PyroSense联机内毒素检测系统

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The PyroSense^® On-line System automatically monitors endotoxin levels in high purity water systems. This robust and reliable system is designed to test around the clock - seven days a week. The Reagent Cartridge contains reagents for running tests on 24 water samples. The starter system comes with WinKQCL^® 21 CFR Part 11 Compliant Software which stores raw data and test results. The software also provides immediate feedback on water quality across your network and provides an efficient tool for trending endotoxin levels.

— Moves in-process water testing from lab bench to the water loop.

— Robust system – consistent hands-free endotoxin testing.

— User-defined testing schedule – results when you need them.

— Endotoxin results prior to production reduce risk.

—WinKQCL® software allows centralized data; exporting to LIMS.

Addresses the FDA’s Process Analytical

Technology （PAT） Initiative

PyroSense® automatically monitors endotoxin levels in water for injection and high purity water systems used in the manufacture of  injectable  drugs,  medical  devices,  and  other  therapeutic products. It allows you to detect the presence of Gram-negative bacterial endotoxin at an early stage in the process rather than risk costly product rejects. This advanced and innovative detection system addresses FDA’s Process Analytical Technology initiative aimed  at  improving  the  current  level  of  quality  assurance  for products manufactured by the pharmaceutical and medical device industries.

PyroSense® On-Line Endotoxin Detection

Specifications

HardwareFeatures                                                             

— LCD display

— Membrane keypad with alphanumeric keys

— Fiber optics system for detection

— Excitation at 375 nm, Emission at 450 nm

— Communication ports: USB or RS-232 to RS-422

— Barcode scanner

— Robotic arm with syringe pump for dispensing reagents

— Cooling area to maintain unused reagents

— Incubation area for controlling testing conditions

— 4 LED status indicators: Fault, Action, Alert and Service

OnboardSoftwareFeatures                                                    

— Easy-to-use menu-driven interface

— Performs Initial Qualification and Routine tests

— Endpoint assay with 3 point range from 0.05 EU/ml to 5.0 EU/ml

— Routine tests are run in duplicate with a 0.5 EU/ml PPC

— Linear regression used for curve fitting

— Automatically stores the test results for 6 Reagent Cartridges, or up to 144 tests

— Interfaces with WinKQCL® Version 3.1 or higher, can be net- worked, can export to LIMS

ReagentCartridgeFeatures                                                    

— Fluorescence assay using recombinant Factor C

— Each cartridge contains reagents for testing 24 water samples

— Each cartridge stocked with tips and microplates

— Barcodes on cartridge for easy lot number entry

Specifications                                                                      Dimensions:

— Depth: 11.5” （29.2cm）

— Width: 29” （73.7 cm）

— Height: 20.5” （52.1 cm） （not including handle or rubber feet）

— Weight: 70 pounds （32 kg）

Environment:

— Temperature: Operating: 15? to 29?C Storage: -10? to 40?C

— Humidity: Operating: 10% to 80%, Non-condensing

             Storage: 10% to 90%, Non-condensing

— Power: Connected directly to power supply

          witchable fuses for 120V and 240V

— Compliance: UL, CE, FCC Class “A”, VCCI-A

PyroSense® Starter System

The following items are included in the PyroSense® Starter System

Catalog Number 25-357:

Description                                 CatalogNumber                  

PyroSense® Instrument                        25-352

WinKQCL® V3.1 Software                       25-362

Bus Converter                                25-358USB Reagent Cartridge, qty 4   50-659U

Optional Accessories

Description                                 CatalogNumber                  

Additional Software License                  25-372

Data Station for PyroSense®                 25-367

Cooled NEMA 12 Cabinet*                      25-356

25-356E for Europe

*The NEMA cabinet is necessary to enclose the PyroSense® instrument when used in areas where the environment is outside the listed specifications