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Fill-Finish Podcast 4 – “Evolving Trends in Aseptic Processing”

Participants

  • Guest: Len Pauzer, President, Pauzer Consulting
  • Hosted by: Rizwan Chaudhrey

Rizwan Chaudhrey: Hi everybody, this is your host Rizwan Chaudhrey, and you are listening to the Fill-Finish Podcast sponsored by ApiJect. The show that shares expertise and all aspects of injectables, vaccines, and aseptic
fill-finish and today I’m delighted to be joined by Len Pauzer, President of Pauzer Consulting, and today we’re talking about Evolving Trends in Aseptic Processing. So first of all Len, it is lovely to see you or meet you. How
are you?

Leonard Pauzer: Fantastic, and yourself?

Rizwan Chaudhrey: I’m very well, thank you very much. Thank you for joining us for this podcast. Now, before we start talking about aseptic processing, would you mind giving listeners a quick overview of your company and your role?

Leonard Pauzer: As you said, owner and President of Pauzer Consulting, which has been established for four total months now. Prior to that, I had 10 years at IPS engineering doing consulting and design in the pharma industry.
Prior to that, I had 12 years working in manufacturing operations for large pharma like GSK, Sanofi, Merck, Schering-Plough and six years prior to that I was in the United States Army and I exited as a captain. Currently as part of my company, I am helping people start up aseptic facilities, equipment and doing that globally, on my own as an independent contractor and consultant.

Rizwan Chaudhrey: Well, congratulations, good luck in the new business. So, my very first question for you is, what area should the pharmaceutical industry advance the use of hydrogen peroxide used the pharma industry. For lay people like myself, perhaps you could explain what hydrogen peroxide is and why pharma would use in the first place?

Leonard Pauzer: Hydrogen peroxide can be used as hydrogen peroxide or used as vaporized hydrogen peroxide for disinfecting and cleaning. And, in some cases, a mild sterilant. Being a true sterilant, getting it with hydrogen peroxide is not always easiest but it definitely is a disinfectant. And one of the great reasons people use hydrogen peroxide, or have used it industry, is that when it condenses, if you use vaporized hydrogen peroxide, it condenses to water. Now, water can cause problems for some devices, but in most cases it’s a harmless byproduct where, if you use some other harsh chemicals, they leave different byproducts. They don’t condense as well, and so people prefer to use vaporized hydrogen peroxide. An example is a filling isolator would decontaminate using vaporized hydrogen peroxide.

Rizwan Chaudhrey: Would that be the main area used or other areas within pharma, that it is also used?

Leonard Pauzer: The history of it was, it started in the fillers. Filling isolators started using vaporized
hydrogen peroxide and very, very slowly, you know when I started my career, no one liked vaporized hydrogen peroxide because it didn’t work well. Then it was used really well in filling equipment. Then people started to expand it to rooms. Then they started doing it for buildings where they basically filled the room with hydrogen peroxide vaporized hydrogen peroxide to decontaminate or disinfect the space. And now, people are using it for pass-throughs or pass boxes, to bring in items from a dirtier space to a clean space. It’s grown slowly because everything grows very slowly in the pharma industry because of risk. Because hydrogen peroxide, even though it might be a parts per million, can affect environments. Some drug products, you need to actually reduce the hydrogen peroxide down to parts per billion from a safety perspective. From a human perspective, parts per million is acceptable, but some products. So it has grown, I mean if you look at a 20-year career I’ve had in pharma, it has gone from something people didn’t like to its it is mainstream in filling isolators. But I think that it has expanded, and it continued to expand into, as we stated, air locks, pass boxes because the current practices are an operator wants to disinfect something and manually wipes on down. They are going to put their hands all over with a disinfectant that may actually have hydrogen peroxide in it. But the problem there is, we all know, humans are the dirtiest feature in a cleanroom. So what do we do? We have them use their hands, which is the dirtiest point on a human. Now we’re using chemicals, which is great, and that does reduce the bio garden or the biomaterial trying to move over the particularly. I think there is a great future for hydrogen peroxide. I mean there are companies out there that are changing and how it’s generated some people will do, as I said, a vaporized hydrogen peroxide so we’re using a mist where they control the particle size of the droplets. But I think it’s just starting. I really think we can push this boundary. Now what slowed it down is all these companies have to invest in this equipment that someone may never buy.

