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How Calibration for Instrumentation Impacts the Life Science Vertical

 

The calibration of tools and equipment is critical to the life science industry. The professionals who work within this sector require safe and accurate tools when they travel into the field or work under strict requirements in the lab.

The calibration process ensures life sciences manufacturers can trust the tools and equipment they use every day. With properly calibrated equipment, the chances of mistakes or errors will be drastically reduced. Appropriate equipment calibration also helps to lower the cost of manufacturing and production—when product quality is ensured during manufacturing, it mitigates the risk of repeated defects in production runs.

Calibration utilizes the scientific method to help predict impending miscalculations, allowing specialists to correct any errors identified during the process. Calibrating equipment economizes labor, time, and other production resources because it verifies product quality before it's too late to fix mistakes.

Calibration is beneficial to researchers and other life science professionals. Scientists and researchers need a set of reliable methods for accurate testing. As such, life science companies are required to perform a host of regular calibrations on their instrumentation in order to meet regulations. These processes can be costly, but modern instrumentation serves to simplify the process.

Legal Requirements for Calibration Instrumentation

ISO9001:2008-7.6, GMP, and WHO regulations and standards require that equipment and instrumentation be calibrated or verified at specific intervals. During these calibrations, equipment must be measured against strict standards that are easily-traceable to both national and international standards.

Plant operators should always remember that the responsibility of setting up and executing maintenance programs falls on their shoulders. The operational budget should always be a concern, and extending the time between calibrations may seem like an appealing way to achieve cost savings. However, plant operators also need to consider how far they can push calibrations before reliability and quality are sacrificed.

Once an instrument has been installed and has operated in normal working order for a time, the first recalibration step will offer insight as to whether that instrument is still operating within specifications. During checks like these, failed "as-found" problems are critical. These issues must be further investigated in case of possible impact on product quality.

Where to Calibrate

Calibration should always occur within accredited calibration labs when possible. Accredited facilities will be certified by ISO/IEC 17025 and ISO/IEC 17025 A2LA standards and be able to provide up-to-date documentation verifying such.

If an organization doesn't have access to a calibration lab or instrumentation is too cumbersome to move, calibration services can be conducted on site by certified professionals using a portable flow rig. These rigs don't offer the same level of accuracy that’s found in a certified calibration lab, but they can still calibrate instruments within tolerances of at least +/-0.25%. The accuracy of a portable flow rig depends largely on the type of equipment being calibrated.

Portable flow rigs offer companies provide convenience and work quickly. Depending on a plant's layout, it's possible for several measuring points to be calibrated in a short period of time.

Endress+Hauser regularly offers reliable, efficient calibration services to clients in the life science industry. To learn more about Endress+Hauser's calibration services, please review this case study detailing the calibration support we provide to a major pharmaceutical supplier.

 

 
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