When using specific equipment, you want it to give accurate and desired results. Why? Because the equipment used in the laboratories, hospitals, medical facilities, research facilities, and even factories impacts the outcome. They must perform accurately. But how do you know if lab equipment is offering correct results? The process of laboratory equipment validation ensures that.
What Is Laboratory Equipment Validation?
It is the process of ensuring whether the instruments and equipment are offering the expected results or not. Every piece of equipment is designed according to accepted international standards to perform the underlying operations. Once installed in the laboratories, the equipment needs constant calibration and validation to ensure result quality.
The process of laboratory equipment validation has four steps: design qualification, installation qualification, operational qualification, and performance qualification.
Process Of Equipment Validation
The process of lab equipment validation is discussed below:
Design Qualification
Design qualification is the process of ensuring that the equipment is designed keeping the industry standards in mind and possesses all the capabilities required to perform the function effectively. The design qualification process takes place before it is installed. It is the manufacturer’s responsibility to ensure it.
If you are a laboratory that has bought and installed equipment, you don’t have to worry about the design qualification stage.
Installation Qualification
Under this process, the validation team ensures that the equipment is installed properly and that the atmosphere is favorable. The current flow, frequency, voltage, temperature, and humidity are tested to determine whether they are suitable for the operation or not.
The area of focus are:
- First, there is a proper power supply.
- The installation location is not cluttered. However, the machine should get the necessary floor space.
- Whether all the ancillary instruments are installed with it.
- Whether the equipment and other instruments are free from damage.
- Whether all instrument details and documents are kept as records.
- Whether temperature, air pressure, and humidity are favorable for the equipment.
- Recording all calibration details.
- Verify connections with peripheral units, if required.
Operational Qualification
This process ensures that the equipment is operating properly in the new place. Why is this process needed? During transit and installation, the equipment might suffer damages that can impact its functioning. The validation team tests fixed parameters, and results at specific ranges to see if the equipment will perform properly in the long run.
The focus areas include:
- Whether the system has effective display units and LEDs are installed.
- The temperature controls are properly functioning.
- Whether pressure controllers are operating effectively.
- Fans and fan-speed controls are on.
- The temperature distribution is even.
Performance Qualification
Performance qualification is the testing of the equipment to see whether it is performing consistently or not during routine operations. Continuous usage causes wear and tear and results in high tolerance, which isn’t acceptable. So performance qualification is performed in an environment that is similar to the routine one, deviations are detected, and calibration is performed to calibrate the equipment.
The focus areas include:
- Operating parameters and component inputs are as per standards.
- A list of data that should be recorded is present.
- Variability limits are defined.
What Are The Validation Protocols?
Every validation process revolves around certain protocols.
There is a standard operating procedure for performing validation which includes standard protocols.
These protocols are:
- A detailed description of the equipment or the process under validation.
- A description of the procedure for performing validation.
- Acceptance criteria for test results. Every piece of equipment has a tolerance margin up to which deviation is allowed.
- Criteria for revalidation or calibration.
Conclusion
To effectively perform laboratory equipment validation, SOP must be followed. Laboratories, hospitals, and other users must hire an experienced equipment validation service provider for effective validation.