Leonard Pauzer: So why you know why would a company like Fran Zeiler, SKAN, who make isolators invest money because they see a market niche. I think, for the pharma industry, use of pass-throughs where operators are wiping things down manually is, I mean hate to say this, is from like 1950. That’s a process from there. As we push our quality boundaries and want to get better quality products, I think we should, there should be some form of mandate from the agency’s pushing towards pass boxes that use some kind of non-manual intervention. Whether it’s automated, an autoclave is a good example, or something like that, but hydrogen peroxide can be used the same way. It’s also cheaper to run. Autoclaves are great at what they do, they use steam, but to generate steam at 128⁰C is a lot of energy. That’s why I believe it’s the way to go, because it condenses to water. It’s also better for the environment, in my opinion, as a byproduct or arla chemicals that you can vaporize there are some gases, you can use. There are still terminal sterilization using other gases, but condensing them is dangerous, expensive, and a leak from those could be failed humans. Hydrogen peroxide or vaporized hydrogen peroxide has less of those risks.

Rizwan Chaudhrey: One thing you said, obviously, so the human element is actually one of the main areas of contamination. I know automation is becoming more and more incorporated within pharma. Will hydrogen peroxide be able to be used in association with automation?

Leonard Pauzer: I see two there’s two questions I heard from that. One is, can the process itself be automated, which is yes, and it has been. All the cycles run automated, and they have measuring devices to say how much hydrogen peroxide went in, how much is condensed, and is it safe? The other pieces, can it be used with automation? As in the environment is highly automated, now will you destroy your equipment? It’s been proven, time and time again, in cleanrooms, if the rooms are designed, equipment designed right, yes, it can be safe to use, and it will not hurt your automated process and it can be fully integrated to build these automated systems.

Rizwan Chaudhrey: Another trend, obviously, is the use of plastics. So, what do you see in terms of the use of plastics, is it going to continue to grow within the pharma industry?

Leonard Pauzer: It is. It’s, again, this is another system I’ve watched for 20 years grow, but it’s so slow and what I mean by that is disposable systems using like plastic bags, plastic tubing, plastic containers. There are companies out there that are making plastic vials and syringes. There’s blow-fill-seal containers which use a plastic resin which is starting to grow, but this technology, blow-fill-seal, has been out for 30 or 40 years and it’s still just entering the aseptic arena. It’s a strong candidate, similar to plastic vials. Plastic vials, if I recall correctly, I think it’s three or four years ago that companies started launching plastic vials. Now, we’ve been using glass and had problems with glass, for my entire career, which is 20 years probably 40 or 50 years before that was ampoules, which again is a glass container. Glass is a great product, but it has some flaws. Plastics, unfortunately plastics in the pharma industry has been very slow. Like I have clients who still to this day. want to go back to stainless fixed tanks and pipes, even though the whole industry is trending for plastics. So, I think it will expand. I think it’s expanding anywhere that the product touches a system, but I think it can grow a little more. As an example, is a lot of people will use plastic tubing, plastic bags and then, when they get to the filling line, they use a stainless-steel needle to dose the product. And then, they have to wash those needles. There are companies that make plastic needles, but I’ve seen a mix match of that where everything is plastic up until the needle, and then they have this one part that has to be clean. And that’s the benefit of plastics is they’re disposable, you throw them out when you’re done. You don’t have cross contamination and you don’t need equipment to specifically clean them. Whereas if you use a stainless needle, now that needle has to go to a specialty device to clean it, you have to sterilize it, bring it back in where you can get these nice packs and plastics. Now, I will state that plastics cannot be used with all products. You have a product has to be tested with it but plastics are lightweight, can be more versatile. Glass has had a lot of defects that people had issues with and a lot of it’s in the forming process because they use E to form it.

