Onset Onset CX402-B2M Brochure

Choosing a Vaccine Storage
Temperature Logger:

5 Things to Look For

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Introduction

In the life science and healthcare industries the proper storage of

temperature-sensitive products – specically vaccines – is a fundamental

and growing concern with respect to public health. Case in point: The

Centers for Disease Control and Prevention (CDC) has asserted that few

immunization issues are more important than the appropriate storage and

handling of vaccines. According to the CDC, approximately 13.5 percent of

all refrigerated vaccines are subject to accidental freezing during storage.

Effective vaccine management has many variables, including the type of

refrigeration unit being used, how the product is loaded into the unit, the number

and duration of door openings, and the ambient/exterior temperature of the

refrigerator’s location. All have an impact on the temperature of the vaccine in

storage.

Vaccine refrigerator. Credit: NIST

Since a refrigerator is “only as good as the temperature monitoring system

inside,” the CDC emphasizes that an accurate temperature history that reects

actual vaccine temperatures is imperative to effective vaccine management.

This time/temperature data is critical to determine the safety and efcacy of

refrigerated drugs. Improper storage not only causes public health concerns but

also can cost vaccine providers millions of dollars a year in spoiled product.

In view of these considerations, maintaining adequate and stable temperatures

within vaccine refrigerators, freezers, and controlled storage units is a critical,

driving necessity. And one that underscores the need for reliable temperature

monitoring to ensure that temperature-sensitive pharmaceuticals are kept within

specied temperature ranges.

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Centers for Disease Control and Prevention. Vaccine Storage and Handling Toolkit

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Monitoring Challenges

The amount of required temperature documentation for stored product has

traditionally posed a real inconvenience for pharmacy managers, vaccine

program coordinators/providers, hospitals, and medical clinics alike. By offering

no automated processes outside of taking temperature measurements, typical

USB data loggers—or older chart recorders and thermometers, in some cases—

have proved inefcient and often burdensome.

Standard Operating Procedures related to daily checks, manual documentation

of minimum and maximum temperatures, and the removal/retrieval of

temperature loggers when information is needed can hinder productivity and

detract from a clinic staff’s main focus – caring for patients. When using USB

loggers, for example, users must physically remove the data logger from the

refrigerator, connect the logger to a USB port on a computer and readout the

data. Moreover, the task of creating and sharing a daily report is often still

performed manually.

Until recently, providers with vaccine and pharmaceutical storage requirements

By offering no automated

processes outside of taking
temperature measurements,

typical USB data loggers—

or older chart recorders and

thermometers, in some cases—
have proved inefcient and often

burdensome.

had no cost-effective alternative offering a comprehensive solution tailored

for their application requirements, along with signicant improvements in

automation through advancements in technology.

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Advances in Data Logger Technology

BLE temperature loggers
provide fast measurement
and wireless transmission
of data to mobile devices,
while eliminating the need
for dedicated equipment,

computer software, or USB

cables.

Advances in temperature-monitoring technologies, specically the integration

of built-in Bluetooth Low Energy (BLE) technology, enable users to overcome

many of the logistical challenges specic to temperature-controlled storage

monitoring. These advances streamline data collection processes and reduce

many of the inefciencies associated with traditional USB loggers. BLE

temperature loggers provide fast measurement and wireless transmission of

data to mobile devices, while eliminating the need for dedicated equipment,

computer software, or USB cables.

Leveraging BLE, users can quickly congure and readout

loggers wirelessly, set alarms, and easily check the

logger status or view current, minimum, and maximum

temperatures on their mobile devices. Users can also

conveniently congure, readout, and manage data from

up to 30 meters (100 feet) away. This provides seamless

and efcient data access for pharmaceutical and clinical

managers responsible for the storage and safekeeping of

refrigerated vaccines, and is a particular advantage when

having to deal with multiple refrigeration units.

As an example, a user can download refrigerator

temperatures remotely, without entering a room. This, in

turn, eliminates the need to undergo any lab clearance

protocols that may be required. And, because data

retrieval can be accomplished without having to open a storage refrigerator,

vaccines are protected from unnecessary ambient air intrusion.

When evaluating BLE temperature loggers, it is important to be aware of

the key automated features and distinct user benets that are available.

Understanding these differentiators—and how they impact monitoring practices

for temperature-controlled products—can help facilitate the most informed

decisions and reduce the time and expense

associated with manual approaches.

Additional advances in temperature-monitoring

technologies include solutions with an optional

gateway device for automatic data downloads and

real-time alerts via email or text should an excursion

occur, and a free cloud-based data warehouse.

Following are ve important features/capabilities

to consider when evaluating data loggers for

temperature-controlled storage applications.

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1. Bluetooth Operation

Advances in wireless technology have

greatly improved the ease and efciency with

which data can be collected, organized, and

shared utilizing mobile devices. By offering

greater visibility on a more frequent basis,

without the need to consistently detach

a logger, Bluetooth Low Energy (BLE) is

particularly conducive to data logging. In

particular, BLE temperature loggers and

their associated apps make record-keeping

requirements easier, quicker, and more

convenient than ever before.

In contrast to USB data loggers, which require cable connections to retrieve and

ofoad data, and strip chart recorders, which offer imprecise views of the data,

BLE technology provides the capacity for users to readout data automatically

to an accompanying app running on a mobile device. This eliminates having to

remove the data logger from its monitoring location, thereby minimizing hassle

and gaps in temperature data. It also allows for quicker action in

the event of temperature excursions.

