Equipment validation, also known as qualification, is a document prepared to provide evidence that laboratory equipment or instruments function according to the specifications of their required operations. Equipment validation offers the users with confidence of obtaining accurate results from the measurements taken from the qualified equipment. Each equipment has specific validation rules that allow it to function according to the specifications of the manufacturer. Equipment validation is conducted repeatedly on a planned schedule to maintain quality. At Biotechnical Services, Inc., we provide the best lab equipment validation in San Diego to ensure your laboratory equipment is accurate and functioning as required. We employ the latest technology in carrying out our analyses on various equipment.

Why Is There a Need for Equipment Validation?

Several reasons call for the validation of lab equipment. These are:

Instrument Qualification

Instrument qualification is documented evidence showing that the lab equipment is specific, properly installed and that the lab environment is suitable and safe for use.

Operational Qualification

Operational qualification is documented evidence indicating that the equipment functions as expected according to the manufacturer’s specifications. It also proves that the equipment is functioning according to the process requirements. At Biotechnical Services, Inc., we perform extensive OQ tests of the individual components of your equipment to ensure that your equipment is functioning as required.

Performance Qualification

It is documented evidence after a performance testing of the entire system, and importantly, all the components are making up the system indicating that the system meets the qualification protocol. Since the performance qualification tests the system as a whole, the software, hardware, and other accessories are firstly tested as a single unit.

Re-Qualification

If your equipment has gone through any repair, it must be tested to show that it meets the standards and is compliant. After equipment breaks down and a repair is done, re-qualification must be done for standard purposes. Biotechnical Services, Inc. offers comprehensive services of re-qualification after repairing your equipment. It proves that the equipment has maintained its accuracy and provides high-quality output.

Preventive Maintenance

It is a standard procedure for every piece of equipment to ensure that it functions optimally and according to the manufacturer’s specifications and the process. Preventive maintenance is performed after a performance qualification and re-qualification. At Biotechnical Services, Inc., we provide lab equipment validation that entails the preventative maintenance of your lab equipment at all times.

Types of Lab Equipment Requiring Validation

There are three classes of equipment or instruments used to manage the risks in the validation processes. These are:

Group A

Equipment in this group has no measurement capabilities or the requirements for instrument calibration. These types of equipment include centrifuges, vortex mixers, magnetic stirrers, and evaporators. The proper functioning of equipment in this class is managed through observation. Formal validation activities are not necessary for this group.

Group B

Equipment in this group provides the measured values and controls various physical parameters such as flow, pressure, and temperature, which need no calibration. Equipment in this group includes microscopes, variable pipettes, titrators, and thermometers. Group B equipment requires calibration, performance checks, and maintenance when verifying proper function.  The extent of validation activities in this group of equipment depends on the criticality of the equipment.

Group C

Equipment in this group are analytical instruments such as the computerized laboratory systems controlled by a different workstation equipment control, processing software, and data acquisition. Software validation is done to the equipment to make sure they are functioning correctly. This group’s equipment includes atomic absorption spectrometers, dissolution apparatus, electron microscopes, x-ray powder diffractometers, and diode-array detectors. At Biotechnical Services, Inc., we perform software validation for your equipment using the best technology. For your lab equipment in San Francisco, Los Angeles and San Diego, always contact us for the best lab equipment validation services.

Parameters of Validation

Accuracy

Accuracy in an analytical procedure indicates how close the parameter results compare with the accurate measure of such a parameter. Analysis of parameters is usually performed by comparing it to certified reference material, inter-laboratory comparison, and data from an independent validating method.

Precision

Precision refers to the degree of agreement of the test results when a procedure is repeatedly applied to multiply sampling through standard deviation of a homogenous sample.

Specificity

It can measure content unambiguously in other ranges such as matrix components, degradation products, and impurities.  An example of specificity is the spectra interference studies.

Limit of Detection

When using a specific method, the lowest amount of an analyte in a chosen sample that can be distinguished reliably is the detection limit. Limit of detection can be instrumental or non-instrumental in its measurement.  It is measured through visual evaluation, standard deviation, and the slope of the response.

Limit of Quantitation

The lowest analyte in a specific sample can be shown with acceptable accuracy, and precision is the limit of quantitation. The limit of quantitation is determined through the calibration curve, the standard deviation of the blank, and the standard deviation of the slope response.

Linearity

The relationship of the assay measurement and concentration on an analytical procedure range is linearity. A non-linear model of validation can be used when the linearity is challenging to attain. The purpose of linearity is to determine the measurement to concentration relationship.

Other validation parameters include:

  • Range
  • Robustness
  • System suitability testing

Best Practices to Follow in Validation

Management and Staff

It is vital to define the structure of your management and staff. Organizational charts should be used to indicate various procedures to be undertaken in the lab. Every staff member in the lab must be on the same page when carrying out operational functions such as calibration and maintenance.

Equipment and Reagents

Your lab equipment should be well designed, ordered, and installed. Records of the equipment should be orderly kept for the proper flow of laboratory validation tasks. All reagents should be safely stored in a suitable location in the lab. It is advisable to purchase lab equipment from a reliable supplier. At Biotechnical Services, Inc., we supply genuine lab equipment at fair prices to our clients. Contact us for any range of lab equipment or reagents.

Operating Procedures and Methods

Always have a sample plan for testing in your lab. Samples are usually divided into three portions. One sample is for testing, the second is for re-testing, and the third is for confirmation. Ideally, a lab should have enough samples for various analyses. After testing, analytical certificates and worksheets should be filled and properly kept for compliance purposes. Always validate analytical procedures.

Safety

Lapses in lab safety could cause disorder, distractions, error, and catastrophic risks. Mark lab materials carefully. Hazardous and poisonous materials should be labeled appropriately

Conclusion

Lab equipment validation is an essential aspect of keeping your equipment working as specified by the manufacturer. It is also vital to conduct equipment validation to ensure that your equipment functions according to the process in your systems. At Biotechnical Services, Inc., we offer a wide range of equipment validation to our clients. We have experienced validation specialists and modern equipment for various validation techniques. Contact us today at Biotechnical Services, Inc. for your lab equipment validation in San Diego, Los Angeles and San Francisco.