Medical processes require precision, confidence, and absolute control. There is no room for mistake or ignorance. Therefore, absolute assurance that everything is in order is vital in medical procedures, chemical procedures, laboratory tests, or laboratory instruments.
But it does not mean that there is no risk involved. On the contrary, there is always an inherent risk involved with laboratory instruments and equipment. This is because these laboratory instruments are used for various processes, and each process is significant, no matter how small. Thus, all laboratory instruments are subject to validation.
Only a qualified and professional team is eligible for laboratory equipment validation in San Francisco. Thus, you need Biotechnical Services Inc. on-board to perform timely validation.
What Is Laboratory Equipment Validation?
Laboratory equipment validation is performing various quality checks and ensuring that the installed equipment conforms to the quality standards and is suitable for the desired operations.
From the initial stage of leaving the manufacturer’s place to installation in the laboratory, various instances might affect the installation of lab equipment and instruments.
The Inherent Risk for Equipment Validation
Risk is the combination of the probability of an unwanted event harming the instrument and the extent of that harm. There are different sources of harm, but their extent is different, and it is the job of the validation team to ascertain the potential harms and save instruments from them.
The risk to laboratory instrument validation comes from different areas, such as the staff, the environment, instrument handling, etc., which will be discussed in length in this blog.
Risks During Laboratory Equipment Validation
Biotechnical Services Inc. has an experienced team for laboratory equipment validation in San Francisco, which considers the below risk factors during laboratory instrument validation.
Point of Validation
There are different points in time when laboratory instruments are validated. The first point is the manufacturer’s place. Every instrument undergoes validation after its manufacturing. It is called commissioning, which ensures that an equipment’s design meets the authorized standard.
Though every piece of equipment is designed per the confirmed standards, an equipment’s design may differ. As a result, it poses a great risk to the laboratory once it has been put to use and also poses severe non-compliance risks. Thus, every manufacturer must ensure that each piece of equipment is validated after manufacturing, so problems can be detected in the factory for repairs.
Every piece of equipment comes with a manual specifying clear installation instructions and a suitable environment in which the equipment will perform the best and offer the correct results. The installation team must adhere to these instructions.
Though, there is also an inherent risk that the equipment suffered any damage during the transit. The first job of the installation team is to ensure that equipment is in good condition.
The laboratories are required to create a suitable environment for the equipment, for example, a flat surface, the right temperature, humidity, availability of required electrical connection, and other accessories which assist in proper functioning.
Most pieces of equipment fail due to non-maintenance of environmental conditions. Therefore, during the installation and future validation, the validation team must ensure the environment is suitable.
Following the manufacturer’s instructions can also save money and time.
Irregular equipment calibration is the most significant risk concerning laboratory equipment validation in San Francisco. Every piece of equipment faces wear and tear over time. The manner of usage and staff training is important in ensuring the equipment’s health. But timely calibration is most vital.
Calibration is the process of ensuring that the equipment offers accurate results. All instruments, such as weighing scales, centrifuges, etc., are subject to calibration. Therefore, the calibration laboratory must prepare a schedule for equipment calibration.
Usually, lab equipment and instruments are calibrated after installation, before undertaking an important project, on client’s demand, or before the equipment calibration period is over.
Every laboratory is required to have a calibration laboratory onboard which can ensure timely calibration; else, the instruments will offer inaccurate results, and the outcomes can be deadly. For example, a medicine can be weighed wrongly, a temperature for a chemical might be recorded inaccurately, and wrong quantities of chemicals can be mixed, which can be fatal to laboratory staff. The risk of equipment qualification is even higher.
How Biotechnical Services Inc. Can Help?
Biotechnical Services Inc. offers laboratory equipment validation services in San Diego, San Francisco, and Los Angeles. It has been doing so for the last 31 years and is known for its strict adherence to regulatory policies.
Our team of professionals has extensive experience, which confirms your staff and equipment’s safety. Timely validation is invaluable, and being in the field for decades, we understand it.
Contact us today for more information.