How IoT & Real- Time Monitoring is transforming the ...

WHITE PAPER

How IoT & Real-Time Monitoring is transforming the pharmaceutical cold chain today

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21.July.2020

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White Paper | How IoT & real-time monitoring is transforming the pharmaceutical cold chain today | Page 2 / 11

Copyright by ELPRO-BUCHS AG | Langäulistrasse 45 | 9470 Buchs | Switzerland |All rights reserved | elpro.cloud

Contents 1. What is IoT anyway? .......................................................................................................................................... 3

1.1. The landscape of wireless technologies – what is IoT for the cold chain? ........................................................ 3

1.2. 2G, 3G, 4G & LPWAN ─ a definition of terms ..................................................................................................... 4

1.3. Why real-time data loggers haven’t worked well… until now ........................................................................... 5

1.4. What are the advantages of LPWAN (Mobile-IoT)? ........................................................................................... 5

1.5. One device, two protocols ................................................................................................................................. 7

1.6. How can you use IoT to monitor rooms and equipment? ................................................................................. 8

1.7. How can you use IoT to monitor shipments? .................................................................................................... 8

1.8. How IoT transforms the use and access to your enterprise-wide data ............................................................. 9

1.9. Benefits of real-time Monitoring in the Cold Chain ......................................................................................... 10



1. What is IoT anyway? In 1982 a modified cola vending machine at Carnegie Mellon University in Pittsburgh (USA) became the first device

in the "Internet of Things". The machine was able to report its stock independently and request a refill. A few

decades later, there are already more connected things than people in the world. According to estimates, there

will be more than 55 billion IoT devices in 2025. Billions of IoT devices in industry and in private households will

produce whole oceans of data that can only be processed with AI (Artificial Intelligence).

But, what is the exact definition of IoT? Wikipedia says:

"The Internet of Things (IoT) is a system of

interconnected computer devices (e.g. data loggers),

mechanical and digital machines, objects, animals or

people, which are equipped with unique identifiers

(UIDs) and the ability to transmit data over a network

without the need for human-to-human or human-to-

computer interaction".

1.1. The landscape of wireless technologies – what is IoT for the cold chain?

In the monitoring of temperature-sensitive pharmaceutical products, wireless technologies have long been part of

the solutions.

In the Cold Chain, IoT devices are often called “Real-Time Data Loggers”.

This is because all shipments have been equipped with temperature sensors for decades but have never been able

to read and process the values in real time.

But are all wireless technologies also part of the "Internet of Things"? According to the above definition, devices

must be able to transmit data over a network without the need for human interaction. Two characteristics

determine the degree of fulfilment whether a solution belongs to the "Internet of Things":

Is the wireless technology based on a proprietary or standard protocol? A proprietary protocol can be

tailored to specific requirements with added security benefits; but proprietary software is required.

Is the antenna network using a private or public antenna network? Public antenna networks have the

advantage that they achieve a much greater range than private networks.



Although LoRa would be a perfect technology for cold chain monitoring in terms of energy consumption and

protocol efficiency, it is not the technology of choice for most vendors. The reason for this is the lack of an

international standard and roaming between national providers. In addition, LoRa allows a comparatively low data

rate.

From the perspective of the pharmaceutical cold chain: IoT technology must communicate in

a public antenna network. Anything else would be too expensive and unrealistic to achieve

meaningful global coverage.

1.2. 2G, 3G, 4G & LPWAN ─ a definition of terms

2G (known as GSM), 3G (known as GPRS) and 4G (known as LTE) are different generations of global systems for

mobile communication. They have grown over the years and have continuously adapted to consumer

requirements. This is driven by the growing number of devices but even more so by changes in user behavior.

The amount of data that has to be transmitted by smartphones today has multiplied, especially through video



streaming. For a data logger, these new broadband standards are extremely unfavorable ─ they are far too

expensive and consume far too much energy.

For this reason, the international association 3GPP, which is responsible for this, opened a second branch for the

"Internet of Things" (IoT) a few years ago: The LPWAN protocols. LPWAN stands for "Low-Power Wide Area

Network". With these protocols, one deliberately moves back into the low bandwidths with lower costs, higher

latency and ─ most importantly ─ lower power consumption. Only in this way is it possible to develop devices for

machine-to-machine communication, where small amounts of data are exchanged at regular intervals over many

months or years and without changing the battery.

