Calibration means checking that a device used to measure things is giving accurate results, whether it’s a ruler showing precise dimensions or a centrifuge spinning at the correct speed. In industries like pharma and biotech, calibration is critical for maintaining product quality, safety and regulatory compliance.
Calibration
What is Calibration? Understanding the Basics and Importance.
Ellab
11 July 2024
In simple terms, calibration means comparing the accuracy of an instrument, such as a thermometer, with a known accurate reference device, known as a calibrator.
Why is calibration important?
Calibration is important in the following ways:
- Accuracy and Precision: Calibration makes sure instruments give accurate readings, which is vital for tasks like mixing ingredients in drug formulation and testing final products. Accurate instruments keep consistent product quality, ensuring they perform as intended.
- Regulatory Compliance: Agencies like the FDA (Food and Drug Administration) and EMA (European Medicines Agency) have strict rules to ensure drugs and biotech products are safe. Calibration is part of the Good Manufacturing Practice (GMP) guidelines that these industries must follow.
- Reduces Costs and Waste: If instruments aren’t accurate, it can lead to costly mistakes such as product recalls, reworks and wastage of materials. Regular calibration can minimize these errors, saving money and reducing waste.
What is the difference between calibration and adjustment?
When you calibrate and compare two instruments, they may give slightly different results. In this case it makes sense to adjust the instrument being tested to measure correctly. This process is often called adjustment or trimming.
Adjustment is the process of fine-tuning an instrument to make sure it gives accurate measurements. For example, if a thermometer consistently shows a slightly higher temperature than the actual reading, adjustment would involve correcting it so it displays the correct temperature.
Generally, calibration and adjustment are separate processes. People sometimes use “calibration” to also mean adjustment. However, calibration does not include adjustment and this is a process of its own.
When should calibration be performed?
Instruments should be calibrated at the following times:
- Scheduled Maintenance: Calibration should take place according to a set schedule to make sure regular maintenance is being carried out. This helps keep equipment in good working condition.
- After Repairs and Changes: If equipment has been repaired or modified, it should be recalibrated to check that it still measures accurately.
- When Accuracy is in Question: If it seems that an instrument isn’t measuring accurately, it should be calibrated as soon as possible. Signs that calibration might be needed include physical damage to the instrument or unusual readings.
- Before Critical Measurements: If an instrument is being used for a critical measurement, such as during final product testing, it is advised to calibrate it.
How often should measuring equipment be calibrated?
Regulatory bodies usually have specific rules about how often to calibrate equipment, often suggesting that once a year is enough. The original equipment manufacturer (OEM) may also give guidelines for how often their equipment should be calibrated.
Equipment that is used a lot or in tough conditions might need more frequent calibration. For example, an incubator used in high humidity might need to be checked every few months to ensure accuracy.
You can also decide how often to calibrate your equipment by monitoring the drift in your measurements. By analyzing the drift between calibration intervals, you can identify when an instrument is likely to go out of tolerance. From this, you can set the appropriate calibration schedule to maintain accuracy and compliance while potentially reducing costs.
At Ellab, we understand the pivotal role precision plays in your operations and the importance of calibration. As your life science compliance partner, we want to ensure your critical systems are accurate, reliable and meet industry standards. To discuss your calibration requirements and how we can partner with you, contact your local team.