Pyrogen Testing Solutions
The PyroMon Pro offers a simple way to document product safety. The reports generated by the PyroMon Pro, documents that the products being used are in compliance with current regulations. There are numerous advantages to using an automated system, as it simplifies operating procedures, saves time and keeps costs under control.
Complies with GAMP & FDA 21 CFR Part 11
To ensure integrity and reliability, the PyroMon Pro system is validated following GAMP and is FDA 21 CFR Part 11 compliant. The software makes use of a SQL database that keeps track of animals, pharmacopoeias, samples, dosages, weights, test results, etc. The information is easily accessible and users stay up-todate on the animals in quarantine, completed sham tests and animals ready for pyrogen testing.
The PyroMon™ System Features:
- Can be expanded to have up to 120 channels
- A sample rate of 1 sec. to 24 hours
- Displays process mode & real-time data as a table or graph
- Preconfigured pharmacopoeias e.g. USP-NF, ph. EUR, JP, KP and BP
- FDA 21 CFR Part 11 / International GMP standards
- Smart USB connector with ID and cold junction compensation
- Fast and reliable data transmission
- Built-in 8-hour battery
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.