What is Calibration? Understanding the Basics and Importance.

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.  

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.

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.