Cause and Effects of Microbial and Particle Contamination in Your Facilities

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TSI Incorporated

At Interphex 2014, Todd and Todd interview Tim Russell, Field Market Developer with TSI Incorporated to discuss how to detect potential contamination events before they occur.  This podcast discusses risk mitigation and the best practices of microbial and particle detection in critical environments for pharmaceutical manufacturing. Also discussed is the methods and roots of contamination.  TSI recently introduced an innovative Portable Viable Particle Counter for monitoring of clean room facilities.  This product combines total airborne particle counts, viable particle counts using patented technology, and integrated sample collection in one instrument.

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Interview Transcription:

Todd S:    Alright, good afternoon and welcome back to Life Science Connect Radio. I am your host, Todd Schnick, joined by my friend and colleague, Todd Youngblood. Todd, the countdown continues to New York City and Interphex 2014. We're just days away now, continuing to look forward to this great event.

Todd Y:    Yes, and I'll tell you what, Todd, you and I are the lucky ones, because we're getting touch base and pick the brains of some of the really smart folks that are going to be at that event, so we're getting a head start.

Todd S:    We are, we're having a great time. Leading up to Interphex, Life Science Connect Radio continues our series of great conversations from some fascinating industry leaders leading up to the event, so let's get right to it. On today's show is Tim Russell. He is a field market developer with TSI Incorporated. Tim, welcome to the show.

Tim:    Thank you very much, delighted to be here.

Todd S:    Well, delighted to have you. Tim, before we get into our conversation, take a few seconds and tell us a little bit about you and your background.

Tim:    I've been involved in contamination monitoring, or particle monitoring now for about 28 years. I've worked for various different manufacturers, installing, maintaining, and calibrating monitoring systems in aseptic processing since probably the late 80s. I started my own business in 2000, developed monitoring software for the life science industry, and around 2008, my company was acquired by TSI.

Todd S:    Well, give us the 10,000-foot view of TSI Incorporated. What do you guys do? How do you serve your market?

Tim:    TSI really has many different product lines, but they fundamentally fall into two main categories, that of flow measurement, and the other one is particle characterization. TSI really is a world leader in particle characterization equipment.
    It's partnered with many research institutes and a lot of the technology that TSI is using has come from collaboration with universities over the years. One of the areas that we're going to cover today, or focus in on, is the contamination control group within TSI.

Todd Y:    Tim, keep going along those lines. Tell us more about how this technology is applied to contamination.

Tim:    In pharmaceutical manufacturing, or certainly in aseptic processing, that's for sure, and other processes as well, these processes are performed in very clean environments, clean rooms, and in order to demonstrate that these environments [INAUDIBLE 00:02:41] or are particle-free, they use something called an optical particle counter.
    This device that's manufactured by TSI is able to tell you how clean the environment is in which you are performing your critical processes. These optical particle counters are basically operating a fundamental principle called light scatter.
    It's a bit like if you see, sitting in a room on a bright, sunny day, and you see a shaft of light coming into the room, suddenly you see all the dust particles in the air?
    Well, this technology is that same principle, whereby we shine a very bright light, suck the air through a very bright light and as each particle passes through that bright light, it scatters. It will scatter the light and we can measure that and tell you how big the particles are, and tell you how many there are present.

Todd S:    Well, talk about airborne particulate and microbial contamination. How are the manufacturers – there's so much technology being developed at such a rapid pace. It's hard to keep up on all these new developments. How do manufacturers educate themselves on these new technologies?

Tim:    Optical particle counters itself hasn't moved on a whole lot over the years. The last 20 or 30 years, really, optical particle counting technology is pretty much the same as it was, although what's really happening is these instruments have gotten smaller, lighter, and have more features and functionality.
    As of late, there's some new innovation in this technique, which is real time airborne viable particle protection, which uses a different technique called laser [INAUDIBLE 00:04:09] fluorescence.
    The way people are finding out about this technology is through these [INAUDIBLE 00:04:15] far more online, for example, which produces a whole bunch of interesting papers from various different vendors, but also a lot of users find out about these new techniques and new approaches through attending and participating in PDA conferences, going to INTERPHEX, for example, and participating in all of those events, working with organizations like ISPE, and going to these events, you'll see the latest regulatory thinking, and also not far behind will be the vendors showing you all this new equipment that helps facilitate some of this new thinking.

