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CMI

Datalogging

Dataloggers are widely used within all kind of industries depending on the measurement that is logged over a certain period of time. In many cases we are interested in temperature datalogging, but other measured units are also frequently used like Relative Humidity, Vibration & Shock, Voltage, Current, Light intensity and Pressure. Depending on your requirements we can select the best datalogger for your application.
Important aspects to consider when selecting a datalogger are:
The other next thing to consider are the possibilities to receive alarms from the system and the requirements needed to comply with the URS.
  • Measured unit(s) like temperature, relative humidity etc
  • Internal sensor or external sensor
  • Accuracy
  • Measurement range
  • IP-rating of the enclosure
  • Combination of sensors in one datalogger
  • Memory buffer capacity
  • Communication possibilities (Reader, USB, WiFi, Bluetooth etc)
  • Software requirements (user interface)
  • Reporting functionalities
  • 21 CFR part 11 Compliance (audit trail)
  • Real-time logging (i.e. monitoring)
  • Alarming options
  • Single-use or Multi-use
  • Pricelevel
Cold Chain Monitoring
Vaccines are key components in disease prevention and control. It is of the utmost importance that vaccines are handled carefully, kept in the right conditions and at the right temperatures at all times. The quality of a vaccine is everyone’s joint responsibility, from the manufacture to the administration of the vaccine.

The cold chain typically consists of several temperature-controlled environments where vaccines are kept and distributed in optimal conditions. It starts with the cold store in the production plant and extends via the transport of vaccines to the distributor. From there, the vaccines are delivered to the supply facility, where they are stored. The cold chain ends when the vaccine is administered to the patient. It is important to properly handle and store vaccines at every link in the cold chain.
Errors in storage and handling can result in high costs through wasted vaccines and unnecessary re-vaccinations. They can also lead to a patient’s loss of confidence if repeated vaccinations are required.  Organizations such as the WHO, the FDA and the European Commission understand that quality must play a central role and have collaborated to define new and critical standards. They emphasize that measures must be taken to ensure consumer safety. Both companies and non-profit organizations understand the importance of change. Therefore, continuous safeguarding and monitoring the correct temperature of these products is the only way!
  • Vaccines must be properly stored from manufacture to administration
  • Joint responsibility of manufacturers, distribution channels, medical personnel and health care providers
Storage of Vaccines
Effective vaccine management has many variables including the type of refrigeration unit used, the way the product is loaded into the unit, how often and for how long doors are opened, and the ambient/outside temperature at the refrigerator’s location. All have an influence on the temperature of the stored vaccine.
Too much exposure to heat, cold or light at any step of the cold chain can damage vaccines, resulting in loss of vaccine efficacy. Any exposure to abnormal conditions further reduces the vaccine’s potency. While inappropriate conditions can affect the effectiveness of cold-stored vaccines, one-time exposure to freezing temperatures will even destroy some. For example, liquid vaccines containing an adjuvant may lose their effectiveness when exposed to freezing temperatures. Novel RNA vaccines, on the other hand, require extremely low temperatures of up to -80 °C.
Against this background, maintaining adequate and stable temperatures in vaccine refrigerators, freezers and controlled storage units is a critical and driving necessity. All this underlines the need for reliable temperature monitoring to ensure that temperature-sensitive medicines are kept within certain temperature ranges.

21 CFR part 11, audittrail

FDA 21 CFR Part 11 compliance dictates that those companies who use electronic systems for document and signature control must provide assurance that the electronic documents are authentic. … FDA 21 CFR Part 11 compliance dictates that signatures whether electronic or handwritten be linked to their respective records. The software should have an audit trail which records any changes made to the system like adjustment of alarm limits, sampling intervals, moreover the raw data must be protected to prevent modification of electronic records. CMI can provide datalogging system that comply to 21 CFR part 11.
Temperature datalogger
Real-time via WiFi
USB Temperature datalogger
with LCD display
Vaccine monitoring datalogger
Dry ice datalogger
With display
Datalogger Selection criteria
When selecting an appropriate datalogger for your application is it critical to define the selection criteria and requirements. What logging interval is required, do I need a single use or multi-use logger. Must it be submerged in a liquid, what temperature range is expected during the logging and what accuracy is required to meet the standards. What are the requirements for programming and reading of the datalogger, do I need a special reader or is a USB connection enough. Is a visual alarm required or must somebody be alarmed by real-time alarms via sms or e-mail.
Monitoring
We provide datalogging solutions for:
  • Vaccine storage at -20°C and -80°C
  • Cold chain logistics of temperature sensitive products
  • GPS datalogging
  • 21 CFR part 11 Compliance
  • Thermal mapping of fridges and freezers
  • Thermal Mapping of Autoclaves
  • Thermal mapping of Incubators
  • Thermal mapping of warehouses
  • Relative Humidity %
  • Pressure
  • Vibration logging for sensitive goods
MESALABS Datatrace Wireless Logging
For more demanding High Temperature Applications like thermal mapping of autoclaves, sterilization tunnels and washer disinfectors we recommend the wireless  dataloggers of Datatrace by MESALABS. The Software can be fully validated to the requirements of the pharmaceutical industry (IQ/OQ/PQ) and complies to FDA 21 CFR part 11. More specific information on the Datatrace datalogging systems can be found below.
Software and reporting options
What are the requirement regarding logging interval, memory buffer, system validation (IQ/OQ), 21 CFR part 11 Compliance, storage of raw data and reporting options. Do you generate the reports yourself or do you want to get a simple pdf report when reading the data. CMI is the official distributor for the Logtag Recorders used worldwide in the pharmaceutical industry, food market, agricultural applications, healthcare and industrial processing. We assist you to find the best logger for your application.

Our Datalogging Solutions

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