SteriSense®

The Ultimate Bowie Dick Test

Global Expertise with Local Reach

2 STERISENSE The Ultimate Electronic Bowie Dick Test

SteriSense®
The Ultimate Electronic Bowie Dick Test

ValSuite
STERISENSE ®

ST E
RI S E N SE ®

Peace of Mind
SteriSense is a brand new and innovative
device for Electronic Bowie Dick Tests that
is unmatched in accuracy, performance and
reliability.

SteriSense provides you with the ultimate

peace of mind, by ensuring that your Steam
Sterilizer functions in accordance with
current norms and is sterilizing as expected.

User-friendly
SteriSense is extremely easy to use and requires
only little training to operate. With just a single
click in the software, the SteriSense measuring
device will start to measure and record data.

Once the Bowie Dick Test Program has ended,

the device is simply placed back in the reader
station where the software automatically
processes the data and provides a test result.

All test results are saved electronically and can

be presented in accessible reports including
audit trails – simple and easy!
 STERISENSE The Ultimate Electronic Bowie Dick Test 3

Verification of critical
sterilization parameters
beyond traditional
methods

ISO 11140-4 Compliant

Tested by 3rd Party
Test Institute

Why use SteriSense® Instead of

?
Traditional Indicators?

Unlike traditional chemical indicators, where you

? ? subjectively decide according to a change in
color, SteriSense provides a much more in-depth
Why use SteriSense® Instead of verification of critical sterilization parameters,
Other Electronic Bowie Dick Test Devices?
eliminating any guess work. The SteriSense software
SteriSense is by far the most compact also automatically generates and stores printable
Electronic Bowie Dick Test on the market. reports, ensuring electronic documentation of the
The Process Challenge Device (PCD) has the process.
unique feature of being replaceable, which
allows the user to run several test cycles In summary, by using the SteriSense for full
in a sequence with very limited need for parametric release you gain the following
cooling. This reduces the amount of time and advantages:
investments spent on unnecessary backup
devices. The replaceable PCD feature is • Economically efficient with high test volumes
patent pending. • Improved safety - objective results that
eliminate the risk of false or grey zone readings
• Ultra-compact size • Additional critical information - checks
• Highly user-friendly software performed according to ISO 17665
• Advanced sterilization analysis • Easy to store, retrieve and compare the data
• Environmentally friendly process from a database - convenient and safe method
• Up to 1,000 test cycles between each that eliminates the need for guessing
calibration • Time stamps included to increase reliability
4 SteriSense® Measuring Device
A Sterisense Measuring Device consists of Three Main Parts

Process Challenge Device (PCD)

The PCD has been specially designed to reflect the

reference method originally developed by Dr. J. Bowie
and J. Dick in the 1960’s. The function of the PCD is to
“challenge” the steam penetration of a steam sterilizer in
accordance with EN ISO 11140-4.

SteriSense® Triple Sensor

1. A temperature sensor that measures inside the PCD

2. A second temperature sensor that measures the
ambient temperature in the sterilization chamber
3. A pressure sensor that measures the ambient
pressure value within the chamber

SteriSense® Data Logger

The SteriSense data logger is designed to store data
during the daily routine control of a steam sterilizer,
which, by many sterilizer-manufactures, is referred to as a
Bowie Dick Test Program.

SteriSense® Single Reader Station

The highly compact reader station is used to start and read the
SteriSense data logger. Much like the data logger, the reader
station is based on Ellab’s 3rd generation of the TrackSense Pro
reader stations, which enables fast and secure data transmissions.
 5

Between tests, the PCD needs to be cooled down to

ambient temperature (approx. 90 minutes), which is
why it is a big advantage that the device can easily be
disassembled from the body (logger) and be changed
with a spare. Due to the PCD design, SteriSense is also
able to check for the presence of non-condensable
gases (NCG).

