Some revolutions are violent and disruptive. Some revolutions are quiet and consistent. Process analytical technology (PAT)
is certainly disruptive, but its adoption has been quiet and relegated to isolated pockets within the industry. As with any
revolution, the skepticism abounds on whether this new way of doing things will stick. Simply put—is it worth the risk to
change?
The pharmaceutical industry enjoys both the world's highest profit margins and intense FDA scrutiny. High margins blunt the
economic incentives for continuous process improvement; heavy regulation stifles technical change. As a result, the pharmaceutical
industry has fallen behind other automation communities.
And so, ironically, this science-based industry does not apply anything close to current science to its manufacturing side.
Process analyzers have played a role in chemical manufacturing for more than 60 years. PAT offers the chance to help close
this gap with our manufacturing counterparts.
This past fall, a KPMG analyst reported that 72% of drug recalls are a result of manufacturing defects. Public safety issues
aside, manufacturing missteps on this scale impose a huge business drain—even before the costs of potential litigation. To encourage progress, FDA initiated "Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach," which defined PAT
as:
"Systems for analysis and control of manufacturing processes based on timely measurements, during processing, of critical
quality parameters and performance attributes of raw and in-process materials and processes to assure acceptable end product
quality at the completion of the process."
It is an exciting time to be involved in pharmaceutical manufacturing. At the same time, the proliferation of off-the-shelf
PAT options makes it tough to know where to start. So, what is a PAT novice to do? Start small—very small. Tackling easily
understood processes can make implementing PAT much more manageable.
Watching timely measurements show up live can be strangely satisfying. Whether you're plugging directly into a programmable
logic controller (PLC) or dipping into a SCADA (supervisory control and data acquisition) system, seeing what happens in near-real-time
is very powerful. This applies even if the process is already well understood. Building a knowledge foundation with PAT builds
momentum and excitement for the next bigger and more complicated processes out there.
The trick is to begin with the right process. Here's how to get started:
- Pick simple.
- Understand all the details and nuances.
- Evaluate the instrumentation you already have, and the information you can easily collect.
- Understand the appropriate intervals for collecting that data.
- Evaluate the tools available for reading and synchronizing the data.
Pick simple
The options for PAT can be overwhelming: A number of technologies already can provide amazing information in real time. For
example, near-infrared (NIR) spectrometry can provide almost instant quality assessment for identification of raw materials,
provide an analysis of complex mixtures or process byproducts, or sniff out counterfeits. The technique is fast and can be
configured to require little operator skill or sample preparation.
Integrating NIR into a production line is not a plug-and-play exercise, however. It demands time, resources, and knowledge.
Still, NIR's robust reputation can tempt PAT novices into selecting it as a first PAT solution. Resist the temptation.
Let's step back for a second and consider other areas of pharmaceutical manufacturing. Take water, the foundation of any pharmaceutical
manufacturing process. If a pharma company has periodic problems with its water-for-injection (WFI) system, it can foul up
a number of subprocesses. Moreover, WFI production can carry high capital and operating costs. Finally, WFI production is
usually well understood. A well understood, critical process with demonstrable influence on the bottom line: WFI can be the
perfect jumping off point for PAT.
Understand the details
Assume that a team is ready to begin delving into PAT and needs to get budgetary approval to begin investigating. They have
astutely picked a simple WFI process to show upper management where the money can be saved.
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