Calibration is the process of configuring an instrument to provide a sample result within an acceptable range. It involves a comparison between a known measurement (the standard) and the measurement captured with your instrument.
Typically, the accuracy of the standard should be ten times greater than the accuracy of the measuring device being tested. However, a 3:1 accuracy ratio is acceptable by most standards organizations.
The accuracy of all measuring devices degrades over time. Devices with inaccurate measurements can harm product quality. Therefore, this is a topic that requires special attention.
It is necessary to keep equipment calibrated and validated to ensure the final quality of your product. But what is the difference between calibration and equipment validation?
The degradation of instruments, equipment, and measuring devices is generally caused by normal wear and tear. However, changes in accuracy can also be caused by electrical or mechanical shock, or by a hazardous manufacturing environment — with oils, metal chips, etc.
Depending on the type and the environment in which it is used, the instrument may degrade quickly or take a long time to do so.
Types of Calibration
Instrument calibration can be performed on different types of instruments across all sectors of the company. Some of the most frequently performed calibration services are:
- Pressure calibration.
- Temperature calibration.
- Flow calibration.
- Pipette calibration.
- Electrical calibration.
- Mechanical calibration.
The exact process of equipment calibration should vary according to the type of instrument, how critical its role is in the operation, and which standards are followed for calibration.
What is Equipment Verification
Equipment validation comprehensively and documentedly establishes that the instrument is operating accurately.
A validation process provides evidence that the components critical to the accurate operation of the equipment consistently meet predefined specifications and operational attributes.
The process involves identifying and quantifying each element related to the result produced during analytical measurements. Validation ensures that internal equipment malfunctions will not negatively affect the quality of the result.
Verification Protocol
The validation protocol is a written plan that expresses the method of performing the validation.
The main characteristics considered are the test parameters, product attributes, production equipment, and the decisive stages that define the scope of acceptable test results.
Difference Between Calibration and Verification
Equipment calibration deals with assessing the accuracy of the equipment’s results by measuring the variation against a defined standard. The equipment is adjusted according to the accuracy of its performance in line with accepted norms or specifications.
Equipment validation is a documented assurance that each component of the equipment complies with the manufacturer’s specifications. This is achieved by verifying performance against traceable control standards.
This provides absolute confidence in analytical measurements and ensures that the accuracy, reliability, and perfection of the equipment are not compromised in any way. However, to maintain the accuracy of an instrument in use, calibration is necessary.
Importance of Equipment Calibration
Calibration is important because it allows you to make accurate measurements, which is necessary for the quality, safety, and innovation of your services or products. This is essential in research, development, and improvement projects.
Many of the goods and services we use daily depend on calibration to function properly. This includes:
- Electronic devices: cell phones, computers, home appliances.
- Life sciences products: medical and pharmaceutical equipment, medicines, vaccines.
- Transportation systems: cars, trains, planes, and gas stations.
- Food industry: production, storage, and shipping of food.
- Science: research, development, and innovation in the scientific field.
The International System of Units (SI) is one of the main anchors in the world of calibration. After all, it allows almost all countries in the world to correlate their results with those of organizations from other nations. For example, an equipment manufacturer may define that its calibration be done at a certain temperature in degrees Celsius (°C).
Calibration allows testing the safety of a particular instrument or whether a product meets its manufacturing requirements. With this, you will be able to demonstrate the performance of equipment and ensure that it serves its purpose.
Importance of Verification
Equipment validation is the hallmark of assurance. It certifies the precise operation of an instrument under a range of environmental and operational conditions. At the same time, it shows that it firmly adheres to the correct operating specifications.
For example, non-compliance with regulatory requirements can make a company’s instrumentation ineligible for use in the sector. This can result in significant losses for the organization, further reinforcing the need for validation.
Instruments Requiring Calibration
Different industries have distinct calibration needs. After all, verifying an industrial oven is very different from checking the machinery of an automotive production line. Therefore, check out the different types of calibration instruments on the market:
1. Pressure Calibration
Pressure is fundamental for different industries, so equipment in this category is often used by organizations in various fields. For those aiming to achieve and maintain quality standards like ISO 9001, proper pressure calibration is necessary.
Some examples that need this type of calibration are:
- Barometers: Instruments used to measure pressure. They are essential in meteorology to predict weather changes and in altimeters to determine altitude.
- Digital indicators: Devices that display pressure, temperature, or other measurements in a digital format. They are known for their accuracy and ease of reading.
- Analog, digital, or test manometers: Instruments used to measure the pressure of gases or liquids.
- Transmitters: Devices that convert pressure, temperature, or other measurements into electrical signals that can be transmitted to control or monitoring systems.
- Transducers: Devices that convert one form of energy into another. In calibration, they are often used to convert pressure into electrical signals, allowing precise measurements and control of automated systems.
2. Physico-chemical Calibration
Organizations in the life sciences, food, and environmental monitoring markets are the ones that most use physico-chemical calibration in their activities. For these companies, even small variations can have serious consequences.
It is necessary to perform the best possible calibration to comply with regulations. After all, agencies like Anvisa are always keeping an eye on companies in these markets.
Instruments that require physico-chemical calibration include:
- pH meters: Used for measuring the acidity or alkalinity of solutions.
- Conductivity meters: Applied in measuring the conductivity of solutions. They allow for precise readings of samples in the production of medicines and food, as well as water quality control.
3 . Temperature Calibration
Make no mistake: temperature calibration does not just involve looking at a thermometer and then checking a table of acceptable values. Instead, calibration must be done with specialized devices, making comparisons with known standards in a stable temperature environment.
See instruments that require periodic calibration:
- Thermal cameras: They obtain images from the infrared radiation emitted by objects, allowing the observation of temperature differences.
- Dial thermometers: Analog devices that display the temperature on a dial with a pointer.
- Data acquisition systems: Used to collect, store, and analyze data from various sources, such as sensors and transducers.
- Infrared meters: Devices that measure the temperature of an object without contact, using infrared radiation.
- PRTs (Platinum Resistance Thermometers) and Thermistors: Temperature sensors that vary their electrical resistance with temperature.
Conclusão
Calibration and verification of equipment are fundamental processes for quality management in various industries. Calibration ensures that measuring instruments provide accurate and reliable results, which is crucial for maintaining product quality and operational safety.
Verification ensures that equipment is operating according to established specifications and standards, preventing failures and non-conformities that could compromise final quality.
Maintaining a rigorous routine of calibration and verification not only ensures the accuracy and reliability of results but also contributes to compliance with regulations and international standards. This is particularly important in sectors such as pharmaceuticals, food, and technology, where small variations can have significant impacts.
Investing in robust calibration and verification processes is investing in operational excellence and customer satisfaction. With precise and properly verified instruments, companies can ensure that their products meet the highest quality standards, promoting trust and loyalty in the market.
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