Podcast | April 24, 2014

Applications For Blow-Fill- Seal Packaging You Might Not Be Aware Of

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Tim Kram , General Manager of US Operations at rommelag ®, discussed the applications of blow-fill-seal packaging systems at INTERPHEX. One of the biggest uses for blow-fill-seal packaging systems worldwide is for IV solutions.   However, many manufacturers might not aware that blow-fill-seal systems can be used for small and large volume parenterals, inhalation products, as well as nebulizer drug products.   rommelag® is the inventor of the Blow-Fill-Seal (BFS) technology and a market leader with a majority market share worldwide.  Their special responsibility lies in developing guidelines for the solution of all our customers' requirements.

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Interview Transcription:

Todd S:            Good morning. This is Todd and Todd live in New York, Life Science Connect Radio on location direct from INTERPHEX day three. Todd we have another exciting guest up next but we are off and running on a great day three so far.

Todd S:            Nice to see to it. And I'm still fired up. I got lots of energy; I got coffee this morning so the brain is ready to just soak in everything.

Todd S:            We didn’t get any coffee yesterday that's why we were so, struggling getting out of the cage.

Todd S:            I know, it was very unnatural.

Todd S:            All right. Next stop is Tim Cram. He is the general manager of the Rommelag Team. Welcome to the show.

Tim:                 Thank you.

Todd S:            Good to have you, thanks for stopping by and joining us. Before we get into our conversation, we’d love to talk about, take a quick, tell us a little bit about you and your background.

Tim:                 Yes, I'm working for Rommelag in a pharmaceutical industry for about 11 years now. Prior to that my background is electrical engineering, so I come from a machine based, in programming and process control.

Todd S:            All right. Well Rommelag give us 10,000 foot view, what do you do, how do you serve your market?

Tim:                 Rommelag is I guess the inventor of the blow-fill seal process. We are 50 years old this year. We have around 1700 people that work in and around the technology to machine manufacturer and contract manufacturing.

                        And what we try to do is promote the technology and bring it out and get it used within the pharmaceutical industry.

Todd S:            Tim I've got to tell you though, the whole glow field thing, I'm still trying to be my brain wrapped around that thing. I still want to know where do you put the bottles in the front end of the machines and I know that's not how it works. So talk us through the whole process of how this does work.

Tim:                 The blow-fill seal process we are taking a raw plastic material and extruding it forming a container, filling it and then sealing it all within a controlled environment. So the whole process is around 12 to 15 seconds. So no feeding containers in the front end and the back end, you just fill container at the front end.

Todd S:            All right Todd, so beginning to understand the process itself. Tim I wonder if you could share with us some of the more common applications of blow-fill seal.

Tim:                 Sure. You know worldwide we use blow-fill for IV solutions, that’s our big use. So if you go to Germany or go to hospital, you get an IV bottle and an IV bag. So basic solutions that are contained in there.

                        We also do a lot of small volume parenterals such as deli watson, local anesthetics, so these are small containers typically less than 20mm for those type of basic water products used in primarily in hospitals.

                        In the US, we are using it primarily for inhalation drugs and aplamix. The nebulizer drug product is prevalent and about two billion containers there.

Todd S:            Two billion with a B?

Tim:                 Two billion with a B. Yeah.

Todd S:            Holy cow! Talk a little bit about the reaction you're getting from the manufacturers to the whole process and what are the ones that don’t get it yet, what are they missing?

Tim:                 Its interesting because you know within, outside of the US we are very well known and even within companies we are very well known. But within the US we sometimes have the work a little bit to find the right people to get it introduced.

                        So it’s a little bit of a conservative to look at what's considered newer technology and see might have a big pharma that actually has two or three facilities outside the US that uses our technology. But then convincing them to move back to the US is sometimes difficult.

Todd S:            Now you're exhibiting here at INTERPHEX obviously. Talk about how you're show casing anything in particular here, what are your goals and objectives here at the show?

Tim:                 A little bit we are introducing, we are kind of moving into a bio technology type products. Yeah one of the things about blow-fill seals if you want to use it, you need to be able to test it and bring your, do the stability study, do clinical studies.

                        And one of the problems we had in the past was these types of products require very special facilities and nobody had that facility. So to consider blow-fill seals, you can even use it because you didn’t have the particular facility.

