Calibration is one of those elements of lab management that is all-encompassing. Wherever there are processes monitoring temperature, testing that relies on controlled environments or storage of sensitive materials, samples or lab equipment, calibration is at the core. Why? Because it is what the ensures the validity of key instruments such as thermometers that produce the results, that maintain the integrity of samples and reliability of equipment. And, since temperature is one of the most universal and impactful parameters in a laboratory, the calibration must be done correctly and consistently. The temperature in a laboratory setting may influence:
- Test results;
- Effectiveness and stability;
- Accuracy and precision;
- Shelf-life and efficacy;
We have seen the effects of inefficient temperature monitoring in vaccine storage, the food industry and medical research. The CDC estimates that more than 48 million people in the US suffer from food-borne illness each year, resulting in annual health-related costs of $77 billion. The improper storage and handling of vaccines, such as the flu vaccine, can cost small clinics thousands of dollars each year. Vaccine manufacturers projected that as many as 151 million to 166 million doses of injectable flu vaccine (i.e., inactivated and recombinant flu vaccines) would be made available for the 2017-2018 season. Storing the vaccines at the right temperature is critical, a public health issue in fact. In February 2015, the Pharmacy Act was amended to require that anyone storing, distributing or administering vaccines must use appropriate storage areas and temperature monitoring instruments, and conduct regular checks, including annual temperature mapping.
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:
- Calculates and provides accurate uncertainty estimation
- Identifies the name of accredited procedure or process
- Identifies the standards through which traceability is established
- Displays an accreditation logo
Put The Pen Down
Historically temperature monitoring has been done with a thermometer, pen and paper, or with an analog chart recorder. The risks of error and inaccuracy with this method are greater due to human error: reading, recording, or interpreting the information, and the fact that the data is difficult to analyze in its original format.
Today, technology avoids the human error aspect. The device takes the readings and records on internal memory. The data, uncompromised, is downloaded and analyzed. The main components of a monitoring system should include:
- Individually serialized, calibrated and certified – Traceable to NIST;
- Remote alarm notifications, and “on device” alarm notification;
- Ability to access data and to set alarm parameters for device remotely;
- Receive multiple format alarm notifications for temperature alarms, loss of connectivity and low battery;
- Cloud-based data interface;
- Reporting – data output needs;
- Assignability of administrative and non-administrative user access
With TraceableLive®, the added assurance is that all communications received from the digital monitoring thermometer are communicated to a cloud database which stores the data, providing real-time access and visibility from anywhere, as well as the ability to get remote notifications of alarm events.
Organizations providing with accreditation for calibration include:
- A2LA Calibration Laboratory Accreditation
- International Laboratory Accreditation Cooperation
- NCSL International
- National Voluntary Laboratory Accreditation Program
- ANSI-ASQ National Accreditation Board