Batch Repeatability through Instrument Performance and Diagnostics

Emerson's Kyle Knutson


Author: Kyle Knutson

Batch repeatability is critical in pharmaceutical and biotech manufacturing. Variations between batches that cause deviations require extensive analysis, either in real-time or post-process, to identify how to control and minimize this variation in the future.

The consequences of unacceptable batch variation can be anything from extensive maintenance hours, to temporary halts in production or even total loss of product. Choosing the right instrumentation can give users better visibility into their process and help them maximize their product output batch after batch.

Ensuring a high level of batch repeatability starts when you install your devices. Over time, changes to the integrity of the installation, such as water in junction boxes, corroded wiring, or failing power supplies, can create on-scale failures without insight as to where these problems occur. Using diagnostics like Power Advisory, available on instruments like the Rosemount 3051HT Hygienic Pressure Transmitter and the Rosemount 3051S Series of Instrumentation, can help manufacturers identify these issues before they can affect batch repeatability.

I like to think of Power Advisory diagnostics as tattletale diagnostics. It’s ultimately the transmitter telling the control room, “Hey! I’m working great, but the electrical loop isn’t and you should check it out!” Without this kind of diagnostic, users can find themselves spending hours repeatedly calibrating transmitters that seem to be working incorrectly; yet in reality, the instrument is working fine—something in the electrical loop is not. This 4:13 YouTube video, Power Advisory Diagnostic Technology – Rosemount 3051S and 3051, explains how Power Advisory diagnostics work.

The performance of instrumentation should also be assessed to make sure critical points provide accurate measurements. Temperature is often the most critical measurement for in-process and clean-in-place/sterilize-in-place (CIP/SIP) measurements. Using RTDs matched with transmitters using Calendar Van Dusen (CVD) constants provides the best accuracy for these critical applications. Instruments can also drift after CIP/SIP processes and require regular maintenance due to the large thermal swings. Choosing transmitters designed to minimize drift from CIP/SIP, like the Rosemount 3051HT Hygienic Pressure Transmitter, can minimize maintenance costs and ensure consistent batch quality.

This 3-minute YouTube video, Improve Batch Repeatability with the Rosemount 3051HT Hygienic Pressure Transmitter, explains this batch repeatability performance in more detail.

Finally, additional insight from other process diagnostics can help ensure continued process uptime and prevent batch or equipment failures. Hot Backup®, available on Rosemount 644 and Rosemount 3144P temperature transmitters, is a great example of a temperature diagnostic that utilizes temperature sensor redundancy to automatically switch temperature control from one sensor to another if an RTD fails. This capability ensures a batch in process or costly CIP/SIP processes can continue uninterrupted.

Process diagnostics can detect changes that might otherwise be overlooked. For example, changes in centrifuge vibration or pump cavitation can’t always be detected by a standard pressure measurement. However, using Statistical Process Monitoring through Advanced Diagnostics on the Rosemount 3051S Series of Instrumentation can give users additional insight into their process by monitoring variation in the process measurements. Having these additional insights can help detect batch or equipment issues before they become failures.

By choosing instruments designed to provide confidence in measurement accuracy and additional insights into a process, users can enjoy less time spent diagnosing instrument challenges and more time improving their process.

From Jim: You can connect and interact with other pharmaceutical, biotech and pressure measurement experts in the Life Sciences and Pressure groups in the Emerson Exchange 365 community.

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