Reuel Sample: Welcome to the KENX podcast. I am your host, Reuel Sample.

Our guest today is Jason Kelly, Vice President of Services, Lighthouse Worldwide Solutions. Jason has over 20 years experience in providing monitoring solutions to the Cleanroom industry and specializes in pharmaceutical, medical device, life science, semiconductor, aerospace, and military Cleanroom applications. Jason presents worldwide on current cGMP and environmental monitoring systems from risk management, system design, GMP protocols, system installation, validation, customer training, and system service support. He will also be a presenter at our upcoming Cleaning University. Jason, so glad you could be with us today.

Jason Kelly: Thanks Reuel. I’d like to say, and to the whole KENX’s team, are doing a great job with delivering knowledge to the industry. The more information and knowledge you have, the better empowered you are to make better decisions about every aspect of what you do. I really commend KENX and thanks for the opportunity to present at your next seminar.

Reuel Sample: Well, we’re very glad that you’re going to be with us. As I mentioned, you will be batting cleanup for us at Cleaning University. Your presentation is entitled “Digitalize your EM Contamination Control Strategy”. Can you give us a brief synopsis of what you will be presenting?

Jason Kelly: Yeah, we’re going to cover the origins of a contamination control strategy, and we need to understand a contamination control strategy, or CCS for short, is a strategy designed to enable a manufacturer to identify and resolve a control risk of contamination to the quality of their products, and to ensure overall end user protection. At the end of the day, the end user could be you or a family member. There will be an overview of the technical elements of a CCS looking at technical measures and organizational measures. We’ll also touch on risks and focus on the key elements of a monitoring system, such as the sounding locations, frequency of monitoring, the monitoring method and trend analysis, looking at alerts and action levels. We’ll also look at a case study where we can see the clear advantages of going from a paper-based analog system to a digital based system.

Reuel Sample: What will be some of the biggest takeaways that our attendees can expect at the end of this presentation?

Jason Kelly: I guess one of the biggest takeaways attendees would get is that there is advanced digital technology available in environmental monitoring on part of the accounting systems. These digital advancements can really make a difference in a contamination control strategy. Not only aligning to a more comprehensive CCS, there are closer alarms to data integrity, and this mitigates against operator error and bad data errors, which are a major issue using a paper-based system.

Reuel Sample: We’re with Jason Kelly from Lighthouse Worldwide Solutions on the KENX podcast. Let’s move away from cleaning university a little bit. What are you seeing as the biggest challenges in non-digital EM systems overall?

Jason Kelly: That’s a great question. Well, there are many companies still using paper-based EM systems, and the biggest challenges are about data integrity, which do not fit well with the FDA’s all color requirements. So using a paper-based approach when taking particle count data, for example, the operator has to take a sample and there’s a process that’s pretty labor intensive, and what can go wrong is the question. And if we look into it, there are a lot of things that can go wrong. For example, the operator has to verify if they have each printout from the particle counter to ticker tape, did each ticker tape gets scanned and signed? Thermal paper is used and it fades over time. Did they document exclusions and what reasons? Did they test, or do they follow the SLP tests? Did every test occur in a time sequence? Did they miss any tests locations? What was the data transcribed into the systems correctly and accurately, and was all the data transcribed accurately without any operator error mistakes?

Jason Kelly: So these are the challenges with a non-digital system, and it’s not a very cohesive system, and it’s very open to human errors, all of which can impact on data integrity and product quality and safety.

Reuel Sample: Digitalization is really about minimizing the human errors that are part of the process.

Jason Kelly: Absolutely. And it also creates better workflows and adherence to SLPs.

Reuel Sample: Which in the end, translates to better product to end users, to our patients, to our providers, all the way down the line.

Jason Kelly: Absolutely. You’ve got a clear pathway from when the sample was taken, who took the sample, the date and timestamp, the batch number. You’ve all that information that goes seamlessly into a digital system without any errors, without any transcribing errors, and locations are all tied into the digital system, which is really important. So it really aligns with the FDA’s all color requirements, which I’ll go into detail during the presentation.

Reuel Sample: The biggest challenge along those lines is actually committing to a digital system.

Jason Kelly: It is a little challenge because if you’re used to using a paper-based system, where do you start? And it’s actually not that difficult, to be honest, to move over to a digital system. And the last couple of years, we have been transitioning a lot of companies into a digitalized environmental monitoring system.

Reuel Sample: We were talking about the challenges, and we’ve been hearing from you and throughout the industry, digitalization and digital transformation. What does that mean to you in the end?

Jason Kelly: I guess what we could say, the key advantages of a digital transformation and environmental monitoring, for example. So when we look at particle counting and in particular portal particle counters when it comes to digitalization, what that means to me is that the digital transformation will have major advantages, such as reduction in labor time, reduction in human error, overall reduce costs, reduction in risks. You’ve automated the data collection, which increases data integrity, and improves the process and integrity and safety of products. So with a digitalized CCS, decision makers can make faster and better informed decisions regarding batch releases with automated data management system, which increases the data integrity and reduces the risk. So the coherence and the environmental monitoring system is just a small part of the overall contamination control strategy, and more and more customers are integrating all aspects together.

Reuel Sample: So we’re getting to the point where digitalization is no longer really an option. It is really going to be mandated in the life science industries in order to have a good product and a good traceability of what we’re doing.

Jason Kelly: I think the new [inaudible 00:07:08] draft when we have contamination control strategy and we talk about that, that really will improve the overall understanding that going digital is definitely the way to go because we have very good technologies out there, and they should be explored. And the overall benefits that you’re going to have from a digital system will far outweigh the old system, which was very labor-intensive and prone to mistakes and errors.

Reuel Sample: Looking forward to those case studies that you’re going to be presenting at Cleaning University to give real world examples of transformation into digitalization solutions.

Jason Kelly: Yeah, we look forward to sending that knowledge out there because we’ve been in this space the last couple of years, developing our products to the digital platform. And a lot of our customers are really seeing the benefits. And, if you look at the FDA Foray trees where you have FDA looking at [inaudible 00:08:09] companies and a lot of the Foray trees that they raised are for gaps in the data, of operator errors, mistakes transcribing the data, incorrect data going into their system. So it definitely will revolutionize and make major improvements in the overall product safety. And that’s what the goal of all of this is, to deliver safe products to end users.

Reuel Sample: We have been talking with Jason Kelly today, Vice President of Services at Lighthouse Worldwide Solutions. Lighthouse provides clean room monitoring solutions for air, liquid, and viable contamination. Please check out their website at www.golighthouse.com. Jason, thanks again for being here.

Jason Kelly: You’re more than welcome, Reuel. And I look forward to talking with everybody at the event.


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