Calibration within the pharmaceutical industry – what you need to know


Did you know that, until 1858, the Apothecaries’ system was the official system of measurement used to weigh out ingredients in medicines (and potions) in the US and Great Britain? Back then – when cocaine toothache drops were prescribed as “patent medicines” and leech therapy was all the rage – apothecaries were using hand scales to prepare and dispense their own medicines.

Prior to the 20th century, medicines were generally produced by small scale manufacturers and there was little regulatory control over manufacturing, or their promise of safety and efficacy.

Today, research and testing labs, manufacturers and other pharma companies are all subject to strict laws and regulations, meaning significant attention has to be paid to safety and compliance. Gone are the days of prescribing mercury, chloroform, and medicinal leeches. Technological advancement has also brought with it many benefits, including highly sophisticated and extremely sensitive measuring equipment.

Calibrating these instruments properly and regularly is a crucial aspect of ensuring that finished pharmaceutical products meet the right quality standards.

How is instrument calibration performed?

Instrument calibration is the process of comparing results from a measurement device against a traceable standard, i.e., one that has been calibrated to an even higher level standard. Any discrepancies found can then be adjusted within the specified limits, ensuring the equipment being used is producing safe and accurate results. For pharma companies, it is an important part of justifying the processes of Qualification and Validation – part of the 3 principles to achieving high quality.

Instrument calibration can be performed in-house or by sending equipment to a calibration laboratory. While calibrating in-house can mean reduced downtime, enlisting the services of a nationally or internationally accredited calibration laboratory, who offer proven accuracy standards, appropriate equipment and the right controlled environments, can give you extra confidence in the traceability of your device.

The role of metrology equipment in pharmaceutical production

There are many types of metrology equipment used in pharmaceutical production, each instrument that comes into contact with the pharmaceutical supply chain needs to meet stringent quality standards, as the measurements taken from these instruments have a direct effect on the quality of the end product.

Flow – Flow meters are used to measure the flow of various liquids and gases. However, even high precision flow meters can easily deter from calibration, and the performance of these instruments will reduce over time. Routine calibration ensures these results are consistently accurate.

Temperature – Similarly, even slight variations in temperature can affect product quality. Thermometers, thermocouples and other temperature monitoring equipment are sensitive and prone to damage during use, meaning they have to be checked and calibrated regularly. The calibration of temperature sensors is also critical to ensure that labs stay within optimal temperatures for the safe production of pharmaceutical products.  

Pipettes – Pipettes are crucial in measuring and transferring the accurate amount of fluid into a product. However, the smallest variation to a recipe could have harmful consequences for consumers. Some volatile liquids and chemicals can also corrode the pipette, throwing off calibration, while air temperature and humidity in a lab can affect its accuracy. With regular pipette calibration, you can significantly reduce these risks and liabilities.

Pressure – A variety of pressure measuring and monitoring devices are used within pharma production, for example, to ensure the pressure within cleanrooms stay at optimal levels. Calibration ensures that they comply with industry and regulatory standards regarding precision, sanitation, and safety – ensuring better conditions for researching, developing, and producing medicines.

How often does equipment have to be calibrated?

Pharmaceutical producers need to implement a routine instrument calibration schedule to ensure compliance with FDA guidelines or to maintain CGMP and other quality control standards.

Each instrument should have a unique calibration record which must be maintained for a certain period of time. How often equipment needs to be calibrated will depend on the type of equipment, how often it’s used and its unique conditions, for example, being exposed to high, or low, temperatures.

Most pipettes, for instance, can be calibrated every six months, but based on the strict regulations of the pharmaceutical industry, the CSLI recommends that your pipettes be calibrated every 3 – 6 months. Make sure to follow the manufacturer’s recommendations for minimum calibration intervals. You can also consult an accredited lab for help with devising an appropriate calibration schedule.

Why use an accredited lab?

The aim of calibration is to establish the accuracy of the equipment used within production – preventing costly recalls, damage to reputation and safety risks to consumers. At the same time, pharmaceutical companies and laboratories need to have confidence in the performance and results of the instruments used to calibrate their measuring equipment.

This is where accredited calibration labs add value. These labs ensure that the equipment used by pharmaceutical companies is calibrated as per the required standards and can produce products that match the pharmaceutical quality as set by the MHRA or FDA.

Labs without accreditation can also provide good service and traceability; however, companies will need to verify these on their own. An accredited lab can demonstrate compliance with ISO 17025, which they can only receive if they meet all the requirements for quality and traceability.

Accredited labs can also provide the appropriate calibration certifications for each instrument. This is a critical part of pharmaceutical regulations – it means companies can avoid problems during regulatory inspections, alongside fines, penalties and even product recalls.

Calibration Select is accredited by UKAS to ISO 17025:2017. We offer pharmaceutical equipment calibrations on-site and at our state-of-the-art labs. For more information about our calibration services for pharmaceutical companies, please get in touch here. We’d love to hear from you!