Contamination Control Strategies in Pharmaceutical Manufacturing Explained

Ryan Murray, senior consultant, ValSource, discussed key themes from the presentation he moderated at PDA Week 2026 in Denver, which is taking place from March 22-27. The presentation, titled Innovative Contamination Control: Far-UVC Technology and Risk-Based Approaches, featured topics including far UVC technology, holistic contamination control strategies, and the critical role of environmental monitoring.

Murray addressed audience questions about far UVC technology, which is increasingly being adopted in pharmaceutical manufacturing and healthcare settings for continuous decontamination. A common concern with any form of continuous radiation exposure is material degradation, but Murray offered reassurance on that front. He explained, "With continuous decontamination at 222 nanometers, there is some degradation concerns, but those concerns happen far beyond the life cycle of any fixed piece of equipment or product contact surface or anything else that would be a legitimate concern for a pharmaceutical manufacturing operation."

Murray highlighted the contributions to the presentation by Takeda, whose contamination control approach aligned closely with Parenteral Drug Association's Technical Report 90, a framework built around a holistic strategy. Takeda examined every potential contamination source across their process, from material and people movement to cleaning procedures and environmental monitoring. Murray emphasized that this comprehensive approach is essential, "you can't really attack just some of them. It's a holistic approach."

When it comes to prioritization, Murray recommends identifying the most likely contamination sources with the highest probability of being realized, then working systematically through each category. Underpinning all of this is a robust environmental monitoring program, tracking microbial trends in critical and adjacent areas to evaluate whether existing controls are working. Regular data review and effectiveness checks ensure operations remain both in control and in compliance.

Transcript:

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

My name is Ryan Murray. I am a senior consultant with ValSource. I consult in the areas of contamination control, aseptic processing, particularly around the processing elements in that. So, I focus largely on technology transfer and commercialization strategies, so PPQ, process performance qualification, and all areas in and around that. I've worked in the pharmaceutical industry for a little over 15 years now. Basically, what's described in the Far UV space for continuous decontamination is 222 nanometers is what's, defined and what's been adopted in some pharmaceutical manufacturing spaces, but as well in healthcare system. So there was a question from the audience that brought that up specifically about material concerns. So continuous exposure to any type of radiation, whether that be gamma radiation or UV light, causes some potential for material degradation. And so, basically what he presented was that with continuous decontamination at 222 nanometers, there is some degradation concerns, but those concerns happen far beyond the life cycle of any fixed piece of equipment or, product contact surface or anything else that would be a legitimate concern for a pharmaceutical manufacturing operation. So there's really no concern with degradation in materials because of this technology. What Takeda presented was their approach that pretty much closely followed the guidance that's in, Technical Report 90 from PDA, which is the holistic approach to contamination control strategy. So what they did was identify all the different areas for a given process that could have an impact on the contamination control strategy, whether that be material, people movement, just movements throughout the facility, their environmental monitoring program, their cleaning aspects. And from that perspective, they took each of those categories, broke it down even further to look at what are the different factors that need to be considered to identify potential risk for contamination in each of those segments. And from there, you can't really attack just some of them. It's a holistic approach. So, as far as prioritization I think you go about it by identifying which are the most likely sources of things with the highest, likelihood of that hazard being realized, and approach it that way. And then at the end, you've covered all your bases from each of those different areas we discussed. So, with any contamination control strategy, one of the biggest aspects of ensuring that you're maintaining control of your environment, is, is how you're detecting it. So what are you measuring to ensure that you're in a state of control? And so much like with Takeda, one of the easiest ways to do that is through a robust environmental monitoring program. So based on the areas, that you identified hazards to be, the most critical areas for monitoring looking at that particular area as well as adjacent areas for microbial trends. That may be showing you where your particular control that you have in place for a specific risk that you identified is either working or not working. So from there, that kind of review cycle of looking at trending, reevaluating your data, and then going back to the effectiveness check, aspect of that particular control to see if it's remaining in control and if you're staying within a compliant state.