agency
EP Chapter 2.6.30
Quality Segment
product line
PyroMAT®
feature
ready-to-use
packaging
pkg of 2 vials
manufacturer/tradename
PyroMAT®
application(s)
pharmaceutical
pyrogen testing
compatibility
configured for PyroMAT® System
shipped in
dry ice
suitability
Pyrogen testing
General description
The PYROMAT® system is a robust, easy-to-perform and ready-to-use solution for pyrogen testing, using the Monocyte Activation Test (MAT). The PYROMAT® cells are cryopreserved human monocytic cells from the Mono-Mac-6 cell line. They have been validated to be used for MAT.The PyroMAT® System is based on the Mono-Mac-6 (MM6) cell line and uses Interleukin-6 (IL-6) as a read out. PyroMATcells contains the cryopreserved Mono-Mac-6 cells, 2 x 1 mL
Application
PYROMAT® cells is used to determine the pyrogenic activity in a solution or suspension by inducing interleukin production in cell cultures with human monocytes. It is used to ensure the safety of parenteral pharmaceutical products.
Features and Benefits
- Cryopreserved ready-to-use monocytic cells
- The first cell line validated by ECVAM and IICVAM and available for Monocyte activation test
- Expression of all the Toll-like Receptors responsible for pyrogen detection
Packaging
1 box of 2 vials, sufficient for 1 test
Other Notes
To be used with PyroMAT kit (PYR0MATKIT), Reference standard endotoxin (144.161.0001), NEP controls (MATHKSA, MATFLAGELLIN, MATFSL1, MATPAM3SCK4, MATRESQUIM0D)
2 vials of cryopreserved Mono-Mac-6 cells
Download the PyroMAT® Method Software from here.
Legal Information
PYROMAT is a registered trademark of Merck KGaA, Darmstadt, Germany
Disclaimer
Due to the sensitivity of the product adding a temperature data logger is required. Please make sure to add one DATAL0GGER95 per every 18 packages of PyroMAT® cells.
警示词
Warning
危险代码
Hazard Classifications
Skin Sens. 1
存储类别
10 - Combustible liquids
怎么回事？
WGK 1
闪点 (F)
Not applicable
闪点 (°C)
Not applicable