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
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About This Item
NACRES:
NA.24
UNSPSC Code:
41116130
Suitability:
pyrogenic bacteria
Manufacturer/tradename:
PyroMAT®
Application(s):
pharmaceutical
pyrogen testing
pyrogen testing
Storage temp.:
2-8°C
feature
Non-endotoxin pyrogen control of heat killed Staphyloccus aureus for use in monocyte activation test
Quality Segment
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
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).
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
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
signalword
Danger
hcodes
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
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
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