Equipment Calibration – In Pharmaceutical industry.

EQUIPMENT CALIBRATION
EQUIPMENT CALIBRATION

This article explains the detailing on Equipment calibration and Instruments used for calibration of equipment which is used in pharmaceutical industry.

EQUIPMENT CALIBRATION

What is mean by Equipment Calibration:

Calibration verifies the readings of a measurement equipment ensure they fall within specifications to improve the accuracy of the device and ensure consistent measurements in testing applications, in addition to that It may also include adjustment of the equipment to bring it into alignment with the standard.

Why Equipment Calibration is Required : 

The significance of calibration is that, it maintains accuracy, standardization and repeatability in measurements, assuring reliable benchmarks and results. Without regular calibration, equipment can fall out of spec, provide inaccurate measurements and threaten quality, safety and equipment constancy

If Equipment Calibration Found out of specification which steps should be Followed :

Step I : Check the Results whether really it is out of specification.
Step II : If it is out of specification Check the measuring Instruments weather its calibration dates are within the range.
Step III : Quarantine the instruments., Necessary  QMS documents will be done if required.
Step IV : Inform to engineering Team/Vendor for rectification of the same.
Step V :  After Rectification do the necessary calibrations again and if found well within the limit then can be used for further usages.

Importance of Equipment calibration in Manufacturing/Packing Operations :

Equipment Calibration plays a major role during operations in avoiding the production of inaccurate output, so the advantages of calibration for your machinery and measuring equipment cannot be overstated. There are several facets of calibration in manufacturing but in general, calibration is important in these two key areas:

  • Calibration for measuring equipment ensures that your quality control processes are accurate and that will produce the Quality acceptable products and those are not accepting that should be rejected.
  • Calibration for manufacturing machines creates a more efficient process by ensuring that equipment is operating as expected. Improperly calibrated or out of calibration equipment’s may  results unpredictable manufacturing results and inaccurate products.

Reason why calibrations of Equipment’s are important:

Accuracy: The most important reason that accuracy is a critical standard in manufacturing operations is quality, safety and efficacy of the finished products. Imprecise parts those outside of the required tolerance cannot be used because the likelihood of them functioning properly is very low.

In addition to above, inaccurately manufactured products caused by uncalibrated machinery can result in the following:

High rates of product rejection — Improperly calibrated machinery creates inefficiencies in qualitative production output and may results in bad Quality Product . If your quality control processes don’t reject Such products, your customers surely will and may results the market product Recall will cause huge cost incur to manufacturer.

Cost and Time overshoot — High numbers of rejected products will require additional production to replace them then these requirements will extend production time and threaten deadlines. They will also add process/production costs that cannot be passed on to the customer.

Reputation damage — Unhappy customers may leave poor reviews about your services, putting your brand and your pipeline of new customers in danger. In addition to that will impact on repeat orders.

Different Types of Instruments used in production area for equipment calibration in  pharmaceutical Industry as below :

 Instruments used for Calibrations.
Sr. No. Test Name Instrument used
1 RPM Calibration Tachometer
2 Noise Level DB Meter/Decibel Meter
3 CFM Calibration Anemometer
4 Light intensity Lux meter
5 Temperature Thermometer
6 Viscosity Viscometer

Need of Equipment Calibration

Calibration of equipment is not just desirable, it is rather a necessity. All measuring instruments, whether they are used in factories or laboratories need to be calibrated on a periodic basis to ensure they are offering accurate results. However, in factories and laboratories, measurement results are usually of a critical value. Deviation from accuracy can not only affect productivity but also cause threat to the life of workers. Hence, it is imperative that instrument calibration be carried out carefully and at regular intervals.

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