Calibration of sophisticated instruments
- 1. Environment Monitoring Lab Anil Agarwal Environment Training Institute CSE India Arvind Singh Senger Principal Scientist- FSM/ Food & Drug, CSE, India Expert in- -Bioanalysis -Chromatography and Spectrometry -Data Integrity & Good Laboratory Practice’s. CALIBRATION & VALIDATION
- 2. Good Practices of analytical equipment management. Operation, Calibration, Maintenance
- 3. Calibration of an instrument is the process of determining its accuracy. The process involves obtaining a reading from the instrument and measuring its variation from the reading obtained from a standard instrument. The act or process of determining, checking, or rectifying the settings or gradations on a measuring instrument or other piece of precision equipment; the resulting condition of the equipment. The equipment used as a reference should itself be directly traceable to equipment that is calibrated according to ISO/IEC 17025. Frequency of calibration would depend on the tolerance level. When the objective of the measurement is critical calibration would need to be carried out more frequently.
- 4. Error, deviation, correctness, precision and accuracy Error is the arithmetic difference between the measured value and the true value of a variable. In a calibration, the error is nothing more than the maximum deviation of the measurement with respect to the reference value indicated by the standard instrument. Of course, the deviation can be positive or negative and will be zero if the value matches the reference value. Errors can be systematic or random (unpredictable). Systematic errors are those that maintenance technicians will try to eliminate by adjusting the instrument, or by applying correction polynomials to the measured values. The accuracy of an instrument designates its ability to indicate the measured value with little variation. Another way to understand this is with the concept of repeatability. On the other hand, the accuracy of an instrument is its ability to hit the correct value, i.e. it tells us how close it is to the real value. Accuracy shall be estimated as the positive or negative deviation observed when calibrating a device under certain environmental and mounting conditions, always following an established procedure.
- 5. Why is Calibration so Important? Calibration defines the accuracy and quality of measurements recorded using a piece of equipment. Over time there is a tendency for results and accuracy to ‘drift’ when using particular technologies or measuring particular parameters such as temperature and humidity. To be confident in the results being measured, there is an ongoing need to maintain the calibration of equipment throughout its lifetime for reliable, accurate and repeatable measurements. The goal of calibration is to minimize any measurement uncertainty by ensuring the accuracy of test equipment. Calibration quantifies and controls errors or uncertainties within measurement processes to an acceptable level.
- 6. CASE STUDY…… How to perform calibration?
- 7. Difference between Calibration & Validation of Equipment Equipment calibration deals with assessing the accuracy of equipment’s results by measuring the variation against a defined standard to decide upon the relevant correction factors. The equipment is accordingly adjusted to fine tune its performance to tally with accepted standard or specification. Equipment validation is a documented assurance that each constituent of the equipment is complying with the manufacturer’s specification under defined operating environment and standard. URS (User requirement specification) DQ IQ OQ PQ
- 12. Method or Test Validation Method validation is a process that is used to demonstrate the suitability of an analytical method for an intended purpose. Validation procedures have been developed by a variety of industrial committees, regulatory agencies, and standards organizations for purposes of quality control and regulatory compliance.
- 13. Method or Test Validation
- 14. Method or Test Validation & Stability
- 15. Method or Test Validation Robustness and Ruggedness The terms robustness and ruggedness refer to the ability of an analytical method to remain unaffected by small variations in the method parameters (mobile phase composition, column age, column temperature, etc.) and influential environmental factors (room temperature, air humidity, etc.) and characterize its reliability during normal usage. Robustness is ability of system to resist change without adapting its initial stable configuration , whereas ruggedness is a measure of reproducibility of test results under variation in conditions other than laboratory.
- 16. Method or Test Validation Case Study…….. How to perform method validation?