PYR0MATCELLS

PyroMAT^® cells

pkg of 2 vials, Cryopreserved Mono-Mac-6 cells for use in the Monocyte Activation Test (MAT) for Pyrogen testing

• UNSPSC Code: 41116129
• NACRES: NA.74
• eCl@ss: 32160606

Properties

• agency: EP Chapter 2.6.30
• Quality Segment: 400
• 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

Description

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.

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Codes: H317
• Precautionary Statements: P261 - P272 - P280 - P302 + P352 - P333 + P313 - P362 + P364
• Hazard Classifications: Skin Sens. 1
• Storage Class: 10 - Combustible liquids
• WGK: WGK 1
• Flash Point (°F): Not applicable
• Flash Point (°C): Not applicable