Learn about calibration definition in pharma. This article discusses calibration, its purpose, frequency and the ISO Standard for calibration.
Calibration definition in pharma is verifying the output of pharma process measuring instruments against standard reference values. If the output follows the standard readings, the calibration becomes successful, and the measuring instrument or device is safe for all process applications.
If, on the other hand, the output does not follow the standard readings, the calibration fails, and the instrument must be rectified or wholly changed. Otherwise, there can be chances of compromising the process integrity.
The primary purpose of calibration is to identify the incorrect instrument and to detect any deviation in its output.
Measuring devices or instruments are common in process industries for various applications such as manufacturing, quality, and safety. In these processes, the measuring device measures physical quantity, and depending upon its output, the main controller executes various decisions.
What is a calibration definition in Pharma?
In the pharma industry, calibration is used along with other quality improvement techniques to prevent deviation in the output specifications of various instruments. It is used to compare different measuring instruments with the standard instruments to detect and point out any faulty instrument, which keeps the pharma process within the accepted limits
Some reasons why calibration in the pharmaceutical industry is critical include the following.
What is a calibration
Maintenance Technique
Calibration is a maintenance technique that technical personnel uses to verify the working of a measuring instrument or device. Industries also keep a proper record of calibration activities for a particular device or process.
Regulatory Requirement
The main reason for performing calibration is the regulatory requirements. Regulatory bodies require pharma manufacturers to calibrate measuring instruments regularly. If not performed, regulatory bodies can issue a warning to a pharma manufacturer.
Calibration helps in accurately executing critical process
Pharmaceutical equipment uses various measuring devices for executing performance processes—for example, a Volume control system to accurately fill the desired volume.
Calibration enables measuring devices to measure the drug’s status at various manufacturing stages accurately and enables machines to decide accordingly.
Calibration helps in detecting faulty Instruments
In the pharma industry, chemical compounds frequently come in contact with measuring devices. Although these measuring devices are protected against foreign bodies, these chemicals can still affect the device’s performance. Regular calibration helps in detecting the faulty instrument.
In addition to chemicals, various mechanical factors such as movement and vibration affect the measuring instrument’s performance. Often, this effect is temporary and can be corrected by simple adjustments. Again, calibration helps to identify these deviated instruments.
What is a calibration frequency?
It is necessary to calibrate the measuring device at regular intervals. Otherwise, calibration procedures will not be able to detect faulty devices. Additionally, it will also not fulfil regulatory requirements.
Before executing calibration, it is necessary to prepare a calibration plan, commonly yearly. This plan sets the calibration frequency for every instrument installed at the facility.
Commonly there are three calibration frequencies – Monthly, Quarterly, and Yearly.
But how often calibration should be done and what frequency to follow depends on many factors. The calibration frequency for the same device type can be different for different industrial applications.
Below are some factors that determine the calibration frequency of an instrument
Manufacturer’s Recommendation
The manufacturer’s recommendations are the most common method to determine the calibration frequency. The manufacturer defines the calibration detail, including the frequency, in the maintenance manual.
Instrument’s Usage
Instrument Usage is a critical factor in determining the calibration frequency. The calibration is frequently performed if an instrument is frequently used in recording process variables. On the other hand, if an instrument is not frequently used, its calibration is not as frequent.
New Installation
Every time a new measuring instrument or device is installed, it is necessary to perform its calibration. Because calibration identifies any faulty instrument before taking it into operation. Or sometimes, a minor adjustment in the instrument is required for its operation.
Calibration after installation also helps to adjust and control instrument parameters according to the requirement of the system—for example, calibration of temperature measuring device before using it to record process temperature.
Operating Environment
The calibration frequency also depends on the environmental factors in which an instrument is being used. Because various environmental factors have varying effects on the instrument’s performance, harsh environments such as high temperatures, high concentrations of dust, or other chemical powders require more frequent calibration than the instrument used in a clean environment.
What is a calibration standard for ISO?
There are various standardization and regulatory bodies for calibration methods development in the pharmaceutical industry. Their primary purpose is to develop guidelines for optimally performing calibration to fulfil the calibration objective.
Each market has its regulatory body requirements for calibration, but the ISO standard for calibration is commonly followed worldwide.
International Organization for Standardization – ISO is an international body primarily involved in developing standards for various industries and processes, including calibration. The current standard for ISO is known as ISO 9001:2015
Clause 7.1.5 of ISO 9001:2015, known as “Monitoring and measuring resources,” defines the requirements for calibration. The ISO awards accreditation status when a manufacturer fulfills its requirements.
According to this clause, the requirements of ISO are
- Always calibrate instruments and devices from ISO-certified laboratories
- Always perform calibration before using the newly installed instrument for the first time
- Calibration frequency must be properly defined
- Proper records and documentation should be maintained
What is a Pharma Calibrator
A pharma calibrator is a device used to calibrate other instruments and devices. It is also called a master calibrator, and it simulates real conditions to calibrate a specific device.
The pharma calibrator can simulate real conditions for testing instruments and devices. An instrument whose calibration is desired is exposed to the pharma calibrator. The instrument’s response (to be calibrated) is recorded and compared to standard values. If the instrument’s (to be calibrated) response lies in the acceptable range, calibration is said to be successful. Otherwise, it failed.
The Pharma calibrator must be periodically checked from an externally recognized laboratory. In other words, it must also be calibrated. Calibration certificates for pharma calibrators must be obtained and retained from the calibrating body.
For every physical variable, there are different Pharma calibrators. For example, a temperature calibrator is used to calibrate temperature-related devices and instruments. The same is the case with other variables such as pressure, level, and airflow.