How Biopharma Cleaning Validation Can Be Life Or Death

Source: Alconox, Inc.
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pharma cleaning validation interphex interview

At Interphex, Todd and Todd interview Jeff Phillips, Senior Manager, Science and Marketing with Alconox to discuss the extreme issues in terms of product safety that are revolving around cleaning validation that goes all the way back to the early Penicillin manufacturing in the 1940's when it was first realized that having such incredible allergies to something like Penicillin and having these anaphylactic reactions that can kill people.

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Interview Transcription:

Todd S:            Good afternoon. This is Todd and Todd live in New York, Life Science Connect Radio on location direct from Interphex day #2. Todd, I think we're in trouble with this next one.

Todd Y:            You think?

Todd S:            It's going to be a fascinating conversation. Before we get to him, we're nearing the end of day #2 coverage of Interphex. It's been an amazing day. The conversations that we've had, the learnings we've gotten, it's been a fascinating day.

Todd Y:            It's a little bit like drinking from a fire hose, just trying to take it all in.

Todd S:            I'm telling you what, that is absolutely the case. Based on our pre-show chat this next conversation promises to be very interesting and intriguing. Say hello to Jeff Phillips. He is a Senior Manager, Science and Marketing, with Alconox. Jeff, welcome to the show.

Jeff:                 Thank you very much. I appreciate that.

Todd S:            We're glad to have you. Thanks for stopping by and joining us. I almost hate to ask, but before we get into a conversation around Alconox, spend a few minutes and tell us a little bit about you and your background.

Jeff:                 No problem. I'll actually keep this moderately serious until we get to anything that can be objectively silly. So, I'll keep this to a little bit of background for now because I know you guys are on a schedule and you've got to rock and roll.

                        Basically, background in terms of like whose Jeff, I've done a lot of things like analytical chemistry, pharmacology. I also have an MBA and things like that. So, I have both sides of the brain; the science stuff and the business stuff.

                        Basically I got pulled out of the lab a couple of years ago and they said, "Wow, you can actually use verbs to push mountains around," and said, "Maybe you can use whatever remaining grey cells that you have to try to talk about cleaning, cleaning validation and ways of being able to keep the industry on track."

Todd S:            Outstanding. Talk about Alconox. What do you do, how do you serve your market?

Jeff:                 I'm happy to do that. It's really easy working for a company like Alconox. It's owned by the same two families since the 1940's. It was one of the first detergent companies in the United States. It really set the ground and set the market in a number of different ways.

                        Like I said, the thing that's really wonderful about this company is that I actually get to talk as much technical information to people as I want to. When somebody calls, you actually will get to speak to somebody, not just as nutty as I am but actually somebody that understands the same type of issues that you're going to have in the pharmaceutical or medical device industry.

Todd S:            Talk about those issues, what are they?

Jeff:                 Oh boy. Like for instance, if you have an issue of needing to clean something out, people will often say, well, let's say I'm making aspirin or something. What's the big deal? You've got a bit of aspirin left over in the next one.

                        Well, I happen to be allergic to aspirin and if I'm taking a drug that has aspirin in it I got about 15 to 20 minutes to get my Epi-pen otherwise you can look through my pockets for loose change, which won't do me so much good.

                        There are extreme issues in terms of product safety that are revolving around cleaning validation that goes all the way back to the early Penicillin manufacturing in the 1940's when it was first realized that having such incredible allergies to something like Penicillin and having these anaphylactic reactions that can kill people.

Todd Y:            Unbelievable. You know Todd--

Jeff:                 That's an issue.

Todd Y:            If you're making pharmaceuticals you would maybe say, well that's a clean environment, but you don't think about the ramifications of someone who may have an allergy. That's fascinating. Talk about some of the actual products and some of the applications of those.

Jeff:                 Yeah, some of the products that we have like some of it I'm really proud of. We have a thing called [3:37], which is used for cleaning biological and proteinaceous materials. I like this one so much because there are a lot of enzymatic cleaners out there but because this is in a powder form, you can actually make it up fresh each time and have 100% activity each time.

