Our manufacturing sites use instruments to measure how a manufacturing suite’s environment is behaving. These instruments behave as sensors for specific measurements such as temperature, humidity, air flow, etc. Many sites use a Building Management System (BMS) or Environmental Management System (EMS) to visualize the behavior of an entire HVAC. Why is this important to measure? Environmental conditions are important for product stability.
Metrology: Mastering Measurements
Understanding Metrology
What do pressure, conductivity and RPM have in common? These are all measurements and sometimes needed as part of critical process parameters to manufacture medicines/devices at AbbVie. This is what encompasses metrology! Read on to learn more about this science and how it is used to measure our processes!
History
The word metrology is derived from the Greek ‘metron’ which means measure and the English ‘ology’ which means a subject of study. Metrology is the science of weights and measures. Metrology has its roots in the French Revolution when the motivation arose to standardize units. Before this, measurements were relative. People would often measure by using portions of the human body for example, the space from the extremity of one hand to the extremity of the other.
Measurements
Measurement is a process of determining how large or small a physical quantity is as compared to a basic reference quantity of the same kind. It is categorized by:
- Type or level: It determines how two property states are compared, such as through ratio, difference, or ordinal preference.
- Magnitude: the numerical value obtained through measurement using a suitable instrument.
- Unit: assigns a mathematical weighting factor to the magnitude, which is derived from a standard artifact or a natural physical quantity.
- Uncertainty: accounts for both random and systematic errors in the measurement process, reflecting the confidence level in the measurement.
Standards
Standards are a reference for a system of weights and measures, against which all other measuring devices or instruments are compared. Metrology technicians use standards to calibrate instruments. The technician calibrates by determining the deviation from a standard to ascertain the proper correction factors.
For example, a metrology technician uses a standard of 50 kg to determine if a scale reads the 50 kg correctly. If the scale reads 51 kg, then the technician adjusts the scale (calibrates) to read the correct number.
How is metrology linked to our processes?
Now that we understand metrology let’s see how it is linked to the pharmaceutical and device industries. Metrology plays a crucial role in ensuring the accuracy and reliability of our products. From method validation to reading process parameters, metrology guarantees the quality and safety of pharmaceutical products. Continue reading to learn more!
Environmental Monitoring
Analytical Setting
Metrology is also used in our laboratories. Here the inprocess, release and incoming testing is done. Pipettes, beakers, graduated cylinders, among other instruments require calibration to ensure correct measurement and testing of product and raw materials. In this setting, accuracy can be different than in manufacturing, e.g., at a lab scale weight can be in micrograms instead of kilograms.
Process Parameters
Another example of where we use instruments is to measure and track process parameters. For example, when mixing, the speed of the impeller is measured and controlled since this can affect the homogeneity of the mixing.
Oxygen is monitored in a bioreactor to determine if a cell is growing correctly.
Measuring hardness of a tablet is also important. This is used to determine if a tablet press is compacting the material correctly.
Examples of process parameters:
Hardness
Temperature
Pressure
Conductivity
Flow