The data logger contains a

battery with enough capacity to
run 1,000 test cycles of 30 min.
The data logger itself is based
Save time by
on Ellab’s 3rd generation of the
changing the
well-known TrackSense® Pro
PCD between
data loggers.
your test cycles
6 STERISENSE The Ultimate Electronic Bowie Dick Test

Protective Adaptor for Electronic Bowie Dick

Test Devices
Ellab has developed a Protective Adaptor for SteriSense and the TrackSense Pro

Bowie Dick sensor. The main purpose of this adaptor is to protect the ambient

temperature sensor. This is especially crucial when utilizing the exchangeability

of the PCD by screwing it on and off.

The Protective Adaptor improves the robustness of the SteriSense unit.

It is easily mounted in 3 steps:

• Unscrew the PCD – no tools required

• Insert the SteriSense or Bowie Dick sensor unit into the Protective Adaptor

with the ambient sensor sliding into the slot. Ensure that it goes all the way

up to the fixating o-ring.

• Mount the PCD again without overtightening – no tools required

Utilize the Full Potential of SteriSense®

You have the option of utilizing SteriSense to perform
even more complex analysis than a simple routine
control, such as:

• Be part of validation studies with Ellab TrackSense

Data loggers*

• Use for batch control during sterilization processes*

• Perform a vacuum leak test*

• Perform a check after the sterilizer has undergone

service

*Will require the software package ValSuite® Medical or ValSuite® Plus

 STERISENSE The Ultimate Electronic Bowie Dick Test 7

The software
is almost
autonomous

User-friendly & Comprehensive Software Package

Absolute Compliance
When compared to traditional methods, the SteriSense provides far more insight into critical sterilization
parameters than previously possible. The standard report showcases all the results from the optional
‘checks’ performed by the software. When using the standard settings, a routine control test will be
performed in accordance with EN ISO 17665.

SteriSense has been tested by a 3rd party certified test institute to comply with the reference method
originally developed by Dr. J. Bowie and J. Dick, using a test procedure described in EN ISO 11140-4.

When analyzing data, the SteriSense software can perform the following “checks”:

EN ISO 17665 EN ISO 11140-4

1. Phase detection (default) 5. Air removal phase (optional)
2. Holding time (default) 6. Heating phase (optional)
3. Equilibration time (default) 7. Drying phase (optional)
4. Maximum temperature deviation (default)
Advanced Check
8. Dilution factor calculation (optional)
8 STERISENSE The Ultimate Electronic Bowie Dick Test

Different
solutions for
different
customer
Pick the SteriSense Solution Ideal for You
needs
SteriSense offers two different software version: one for simpler use and one with
added features called SteriSense Pro. The Pro version offers the following additional
features:

• A Database Management System - allowing you to operate and access multiple databases.

• Generate and store XML files to be used as e.g. an interface for reporting when certain conditions
are met - allowing you to release a unit for routine operation

• A cloud based data logger list that allows you to operate the system from various remote
positions within the same organization/network

How to Use the SteriSense® System

See the step-by-step instructions below, illustrating exactly how easy and intuitive the SteriSense
operating system really is:

2
Place the SteriSense measuring device in the
reader station and open the SteriSense
Software. Define a unique Session Name.

Press Start to activate the SteriSense

measuring device, and place the device
inside the steam sterilizer.
 9
3

4
After the test program is completed, place
the SteriSense measuring device back in
the reader station to read the data.

The result of the test will either pass or fail,

5 which will appear on the screen shortly after
the data has been processed.

6
Detailed performance information
and time stamps are included to
increase reliability.

The test results will be stored in the software

and be included in an automatically generated
PDF report.

In addition to the steps mentioned above, the SteriSense software offers an Advanced
Trending Report to compare the measured values from the defined vessel (sterilizer) over
time. This allows you to know in advance if any changes might jeopardize the performance,
and thereby avoid down time - ultimately providing Pre Maintenance Warnings.
10

Designed with Your Needs in Mind

Purchase with or without Service Plan
We know our customers have different needs, which is why we have made two options
available to choose from when investing in a SteriSense system.

