The Role OF The FDA And Patient Safety In Aseptic Liquid Dose Packaging Systems
Chuck Reed, VP of Weiler Engineering recently sat down with our editorial team to discuss blow-fill-seal packaging technology at INTERPHEX 2014. “The FDA is totally focused on patient safety so there is a big focus on risk management in the industry right now. It goes with our technology again because our machines operate with no human intervention” says Reed. Weiler Engineering is America's leading provider of aseptic custom packaging for pharmaceutical and healthcare applications. Weiler Engineering’s focus is to provide the most advanced aseptic liquid processing technology available through the application of customized ASEP-TECH® Blow/Fill/Seal machinery and integrated services. Chuck Reed is a past chairman of the ISPE Packaging COP.
Todd S: All right. Good afternoon this is Todd and Todd live in New York with Life Science Connect Radio live on location direct from Interphex. This is day two. Todd an exciting guest is up next but gosh before we get to him what a great day so far this has been a fascinating set of conversations.
Todd Y: It is a good thing that a couple of guys like us have the chance to get an education listening to all of the smart folks that we get to talk to.
Todd S: It is a good way to go to work and so grateful that we can share this knowledge with our audience. Our next guest is Chuck Reed. He is the Director of Sales and Marketing with Weiler Engineering. Chuck welcome to the show.
Chuck: Thank you. I am glad to be here.
Todd S: We are glad to have you. Thank you for stopping by and joining us. Before we get into our conversation Chuck take a second and tell us a little about you and your background.
Chuck: Okay. I am a degreed chemical engineer. I have a master’s in management and I have spent about 25 years in the industry. The last 17 of which have been with Weiler Engineering.
Todd S: Speaking of Weiler Engineering give us the 10,000 foot view. What do you do and how do you serve your market?
Chuck: We are a manufacturer of blow/fill/seal systems which is a specialized niche in the fill/seal marketplace serving the pharmaceutical industry exclusively with liquid packaging products.
We have a unique niche in the marketplace. What we do is a single compact machine frame that we produce a container, fill a container and seal a container in one compact machine.
We have been in business for about 50 years.
Todd S: Can you give us another level of detail in that whole process?
Chuck: Sure. We start with resin pellets. Typically they are about the size of peas and they are extruded. We melt the product in an extruder and then we produce a tube of plastic called a parasin and that parasin is then captured within a mold.
We cut the top of the parasin and move the mold forward onto the Class 100 fill volume area and fill the container with a liquid product and seal it. The product then exits the machine.
Todd S: Okay I get the process now. What are its applications?
Chuck: In the United States we have traditionally been very commonly used in the optomic and respiratory therapy marketplaces. This is a plastic product so it is very user friendly for those two areas. There are a lot of units in those applications.
We also have products in the oral drug application area as well as injectable products primarily outside of the United States.
Todd S: What kinds of questions are your customers asking about the technology and how it is applied?
Chuck: Well because a lot of the industry is used to conventional packaging one of the first questions that I get asked is where do you put the bottles in the machine? That doesn’t work because we actually produce the bottle in the machine. That is the comical answer to that.
The more scientific questions come in the realm of resins. What are the resins that we can use and the concepts? What is the drug interaction potential with the plastic if people are coming from a glass industry?
It is really related to the product and specialty designs related to containers.
Todd S: What are the advantages to this versus traditional like glass?
Chuck: Well there are basically three. One is that glass has a breakage issue. A lot of the users particularly in a hospital format really don’t like that fact that when they break open an ampule they have glass shards. Plastic is a clean opening and a safe opening so safety is an issue.
The second is cost. To produce a blow/fill/seal ampule is about one third of the cost of the glass process which is a huge benefit to the consumer.
The last is that plastic is recyclable. We have been very successful in the veterinary industry where plastic is now being used to inoculate herds of animals and flocks of fowl. It is much safer to use in the barnyard and the product can be recycled so the farmer can throw these all into a package and either have them incinerated or the plastic recycled.
Todd Y: I am not sure this is an answerable question but why would anybody want to use glass?
Todd S: Why does there need to be a marketing guy to talk about this?
Chuck: We aren’t all things to all people. Keep in mind that what we do is liquid products first of all. There are other applications that may not have liquids available that would be using glass.
Also glass is the traditional, accepted, long time in the industry and there is a lot of installed glass so the economics have put in a brand new process when a customer has already installed basis is significant.
Todd S: Chuck talk a little about the trajectory of the technology. Where is it going and what kind of technology cases are we going to be talking about years from now?
Chuck: As I mentioned before we have a very limited injectable market in the United States right now. Overseas injectable are very commonly put in blow/fill/seal packaging.
We view the domestic market moving towards the plastic; specifically blow/fill/seal for the injectable market. Also the increase in generics internationally is driving the low cost volumes for greater patient services like India and China.
Because of the cost factor I think that we see those as huge growth areas.
Todd S: It is exciting for all of us that the industry is continuing to innovate. There are always new formulas being developed or new packaging being designed. How can the market educate themselves on this BFS technology?
Chuck: We have a unique benefit for the customer with our facility. We have the ability to prototype containers, develop market samples for focus groups and then we work with CMO’s that have our equipment.
We can hand off the prototype and they can actually do clinical trials and small product runs. That gives the customer the flexibility to take a look at the technology to see if it works in their product.
The second part of this is that on just the research side we have always been about the science of the technology and we are really focused on producing technical documents that support the validation efforts for the equipment.
You will see on our website www.weilerengineering.com that there are technical papers available for download and a lot of our customers and potential customers make use of that and download those documents to make them a part of their research process.
Todd Y: Chuck no small amount of time, research and money goes into exhibiting at Interphex. Why are you here?
Chuck: We view this as the best opportunity for Weiler in the pharmaceutical market in North America. We do a lot of shows. We do a lot of international shows and to date this one is the one that generates the most significant return for the money.
Todd S: Let’s go up to 10,000 feet again and observe the broader market and what Chuck Reed is observing with what is going on. What do you see as the coming trends that we ought to be paying attention to?
Chuck: There is a big focus on making—the FDA is totally focused on patient safety so there is a big focus on risk management in the industry right now. It sort of goes with our technology again because I alluded to safety earlier but it is also about the fact that our machines operate with no human intervention.
You are delivering an ultra-safe product in a sterile environment for the consumer. We see that as an increased focus going forward. The cost of medicines is one of the drivers in healthcare issues today and everyone is looking for ways to reduce their costs and reach a broader audience.
Todd S: Chuck I hate to say it but we are about out of time. Before we let you go how can people get in touch with you and learn more about Weiler?
Chuck: They can either drop an email firstname.lastname@example.org that is Weiler W-E-I-L-E-R engineering dot com and that is all one word. They can go on our website and there is a direct link that they can access there as well. That does come directly to me.
Todd S: Chuck Reed, Director of Sales and Marketing with Weiler Engineering. It was good to have you. Thank you for stopping by.
Chuck: Thank you for the opportunity.
Todd S: Our pleasure. That wraps this broadcast. On behalf of our guest Chuck Reed my co-host Todd Youngblood I am Todd Schnick. Life Science Connect Radio’s live coverage of Interphex will be right back.