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OM-CP Autoclave Validation Systems - FDA 21 CFR Part 11

Autoclave Validation Systems

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OM CP Autoclave Validation Systems FDA 21 CFR Part 11 09421

 The OM-CP-AVS140-1 and OM-CP-AVS140-6 are complete systems used to perform autoclave validations. The OM-CP-AVS140-1 system for autoclave temperature monitoring consists of a NIST traceable OM-CP-HITEMP-140-1 temperature data logger, an OM-CP-IFC400 USB docking station and FDA 21 CFR part 11 secure software. For larger size autoclaves or mapping projects, the OM-CP-AVS140-6 is a system for autoclave temperature and pressure monitoring that includes five OM-CP-HITEMP-140-1 temperature data loggers, one OM-CP-PR140 pressure data logger, an OM-CP-IFC406 multiplexer interface (allows up to 6 data loggers to be interfaced to a single USB port on the computer) and the secure software.

 
The secure software aids users in compliance with FDA 21 CFR Part 11 requirements. The software ensures standards in which electronic files are considered equivalent to paper records, saving time and effort. The secure software contains criteria such as electronic signatures, access codes, secure data files and an audit trail which meets the requirements of 21 CFR Part 11 and helps provide data integrity. IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) protocols are included to validate that the software has been installed and is operating correctly. The layout of the secure software is similar to the OM-CP Series Data Logger standard software, allowing users to easily learn the additional features. The Windows® based software package allows the user to effortlessly collect, display and analyze data. A variety of powerful tools provide the ability to examine, export, and print professional looking data with just a click of the mouse.
• Complete Systems for Autoclave Validation 
• Enables Compliance with FDA 21 CFR Part 11 
• NIST Traceable Calibration Included 
• OM-CP-AVS140-1 for Temperature Monitoring 
• OM-CP-AVS140-6 for Temperature and Pressure Monitoring
Computer InterfaceOM-CP-IFC400 USB docking station or OM-CP-IFC406 multiplexer interface required, 125,000 baud
SoftwareXP SP3/Vista/7 and 8 (32-bit and 64-bit)
Battery Type3.6V high-temperature lithium battery (included)
Calibration DateAutomatically recorded within device
CalibrationDigital calibration through software
Reading RateOne second up to once every 24 hours
Memory32,700 readings; software configurable memory wrap
Real Time RecordingMay be used with PC to monitor and record data in real time
COMMON SPECIFICATIONS (OM-CP-HITEMP140-1 and OM-CP-PR140)
EnclosureStainless steel
Weight85 g (3 oz)
Dimensions50.8 L x 25.4 mm dia. (2.0 x 1.0')
Operating Environment-20 to 140°C, (-4 to 284°F) 0 to 100% RH, may be used above 60°C (140°F) for up to 8 hrs per 24 hr period
Time Accuracy±1 minute/month at 20°C
Battery Life2 years typical
Data Formatpsia, bar, mbar, atm, Torr, Pa, kPa, MPa, mmHg, inHg, inH20, mH20, ft, m
Repeatability±0.5% FSR; ±0.2% typical
Pressure Response Time0.1 ms (10 to 90% FSR)
Calibrated Accuracy±0.03 Bar (±0.435 psi) (20 to 140°C/68 to 284°F)
Pressure Resolution0.1 mBar (0.0015 psia)
Pressure Range0 to 5 bar (0 to 72.5 psia)
Pressure SensorSemiconductor strain gauge
OM-CP-PR140 PRESSURE DATA LOGGER
Material316 stainless steel
Weight120 g (4.2 oz)
Probe27 L x 3.2 mm dia (4.8 mm transitional dia) [1.1 x 0.125' dia (0.188' transitional dia)]
Body40 H x 25 mm D (1.6 x 0.97')
Dimensions
Operating Environment±1 minute/month at 20 to 30°C (68 to 86°F) (stand alone mode)
Time Accuracy±1 minute/month at 20 to 30°C (68 to 86°F) (stand alone mode)
Data FormatDate and time stamped °C, °F, K, °R
Battery Life1 year typical [1 minute reading rate at 25°C (77°F)]
Calibrated Accuracy±0.1°C (±0.18°F) [20 to 140°C (68 to 284°F)]
Temperature Resolution0.01°C (0.02°F)
Temperature Measurement Range (Probe)-200 to 260°C (-328 to 500°F)
Temperature Range (Body)-40 to 140°C (-40 to 284°F)
Temperature Sensor100Ω Platinum RTD
OM-CP-HITEMP140-1 Temperature Data Logger with 27 mm (1.1') Probe
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    Data Sheet - OM-CP Autoclave Validation Systems - FDA 21 CFR Part 11

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