Choosing the Right Temperature Monitoring Solution

Choosing the Right Temperature Monitoring Solution

Globally, pharmaceutical regulators are becoming attuned to cold chain issues as biologics, vaccines, and other
temperature‐sensitive products are commercialized for a global clientele. Many regulators now recommend including
temperature monitoring technology in every cold chain shipment. Controlled-temperature shipping is increasingly
important in the food, chemical, and aerospace industries, too, to ensure that their products are handled at optimum
temperatures to ensure they last as long as they should.

Documenting chain of custody for temperature‐sensitive products enhances regulatory assurance and alerts shippers
to conditions affecting products’ shelf lives and efficacy. Knowing whether, when, and where temperature excursions
occurred helps shippers ensure safe products, thereby protecting their clients as well as their own reputations.
Temperature monitoring also assigns accountability when excursions occur.

Solutions range from inexpensive indicators that alert shippers to mishandling to sophisticated monitors and data
recorders that pinpoint when, where, and for how long excursions occurred. Companies, therefore, can match the
technology to their needs.

Data Loggers
Electronic recorders, sometimes called data loggers, collect
information continuously. They measure and record such
parameters as temperature, and humidity. The devices
can be programmed to trigger alarms at specific damage
boundaries – when products become either too hot or too
cold – for single or multiple events.

Typically, data from these monitors can be downloaded

either directly from the device or wirelessly, enabling
analysis and documentation of when damage may have
occurred so responsibility can be determined. The latest
technologies can be as small as a matchbook, yet read data
wirelessly without anyone ever opening the packaging.
custody by letting shipments remain in qualified, unopened,
This is a huge advantage for quality control and customs
packaging . In contrast, opening the shipping packaging
inspections because this maintains an unbroken chain of
introduces unknown conditions into the cold chain.
Data recorders are best used for high‐value shipments and
challenging shipping lanes. They are particularly important
for large crates or reefers using active cooling systems that
are subject to mechanical failure and human error. Their
use is limited by memory capacity and battery life,
particularly during multi‐week transits.

Therefore, data recorders should have the ability to

conserve batteries to enable at least 30 percent longer
life than the expected shipping and storage duration to
minimize the risk of data loss towards the end of the
journey. Because battery life is diminished by constant use,
it is more efficient to record data periodically.

1 Choosing the Right Temperature Monitoring Solution

Choosing the Right Temperature Monitoring Solution

For example, the SpotBot BLE, made by Spotsee in single or multiple temperature thresholds are passed. For
partnership with Bosch, measures temperature, humidity, example, an indicator may be activated if the product
tilt, and shock every 10 minutes. It has a battery life of up to temperatures become either too hot or too cold, based
two years, making it robust enough to use during multiple upon a user’s predefined parameters.
transits.
Indicators work in a wide range of conditions, including
Data Monitors frozen and deep frozen (‐75°C and below) shipping. They
Like data recorders, data monitors can track temperature, are moisture‐ and tamper‐resistant, irreversible, and are
humidity, and impact but, in contrast, only report excursions highly accurate. They can be activated at any point during
from predefined thresholds. This extends battery life by up the packaging and shipping process, sometimes without any
to 12 months and allows shippers to make Data monitors’ preconditioning required.
small size makes them easy to insert into shipments without
changing the packaging. Indicators are inexpensive, making them good candidates
for smaller packages that often are non‐returnable and non‐
Temperature data monitors are best used to ensure that recyclable. They typically are accurate to +/- 1°C.
product stability data after shipping matches the data before
shipping. Their data also can be correlated with transit Indicators like the Spotsee ColdMark and WarmMark are
records to determine when and where single or multiple available for a range of temperatures. They change color
excursions occurred, and to indicate time and temperature when the temperature threshold is breached,, making
for mixed‐product loads. excursions instantly noticeable. The WarmMark Duo records
temperature excursions above 10°C and their duration,
The Log-ic Temperature Recorder has a battery life of up to and also notes when temperatures exceed 34°C, thus
three years. It focuses solely on temperature and can store helping the product’s users to more accurately calculate
up to 4,000 logged data points and 16 million histogram the product’s useable life. Chemical indicators don’t use
points to provide a detailed look at shipping conditions. batteries and have a shelf‐life of one to three years, so can
be purchased in bulk and stored. They may be mounted
Because data monitors are less expensive than data on the product, inside the packaging, or on the packaging.
recorders they are good solutions for last mile transport. While internal mounting shows environmental conditions
inside the packaging, external mounting provides a visible
Chemical and Mechanical Indicators deterrent to mishandling. Both provide a permanent
Indicators identify excursions visually, changing color when exposure record.

2 Choosing the Right Temperature Monitoring Solution

Choosing the Right Temperature Monitoring Solution

Combinations or chemicals, which can be harmed by temperature

excursions as well as by impacts that may break seals or
Indicators often are combined with data monitors or
crack vials or bottles.
recorders, providing a double layer of protection.
Temperature indicators also can be combined with
Of course, not every product requires a high‐tech solution.
impact indicators, either in one product (the Spotsee
Choosing technology based upon the product and its risks
SpotBot BLE) or as multiple products. This makes them
can contain costs while still providing assurance – and proof
particularly valuable for products like wine, pharmaceuticals,
– of how product actually were handled.

SpotBot BLE
The device was created in partnership with Bosch to make the supply chain transparent.
Once attached to the shipment, the SpotBot BLE measures and records temperature,
humidity, tilt, and shock, with the data visualized through the SpotBot BLE app. The limits
of each parameter can be individually configured, and any violation is traceable and
assignable.

LOGIC Temperature Recorder

Designed to be low-cost and help optimize the cold chain by alerting manufacturers,
handlers and shippers when a product has been exposed to temperature conditions
beyond a specified threshold. All LOGIC units are water resistant (NEMA 4) recorders with
USB in addition to integrated wireless capability that allows for fast data downloads.

WarmMark
Single-use, ascending time-temperature indicator which alerts users of exposure to
unacceptable temperature conditions.

ColdMark
A single-use descending temperature indicator, is designed to help shippers identify
and correct gaps in their cold chain. The ColdMark turns from clear to violet when the
temperature goes below a predetermined threshold.

Contact Spotsee to choose the best temperature monitoring device for your application.

3 Choosing the Right Temperature Monitoring Solution www.spotsee.io Rev: 7/2018