                        So we went ahead and built that facility in Switzerland and somehow we had that capability to do this test work. [00:03:51] [Inaudible] allowed us to do particularly for higher tech; we've been looking at vaccines initially.

                        We've provided on two vaccines and both of them have come out really well. So we are looking into promoting that into other biotechnology realm.

Todd S:            I've got to tell you Tim, I'm going to take you back a little bit because something you said a couple of minutes ago that is just sticking in my head. If you’ve got a company with facilities in Europe, that you’ve involved blow-fill seals but it’s not back in the US.

                        I mean I'm just thinking about it, it’s got to eliminate steps in the manufacturing process which you’ve got to save some time, you’ve got to save some money. I'm scratching my head, is it just lack of knowledge? Or what the heck is blowing it down? The adaption of the technology?

Tim:                 I think in general there’s like thicken glass vial has a very big comfort level with that. There are particular issues to different technologies and those associated with glass are know.

                        And with blow-fill seal you know you have to be compatible with the plastic material. To a certain extent I think being a little conservative and not wanting to change from conservative and not wanting to change from the standards of you know kind of the devil you know.

                        If you change into a new technology you may find something you didn’t know about and that…

Todd S:            What do you think the long term players, I mean do you think when we sit together and talk to you at the INTERPHEX 2016, 2017, would that be the standard?

Tim:                 I think so because within other markets, it’s just not the US, we are moving into South America to Africa. So we are seeing adaption over other technologies in those places. And because of that, sooner or later it’s just going to get to a head that somebody is going to take a leap and move forward.

Todd S:            And market later.

Tim:                 Yeah. And within like I mentioned the [00:05:26] [inaudible] and the inhalation drug, they are the standards. So we are the opposite direction. The other technology you can’t get into that area because we do too well. So I could see if from the other side too.

Todd S:            Well I think it’s pretty clear; it’s a matter of time until the technology is adapted. Let’s talk about the technology itself.

Tim:                 Okay.

Todd S:            What's going to get added to it, what kind of direction is it taking? Opening up new applications, new industries maybe?

Tim:                 Sure the trending, you know our biggest customers out there, large of other parenterals, IV products. And those customers are, you know these are large bottles and they want to make them more efficiently.

                        So what they want to do, they’ve been pushing us to get bigger and faster and more efficient. So you know in the last probably 10 years, we've doubled our capacity, our capability for our system. And that really allows them to be more cost effective and promote their products easier.

Todd S:            All right. Let’s set Rommelag aside for a second. I want to hear about Tim Cram, his thinking. As you are on these hallowed halls here in INTERPHEX and you're a keen observer at the industry no doubt, what would be the key take aways from you from this event?

Tim:                 A little bit I've been stuck in my boots but…

Todd S:            What are people asking you about?

Todd R:            I was glad by the way to pick you out from…

Tim:                 From my stand point, the parenterals syringe market is really jumping out there. A lot of interest and while we aren’t really, there we make an [inaudible] [00:06:51] product and so there are people that are taking their products to developing worlds or something like that.

                        They need a cost effective solution and then what are your or rather relatively or rather expensive syringe will give them since we are looking at what kind of delving in that whole area. So we get regular visits and it’s kind of a hot bug where I am right now.

Todd S:            Seems like yours has got a keen eye on the innovation though, uh-huh?

Tim:                 Yeah we try to innovate, that’s the way we open market. We've got our bread and butter, we've got our regular customer they will continue to use this and they support it very well. But really the growth in new products and new regions and new applications.

Todd S:            Well good luck with that. All right Tim I hate to say it but we are running a little on time. Before we let you go, how can people get in touch with you and where can they learn more about Rommelag?

Tim:                 You can go to our website at rommelag.com that’s the easiest place. And then personally our office phone number is 303 674 8383.

Todd S:            That’s it, all right. Tim Cram general manager with Rommelag. Tim it was great to have you. Thanks for stopping by and joining us.

Tim:                 Thank you very much.

Todd S:            All right. That wraps this broadcast. On behalf of our guest Tim Cram, my co-host Todd Youngblood, I'm Todd Schnick. Life Science Connect Radio live coverage from INTERPHEX.