by Kevin Ashton, an internet pioneer, in 1999. He stated that computers would still be heavily dependent on humans for informational input. The next step of technical evolution would be to enable computers to think and act for themselves:

We need to empower computers with their own means of gathering information, so they can see, hear and smell the world for themselves (…). RFID (radio-frequency identification) and sensor technology enable computers to observe, identify and understand the world—without the limitations of human-entered data. (Ashton, 2009, par. 4)

Download ePaper


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real-time data logger cold chain

Real time tracking devices in cold chain logistics

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We are craving for real time data. This morning I was sitting squeezed like a sardine in the train to work and eavesdropped on a man commenting via mobile phone live on the train´s journey: “I´m leaving Bensheim (…) just passing Eberstadt (…) now arriving at Darmstadt main station.” ‘Live tracking’ can be more or less adequate. In some cases it is indispensable.

Tracking and tracing the cold chain

Live data monitoring does make sense in temperature controlled logistics. Especially when it comes down to shipping high value medication like IMPs, vaccines, APIs, biological samples or batch samples. For many years, common data loggers with USB connection have been the tool of choice in cold chain logistics. They save data locally during transit, which is then retrieved at the destination. Pitfall of those data loggers: e. g. temperature excursions are only discovered after the damage is done.

Improvements and cost-reduction in GPS (Global Positioning System) technologies in the past years gave rise to real time tracking devices. Combined with sensors to monitor temperature, humidity, light (opening) etc., they enable monitoring location, movement, temperature, humidity and light detection (which discloses whether the shipment was opened). Thus documenting regulatory compliance, preventing loss and reducing risks.

GPS real-time tracker – how do they work?

Live tracking devices are equipped with a GPS receiver. The tracking device is thus able to receive signals of various GPS satellites circling the earth. There are more than 24 working GPS satellites in total, which follow different orbits. Due to their number and arrangement, GPS devices receive signals from minimum 4 GPS satellites at a time.

Based on the period of time the GPS signal needs to travel to the GPS receiver, the latter can measure its location, movement and speed. So far, so good. But how does the data get to the recipient? Two different technologies are used to transmit data. Both drag along pros and cons.

  • GPS GSM tracker:

The live tracking device using GSM (Global System for Mobile Communications) or UMTS[1] (Universal Mobile Telecommunications System) in other words is using the mobile telephone network with a SIM card. The live tracking device sends the data to the nearest mobile mast. The mobile mast is an intermediate station that transforms the incoming radio signal into data packets that are sent via the Internet to a server (e. g. the server of the tracking device provider). From there, the logistics data is sent to the end-user who can see the temperature, humidity profile etc.

GSM GPS real time trackingPro: In using common mobile technology, the data transmission of a GPS GSM tracker is cheap, given country borders are not crossed. In this case roaming fees are high.

Con: The technology falls short in areas that are not covered by GSM such as in remote areas, on the sea etc.

  • GPS satellite tracker:

A monitoring device using satellite networks functions slightly different. The device sends the data via satellite to a satellite relay which hence sends the data in packages via Internet to a server.

GPS real-time trackingPro: GPS satellite tracking devices make sense in remote locations and when tracking shipments across country borders.

Con: Satellite-based tracking is in general more costly than devices working on GSM basis.

­Often the pros of both technologies are combined in using satellite driven tracking functions in shippings across borders and GSM based systems where GSM coverage is good.

Real time data tracking in cold chain logistics is more than a short-lived trend. It is the future. We are getting ever more used to receiving information, no matter where we are, in real time.

Thinking about it: You are familiar with Glympse? It´s an app to automatically share one´s location to others. Next time I meet the man, I´ll drop him the hint.

[1] Which achieves a higher data transmission rate than GSM.

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temperature sensitive medication

Future market: Temperature sensitive medication

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Cold chain requiring medications and samples are pretty sensitive. They feel comfortable between 2-8°C and do not like it at all when the temperature deviates upward or downward. If this happens the delicate protein structure they consist of is being destroyed and the medicine gets ineffective or even dangerous: As proteins decompose toxins and antigens may develop that lead to a counter-reaction of the immune system. In the worst case, the immune system turns against the body’s own substances.

There are many such sensitives. In Germany alone there are 2.000 cold chain requiring medications . These include, for instance, vaccines against rubella, measles, tetanus, mumps, special eye drops, asthma medicine and so called biologicals. Biologicals are produced by genetically engineering protein molecules . They come to use in rheumatism and cancer therapy and help to regulate the patient´s immune system.

The proportion of temperature-sensitive medicines is increasing steadily: Every tenth medication that is introduced to the German market is requiring a cold-chain. In the USA already every third newly approved drug is subject to cold chain transportation and storage. One reason for this trend is the increase in biologicals , which are seen by many in the industry as a new wonder weapon. They are complex and expensive in the manufacturing process and therefore generate high prices. The rheumatic drug of the pharmaceutical company AbbVie – Humira – costs, for example, 5.200 € per syringe .

It is no surprise that cold-chain medications generate astronomical revenue: Humira (11.25 billion USD ), Solvadi against hepatitis C ( 9,25 billion USD ), Remicade for rheumatoid diseases ( 8.31 billion USD ), MapThera against lymphomas (7.79 billion USD ) and Enbrel for rheumatism ( 7.68 billion USD ) . According to a prognosis of BT9 – Tech 8 of the 10 best selling drugs worldwide in 2018 will require a cold chain.

Such valuable goods need to be securely packed, since the economic damage would be enormous otherwise. For this reason, spending on worldwide transportation of cold chain requiring drugs increases correspondingly with the rise of the latter. By 2018, the costs will increase to 10.3 billion US $ from currently 9.3 billion US $ . For 2020 an expenditure of 16.7 billion US $ is being predicted.

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