Pyrogen Testing Solutions

Pyrogen Testing Solutions

Today pharmaceutical companies have to test their injectable products. However, certain protein-based injectables can only be tested with the traditional Pyrogen test.

Pyrogen testing is paper consuming and tedious work. However, Ellab provides a solution helping the customer develop the necessary documentation according to the specified pharmacopoeia with a minimum amount of manual paper work.

Pyrogen testing with Ellab PyroMon™ system

One Stop Shopping for the Best and Safest Pyrogen Test System in the World

Safe pyrogen testing can be done with the PyroMon™ system which combines safety with accuracy. The software logic simplifies the work and in the long run both time and costs are minimized.

For many years there has been doubt if a test result was valid using manual temperature/time collection, but when using Ellab pyrogen systems there is no uncertainty due to the security of the PyroMon™ system. This system is extremely valuable because of the time savings. No paper copying or archiving is needed.

The PyroMon™ System Features:

  • 80 channel capacity
  • On-line graphic and data
  • One database for tasks and results
  • Capable of doing several Pharmacopoeias simultaneously
  • User configurable Pharmacopoeia
  • User configurable printout interval for temperature data
  • Possibility to simulate runs with other Pharmacopoeia e.g. EUR to USP
  • Keeps track of animals that need to be re-tested (Sham)
PyroMon Modules

PyroMon Modules

The system can be configured with the maximum of 5 temperature modules, each with a capacity of 16 channels resulting in a capacity of 80 channels. The system can also be equipped with active monitors where all relevant information is displayed.  Examples of this are Test ID, Animal No. & dose.

Local support? We are ready to respond to your technical inquiries and other customer needs.

Technical Specifications for PyroMon System

Measuring Range:

+35 to +45 °C

Measuring Accuracy:

±0.1 °C

Resolution:

0.01 °C

Ambient Temperature Range:

+10 to +35 °C

Capacity:

80 Channels - 5 modules of 16 channels each

Sample Rate:

1/ min. to 1/hour

Calibration Function:

Yes

Time Indication:

Relative Time

Pharmacopoeia:

EP III, JP XIII, KP VII, USP XXIII

Alarm Functions:

Immediate on-screen alarm notification and output for external alarm relay box

Dimensions (WxHxD):

230x190x60 mm

Weight:

2.7 kg

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