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HONGKE Solution] Accurate and Compliant: HONGKE ELPRO Temperature Recorder in Refrigerator Certification

Maintaining accurate temperatures is not only critical to the quality of pharmaceuticals and food, but is also a core element of many other products and industrial processes.
Therefore, it is important to make sure that the products used in refrigerators, freezers, ultra-low-temperature freezers, cryogenic containers, or incubators are not used for any other purpose.Temperature Data Loggers and SensorsBeing in good condition and calibrated is essential to the daily work of the laboratory when handling, analyzing or storing.
Monitor the temperature of refrigerators, freezers, etc. with a temperature logger that can provideReliable temperature monitoring dataup toProof of ComplianceThe

During the operation of refrigerating or freezing equipment such as refrigerators, the temperatures at various locations inside the equipment may differ, even significantly, due to the way the refrigeration operation is carried out and the way the samples are placed.
Therefore, throughTemperature Distribution VerificationThis ensures that the temperature at all points inside the device is within the specified range, safeguarding the safety and quality of stored items.

How to choose the right temperature recorder for verification?

  • Select ECORDER type: Internal sensor, external sensor, wireless recorder, recorder with display, etc.
  • Select ECORDER parametersMeasurement Accuracy, Temperature Range, Storage Capacity, Battery Life and Data Transmission Methods

According to GB/T 34399-2017 It is required that the temperature recorder should be periodicallyCalibration or Verification::

  • Measurement range 0 ℃ ~ 40 ℃, maximum tolerance ±0.5 ℃.
  • Measurement range -25 ℃ ~ 0 ℃, maximum tolerance ±1.0 ℃.

To enhance ease of use, companies often choose toHigher storage capacity,Longer battery lifeThe recorder is a recording device that is used to record the number of times that a person has been in contact with the computer.

  • Data analysis capability: Ensure that the recorder is compliant, that no data is lost, and that it produces complete data suitable for analysis.

Practical Case Sharing

case (law)A large-scale integrated pharmaceutical group in Chengdu selected Hongke ELPRO LIBERO C series temperature recorder for refrigerator/freezerTemperature Distribution VerificationThe temperature accuracy is required to be within ±0.5℃.

User needs and challenges:High precision and equipment stability; Ensure stable data recording and no data loss during the verification process; High compliance; Wireless transmission, easy installation and operation; Multi-purpose, enhance the value of the recorder

Solution: HONGKE LIBERO Multi-Use Thermometer Series

HONGKE's LIBERO series consists of three models to cover different temperature ranges and humidity measurement needs, fulfilling all of the above requirements and solving customer's pain points.

Achievements and Strengths:Accurate temperature monitoring with non-modifiable and fully compliant data reduces quality and compliance risks; can be used for cold chain transportation to save costs, and with DGM and Dangerous Goods Safety Identification report, can be safely transported by air to meet rapid distribution and patient safety needs; based on GAMP5 Designed to meet FDA 21 CFR Part 11 Request.

Product Description: HK-LIBERO CL Multi-Use Temperature Recorder

  • Measurement Range: -30 °C to +70 °C
  • parameters: Temperature
  • Type of use: Multiple use, generating PDF reports
  • Content of the report: Alarm Statistics and Charts
  • Alarm Level: Level 8
  • Data Reading: USB or Bluetooth
  • Battery Life: LIBERO CL up to 2 years in the core temperature range 0 °C ~ 25 °C and 14 months for the entire measurement range.
  • Battery Type: Button Battery (IATA compliant)
  • Compliance: GAMP5 verified to be in compliance with FDA 21 CFR 11.
  • include (as a free gift, when buying sth): Free Calibration Certificate
  • Apps: iOS and Android

Temperature Distribution Verification Procedure for Refrigerators with HONGKE LIBERO CL

  1. Use the free configuration software liberoCONFIG Setting ECORDER Parameters
  2. Activate the recorder and place it in a fixed location, usually in a refrigerator. 9 evenly distributed points
  3. Perform temperature distribution validation procedures
  4. Connect the USB directly to the computer to get the raw data report that cannot be modified.
  5. Use of free data analysis software elproViewer Conduct analysis to produce detailed reports and statistical data such as maximum, minimum and average values.
  6. Produce a complete temperature distribution validation report.

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