1. Purchase Excl. Service Plan 2. Purchase Incl. Service Plan

This is the most straight forward option. You In addition to buying the equipment with full
buy the equipment and get full ownership ownership, this option includes an all-inclusive
and control of when to calibrate and conduct service plan. The service plan ensures that Ellab
service. Ellab recommends a maximum of performs calibration and service after 1,000 test
1,000 test cycles or 12 months between each cycles or after 12 months of use (whichever
calibration (whichever comes first). comes first). The factory warranty is also
extended as part of this service plan.

1 2
Purchase excl. Service Plan Purchase incl. Service Plan

 
Ownership
of equipment

Calibration and battery change Ad hoc


Service and Repairs Ad hoc

Maximum number of test cycles 1,000
1,000
between calibration (recommended)
 11

Up to 1,000 test
cycles between
each calibration

SteriSense Unit Technical Specifications

ISO Standard Compliance: 11140-4:2007 type B1, B2 and B3, 134 °C

3rd Party Test Institute: SAL GmbH

Steam Sterilizers / Autoclaves qualified for sterilization at +134 °C according to EN 285
Type of Sterilizers:
(volume larger than 60 L) and EN ISO 17665 (moist heat autoclaves)
Measuring Principle: Piezoresistive / Electrical Resistance

Sensor Type: Strain Gauge / Pt1000 Temperature

Temperature Measuring Range: 0 to +140 °C (Calibrated +25 to +140 °C)

Temperature Accuracy: +25 to +140 °C: ± 0.05 °C

Pressure Measuring Range: 10 mBar to 6 Bar

Accuracy: ± 0.25% Full Scale (± 15 mBar)

Logger Housing Material: 316L Stainless Steel

PCD Housing Material: PEEK

Operating Temperature: -20 to +150 °C

Operating Pressure: 0.001 mBar to 10 Bar ABS

Diameter: 25 mm

Length: 125 mm including PCD (30 mm)

Weight with Battery: 240 g

Memory Capacity: 40,000 Data Points / 10,000 Samples

Minimum Sample Rate: 1 Second

Maximum Sample Rate: 24 Hours

Intrinsically Safe: Ex II1GD ia IIC T3 Ga, -55 °C ≤ Tamb ≤ +105 °C

Time Accuracy: ± 5 Seconds per 24 Hours

Battery: TSP 150L Battery

Expected Battery Lifetime: 1,000 Tests / 500 Hours (at +134 °C with Sample Rate of 1 Sec)
 Global Expertise with Local Reach

ELLAB A/ S Ellab has been your validation and monitoring partner since 1949, offering
T: +45 4452 0500 both validation equipment and validation services as well as environmental
E: [email protected] wireless monitoring solutions.

We serve both small and large companies within the Life Science and Food
THE BRAND MANUAL
industries and have solutions for almost all applications such as sterilization,
freeze drying, environmental chamber testing, depyrogenation, warehouse
mapping, pasteurization, controlled temperature units (CTU) and many more.

Ellab develops unique and innovative solutions based on input from close
interactions and dialogues with our customers. Our goal is to help our
customers overcome challenges and increase their productivity by providing
reliable and efficient solutions.

Ellab also offers complete turn-key or supplemental rental solutions,

equipment qualification and validation services and our specialized training
courses within Ellab Academy.

Ellab has a long tradition and dedication for delivering the highest
performance and quality in our industry. Our user friendly and flexible
validation and monitoring solutions are recognized and used by thousands of
customers worldwide.

Ellab A/S in Denmark is ISO 9001, ISO 14001 & ATEX IEC 80079-34 certified.
Ellab A/S Calibration facilities are accredited according to ISO 17025 by
DANAK under registration no. 520 and our affiliates in UK, Germany and Italy
also carry the ISO 17025 accreditation executed by local authorities.

For further information all certificates for the Ellab Group can be found here.

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