Leonard Pauzer: If people don’t know, a glass tube is about 7-8 feet long. It’s actually cut into the individual sizes for the containers so that process does sometimes leave particulate, some imperfections. Tube glassing is better than mold glass which, in the beginning of my career, was still in the industry, now it’s almost completely gone. You don’t see molded glass that was actually formed in molds. But I do see it moving that direction, unfortunately it’s slow. You see plastic containers everywhere in the world. Medical devices actually taking plastics on quicker, but injectables and fill-finish facilities are slow to move towards it. I think there’s growth there too. As in what else could be disposable. I mean at the beginning of my career, if you threw away a whole system like that everyone say oh you just throw away $1,000 that’s terrible. But the cost of ownership for stainless was calculated and you’re actually sometimes breaking even or saving money, so I think we have to push the boundaries and say what is better. The reason why is because, if you want to deploy something quickly. Could you actually mix plastic devices and 3D printing to make a part for a fill line as in a stopper? Some rolls, probably, I mean a lot of people throw stones at me and say at the terrible thing because they have to be tuned. But I really think people need to start looking at what, how can plastics, containers, devices, parts for the line. We’re getting there slowly, but I hope to see a faster growth for them.

Rizwan Chaudhrey: One question comes to mind, though, is again when we talk about plastic, so that everyone talks about sustainability and plastics, obviously, if you if you talk about it is sort of contradicting that whole sustainable angle that companies are moving towards. How would you answer that particular question?

Leonard Pauzer: That I am with everyone that plastics are not great for the environment, but the glass that use for a vaccine, there is probably no way you would ever recycle that glass. Most companies that use that glass incinerate it. So, they double bag it, they box, it they ship it to an incinerator, even if the glass is empty. Because you never want to have a cross-contamination of whatever drug might have touched it. A vaccine, chemo therapeutic, a dangerous drug. So, there is no recycling of the glass. If you go to a doctor’s office, they put it into a sharps container. Think of it, it’s a plastic container, right? So, think about the that piece. Unfortunately, because of the risk to people/humans, we are wasting it. We are not recycling those containers today. Now if someone comes up with a way of doing it, which is us not spending more money and fossil fuels to make it sterile or clean, I’m all for it, as in a sterilization process or a decontamination process, they can remove the drop.

Leonard Pauzer: I’m all for it and I completely agree, but until we find that, I would rather, again, the reason why is because plastics are lighter. When I ship something, I’m costing more to ship it, which is burning more fossil fuels right or whatever fuel we use. Hopefully we’re using electric but how is it generated? So that’s how I would answer the questions on plastics. I am not everything should be 100% plastic. There are clients where I tell them X should be stainless because here’s why. Here’s the 50 great long-term reasons, but here’s the 50 reasons why this segment of your process should be plastic. I would never run plastic pipes for a pharma facility through the whole building. Are there sections of plastic tubing? Yes. Short distances, because you can’t clean plastics, as you could stainless.

Rizwan Chaudhrey: So, let’s talk about modular cleanrooms. Modular cleanrooms have been growing, but they are experiencing growing pains as they develop. So, how do you see them developing in the coming years?

Leonard Pauzer: So, modular cleanrooms actually have done very well the past few years. They’re just some great companies out there deploying them globally specifically for the pandemic. They’ve improved, again I’ve only had a career of 20 years in pharma, but in those 20 years, the same thing. Modular came out everybody jumped on board and then there was a lot of issues and growing pains with them.

