— 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
Hardware Features
— 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
Onboard Software Features
— 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
Reagent Cartridge Features
— 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 Catalog Number
PyroSense® Instrument 25-352
WinKQCL® V3.1 Software 25-362
Bus Converter 25-358USB Reagent Cartridge, qty 4 50-659U
Optional Accessories
Description Catalog Number
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
