Calibrating in a Regulated Environment

Digi-Sense Traceable

By Mary Vessele, Product Marketing Manager, Test & Measurement

Temperature measuring instruments need to be calibrated

Why is calibration so important in a regulated environment? After all, what difference does one degree really make? Does anyone even notice such an insignificant change in temperature?

Accurate instruments can save money

One degree out of calibration on a temperature measuring instrument for a pharmaceutical company can mean batches of expensive drugs recalled and big money wasted. The one degree out of calibration means the company would have to run an impact analysis to see if the product was affected. If it was, then all of the product produced in that batch or with that instrument needs to be recalled. I can only imagine the pressure process and quality engineers experience when this happens. All eyes are on them and the performance of their equipment.

Calibrate at regular intervals

To ensure equipment is calibrated on a regular basis, companies are required to keep calibration certificates on file showing that the equipment has been calibrated. If they don’t have the certificates, then the equipment cannot be used. Regular intervals of calibrations are set based on industry standards and facility production needs. In a regulated environment, equipment that is not performing its job, even during regular scheduled calibrations and maintenance, creates stress for everyone as time is $$$, especially in the pharmaceutical industry.

Traceable calibration meets regulatory and compliance needs

So how do companies effectively ensure that their equipment is calibrated correctly on a regular basis as efficiently as possible? One option is for them to do it themselves. I bet you can imagine the resources involved here, not to mention the training needed when there is turn over. Another option is to leave it to the professionals and send the equipment to an A2LA-accredited calibration laboratory. These types of laboratories can make sure your calibrations are traceable and provide you with peace of mind that your equipment is precise and accurate. You also receive a data-rich calibration certificate which validates that your instrument is meeting ISO, FDA, USDA, EPA, GLPs/cGMPs and other quality standards.

These types of calibration laboratories are also familiar with a large network of instruments and the calibration needs that go along with them. They are exposed to just about every need in a variety of industries, crafting them into the calibration expert. Calibration companies can customize their operations to your needs and can do the calibrations at an accelerated pace.

Are you interested in outsourcing your calibration needs? Learn more

Shop temperature measurement instruments.

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