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Ultra Low Freezer Temperature Validation System with 21 CFR Part 11 Secure Software
OM-CP-ULT90-9 and OM-CP-ULT90-15
PLACE ORDER - FDA 21 CFR Part 11 Compliant
- IQ/OQ/PQ Validation Protocols
- Splash Proof OM-CP-CRYO-TEMP Logger
- -86 to 35°C (-122 to 95°F) Temperature Range
- 0.1°C Resolution and ±1.0°C Accuracy
- 1 Year Battery Life at -80°C (-112°F)
- User-Programmable Temperature Alarms with LED’s (OK, Warn, and Alarm)
- Hardware and Software Password Protection
- Simultaneous Starts, Memory Wrap
- User-Programmable Start Times, Sample Intervals, Logger Descriptions, Unique IDs
Description
Description
The OM-CP-ULT90 ultra lowtemperature freezer validationsystem can measure and log dataas low as
-86°C (-122°F). It can beplaced in small and large freezers ofvarying configurations.The system provides a completestand-alone temperature mappingand validation solution for freezersto ensure uniform storage andtesting conditions.The OM-CP-ULT90 includesa USB docking station with1.8 m (6') of cable (OM-CP-IFC300),the OM-CP-CRYO-TEMP datalogger, and FDA 21 CFR Part11 Secure Software and IQ/OQ/PQvalidation protocols. For largerfreezers, loggers can be plotted inone graph to show variances indifferent parts of the freezer. Finally, as failure to monitor externalfreezer temperatures may invalidateinternal freezer temperatures, anadditional OM-CP-CRYO-TEMP canbe included for placement outside ofthe freezer.
Specifications
TEMPERATURE
Sensor: NTC thermistor
Measurement Range: -86 to 35°C (-112 to 95°F)recommended, may be usedup to 55°C (131°F)
Resolution: 0.1°C
Calibrated Accuracy: ±1.0°C
Specified Accuracy Range: -80 to 0°C (-62 to 32°F)
Memory: 32,767 readings; softwareconfigurable memory wrap
Reading Rate: 5 seconds to30 minutes, selectable in software
Start Modes: Softwareprogrammable immediate start,delay start up to 30 days inadvance or manual start withmagnetic switch
Temperature Alarm: Softwareprogrammable high and low alarmlimits and high and low warn limits,each setpoint may be individually
Alarm Delay: Softwareprogrammable time delay forwarn/alarm limits; logger will notindicate out of range status until thetemperature has been out of rangefor a set period of time
Status Indicators:
Green: (OK) indicates safeconditions during logging
Yellow: (Warn) indicates warnlimits have been exceeded
Red: (Alarm) indicates alarmcriteria (limits/delay) havebeen exceeded
Password Protection: An optionalpassword may be programmed intothe device to restrict access toconfiguration options; data may beread out without the password
Calibration: Digital calibration isavailable to the user through software
Calibration Date: Automaticallyrecorded within device
Battery Type: 3.6V lithium battery,factory replaceable only (included)
Battery Life: 2 years typical@ 25°C, 1 min. reading intervals;1 year typical @-80°C, 1 min readingintervals
Time Accuracy: ±2 minutes/monthmax at 20 to 30°C ±5 minutes/monthmax at -80°C (-112°F)
Data Format: Date and time stamped°C, °F, K, °R
Computer Interface: USB dockingstation to PC (OM-CP-IFC300) 38,400 baud
Software: XP SP3/Vista/7 and 8 (32-bit and 64-bit)
Operating Environment: -86 to 35°C (-123 to 95°F)(may be used up to 55°C); 0 to 100% RH
Dimensions: 83 H x 54 W x 11 mm D(3.3 x 2.1 x 0.4")
Ingress Protection/IP Rating:IP64 (splash resistant, not submersible)
Enclosure: ABS plastic, white, polycarbonate labeling
Weight: 40 g (1.4 oz) each
Total Weight for Packages:
OM-CP-ULT90-9:1443 g (50.9 oz)
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