While we tend to think of pharmaceutical companies as having very sophisticated manufacturing processes, when we get into the real world sometimes we discover things aren’t what we’d hoped. Naturally such companies are very careful with processes and practices that have a direct bearing on product quality, but some of the ancillary activities might be a little behind the curve. One of those is instrument calibration.
Michalle Adkins spent a lot of time working in the pharma industry, and she calls on her experience in her article in the December, 2017 issue of Pharmaceutical Manufacturing, Improving Performance and Regulatory Compliance with Instrument Calibration. Companies in all sorts of industries have to calibrate instruments under requirements from ISO, API, FDA or just plain common sense. How they handle the mechanics and record keeping can be all over the map, even in pharma plants. As is often the case, the FDA says that calibration needs to be done, but doesn’t go into much detail on how.
[FDA] regulation places the burden for creating a compliant calibration program on the facility. It does not specify how or how often any specific instrument must be calibrated or checked. At the same time, when the facility is being inspected by a government agency for regulatory compliance, those details will certainly be examined. A facility will have to defend its calibration practices within its larger validation and verification programs. So ask yourself if your calibration program is appropriate for the instruments you’re using today, or if it still reflects the needs of less sophisticated process instruments of years past.
To Michalle, this is the dividing point: is your company taking full advantage of modern instrumentation or is it still using the techniques of yesteryear, both in how the calibration is done and how records are kept. Both elements can and should advance into the modern age.
Electronic records for product movement and manufacturing have largely replaced expensive and troublesome manual techniques. Unfortunately, in a surprising number of facilities, manual recordkeeping for process instrument calibration and maintenance persists. Since calibration tasks tend to be manual by nature, recordkeeping by hand often follows, but better methods are available. Just as electronic batch records improved manufacturing processes, they can also do the same for calibration.
She goes on to point out that many companies have procedures from the era of mechanical and analog electronic devices, back when it was often necessary for a technician to correct the performance of a device, even a brand new one. Fortunately, today’s digital field instruments are much more accurate and stable than their predecessors, and many have self-diagnostic and calibration features.
These capabilities have greatly improved the calibration picture. A smart transmitter can be linked to control and monitoring systems via a digital data network, which can communicate its internal diagnostic information along with the basic process variable. Since verification is a process rather than an event, it is possible to monitor the condition of all process instruments on a unit continuously while the process is running. Internal diagnostic routines can warn of a problem developing with any instrument. Calibrations still need to be performed, but they become opportunities to verify known performance, rather than to correct drift and errors.
Therein is the key difference: calibration verifies correct performance, rather than determining how much the instrument needs to be adjusted. At the same time, the condition of a given device can be monitored automatically using asset management software such as Emerson’s AMS Device Manager.
Effective companies automate the process of sorting through the [diagnostic] information by using an asset management system. Each smart instrument has its own record in the system, and AMS Device Manager can communicate with each instrument through plant networks. Using a communication protocol such as HART, WirelessHART, or a mix of both, the AMS Device Manager can poll each instrument following a pre-determined interval based on criticality. Each attribute has its appropriate operating range, and any critical deviation can be set up to trigger an alarm.
These capabilities work together to bring process manufacturers of all kinds into the modern age. You can find more information like this, and meet with other people looking at the same kinds of situations in the Emerson Exchange365 community. It’s a place where you can communicate and exchange information with experts and peers in all sorts of industries around the world. Look for the Life Sciences Group and other specialty areas for suggestions and answers.
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