Ultra Low Freezer Temperature Validation System with 21 CFR Part 11 Secure Software

OM-CP-ULT90-9 and OM-CP-ULT90-15
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The OM-CP-ULT90 ultra low temperature freezer validation system can measure and log data as low as
-86°C (-122°F). It can be placed in small and large freezers of varying configurations. The system provides a complete stand-alone temperature mapping and validation solution for freezers to ensure uniform storage and testing conditions.

The OM-CP-ULT90 includes a USB docking station with 1.8 m (6′) of cable (OM-CP-IFC300), the OM-CP-CRYO-TEMP data logger, and FDA 21 CFR Part 11 Secure Software and IQ/OQ/PQ validation protocols. For larger freezers, loggers can be plotted in one graph to show variances in different parts of the freezer. Finally, as failure to monitor external freezer temperatures may invalidate internal freezer temperatures, an additional OM-CP-CRYO-TEMP can be included for placement outside of the freezer. 

Specifications

TEMPERATURE

Sensor: NTC thermistor

Measurement Range: -86 to 35°C (-112 to 95°F) recommended, may be used up 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; software configurable memory wrap

Reading Rate: 5 seconds to 30 minutes, selectable in software

Start Modes: Software programmable immediate start, delay start up to 30 days in advance or manual start with magnetic switch

Temperature Alarm: Software programmable high and low alarm limits and high and low warn limits, each setpoint may be individually

Alarm Delay: Software programmable time delay for warn/alarm limits; logger will not indicate out of range status until the temperature has been out of range for a set period of time

Status Indicators:

  • Green: (OK) indicates safe conditions during logging
  • Yellow: (Warn) indicates warn limits have been exceeded
  • Red: (Alarm) indicates alarm criteria (limits/delay) have been exceeded

Password Protection: An optional password may be programmed into the device to restrict access to configuration options; data may be read out without the password

Calibration: Digital calibration is available to the user through software

Calibration Date: Automatically recorded 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 reading intervals

Time Accuracy: ±2 minutes/month max at 20 to 30°C ±5 minutes/month max at -80°C (-112°F)

Data Format: Date and time stamped °C, °F, K, °R

Computer Interface: USB docking station 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)
  • OM-CP-ULT90-15: 1681 g (59.3 oz)

The OM-CP-ULT90 ultra low temperature freezer validation system can measure and log data as low as
-86°C (-122°F). It can be placed in small and large freezers of varying configurations. The system provides a complete stand-alone temperature mapping and validation solution for freezers to ensure uniform storage and testing conditions.

The OM-CP-ULT90 includes a USB docking station with 1.8 m (6′) of cable (OM-CP-IFC300), the OM-CP-CRYO-TEMP data logger, and FDA 21 CFR Part 11 Secure Software and IQ/OQ/PQ validation protocols. For larger freezers, loggers can be plotted in one graph to show variances in different parts of the freezer. Finally, as failure to monitor external freezer temperatures may invalidate internal freezer temperatures, an additional OM-CP-CRYO-TEMP can be included for placement outside of the freezer. 

Specifications

TEMPERATURE

Sensor: NTC thermistor

Measurement Range: -86 to 35°C (-112 to 95°F) recommended, may be used up 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; software configurable memory wrap

Reading Rate: 5 seconds to 30 minutes, selectable in software

Start Modes: Software programmable immediate start, delay start up to 30 days in advance or manual start with magnetic switch

Temperature Alarm: Software programmable high and low alarm limits and high and low warn limits, each setpoint may be individually

Alarm Delay: Software programmable time delay for warn/alarm limits; logger will not indicate out of range status until the temperature has been out of range for a set period of time

Status Indicators:

  • Green: (OK) indicates safe conditions during logging
  • Yellow: (Warn) indicates warn limits have been exceeded
  • Red: (Alarm) indicates alarm criteria (limits/delay) have been exceeded

Password Protection: An optional password may be programmed into the device to restrict access to configuration options; data may be read out without the password

Calibration: Digital calibration is available to the user through software

Calibration Date: Automatically recorded 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 reading intervals

Time Accuracy: ±2 minutes/month max at 20 to 30°C ±5 minutes/month max at -80°C (-112°F)

Data Format: Date and time stamped °C, °F, K, °R

Computer Interface: USB docking station 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)
  • OM-CP-ULT90-15: 1681 g (59.3 oz)

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