Laboratory Instruments

The essential technical resources in the life sciences sector are laboratory instruments. Instrument qualification and method validation allow successful data collection, and this requires a good understanding of problem-solving, prevention procedures and regulatory requirements.

At BioGlobaX, we have developed programs for instrument qualification, as well as new applications with the main focus on HPLC (High-Performance Liquid Chromatography) and UV/Vis. Our programs allow low-cost, reliable data collection to become a routine business practice.

Instrument Qualification

Analytical Instrument Qualification (AIQ) is the foundation for generating quality data. Then the next critical steps, analytical method validation, system suitability test, and quality control check samples, as described in USP 1058 (the last revision you can find here),  can take place. AIQ is a continual process over the lifetime of the instrument usage and consists of interconnected activities. It is important to establish the “fitness for purpose” program for every single user of the instrument. The program includes four phases: design, installation, and operational and performance qualifications. Changes to qualified instruments are required when users need them. They may occur if suppliers add new features or correct defects. Or if maintenance, relocation, or repair of the instrument can take place.

Instrument Categories:

A

It includes standard equipment with no measurement capability or usual requirement for calibration, such as magnetic stirrers, vortex mixers, and centrifuges, etc.

B

It includes standard instruments and equipment that provide measured values and control physical parameters, such as temperature, pressure, or flow, and which need calibration.  Examples of these instruments are balances, pH meters, variable pipets, refractometers, thermometers, titrators, etc.

C

It includes instruments and computerized analytical systems where users specify requirements for functionality, operational, and performance limits for analytical applications. Examples of these instruments are UV/Vis spectrometers, high-performance liquid chromatographers, mass spectrometers, elemental analyzers, etc.

In general, the industry still underestimates the need for qualification of the instruments from category B. But, they are a source of errors that multiply depending on maintenance, user training, and other factors. The establishment of procedures with appropriate control samples provides an error-free environment of operation.

Maximizing the Use of Category C Instruments

Category C instruments require more theoretical knowledge and practical experience than other laboratory instruments. Some of the instruments, such as HPLC, are very complicated to maintain. Government programs (Canada-Ontario Job Grant) support training on proper instrument use which results in an efficient error-free environment. It also enables individuals to get the most out of instrument capacity. Some instruments, such as UV/Vis Spectroscopy, are easy to maintain, and besides, they are persuasive analytical tools that are still not used at their full capacity. Therefore, the USP Chapter for UV/Vis Spectroscopy <857> was recently revised to reflect the need for more flexibility. Particularly, regarding the practical applications in the visible spectral range. Some UV/Vis-based methods can have significant applications in your laboratory practice. Their main advantages compared to HPLC methods are easily achievable reproducibility of the results and cost-effectiveness.

The USP Chapter for Chromatography <621> The USP Chapter for Chromatography <621> was also updated to help laboratories adopt new technologies. Mainly, it is valid when adopting HPLC methods with new generations’ columns or instruments. However, we should not accept the guidelines as perfect documents that we must follow. Often, HPLC operators may become confused if they rely mainly on the information provided there. A solid theoretical background is critical to managing the process and data in the chromatography world better. With us, scientists have grown more competent and confident in chromatography and its instrumentation. If you want to eliminate errors in the workplace, please do not hesitate to contact us.

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