From psychrometers, to chart recorders and finally highly automated smart data loggers, pharma monitoring has come a long way. An insight by Ishan Dave, Enterprise Sales Manager, Inventrom
Temperature and humidity are critical parameters for several pharmaceutical manufacturing and storage processes. Over the past few decades, several guidelines dictated by WHO and FDA have come to place, and have been adopted by pharma companies across the globe.
Golden days of chart recorders and hygrometers
In the old days, wet and dry bulb hygrometers were the last word in temperature/humidity logging and in-fact, are still in use in a few pharma companies. While these are reasonably accurate and dependable, it is incredibly hard to maintain them over a long period.
Firstly, it should be ensured that sufficient purified water is present in the cistern and that the wick is clean and wet at all times. Secondly, the wick has to be kept clean and often needs replacement as well. Even logging data requires extensive human intervention, which ends up taking a lot of time and resources.
In the past, another device used extensively in pharma companies for monitoring temperature and humidity was the traditional chart recorder. Chart recorders use bi-metallic coil technology. A pointer, or stylus, is attached to the end of a bi-metallic coil, and that moving pointer can record temperatures on a strip of moving chart paper beneath the stylus.
While these recorders make it easier to retrieve historical data and observe large excursions in temperature/ humidity, they are often not accurate enough to meet stringent pharma monitoring guidelines. Also, mechanical equipment with coils and moving parts are susceptible to mechanical wear and tear. Furthermore, newer WHO GMP guidelines dictate that not only should temperature/ humidity values be logged, but the monitoring equipment must alert the right personnel remotely if there is any unwanted excursion.
Enter – Data Loggers. Data loggers are digital instruments that use sensors to log and document parameters. Temperature and humidity loggers have already replaced the traditional chart recorders and hygrometers due to several reasons.
The benefits of going digital
Temperature and humidity data loggers are a large departure from traditional chart recorders. Not only do they log data in real time, but make data download + logging tamper proof and automatic. This means that pharma companies no longer need to keep a human resource who manually logs data from recorders every two hours, and can also rest assured that the data recorded does not have any scope for human error.
Going digital also makes remote monitoring easy. For example, Inventrom’s BTHM – Bolt temperature and humidity monitors allow environmental conditions to be monitored so that any out-of-range condition triggers an SMS, email message or desktop alert on a computer or the company network. BTHM’s dedicated online dashboard also lets you analyse data in real time and allows you to download temperature/ humidity data for audit reports.
The future
IoT devices like the BTHM are cutting edge in temperature/ humidity monitoring for Pharma. More and more companies are shifting to IoT solutions, as the modern solution for temperature and humidity recording. Does this spell the end for chart recorders in the industry? Not necessarily. What it does mean is that products like the BTHM, which boast a wide sensor range, higher accuracy and real time visibility into pharma operations are slowly becoming the norm for critical process monitoring.
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