                        When you start getting liquid enzymatic cleaners, the problems with them is that if it's sitting on the docks somewhere, you know, those are proteases. By definition, they're autocatalytic. They ain't going to be around--you know.

                        I've talked to some of the greatest minds in enzyme manufacturing in the world who say you can stabilize for three, six months on the outside. If something is sitting around on the dock, it ain't got no activity after a while. That one I certainly like.

                        I like our Solujet, which is used in a lot of CIP systems because Solujet is not only a higher pH but contains well-matched surfactants. A lot of people doing CIP cleaning and don't have surfactants in their cleaning are not getting as good cleaning as they really could and certainly does not cover as broad as a variety of pharmaceutical clean as they really could. So those are a couple of them. I have a couple others but will do those just for the time thing.

Todd Y:            Jeff, say you're providing some free consulting to our audience and I want to--

Jeff:                 Did you say free?

Todd Y:            Yeah, I did, free. You going to be all right?

Jeff:                 I don't know. I think I lost a couple beats there man.

Todd Y:            Let's say someone is our audience is responsible for making a decision, not only about cleaning products but the cleaning process itself. Talk us through how I should go about making that kind of a decision.

Jeff:                 That's a very, very good question. In order to do it you need to think about three basic things. These three things are; a, what is being cleaned off. In other words, it all about the chemistry. If you fight chemistry, you will lose. That is a truism. So, you need to understand the chemistry, discuss that chemistry so that you can match good cleaning chemistry with it. That's one.

                        Two, what are the materials of construction you're trying to clean the stuff off of. Why? Because you don't want to (blank) it up. You know, the bottom line is don't screw it up.

                        Number three, how is the cleaning being performed. Is it manual? Is it soak? Is it ultra-sonic? Are you worried about CIP systems or whatever?

                        These are the three main questions that if they are not asked and answered then run the other way from that company because those are the three biggest issues.

Todd S:            I have to imagine that there are other detergent companies, maybe even on this floor. Talk to me. You touched on it a bit but just summarize it. Talk to us about how Alconox is different.

Jeff:                 No problem. One is well; of course, you can get some great jokes by calling up and asking for Jeff. But in all seriousness, we have a technical department that is second to none.

                        Literally one of the most quoted books Innocuous Cleaning and Cleaning Validation my boss wrote. So, I can literally say he wrote the book. Even some jerk like me has done lecturing on this stuff in about seven countries and after this year it will be 15.

Todd Y:            World tour.

Jeff:                 It’s going to be interesting especially with my twin boys that are about to turn one year old.

Todd S:            Congratulations.

Jeff:                 At my age, man, you rock on. All seriousness, those are really, really important issues.

Todd Y:            We're here at Interphex, Jeff, and there's no small amount of time, resource, focus, money that goes in to exhibiting here. Why did you make the decision to do that?

Jeff:                 To come here to Interphex?

Todd Y:            To come to Interphex, yeah.

Jeff:                 Well, first off, we've been coming here for a number of years. The things is that we have serviced the pharmaceutical industry for literally over half a century. We understand this industry.

                        I was basically brought in, like I said again, not just for being silly but because I've worked in the medical device industry. I've worked in the pharmaceutical industry for years. We understand the needs of the pharmaceutical industry and we address those needs specifically and accurately.

Todd S:            We're nearing the end of day #2 of Interphex. Take Alconox out of it for a minute. When Jeff Phillips is walking around and I'm sure you're a keen observer of what's going on in the industry, what do you think will be the key take-aways when the gavel comes down and this event comes to a close? What will be the big take-aways for you?

Jeff:                 In terms of the technology here?

Todd S:            Everything. What have you learned? What technologies have amazed you? What trends are exciting you?

