Our pyrogen test system, PyroMon Pro, offers a simple way to document product safety. The reports generated by the pyrogen system, provide documentation that ensures tested products are in compliance with current regulations. information is easily accessible and users stay up-to-date on completed sham tests, animals ready for pyrogen testing and quarantined animals.

1. PyroMon Pro
High
performance
systems for
professionals
AutomaticPyrogenTestSystem

2. Stay Safe & Compliant
PyroMon Pro offers the perfect solution to ensure
product safety with the report generated by PyroMon
Pro documenting that products are in compliance with
current regulations. The advantages of using an
automated system are numerous. It simplifies operating
procedures, saves time, and keeps costs under tight
control.
Validated per GAMP & FDA 21 CFR Part 11 compliant
To ensure integrity and reliability the PyroMon Pro
system is validated per GAMP and it is FDA 21 CFR
Part 11 compliant, including electronic signatures/
records. The software makes use of an SQL database
that keeps track of rabbits, pharmacopoeia, sample,
dose, weight, test results, etc. The information is easily
accessible and the user stays up-to-date about rabbits
in quarantine, sham tests completed, and rabbits
ready for pyrogen testing.
PyroMon Pro
Automatic Pyrogen Test System
Preloaded Pharmacopoeias
The PyroMon Pro system is preloaded with all pharma-
copoeias (EUP, JP, KP, MRBP, and USP). For full flexibility,
all pharmacopoeias are user configurable. The software
will automatically analyze the recorded temperatures
per the pharmacopoeias and generate a report. The
calculations and interpretations of the results are done
automatically, which eliminates the risk of making
errors and saves time.
Automatic Weight Detection
The PyroMon Pro system has a direct interface to an
animal scale making it easy to keep track of the weight
of the rabbits. When the scale is connected to the
software the rabbit’s weight is registered automatically
in the database.
PyroMon Pro
40 channel
module

3. Features
Automatic Pyrogen Testing – up to 120 channels
Several pharmacopoeias (EUP, JP, KP, MRBP, and USP)
Keep full database on rabbits and test results
Certified accuracy of +/- 0,1 °C
GAMP / FDA 21 CFR Part 11
IQ/OQ protocols
Interface to scale with automatic weight transfer (please ask for specifications of the scale)
User calibration (please ask for specifications of the calibration equipment)
Backup battery
Windows 7, 8 and 10 compatible
P Y R O M O N P R O I P A G E 3
Automatic Calibration
The measuring capacity of the system is 120 highly
accurate temperature channels. The total system
accuracy is +/- 0,1 °C from 35 to 45 °C. It is critical the
system measures correctly always. Therefore, calibrations
mustbeperformedperiodically.
The PyroMon Pro software includes a user calibration
feature making it possible to certify the system
accuracy. The calibration runs fully automatic when using
an Ellab Temperature Standard (ETS) and calibration bath.
The ETS and calibration bath have direct interface to the
PyroMon Pro system. After completion of the calibration
the software generates a report documenting ID number of
the probe, reference value, and the deviation.
PyroMon Pro
Automatic Pyrogen Test System

4. Ellab
Ellab A/S
Trollesmindealle 25
DK-3400 Hilleroed
Denmark
P: +45 4452 0500
F: +45 4453 0505
info@ellab.com
www.ellab.com
For over 65 years Ellab A/S has been a leading manufacturer of process validation and
monitoring systems used in the food, medical device and pharmaceutical industries.
Calibration Certifications and Service
Ellab maintains a complete calibration facility for annual certifications and service.
Ellab A/S temperature, resistance, pressure and humidity calibration laboratory is
accredited according to ISO 17025 by DANAK under registration no. 520. Service and
maintenance contracts are available.
Rental & Demos
Demo systems are available for trial and rental. Please contact your local Ellab
representative for details.
Training
Ellab Academy offers regular training courses for end-users. On-site individual
training and equipment installations are also available through Ellab. Our Validation
Consultants are available to assist you with IQ, OQ, and PQ procedures.