With information stored electronically, users no longer have to

log monitoring data manually. This, in turn, can simplify and

digitize the common daily checking process. Digitizing the

documentation of temperature levels (traditionally done by

hand) also greatly reduces the chance of human error, fostering

improved monitoring accuracy and more reliable temperature

data.

Additionally, as Good Distribution Practices are integrated into

other areas of the supply chain, such as last mile distribution,

BLE can help contribute to more secure electronic records.

The security encryption of a BLE device ensures that only

designated individuals can access data and PDF les, providing

secure traceability for regulatory audit purposes.

Sample report generated using an InTemp CX402 Temperature
Logger

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2. Powerful Mobile Software

BLE temperature loggers
provide fast measurement
and wireless transmission
of data to mobile devices,
while eliminating the need
for dedicated equipment,

computer software, or USB

cables.

When evaluating temperature loggers, it is important to understand the features

of the accompanying mobile app. Be sure the app makes the initial logger setup

easy and efcient, allows users to choose from a range of preset congurations

(ones for clinical refrigeration or ambient storage monitoring, for example),

and enables users to create custom congurations for other applications as

necessary.

The app should also allow users to download and send data in one simple step

and easily share automated reports. This enables personnel responsible for

storage monitoring to meet regulatory compliance requirements much more

quickly, reliably, and effectively.

Make sure the app supports the secure transmission of PDF and Excel les, and

provides exibility with respect to where data can be transmitted so information

can be shared easily with numerous units or departments. Users should have

the ability to standardize across multiple labs and communicate information to

central sites. Collected data should be easily exported into Excel for advanced

analytics, and it should be easily accessible for audits so the audit preparation

process is more efcient.

Users with multiple loggers at multiple sites may nd it especially benecial to

consider technology that allows for automatic transfer of data to a cloud-based

warehousing service where all data can be viewed from any location and easily

shared with others.

Finally, to keep things secure, look for an app that enables users to set

encrypted passkeys that other mobile devices will require for connection to the

logger.

3. “Daily Check” Features

If the monitoring application requires users to perform daily or twice-daily checks

of the logger, it’s advantageous to look for a temperature logger designed to

streamline these tasks. Some loggers enable the accompanying mobile app to

connect to the logger to perform checks. Once a check is completed, it can be

recorded as a logged user-action and should be visible on the logger screen and

in the reports. This helps users keep track of temperature checks throughout the

day, while providing documentation that the checks were performed and of who

performed them.

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4. Remote Alarms

In temperature-controlled storage monitoring applications, it’s critical that the

data logger being used is able to notify personnel in the event of a temperature

excursion or a disconnected temperature probe. Look for temperature loggers

that have the ability to notify you of events like these in a variety of ways. Some

models provide a blinking indicator on the logger LCD screen, an alarm icon

on the LCD and corresponding mobile app, and even an audible alarm that will

beep until corrective action is taken.

It may also be worthwhile to check into the logger’s advanced alarm capabilities.

Some loggers can connect to an optional gateway device and a free cloud-

based data warehousing service so you can get real-time notication of

temperature excursions via text or email no matter your location.

The images above indicate an alarm state as a result of breaking the preset high temperature threshold.

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5. Large Temperature Display

Look for models that
display all temperature
values on a single screen
vs. ones where you have to
use buttons to toggle your
way through a series of
screens.

With traditional USB temperature data loggers, half the battle is being able to

easily view temperatures on the logger display.

Some of today’s advanced temperature data loggers are equipped with a large

LCD display to make it easy for users to view current and daily minimum and

maximum temperatures throughout the day. Look for models that display all

temperature values on a single screen vs. ones where you have to use buttons to

toggle your way through a series of screens.

Additionally, some loggers can display checkbox icons on the

screen when daily temperature checks are done, which can be

particularly useful in applications where CDC guidelines for

temperature monitoring need to be met.

Finally, the data logger should provide a visual indicator for

alarm conditions if an excursion occurs, as well as indicators

for battery level, storage capacity, and other diagnostics.

Beyond the considerations discussed above, it may also be

advisable to consult a data logger supplier that offers a range of

form factors/hardware congurations. This way, you can select a

solution best suited to the particulars of your monitoring application.

Among the most common conguration in hospitals and clinics is a temperature

logger connected to an external probe with attached Glycol bottle. By insulating

temperature probes and delaying their thermal response times, the Glycol

bottle is meant to simulate the actual product being stored.

Some loggers also include an additional temperature sensor

built into the housing to monitor ambient temperature outside

the refrigerator, freezer, or storage area. These loggers

eliminate the need to buy a separate logger to monitor room

temperature, and can provide useful information about room

conditions during an excursion event.

Data logger suppliers may also offer probe-only versions,

which can be useful in situations where users need to track

actual refrigerator temperatures (without Glycol buffers) or in freezer applications.

Suppliers may also offer loggers with internal temperature sensors only, designed

for room temperature monitoring.

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About Onset

Onset is a leading supplier of data logger and monitoring solutions used to measure,
record and manage data for improving the environment and preserving the quality of
temperature-sensitive products. Based on Cape Cod, Massachusetts, Onset has been

designing and manufacturing its products on site since the company’s founding in 1981.

Copyright © 2017, Onset Computer Corporation. All information in this document is subject to change without notice. Onset and InTemp are registered trademarks of Onset Computer Corporation.
All other trademarks are the property of their respective owners. All rights reserved. Printed in the USA. Lit. No. MKT1192-1217

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Onset Computer

Corporation