The Past And Future Of Pharma Packaging

Bernie Giletta, President of PharmaSystems, takes some time at Pack EXPO/Pharma EXPO 2014 to discuss the major changes in package manufacturing.  As a 30 year veteran in the pharma packaging industry, Giletta shares his thoughts on the future of aseptic processing, and what pharmaceutical manufacturing facilities will look like in 10 years. 

Interview Transcription:

Todd S:       Alright. Good afternoon. Todd and Todd live in Chicago, Life Science Connect Radio day 3. Todd, the morning session was just unbelievable, the amazing technology, the amazing innovation-raising people.

Todd Y:       Yes, I just want to slow the whole pace down here because I don’t want this to end. This has been fun. Lots and lots of learning, lots of new insights.

Todd S:       We’re deep into day 3. Our next guest promises to be just as enlightening. Say hello to Bernie Giletta, President of Pharma Systems Inc. Bernie, welcome to the show.

Bernie:       Thank you for having me.

Todd S:       The pleasure is ours. Bernie, thanks for carving out some very valuable time for us. Before we get into our conversation, do take a few quick seconds, inform the audience about you and your background.

Todd Y:       I got a mechanical engineering degree from University of Detroit and went on to get an MBA at night when I was working for Becton Dickinson as a project engineer. Then in ’83 we started sales agency, myself and my partner Walter Dempsey. If you like, I would continue about the company, how it was formed, if that’s interesting.

Todd S:       Let’s talk about Pharma Systems. So give us the 10,000-foot view, what do you do, how do you serve your market.

Bernie:       Basically, we’re a manufacturer and sales representation and we started in ’83 with the cooperation of 2 major German manufacturers, Onin Pack Systems, that’s the packaging of solid oils. And Bausch+Stroebel for parenteral aseptic filling lines. Onin was actually established in America in the late 70’s but Bausch+Stroebel actually did not have any in-loads until we joined up and then with their help, we formed an agency, myself and Walter.

                      Walter was my boss when we worked for package machinery. That was in 83. In the ‘80s were actually a good year, a good decade for us because we expanded the Onin sales and it was successful in introducing Bausch+Stroebel into the US market.

                      Today, both of the companies both privately owned are well over 1000 people. Bausch+Stroebel has a real presence here now from no machines in the early ‘80s to well over 500 or 600. They went direct on their own some years ago with a direct force and now what we do is to continue in that same range. We sell for FRANZ ZIEL which makes isolators, isolation technology, laminated flow systems.

                      We sell for a company called ROTA which is a typical or similar system to Bausch+Stroebel in that they produce fill finish lines for ampoules, vials, and syringes. The isolation units from ZIEL can work together with them, so there’s a synergy there. We sell for a company called ATEC. Basically they make stopper processing equipment that takes raw stoppers and in the end provide sterile, dry, ready to use stoppers that the end would take the vessel away to the filling line docket to an isolator port. So there’s that combination of the three. It’s nice because we’re focusing on that parenteral niche, aseptic.

                      We do represent an American company called dynamic automation which make a special laser system that measures the gap that the stoppers place on a vial. It basically is enabling the user to have let’s say less false rejects which is important because typically a drug that is expensive (0:03:54) than lasers tends to be not as quite as accurate so you wind up rejecting good products.

                      So those 4 companies are which makes up our basic principle.

Todd S:       Wow. What an interesting diverse portfolio. That’s kind of fun.

Bernie:       Luckily, it’s all in the same industry and it’s also complimentary to each other, one that we can sell our system together.

Todd Y:       I got to ask you about the perspective. Thirty plus years watching the industry evolve. Just walk through the major changes you’ve seen over the last 3 decades.

Bernie:       Well, there are so many changes but I’d like to probably focus on the controls in automation of these systems has changed dramatically where many more systems come now as PLCs or obviously PLC servomotors, things that enable the setup mechanic to changeover as much quicker.

                      The advent of servomotors I think is quite a big innovation because now you can do changeover sometimes without even any manual intervention, mechanical intervention. You just work it from the HMI and things.

                      So that in and of itself seems to have done quite a bit for automation and essentially making the job of the mechanic easier, but changeovers take much less time, things like that I think tend to be the best innovations as far as the mechanics of the equipment goes.

                      We can talk about other things like what ZIEL does and how they do it, but as far as innovations go, I would say just the controls in automation is a big area.

Todd Y:       You mentioned aseptic equipment a few minutes ago and you’re offering the ability to be a turnkey supplier there. What’s the advantage of that? Help us understand that better.

Bernie:       That’s an interesting question because I have my varied thoughts about turnkey. Essentially, turnkey means that the end user or customer is going to buy a system potentially from 2 or 3 sources, but one source that they buy would be responsible for the whole line. That usually costs you more money because you’re buying it through one supplier and they of course are going to charge what they need to charge.

