Process monitoring is integral to manufacturing, as it monitors minute details of the process, product and equipment. It helps to keep track the process, enabling personnel to detect anomalies timely and initiate corrective & preventive actions.
For the pharma industry, process monitoring ensures quality in the manufacturing process and the output produced by monitoring every step and enabling personnel to mitigate deviation and prevent errors.
Inline process monitoring is an innovative way to monitor the process, where it measures, compares results, and makes decisions without halting the process. It is achieved by utilizing the latest sensing techniques and software systems, which are different from the traditional monitoring system and offer benefits that traditional can't.
What is inline process monitoring?
Inline process monitoring is a system where measuring / monitoring of the product is carried out without taking out or extracting the sample from the running production process in an equipment or machine. An inline sensor installed at an appropriate location automatically measures the current value and updates it in the recording system, which can later be retrieved. If required, the estimated value can also be used to adjust process variables to keep the process according to its design specifications.
The main advantage of this technique is its ability to take measurements without taking out samples from the production batch, taking this sample to the lab and waiting for results to be implemented.
Inline process monitoring enables monitoring quality parameters of the production process in a real-time manner. It enables manufacturers to adjust quality parameters in response to product deviations and can remove the erratic product from the batch.
What is the traditional process monitoring method, and how does it differ from inline process monitoring?
The traditional process monitoring method involves taking samples from the production process and physically taking them to the lab to perform tests. During this process, the process/machine is stopped until the results are out. If the samples pass the test, the process is advanced to its next stage. Otherwise, the process is altered and again tested. If the results are satisfactory, then the process is allowed to move forward to its next stage
This method differs from the inline in many ways, such as
● The process is halted throughout the testing process. Lab testing takes time, typically hours, depending upon the test type, and it can also take days to complete some tests. In this scenario, a batch takes more time to complete, increasing the time required for a product to market.
●The sample also requires safe handling throughout the testing procedure and appropriate storage conditions to prevent changing the sample characteristics.
● It requires resources, such as compliant humidity & temperature for safely storing the product during the time test results are awaited. Otherwise, it will change the product characteristics and eventually destroy the entire batch.
● There is a probability of human errors in the lab testing procedure. Although lab testing is performed through reliable and automated machines, human involvement cannot be eliminated, such as transferring samples from the production floor to the lab and preparing samples for testing.
●Lab testing requires a series of tests, sometimes many tests in a day or per batch. Stopping the process or machine every time to take a sample makes the process time-consuming and tedious. Additionally, in the lab, some tests require various stages until the final result, making the process time-consuming.
On the other hand, the inline method does not suffer from the limitations mentioned above and can be used to increase the productivity and reliability of the testing procedure.
How inline measurement is implemented in the Pharmaceutical industry
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