Leonard Pauzer: I use an analogy any time I talk about modular cleanrooms. Modular cleanrooms are fantastic for engineers in the Asian market, they are okay for the European market, and they’re not great for the US. Here’s why. Different engineers globally design with less variability. A US engineer is very flexible, you can change the design, in the middle. A European engineer will get very upset if you decide midstream change. Asian engineers are exact. Everything will be perfect. I mean, as people know, the Japanese market is precision, if you go to that market. The problem is, is if you change something midstream in a modular design, you’ve already built the pod, and now you want to change a pipe route. It’s less flexible then stick-built because stick-built waits till the end to be built as you’re going through the building and it falls the pipe. So, your exactness as an engineer has to be better, which is great, It pushes engineers to be better and it doesn’t mean it can’t be done. But the problem is, in the US, we’ve come to this engineering thing, where you know we’ll wing it. We will take a 70% answer and that’s kind of our cultural thing and we’re successful with it. That 30% we could manage, you have to be a little more exact with modular because a change, it’s not as simple as telling a man in the field, oh move it here two inches. These are being built in factories. They’re exact to the drawings. There’s some field work and that’s the benefit of them. They’re exact, they’re seal tight, they’re built in great facilities. The other thing is they’re great rooms, they’re great modules, they deploy quickly, but very few companies have them. What I mean by that is, is say you’re a maintenance person and you get a hole in a traditional cleanroom wall, you’ve been dealing with that for 20 years. Now, I’ve got a hole in this wall. I’ve never done this before, it’s an education. It doesn’t mean I can’t learn it, it’s just a new process. So, you’ve brought in a new technology, which is fantastic, but that’s where 3-5-10 years down the road these facilities have to evolve. As in they’re going to get damaged. How do we repair? We have to teach people how to do that. Then the next step is, “hey I want to change it, because I changed a whole new product line and I’ll bring it into this modular suite”. What does that mean? Our engineers have to be trained to how to design for.

Leonard Pauzer: Again, I’m a proponent for them, I think they’re a great technology, but there’s a learning curve and I actually think the next evolution of them should be pre-built. Where you just put your equipment in. As in there’s a modular cleanroom just sitting in a warehouse, and I buy it off the shelf. Now people think that’s crazy, but most of the high-tech filling lines have what they call an off the shelf version, still takes nine months to build, but it cuts the time in half, you get less flexibility you buy what’s off the shelf, but it gets it to market quicker. I hope cleanroom modules, some people refer to them as pods, some call them truckable solutions, connexes refer to that, I think I think it’s the way of the future. I don’t see terribly many negatives, except for, in fact, we have to educate people it’s a new technology. Again, this follows VHP, this follows plastics; it’s a new idea and pharma is slow to move to it.

Rizwan Chaudhrey: You mentioned the pandemic just now. What industry hurdles were removed during the COVID period that may now return. Obviously a lot of things had to change quite dramatically to speed things up and get things to market and certain things were removed, obviously in terms of the process, so what do you think was removed and may come back?

Leonard Pauzer: I think it’s exactly some of the things we touched on was new ways of thinking. So, people had 50 ways of doing business and they were stuck in this is the way we’ve always done it, and this is the way we must do it. Now people say we don’t have time for that, we have people dying, how do we react? And so, what was removed was bureaucracy. If you listen to Warren Buffett, who’s in the finance industry, one of the killers of American businesses is bureaucracy. And pharma unfortunately has that and what was removed was people said listen, we just need to get things done properly with good quality standards and we need to remove the bureaucracy. and how that was done was teams were very focused, as if someone was working on a COVID project that’s all they worked on. And I see this, because I’m a contractor consultant I go and I see a poor person working on four projects at once. And they’re told they’re all priority. When COVID came, a few say focus on one project, do it right and do it well, and oh, by the way, do it quicker. A lot of norms changed people were allowed to focus on one job. They were allowed to actually push the envelope on new technology. That that’s how I got to do some odd projects. That’s how I got to do some blow-fill-seal, different classic technologies were used. Because people had to think differently, and a lot of bureaucracy was cut out and some bureaucracy is good and some of it is bad. Some of it is this way we’ve done it for 30 years. Okay, great. Does it add quality to the product yesterday? That’s a question I always ask, If the answer is yes, keep it. If the answer is no, we just added because we’ve always done it that way, that’s when you should challenge. So, I saw lot clients do that. They challenged their ways of thinking, they asked for new ways of thinking, they asked for new technology and they used them. I hope it continues, but I don’t know if it will.