1.3. Why real-time data loggers haven’t worked well… until now

When we talk about real-time temperature data loggers, we omit all wireless technologies with proprietary

antennas, and focus only on battery-powered data loggers operating on a public network. In the modern logistics

world, real-time tracking of trucks, ships and containers has become popular with the international introduction of

the GSM network. However, early devices using the GSM network (2G) had three problems:

High battery consumption, resulting in bulky devices and short battery life

Roaming problems:

− Lack of standardization in roaming and in the handling of SIM cards

− High roaming charges that are charged separately

Lack of an international standard for airline licenses

As a result, these units were mainly used for the local truck markets ─ especially in the USA. In the sea freight

sector, there are various solutions on the market that transmit their values via proprietary antennas on ships. One

of the first companies to market a true international real-time temperature and position logger was a cargo

express company with its own fleet of aircraft. The price of a device was more than 1’000 USD per device ─

connectivity and roaming not included.

To achieve better network coverage, combined modules (2G/3G) were later used. They were powered by lithium

batteries and reached a battery life of about 21 days. In order to obtain the airline's approval, they must be multi-

sensor devices that monitor all kinds of parameters such as pressure, acceleration and light. However, the use of

lithium batteries (with the exception of button cells) led to a new problem. In 2017, IATA published a new

regulation that limited the number of lithium cells per handling unit and also required the declaration of each data

logger used in a shipment. This was another setback and along with the incalculable roaming charges, one of the

reasons why real-time temperature loggers have not been able to establish themselves so far.

1.4. What are the advantages of LPWAN (Mobile-IoT)?

If GSM (2G) is not the solution, what is the right solution for the "Internet of Things"? The "3rd Generation

Partnership Project" (3GPP), the worldwide cooperation of standardization bodies for standardization in mobile

communications (UMTS, GSM, LTE and 5G/NR), has defined LPWAN technology as the current solution for the

"Internet of Things" as a standard.



LPWAN, also known as "Mobile-IoT", is a secure operator-managed IoT

network in the licensed spectrum, defined by 3GPP. The two protocols,

LTE-M (for mobile applications) and NB-IoT (for deep building

penetration), are designed for Internet of Things (IoT) applications that are

cost-effective, use low data rates, require long battery life and are often

operated in remote and inaccessible locations.

LPWAN networks are not suitable for smartphone, voice and Internet

access. They are often introduced in parallel with 4G networks and will be

used in all kinds of applications by billions of devices communicating over

IoT in the coming years.

LPWAN is an international standard in which many companies are investing. Microchip manufacturers have

established chip platforms that are constantly evolving. Telecommunications and network companies are in the

process of building an international network with roaming contracts. Competition and economies of scale are

reducing component and communication/roaming costs ─ resulting in lower costs and much simpler processes

compared to previous technologies.

The main advantages of LPWAN (Mobile IoT):

Availability and deployment

LPWAN is a global technology standard of 3GPP. It integrates with cellular systems and is

rolled out by international and regional network providers:

Reuse of the existing cellular infrastructure (2G/3G)

Low data rates enable thousands of devices in the smallest space (>10'000 devices

per mobile phone cell)

No complex SIM card handling, roaming is solved and included

Battery life of over a year

The communication protocols are specifically designed to save energy and result in a much

longer battery life than conventional tracking and real-time monitoring devices:

Low data rates compared to 3G/4G/5G

No constant network connection (PSM/eDRX)

NB-IoT is optimized for long-term stationary applications with an energy saving

protocol

LTE-M is optimised for mobile applications with an efficient energy-saving antenna

handshake

Mobile IoT



Strong connection

The narrowband frequencies used are ideal for the “Internet of Things”:

Strong coverage both indoors and outdoors

Deep penetration into buildings, trucks and containers

Backup coverage: Automated protocol switching between LTE-M

and NB-IoT

Cellular positioning without the energy-guzzling satellite-based GPS

Security

Secure communication protocol based on industry standards:

Mobile IoT networks use dedicated frequency bands

Operation in a licensed, secure mobile network (LTE)

Redundant VPN tunnels within the network

Roaming via protected GRX network (independent of the "Internet")

1.5. One device, two protocols

2G/3G has a good level of security but is weak on all other key performance indicators (power, connectivity,

roaming). Add to this the fact that in many countries 2G and/or 3G will be switched off over the next few years.

Mobile IoT devices using LPWAN technology

may have two complementary protocols. If the

preferred protocol is not available, the device

automatically switches to the other protocol.

The LTE-M protocol is optimised for "moving"

applications ─ i.e. a data logger or tracking

device that continuously changes its position.

One of the main strengths of this protocol is the

optimised antenna handshake, which results in

lower power consumption compared to other

protocols.

NB-IoT is optimized for stationary applications ─

i.e. for data loggers in a warehouse, refrigerator

or basement. This protocol not only consumes very little energy for communication, but also leads to deep

penetration.



