How to Laboratory Equipment Validation Procedure?

The laboratory equipment validation procedure is a standard and easy process. This validation process is an influential part of a laboratory. Before applying equipment in a new project, equipment validation is most needed.

Selection Qualification (SQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) are the four methods used in a laboratory for validating equipment.

Now, I will provide you with the definition of these methods. To justify the methods, let’s take a look at the whole article to find what you want.

Selection Qualification (SQ)

The first step is selection qualification, which means researchers need to select a project. This part is very important for lab equipment validation. Then, they give a design to the project.

Making a design is important before installing it. Because if researchers design it before making it, they won’t face difficulties, and they can do their work suitably.

They make a proper structure so that they provide the best service while installing the new instrument. They design the parts of the instrument through their imagination and research.

When they design it, they keep in mind where, why, and when they need to use it. So, they design their new formula accordingly. They set all the useful functions and avoid unnecessary elements.

Installation Qualification (IQ)

Now, the next step is to analyze the installation project. After installing the project, they analyze the project to make a report on it. According to their environment and needs, they give a visible look to their project. Then, they check the requirements list.

They determine the manufacturer’s conditions, buyers’ conditions, and instrument validation checklist. Finally, they produce a database report on it.

A user can face many problems while using equipment if the validation equipment isn’t capable of fulfilling their requirements. So, determining all the functions is important.

Operational Qualification (OQ)

Operational qualification is also a very important unit of equipment validation. This unit checks the working power of equipment. Working power provides an important impact on any equipment. If the working power isn’t satisfactory, anyone can’t use the equipment for their needs.

General functions, limits, specifications, and operating systems overall, everything is scanned through operational qualification.

Then, they write the information in the report. Before passing the final step, passing this step is very crucial. Mainly, this unit plays an important role in the equipment validation protocol.

Performance Qualification (PQ)

Performance qualification is the final process of validating an instrument. This process helps to demonstrate that the equipment performs according to industry requirements.

Before approval of the equipment, it needs to pass this step. Equipment is a very important aspect of the industry. That’s why everyone wants the best for their equipment.

Many projects can fail due to a single mistake. If the equipment can’t meet the required capacities, many risks can arise.

Why Does Laboratory Equipment Need Validation?

A laboratory works with pharmaceutical industries, hospitals, schools, and colleges. That’s why they need to deliver a lot of equipment to them. Most of these are related to healthcare. Students learn from the instruments of science. So, laboratory equipment validation is needed for a laboratory.

Validation equipment protects against unethical practices. If anyone mistakenly or intentionally adds wrong ingredients to medicine or anything, it can produce harmful effects.

Furthermore, during the manufacturing process, many mistakes can happen. The equipment can be produced differently than intended. So, instrument validation covers all the issues of an instrument.

When Does Laboratory Equipment Need Validation?

When a laboratory collaborates with other industries, it needs to validate the new equipment it creates for these industries. Even every new piece of equipment needs process validation.

Furthermore, when a piece of equipment is moved to another place, when adding more features, or when changing any features, an equipment validation procedure is required.

Equipment validation provides a valid certificate for the equipment. Also, through instrument validation, many uncertainties can be overcome.

Validation vs. Verification

Validation means an inquiry into equipment after production. This process assesses the outcomes, designs, regulations, and characteristics of a ready product.

But, verification means an inquiry of equipment during and after making a product.

Between the two, validation is more difficult because it assesses a ready product. In contrast, verification occurs during and after production.

In the verification process, if anything needs to be changed, it can be easily modified.

However, changing anything during validation is difficult. Nevertheless, both processes are necessary. For better results, both are needed.

Significance of Laboratory Equipment Validation for the Medical Field

A lab delivers many medicines and instruments for the medical industry. So, they must follow the laboratory equipment validation procedure. A single fault can create a significant risk for everyone.

Mainly, instruments and medicines are used for patients. Even a patient can die or become ill due to a mistake. Before sending any equipment, a lab should conduct a thorough equipment validation.

They can make their product secure and safe through laboratory equipment validation. Otherwise, life-saving instruments can turn into life-threatening instruments.

Protocols for Successful Equipment Validation

• Document Making: A document is required for legal authorization of the equipment. An informative document is a crucial element as it provides complete information about the equipment.

• Design: Standard equipment needs a standard design. Designs play an important role in equipment functionality. A well-designed instrument attracts users.

• Safety Capacity: Equipment must have safety measures in place. Without safety assurances, equipment can’t be finalized.

• Environmental Capacity: Equipment should function according to environmental conditions.

• Working Capacity: Ideal equipment has perfect and functional capacities. This applies not only to lab equipment validation but to all types of instruments.

• Electrical Connections: If the equipment is electrically powered, it should have flawless connections.

• Standard Operating Procedures (SOPs): SOPs are vital for equipment.

Conclusion

SQ, IQ, OQ, and PQ are four vital terms for validating equipment. These are essential for laboratory equipment validation.

If any laboratory collaborates with an industry, the laboratory should validate its equipment before delivery.

If they fail to conduct equipment validation, they may face crises in many cases.

FAQs

What is equipment validation, and why is it important?

Equipment validation is a process that ensures laboratory equipment meets industry standards, performs as expected, and provides reliable results. It prevents errors, ensures safety, and enhances efficiency.

What is the difference between process validation and equipment validation?

Process validation ensures that an entire manufacturing process consistently produces quality results, while equipment validation verifies that individual equipment functions correctly within the process.

How often should laboratory equipment be validated?

Laboratory equipment should be validated whenever a new instrument is introduced, after repairs or modifications, and periodically based on industry regulations to ensure consistent performance.