Todd Y:    Well, Tim, most if not all recently of the manufacturers Todd and I have talked to or really focused on the recent FDA recalls, particularly the ones focused on microbial contamination. What kind of advice would you give to someone responsible for a manufacturing facility and keeping the high quality standards in their clean rooms?

Tim:    I think the best advice is – it's quite fundamental – it's to understand your process. Before you can get a really deep and meaningful understanding of your process, you really need to gather data associated with that.
    For example, you would use the optical particle counters, or portable particle counters, to understand where there are sources of contamination, for example, in your clean room. Where are the parts, where are the worst case scenarios? Where is your clean room performing well?
    Based on that data you've collected, you can start to build up a picture of your facility. You can start to, for example, map roots of contamination into your critical areas. Based on that information, that's going to build knowledge and understanding of your process.
    That fits in with the regulatory view of how you should monitor the particulates. You collect data, build up information, understanding of your process and it builds to greater knowledge. You cannot achieve high quality standards unless you understand your process and you have monitoring data to support that.

Todd S:    Tim, I want to continue talking about the FDA. Help me better understand their role in particle counting and microbial detection. Give us a little bit more understanding of what they do there.

Tim:    The FDA, and regulatory authorities globally established guidance. That's one of the first things they did, is establish guidance regarding, for example, aseptic processing.
    There's some well-established guidance that's called aseptic processing guidance, 2004, and [INAUDIBLE 00:06:42], which is mostly adopted globally, which details what that level of expectation is in terms of how you should monitor your critical processes during manufacturing.
    Then the FDA and other regulatory authorities will come out and audit your facility and expect you to be following these guidelines. At another level, the regulatory authorities are encouraging innovation in industry.
    For example, rapid microbiological methods is the very key part of some of the FDA initiatives right now, because it enables people to understand the level of cleanliness of their environment very, very quickly, rather than having to wait three or four days, as is the current state things is right now.
Todd Y:    Tim, you gave us just then a little glimpse into your crystal ball, with the real-time monitoring. What other things do you see on the horizon? What kind of things are pharmaceutical manufacturing facilities going to do in the future to assess risk and respond to it?

Tim:    Well, there are various different things going on right now. One of the interesting things that we're seeing and hearing is that, for example, in a Grade A manufacturing environment, or an ISO5 aseptic process environment inside an isolator, these areas are very, very clean.
    We're hearing from some manufacturers that they'll see no microbiological contamination in these environments, in possibly three years. What's starting to happen – and three years is a long time to see nothing, so what's starting to happen is that the current technology that's measuring these very clean areas isn't seeing anything.
    It's starting to get down to the noise. I see, moving forward, more emphasis on monitoring and demonstrated control of dirtier areas, areas further away from those clean zones, to be able to detect potential contamination events before they occur in these very, very clean areas, because quite frankly, bugs don't just appear, and microbes don't just appear in these very clean, isolated environments. There is a method, a root of contamination. We've been seeing possibly more emphasis in monitoring those dirty areas.

Todd S:    Tim, I understand we're going to see you at INTERPHEX. We're looking forward to that. What are you hoping to achieve here? What are your objectives by attending this show?
Tim:    Well, we're hoping to spread the word about our new rapid microbiological method, which is real-time viable particle counting, really show people the real benefits this technology can offer, how end users can become more competitive, using this technique, rather than waiting five days to see whether or not they have microbial contamination.
    They can find out right away, but at the same time, we're also looking to learn from end users as well, hear what they have to say, see what they're looking for, and shape our offerings accordingly. I'm really, really looking forward to being there. It's always a very, very good show and I'm going to be very excited to be there.

Todd S:    Well, we're excited to get a chance to meet you, Tim. I hate to say it, but we're about out of time. Before we let you go, how can people get in touch with you and learn more about TSI?

Tim:    You can contact TSI at www.TSI.com. It's a very comprehensive website, if you want to get in touch and tell you more about our products and offerings. We'll be in touch, if you want to contact me directly, at Tim.Russell@TSI.com. I'll be pleased to answer any questions you may have.

Todd S:    Tim Russell, field market developer with TSI Incorporated, Tim, it was a real pleasure having you. Thanks for stopping by and joining us.

Tim:    Thank you.

Todd S:    Alright, that wraps this broadcast. We'll enjoy seeing you at Interphex in New York City, March 18th through the 20th, and you can catch Life Science Connect Radio, broadcasting live from booth 1265. On behalf of today's guest, Tim Russell, my cohost, Todd Youngblood, I'm Todd Schnick, we'll see you soon on Life Science Connect Radio.