Lab Guide to Installation, Qualification, and Calibration of Monitoring Systems
Lab equipment management is vital for the proper functioning of the lab and the safety of end-users. Critical elements in lab machine management are installation, qualification, and calibration. All these procedures work together to provide proof of proper equipment performance and rectification for faulty devices.
Equipment management in the laboratory should entail a lot of thorough planning. If machines are not in good working condition, the lab will not perform at optimum efficiency. Apart from ensuring efficient lab performance, well-maintained equipment minimizes chances for skewed results that could negatively impact consumer safety.
Having proper preventive maintenance procedures will help reduce repair costs and equipment downtime. Preventive maintenance will also lengthen the machine’s life and contribute to cost-effectiveness in the lab.
Therefore, a practical lab guide for equipment management should give clear standards for installation, qualification, and calibration to ensure better performance and uptime.
Right from installation, adherence to standard operating procedures will significantly influence the performance of the machines. ELPRO acknowledges that lab machines and devices are at the core of the lab activities and that every lab guide must outline precise installation, qualification, and calibration procedures.
The qualification process assures that the machine after installation works efficiently and performs the intended job. Calibration offers evidence of the machine’s accuracy and precision.
Suggestion: Calibrated sensors ensure precise, reliable measurements. Find answers to basic questions about GxP-compliant calibration.
Installation and Qualification
After procurement and acquisition of lab equipment, installation follows. This process involves setting up a piece of equipment in its designated position in the lab. Many manufacturers usually attach a lab guide to show the installation procedure. Alternatively, the lab may request installation services from the device manufacturer or supplier at an agreed upon fee.
Qualification should follow the installation process. Qualification is a necessary procedure to ensure that the machine meets user requirements. The qualification lab guide outlines a series of inspections to show that the machine under test satisfies product quality requirements. Several good sources for these defining requirements are user specifications, instructions from the equipment manufacturer, and transfer reports.
Under the qualification stage, ELPRO recognizes three crucial procedures.
The first step is the installation qualification that seeks to prove the accuracy of the installation project. Apart from being the initial step in qualification, it defines whether the subsequent processes can occur. If the installation results in a fail score, all other qualification procedures cannot proceed until necessary corrections occur to pass the inspection.
According to the lab guide, there are several things to check when performing installation qualification. One can identify critical components that significantly influence the machine’s performance and check that they are all available. The best way is to look at the supplier’s list of deliverables and confirm that each one is present. For machines with accessories and consumables, one must be sure that all these are available for the device to work efficiently.
Lab machines require a clean environment, free from contamination, with favorable temperature and relative humidity.
Additionally, the machine’s operational utilities and resources should be available, including connection to a power supply, water, and drainage facilities. The installation qualification procedure confirms that all these requirements are in place before using the machine.
Operation qualification follows installation qualification to establish that the device’s operation meets the intended need. The process checks that critical operational requirements as stipulated in the lab guide have been adequately satisfied.
Lab monitoring utilizes temperature sensing technologies and control systems that need precise operational standards. Part of the operational qualification will check that the sensors are working as intended.
A significant step, as ELPRO explains, is temperature mapping of the unequipped lab facility. The intention is not to look for system accuracy or precision but to confirm that it operates as desired.
Another critical element of operation qualification is conducting alarm tests. That involves changing the parameters beyond acceptable limits to see if the system will detect the fluctuations and sound the alarm. One must check for the upper and lower limits alike. It is also mandatory to perform a power-fail test. It determines the machine’s response in the event of power loss.
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Key considerations are temperature mapping of the fully equipped lab and checking temperature recovery after opening and closing the door. The purpose of an equipment management lab guide is to establish concrete evidence that the machine works as intended and produces dependable results. Performance qualification is crucial for instilling confidence in the lab workers and comes in handy in proving regulatory compliance with pharmaceutical standards.
In more detailed procedures, performance qualification also looks into facility design specifications. In this stage, ELPRO also recommends the qualification of relevant utilities to confirm compliance with required standards. For example, one should ensure that a device that uses distilled water receives distilled water for operational purposes.
Equipment qualification goes hand-in-hand with calibration to ensure optimum efficiency, utmost consumer safety, and product quality. ELPRO designs robust and sophisticated sensors to ensure your lab maintains compliance.
However, any device will begin to show deviation in terms of accuracy and precision after use. That is why the lab guide must include procedures and standards for calibration.
While some machines may have self-calibration capabilities, it is prudent to use another test equipment certified to be accurate. In-house and outsourced calibration procedures rely on using a certified accuracy standard set by the national regulating authorities.
Calibration has two primary purposes. The first is to check whether the device under test is producing accurate and precise results. Accuracy relates to how close the result is to the expected, while precision looks at consistency in reproducing the result. The second purpose is to provide a chance for realigning the device if there are any discrepancies. Since today most modern temperature sensors can technically not be adjusted, they are typically replaced in this case.
There are several methods suitable for the calibration of lab monitoring solutions and equipment.
Liquid bath calibrators are excellent for calibrating small sensors and also offer high levels of accuracy. Due to their large size, the calibrators are not portable.
For calibration needs that require portability, ELPRO recommends dry block probe calibrators. They have a quick response time, but offer less accuracy than liquid bath models.
When doing the in-house calibration, one may consider electronic calibrators that are affordable and portable. However, one will need to calibrate at regular intervals to incorporate external calibration with more accurate calibrators.
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Successful equipment management depends mostly on the availability of resources. Qualification procedures require trained personnel, while calibration relies on proper test equipment.
Additionally, there must be administrative goodwill to make equipment management a standard practice in the lab by providing financial and technical support.