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Boost Product Safety with Reliable Pyrogen Testing

Boost Product Safety with Reliable Pyrogen Testing

- Quick and easy solution for process compliance

Our PyroMon™ Pro system helps you maintain a clear overview of your pyrogen testing process. The validated solution makes it easy for you to monitor and document samples, dosages and animals used in pyrogen studies.

Pyrogen Testing Solutions

Pyrogen Testing Solutions

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. Some of the advantages of using an automated system include simplified operating procedures, time savings and cost control.

 

Technical Specifications

Complies with GAMP & FDA 21 CFR Part 11

To ensure integrity and reliability, our pyrogen test system is validated following GAMP guidelines and is FDA 21 CFR Part 11 compliant. The software uses a SQL database which streamlines tracking samples, dosages, weights, test results, animals, pharmacopoeias etc. The information is easily accessible and users stay up-to-date on completed sham tests, animals ready for pyrogen testing and quarantined animals.

The PyroMon™ System Features:

  • Up to 120 channels in one study
  • Process mode and real-time data displayed as a table or graph on module
  • Preconfigured pharmacopoeias USP-NF, ph. EUR, JP, KP and BP
  • Compliant with FDA 21 CFR Part 11 and International GMP standards
  • Serialized Smart USB Connectors with built-in cold junction compensation
  • Fast and reliable data transmission
  • Built-in 8-hour battery
The PyroMon Suite Software

The PyroMon Suite Software

The PyroMon Suite software, in conjunction with the PyroMon Pro equipment, offers a complete system for Pyrogen tests in accordance with the demands from the pharmacopeias (USP-NF, ph. EUR, etc.).

The system collects, analyzes, displays and then reports the results of an animal pyrogen tests. PyroMon Suite has been validated in accordance with GAMP and developed to allow maximum operation flexibility. The software ensures security and compliance with all the relevant requirements that are stated in the pharmacopoeias. It delivers tamper-free documented evidence, making manual recording obsolete. In addition to this, the PyroMon Suite provides essential benefits for the operators and management, i.e. audit trails, animal database and password protection.

 

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