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JUL-AUG 2019

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38 INTECH JULY/AUGUST 2019 WWW.ISA.ORG By Kyle Shipps and Nathan Hedrick The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) pub- lish guidelines and requirements for process instrumentation. Guidelines such as "Process Validation: General Principles and Practices," by the FDA, and Annex 15 issued by the EMA offer in put to help drug manufacturers manage instrumentation correctly. The chemical industry has requirements for proof testing per IEC 61508 and IEC 61511, while the oil and gas industry must adhere to contractual agreements between buyer and seller, while also complying with government agency mandates. For example, a company pro- ducing oil from a well under an agreement with the Bureau of Land Management or other prop- erty owner may have to prove flowmeters at a determined frequency. Traditional practice drawbacks Because measurements are so critical to many processes, the traditional industry standard is to calibrate annually, even though it might not be necessary. For most companies, annual cali- bration is performed as a traditional ritual with no scientific basis, other than being the longest duration of time they are willing to risk. F ailure to calibrate instrumentation can negatively affect performance, while cali- brating too frequently can result in exces- sive costs without providing any benefits. The question is, how do you determine if calibration is needed? In many process plants, instruments are cali- brated annually, or based on some other time- based criteria. New instruments and technologies, combined with careful planning and study, allow plants to calibrate instruments at an optimal fre- quency, for improved operations and cost savings. In some cases, instrument calibration is deter- mined by industry regulations. In the water and wastewater industry, for example, typical flow - meter requirements are: • Flowmeters have to be verified at regular in tervals. • Verification has to be performed by a quali- fied third party and with an accepted inspec- tion method that is based on quality regula- tions such as ISO 9001. • A test report needs to be provided for docu- mented proof of verification. In the pharmaceutical industry, quality risk management has become a mandatory regu- latory requirement for drug manufacturers. A plan determines when instruments need to be calibrated, saving time and money by eliminating unnecessary work Flowmeters are calibrated to meet applicable standards using a certified flow calibration rig like this one found at Endress+Hauser's ISO/IEC 17025 A2LA Accredited Calibration Laboratory in Greenwood, Ind. Setting up an instrument calibration plan

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