Pyrogen Testing Solution

  • 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

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Description

Pyrogen Testing Solution

Brand: Ellab – Denmark

PyroMonsystem

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

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.

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)
  • 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 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.
  • The probe for pyrogen testing is designed to measure the rectal temperature on rabbits.

RECTAL PROBE FOR PYROGEN TESTING:

  • The rectal probes are offered in one size for rabbits and animals of similiar size.
  • The expanded area tells the operator when to stop the introduction of the probe in the anal canal.
Technical Specifications

Thermocouple Type:

Cu/CuNi

Diameter:

6.2 mm.

Length:

5 mm.

Material of Electrode:

Polyoxymethylen

Response Time:

10.5 sec.

Accuracy in the Range 15 – 45°C:

±0.1°C

Cable Length:

2.75 m.

Rabbit Safety: The probes have passed an isolation test of 1.5kV.
The silicone cable is inactive and not irritating to the skin.
Disinfection: 70% alcohol, 0.5% chlorexidine and 29.5% water
Sterilization: Autoclavable up to 120°C or gas sterilized by EtO.

PYROMON TEMPERATURE MODULES

The PyroMon temperature modules are available in 16 channel modules.

Pyro_modules

Technical Specifications

 
 

Module

System

Measuring Range: -100…+400°C +35 to +45°C
Measuring Accuracy: ±0.025°C ±0.1°C
Resolution: 0.01°C 0.01°C
Ambient Temperature Range:   10 to 35°C
Capacity: 16 Channels 80 Channels
Sample Rate: 2 Seconds For All Channels 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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