MATHKSA

HKSA Non-Endotoxin Pyrogen (NEP) Control

for use with PyroMAT^® System

• Synonim(y): 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

Właściwości

• Quality Segment: 400
• product line: PyroMAT^®
• packaging: pkg of 1 vial
• manufacturer/tradename: PyroMAT^®
• application(s): pharmaceutical; pyrogen testing
• compatibility: for use with PyroMAT^® System
• shipped in: ambient
• storage temp.: 2-8°C
• suitability: pyrogenic bacteria

Opis

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. It is designed to mimic the NEP of Gram positive bacteria origin.

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

Legal Information

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

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Informacja o środkach bezpieczeństwa

• Piktogramy: GHS07
• Klasa składowania: 11 - Combustible Solids
• Temperatura zapłonu (°F): Not applicable
• Temperatura zapłonu (°C): Not applicable
• Słowo ostrzegawcze: Warning
• Kody zagrożeń: H302
• Ostrzeżenia: P264 - P270 - P301 + P312 - P501
• Hazard Classifications: Acute Tox. 4 Oral