Jeff:                 I was going to say I don’t want to end this on a sour note. One of the trends that I've been more disappointed with is the cut back on R&D. You know, I don't want to mention any companies, especially those that are customers of ours, but I get rather dismayed when I see that R&D is being cut back tremendously and the focus is on who has a good idea that we can buy.

                        Because at the very base of something, a person has to decide or a company has to decide what are they? Are you are pharmaceutical company or are you a bank. Are you there just to go and buy things and turn a profit or are you there to make a pharmaceutical, to really come up with the next generation of pharmaceutical. It's a very discreet way of looking at things. Like I said, I didn't want to end on a sour note, man.

Todd S:            We won't end there. I promise that.

Todd Y:            That's interesting. That's not something we hear about maybe because people don't want to talk about it.

Jeff:                 As you can probably tell, I don't have a whole lot of things I won't talk about. In all seriousness, the funny thing is that because of so much talent being lost it's actually been tremendous for our company, for Alconox, because we supply so much of that information.

                        We help make that process of critical cleaning and cleaning validation so much easier. We've actually been having to hire people because we can't keep up with stuff. So that's good.

Todd S:            It's funny you say that because I was just about to ask you, where do you find the skill and the knowledge? Is that something you hire? Is it something you grow internally? Is it a little of both?

Jeff:                 It's becoming less and less common. Not to many years ago I did massive amounts of consulting and there were so many really bright and I say experienced consultants out there but a lot of them have either retired or shuffled off to Buffalo so to speak.

                        So, what has happened is that, you have corporate restructurings, you have people getting older and other things and what's happening is you just aren't going to see the talent. Not because there aren't plenty of bright people out there, it because their inexperienced and that's becoming an issue.

Todd S:            How do we turn that around?

Jeff:                 You need, again, people who are more visionary, who have a visionary spirit. Like I forgot the guy's name. The guy who basically started [10:57].

Todd Y:            [10:57 inaudible]

Jeff:                 Thank you. People like this who have more of that entrepreneurial spirit, that's really what we need. The problem is that with a hyper-focus on quarterly profit and on what can be done for the immediate stock price without thinking of long-term trends and consequences, I believe is going to be a serious detriment until some of that's turned around.

                        I'm hoping that what's going to happen is a lot of scientists and engineers are going to start forming their own groups and that you'll start seeing those starting to form, some of the next generation of companies that will bring that inventiveness back.

Todd Y:            That's an interesting perspective. Do you think that an event like this where you would assume most of the talent in the industry is under this roof, that an event like this can it kick-start some of that entrepreneurial spirit?

Jeff:                 Certainly, when they have mixers and when they have events where people can get together and talk, they feel relaxed, and maybe they see people in different industries. I know this may come as a shock but usually when people work with me they usually don't forget for either good or ill.

Todd Y:            I'm not going to forget this. Let me promise that as hard as we tried.

Jeff:                 Funny, my wife says the same thing. But, I've literally had a guy come to me 15 years later and say, "Hey, Jeff, how you doing?" Now it's when those situations happen and when you start getting people together that have seen each other and are in a more relaxed atmosphere or something, that's when I think people can be brought together and then you can have some change.

Todd S:            All right. On that positive note, we'll wrap this conversation. Jeff, before I let you go, how can people get in touch with you and where can they learn more about Alconox?

Jeff:                 It's easy. Our website is filled with boatloads of information, www.alconox.com. You can give us a call at 914-948-4040. My extension is 151. My name is Jeff. If you don't reach me there, just call the front desk type of thing and just ask for Jeff. Everyone knows me. I'm the loudest guy there.

Todd S:            Jeff Phillips, Senior Manager of Science and Marketing at Alconox. Jeff, it was a real pleasure. Enjoyed our conversation. Thanks for stopping by and joining us. That wraps this broadcast.

                        On behalf of our guest, Jeff Phillips, my cohost, Todd Youngblood, I'm Todd Schnick, Life Science Connect Radio's live coverage of Interphex. We'll continue tomorrow morning for day #3 of Interphex. We'll see you then.