1.6. How can you use IoT to monitor rooms and equipment?

The monitoring of rooms and equipment has been networked and carried out in real time for many years. From

small central monitoring systems (CMS) to complex building management systems, there are hundreds of different

solutions for monitoring any number of measuring points in laboratories, cleanrooms and warehouses. The

distributed sensors (wireless or wired) usually deliver the values to central software on a company's own server

where processing, alarming and archiving is performed.

It always becomes a challenge when many sensors are used across various distributed

locations.

Here, not only the connection of the data loggers is a problem (traditionally e.g. via a VPN) but also the local

installation and maintenance at places where no personnel is available.

Situation Many distributed measuring points (remote monitoring)

Challenge No IT infrastructure and no trained personnel available

Benefit IoT Simple worldwide commissioning and overview of distributed installations

Another problem with systems using a proprietary radio protocol can be the density of the devices.

The allocated frequency bands (868/915 MHz) are very narrow. Especially in warehouses

with high density, radio interference can occur.

The LPWAN standard does not have this problem: it is located in a generously dimensioned frequency space and is

designed to allow thousands of devices to transmit simultaneously in the same mobile phone cell (i.e. within

approx. 3km).

Situation Many radio measuring points in a confined space

Challenge Proprietary radio protocols (868/915 MHz) have a narrow frequency band ─

interference may occur

Benefit IoT LPWAN is designed to allow thousands of devices to be in one place at the same time

1.7. How can you use IoT to monitor shipments?

For the sale of medicines, the consignor must provide proof after transport that the transport and storage

conditions have been observed. For this reason, temperatures have been monitored and documented during the

transport of pharmaceutical products for over 30 years. In the past, due to a lack of technical possibilities, this was

mainly done offline ─ i.e. temperatures were measured and evaluated upon arrival to decide whether the

remaining stability budget was sufficient.

But, would it not be better to react before the problem arises?



With the advent of affordable real-time devices and new LPWAN technology, this is finally possible.

Situation Thousands of shipments

Challenge Reacting post-shipment (instead of active intervention) and manual processes at the

destination

Benefit IoT Automation & Intervention (through real-time alerting and position knowledge)

1.8. How IoT transforms the use and access to your enterprise-wide data

Along the supply chain, pharmaceutical products pass through many different storage and transport segments

from production to the patient. Although every drug has a limited stability budget from which the temperature

deviations can be deducted, end-to-end monitoring is still a major challenge today. One reason for this is that

traditional systems focus either on space and equipment monitoring, or on transport monitoring, but not on their

combination. IoT allows to combine all data in one cloud. Not only can warehouse data and transport data from

different sections be combined, but also other data sources can be used (e.g. weather, logistics). LPWAN opens up

completely new possibilities for "Big Data".

Situation Different systems for storage and transport

Challenge Each system in itself is isolated, has no suitable interfaces and uses only its own data.

The management of stability data is so difficult

Benefit IoT Stability data can be easily managed centrally as the deviation data from different

segments can be combined (Remaining Stability Budget)

Situation Proprietary systems

Challenge Every customer "hoards" his own data on his systems. Exchange and comparability are

difficult.

Benefit IoT Data of many customers can be easily anonymized and shared (heat maps, risk

management)

Situation Isolated on-site systems

Challenge Customer systems are usually isolated for security reasons and do not have suitable

interfaces. They therefore only use their own data.

Benefit IoT In the cloud, it is easy to combine data from different sources (weather data, logistics

data)



1.9. Benefits of real-time Monitoring in the Cold Chain

Only in the last 1-2 years, so much has changed for real-time monitoring of pharmaceuticals. We now know, using

public networks and new LPWAN Mobile IoT wireless technologies enables longer battery life, stronger/deeper

connections and more secure protocols.

What does this mean for your temperature sensitive pharmaceutical products? Using real-time monitoring devices

with longer battery life protects your products in longer duration supply routes while they travel through many

partner’s hands and depots. For example, a device could even continue monitoring after a clinical product into the

site’s refrigerator.

By implementing real-time monitoring, you gain extreme supply chain operational efficiencies, a more secure

supply chain and peace of mind.



ELPRO.cloud

This White Paper is an addendum to our expert summary of Real-Time Monitoring of Pharmaceutical Products. Most content in this white paper can also be found on https://www.elpro.cloud. It discusses cold chain pharmaceuticals history and challenges, temperature sensitive clinical trial products, use of MKT and defining stability budgets. If you have further questions about our monitoring solutions contact us today at [email protected].

More ELPRO Knowledge online: https://www.elpro.cloud/en/resources

https://www.elpro.cloud/

mailto:[email protected]?subject=Request%20from%20Download%20E-Booklet:%20Experts%20in%20Temperatur%20Monitoring

https://www.elpro.cloud/en/resources

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