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Why Calibration is Key

Posted by Mike Blazes on 26 October, 2017

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.

Summary of content (4 pages)

PAGE 1
Why Calibration is Key Posted by Mike Blazes on 26 October, 2017 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.
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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.
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· · · · 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.
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Written by Mike Blazes Michael Blazes is the Chief Executive and champion for Control Company, the laboratory test, measurement, and monitoring instrument company that has been bringing innovative Traceable® branded products to prominent biopharmaceutical and healthcare organizations and institutions around the world for the past 40 years. Mike has 20 years’ experience in the laboratory products and equipment industry.