Because if you look at how fast, some of these projects deployed filling lines they cut the timeline in half and saved good quality product, the budgets will probably increase because of the time, but I bet you if you look at the time the market would actually make up for the capital costs to get done faster. So, I hope it stays. Everybody thought that the regulatory was the hold up and that’s how we save time. I think the scientists at all the regulatory agencies, yes, did speed it up and had better communication, but it was the execution in the field which really got us to deployed.

Rizwan Chaudhrey: My final question is when can a flexible design become too flexible that it hurts the process and project?

Leonard Pauzer: I think everyone wants 100% solution, 100% perfect and everything that will happen in the future, we know. And, and where it starts to hurt the project or whatever you’re doing; project, process, people is that you get in a quagmire of so many design flexibility changes that you can’t actually finish the project. The project never finishes. It’s a continual project because you’re continually designing and not really executing. Again, the pharma industry is there for the health of people but it’s also a business, and if you can’t get to the market or to your patients, having the most flexible line in the world doesn’t help. The other thing is, you’re trying to predict the future. Well, maybe this will happen, and we need this option, maybe we need this option, or we need this option. Well, the thing is, you don’t know. People don’t like that in the pharma industry, they don’t like uncertainty, so there is going to be that 10% uncertainty where Okay, maybe we need to design ahead. The other thing is cost. If you put every option on your car. I use a car is a great example because everybody buys a car. You can get a base model car for $25,000 with options it’s $50k. It’s the same thing for equipment in the pharma industry.

Sure, I can add every option, but now I’ve priced my project to where my corporation doesn’t want to do the project because I’ve added every possible option. And then the other thing is complexity. Again, cars are a great example. There are features on my car that I will never use. I don’t even know how to use them. But they are a feature that I paid for. It’s the same thing when you make an automation system of a piece of equipment so complex because you’ve added every option, the operating end of it is one problem, but then the validation of it, proving that it will always repeatedly do it, makes your process so complex. Again, it takes forever to get to market, it costs an incredible amount of money, and you may or may not use that feature.

Leonard Pauzer: Now, I’m discussing this when you’re trying to commercialize, when you’re trying to actually make product. If you’re in a lab, and you’re doing research and development, it’s a different story because you’re looking to the future, you’re inventing a new way. As you scale up and you get to commercialization, being too flexible will hurt you from the ways I just said. Again, I like the 90% answer, which people don’t like in the pharma industry, they want the hundred percent. Because it means you, as long as we’re making good quality product that’s the thing. This flexibility gives you commercial flexibility. Or I can commercialize, I can bring a different product, and I can do this process now, but it’s not about the product it’s not changing you’re making a product.

Rizwan Chaudhrey: Thank you very much for that. We could literally talk for hours because there’s loads of stuff I’d love to ask you, but I know we have a bit of time. So, all I want to say is thank you very much for sharing the information. if people want to find out more about Pauzer Consulting, how can they get more information?

Leonard Pauzer: The best way is LinkedIn, Leonard Pauzer or you can use our Pauzer Consulting. It’s a small company with myself, so you know we don’t have it web pages; As I said, I’m a small business that’s been networked, so luckily, I got on this podcast because I’m well networked from old, let’s call it old school people to people type things. Butt yes, LinkedIn is the best option to get a hold of me at Pauzer Consulting.

Rizwan Chaudhrey: Well, thank you very much for your time today. It’s been really interesting. There you go listeners. If you’d like to learn more, then check out Len’s LinkedIn page and contacting him via LinkedIn. Thank you very much for listening everybody until next time see you soon and goodbye.


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