                      But it really depends on the complexity of an integration. I mean, if you look at say a filling line with an isolator, that would be something that people typically feel comfortable buying as a system, a turnkey because then they just have to go to one source and deal with one source and nobody’s pointing their fingers at each other.

                      On the other hand, if the integration is relatively simple like vials coming out of a filling machine, a labeler, and then going to a tray loader, the integration is very simple. So you buy a turnkey, you might spend more money than you need to. So it’s always up to the end user and the type of equipment that you’re using and integrating basically. That’s it.

Todd Y:       Bernie, focusing on the aseptic processing technology, where is it headed? What kind of innovations are hitting the market right now? And where is it headed next?

Bernie:       I would say that the idea of using isolators instead of clean room is not really new but it’s what’s coming more and more. You’re seeing more isolated filler lines which require then less clean room space, less human intervention which is always what you want to try and do is to keep the people out of the fill sweep, the aseptic area.

                      So that’s one area. The use of robotics in the (0:07:30) room conditions require certain things that typically normal industrial robots don’t give you. That’s another big area that I see as being used more and more again to take the humans out and separate them.

                      Isolation technology also is very interesting because if you’re putting up a drug that’s toxic like cytotoxic, then because typically what you’re doing is you’re protecting the drug from the human being but in the other case, you have to protect the human being from the drug too.

                      So then you have a negative positive pressure inside your isolation systems and that helps the overall efficiency of the line and meets certain requirements Some of these products are extremely dangerous, so in that respect it’s a definite innovation that’s helpful.

Todd S:       Todd asked you to look back 30 years and focus on the changes. I’m going to ask you to look ahead of it. What does a pharmaceutical manufacturing facility look like in, say, 10 to 15 years?

Bernie:       I would imagine that there would be more and more robotic motion, robotic function, less humans interacting in the fill rooms. There was actually something that was talked about some years ago called Lights Out Production where you actually have a filling room or let’s say a suite operating with nobody in there.

                      The lights could even be out and everything is being controlled maybe in another room. That’s something that has been talked about. I would assume that would be coming also or if it’s already here, then I’m not aware of. But essentially, I think it’s going to see a lot of robotics and more electronic control systems that are very sophisticated in that respect.

Todd Y:       Bernie, it takes a good bit of time and a good bit of investment here at PACK Expo, PHARMA Expo. Talk a little bit about your booth, what you’re featuring there.

Bernie:       Booth number is 624. We have ZIEL sterility test isolator installed and also a glove tester in our same booth to show how we test the gloves within halls and a small unit that’s from dynamic that’s doing the annex check which is that laser checking of stopper placement. Those are the 3 products that we have.

Todd Y:       Outstanding. Bernie, you’ve been a keen observer of this market, this industry for a good amount of time and you’ve seen a lot. As we talked about your diverse portfolio, some of the interesting organizations that you’re partnering with, probably you have a good pulse on what keeps these organizations innovated.

                      How does this industry continue with that pace? So much has changed and the pace of change is increasing. How does the market continue to innovate in a way that uses it for in a positive way?

Bernie:       Well, I would think that the FDA is a big driver of this. They’re pushing always for a better technique, cleaner and more aseptic parameters. So that’s one of the forces that drive people to innovate more. Essentially, that’s a big item I would think.

Todd Y:       Bernie, one thing Todd and I hear a lot about, and I frankly personally wonder about it a lot is the skill levels of the people that are in this industry. I mean, you’ve talked about the changes in technology and the advances and the applications. That’s not going to slow down. If anything, it’s going to get faster. What do you think companies can do just to keep up with the knowledge and skill levels that are going to be required?

Bernie:       I would say like there is apprentice programs at a lot of these companies that make this equipment especially the German equipment and this keeps the people ahead of the curve so to speak. Most of the line mechanics are much more than just mechanics.

                      They’re actually software savvy because they have to deal with the PLC type of controls and so it’s sort of an evolving things, but more and more you see that people have to be programmable like with code, people that can write codes, things like this tend to very important.

Todd S:       Alright. Well, Bernie I hate to say it. Running low on time. Before we let you go, how can people get in touch with you and learn more about Pharma Systems?

Bernie:       They can come by the booth and see us of course or they can go on our website. It’s www.pharmasystemsusa.com and our office is in Hawthorne, New Jersey. We also have service engineer with us. We’ll be happy to have anybody give us a call and we can help them out and come up with a solution. We have a varied approach. So I appreciate you guys having me here because it helps get the word out about our company.

Todd S:       Outstanding.

Todd Y:       Our pleasure.

Bernie:       Thanks very much.

Todd S:       Bernie Giletta, the president of Pharma Systems. Again, great to have you. Thanks for stopping by.

Bernie:       Thanks again.

Todd S:       Alright. That wraps this segment. This has been Life Science Connect Radio. Todd and Todd signing off from Chicago. Our live coverage will be right back.