User Guide

Industry Standards
Driving the need for stronger industry standards in environments requiring temperature
controlled monitoring are several governmental agencies, such as the Food and Drug
Administration, the USP and the ISO. All work environments (labs, medical research, food
storage, pharmaceuticals for example) held accountable to any regulatory body should use
individually calibrated measurement instruments – for all process variables.
Critical to drug manufacturers, shipping companies and warehouses storing Pharmacopeial
products, the UPS is requiring temperature and humidity monitoring devices a temperature data
logger, or other such device that is suitable for its intended purpose should be used. Electronic
temperature monitors should be calibrated to National Institute of Standards and Technology
(NIST). ISO is the single most important standard for calibration and testing laboratories around
the world. Laboratories that are accredited to this international standard have demonstrated that
they are technically competent and able to produce precise and accurate test and/or calibration
data.
Calibration- Ensuring Its Accuracy
Calibration is a process to validate the performance of a measurement device. Therefore, it is
critical that this process is accurate as many factors depend on it. In order to validate the
performance of each unique unit, it must be tested or used in a controlled environment. The more
stringent the accuracy and repeatability requirement, the more necessary to calibrate. The process
involves the unit you are testing and another unit to compare it to – generally at least four times
the accuracy; a controlled standard or medium to measure; and a documented process to follow.
When you design and manufacture a measurement device, each individual unit will have unique
performance characteristics because of variance in materials, variance of assembly, and
environmental conditions. By using a calibration process that has been verified by a third party
organization with metrology expertise at each step in the chain, you can ensure the validity of the
process used to record those measurements. This provides a link (Traceability) to national
standards that any device is calibrated against. It ensures that the process: