MATHKSA

NEP Control HKSA- PyroMAT^® System MAT

Non-endotoxin pyrogen control of heat killed Staphyloccus aureus for use in monocyte activation test

• Synonym(s): NEP, NEP control
• NACRES: NA.24
• UNSPSC Code: 41116130
• Suitability: pyrogenic bacteria
• Manufacturer/tradename: PyroMAT^®
• Application(s): pharmaceutical; pyrogen testing
• Storage temp.: 2-8°C

Properties

• feature: Non-endotoxin pyrogen control of heat killed Staphyloccus aureus for use in monocyte activation test
• Quality Level: 400
• packaging: pkg of 1 vial
• manufacturer/tradename: PyroMAT^®
• application(s): pharmaceutical; pyrogen testing
• compatibility: configured for PyroDetect System, configured for PyroMAT^® System
• shipped in: ambient
• storage temp.: 2-8°C
• suitability: pyrogenic bacteria

Description

General description

The PyroMAT^® System uses cryopreserved Mono-Mac-6 (MM6) human monocytic cells as a source of monocytes. The response to a full range of pyrogens, including endotoxins and non-endotoxin pyrogens (NEPs)is determined by the measurement of interleukin-6 (IL-6) produced by the Mono-Mac-6 cells using ELISA.
NEP control HKSA is a heat-killed preparation of Staphylococcus aureus, supplied in a lyophilized form. HKSA is a non-endotoxin pyrogen (NEP) that activates the TLR2 receptor of monocytes and can be used as a positive control with the PyroMAT^® System (Monocyte Activation Test for pyrogen detection).

Application

NEP control of heat-killed Staphylococcus aureus can be used as a positive control with the PyroMAT^® System. It is to be used for Product Specific Validation (PSV) and routine testing to show that the system can detect non-endotoxin pyrogen contaminants in pharmaceutical products.

Biochem/physiol Actions

TLR-2 agonist

Features and Benefits

Endotoxin-free product at concentration of use in MAT

Preparation Note

Store unopened vials at 2-8°C
Do not use unopened vials after expiration date
Store resuspended aliquots at -20°C
Shelf life of aliquots can be found on the technical datasheet

Legal Information

PYROMAT is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety Information

• pictograms: GHS06
• signalword: Danger
• hcodes: H300
• pcodes: P264 - P270 - P301 + P310 - P405 - P501
• Hazard Classifications: Acute Tox. 2 Oral
• Storage Class: 6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials
• flash_point_f: Not applicable
• flash_point_c: Not applicable