How embracing new technologies protects your pharmaceutical products
As technology evolves to accommodate stringent environmental monitoring (EM) requirements, some companies struggle to incorporate new features into their existing facilities.
A webinar titled ‘On demand webinar titled “Navigating Pharmaceutical Environmental Monitoring in a Changing Industry” has outlined features of contamination control strategies companies should prioritise to stay ahead of potential breaches.
The webinar was run by speakers from four companies:
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Russo Consulting Group: Joel Russo, Pharmaceutical Microbiologist, Manufacturing & Lab Compliance Senior Consultant
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Consulting group Valsource: Fred Ayers, Senior Consultant in Microbiology
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Pharmaceutical company Merck & Co.: Christine Caruso, associate director of global microbiological quality and sterility assurance
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Pharmaceutical company Charles River Laboratories: Mirna Vazquez, associate product manager
Russo referred to the EM programme as separate rings of control that protect a core product while emphasising the importance of a risk-based approach. Each ring represents an aspect of the strategy such as procedures, facilities and airflow.
“All of those things together comprise the shell of the product,” said Russo. “A breach in any one of those rings may not mean that the product is in danger, but you may want to be more active in finding out why that’s happening and getting rid of that issue.”
If one ring has been breached, it is possible that the next ring could be breached soon after as the contaminant moves toward the product.
The importance of data
Relying on fast, accurate data is vital to obtaining a species ID, which enables scientists to understand the nature of a cleanroom’s encroaching contaminants.
“If you don’t have an ID, you never knew what was in your environment,” said Vasquez.
Real-time data is key to making an identification, as is embracing newer technologies that can process information more quickly, allowing scientists to act before problems become severe.
“The biggest thing is: how do we transition to newer technologies that allow us to be more proactive versus reactive?” said Ayers. “How we integrate those technologies into the current programs is one of the biggest things because you’re looking at your environment in a different light with a new set of eyes.”
Integrating new technologies
According to Ayers and the others, the new technologies should complement existing systems. To ensure this complementary relationship, scientists may consider the cleanrooms characteristics and ongoing processes—locations of people, high-touch areas and previous contamination events, for example.
“EM is really an indirect measurement of a lot of things which is why you have to use all your data,” said Ayers.
Considering these aspects of a cleanroom can enhance the precision of new technologies, encouraging a flow of quick and accurate information from the air and surfaces into data that guides decision-making.
Machine learning, AI and LIMS systems are some of the technologies that can keep a company ahead of potential threats.
“I’m still hearing about companies that are still paper based which to me is a really big shock,” said Vasquez. “I see it as an opportunity for us to use these technologies to our benefit and be proactive with our EM and understand where microorganisms are coming into our processes.”
Looking forward
Ultimately, expectations are shifting, and regulators are accustomed to seeing an acceptance of newer EM strategies.
“As industries are pushing toward isolators and closed processes, those companies that still have legacy open RABS and truly open aseptic processing with human intervention will experience more scrutiny because the industry is moving in a different direction,” said Caruso.
To achieve a proactive and comprehensive contamination control strategy, transitioning to newer technologies that support a proactive approach is key.
