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!
