Effectively Develop A Container Closure Integrity Testing (CCIT) Strategy

Oliver Stauffer, Chief Operating Officer, of PTI Inspection Systems to discuss innovations and guidelines to establish a container closure integrity testing strategy.   Defining and understanding what it is that you need to test is when you can actually launch or deploy a test method that’s going to serve your need.  PTI Inspection Systems is a leading manufacturer of non-destructive package inspection technologies for the pharmaceutical industry.  PTI offers inspection systems for package integrity , seal integrity , leak integrity and container closure integrity testing. 

 

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 two. Todd gosh, we are almost halfway through day one. I can’t believe how fast it’s going and we are having a great time so far.

Todd Y:            Not only is the day going fast, you can feel the pulse of this place starting to pick up still more and more people, there are conversations going on all over the place around and this is a pretty cool place.

Todd S:            We are having a good time. Well the next guest promises just to be as exciting. Say hello to Oliver Stauffer. He is the COO of PTI Inspection Systems. Oliver welcome to the show.

Oliver:             Todd and Todd, thank you so much for having me.

Todd Y:            A pleasure.

Todd S:            The pleasure is ours. Oliver I assure you before we get into our conversation, take just a few seconds, tell us a little bit about you and your background.

Oliver:             All right. Well I've been with PTI for over 10 years and during that time I've had just a vast amount of experience with packaging, integrity testing package quality in a variety of industries dealing with a range of new packages development too as the industry progresses.

                        My background is in science and I certainly take a very scientific approach to the work that we do and what we bring to the industry. So we also aim to bring nothing but true science, show the real data and that’s what we really rely on. So that’s my background and that’s what we focus on.

Todd S:            Well PTI Inspection System, give us the 10,000 foot view. What do you do, how do you serve the market?

Oliver:             Well PTI Inspection System, we manufacture non destructive quantitative test solutions for packet and integrity testing and we really focus on reliable quantitative solutions, we focus on providing more sensitive and reliable test systems, always bringing new sensory technologies to the market.

                         And we are always developing new technologies with a few patents. At least one patent for every two employees. So we are really at the leading edge of quality control and the detection system. One patent for every two employees.

Todd Y:            Todd you and I just for the record, we have no patent. I thought about a patent once, does that count for anything?

Todd S:            Container closure integrity. It’s a heck of a big issue. You hear a lot about it. Give us some background of why it’s so important.

Oliver:             All right. So container closure integrity is also known as CCI. It’s basically one of the most important or hot burning issues in the industry because it is one of the leading quality control issues that you see that’s process related in the market.

                        So CCI is a very important issue especially in the life science space where many of the solutions or products are injectable or parenterals products and if you have a CCI issue on any product that’s an injectable, jeez you're injecting someone with a microbial suite.

                        So the risk is extremely high, irrelevancy of that space is so important right now to the industry because quality is just, there is no compromise on quality.

Todd S:            To manufacturer who is striving to achieve a high quality standard, what are the biggest obstacles that they're facing?

Oliver:             So certainly what we see in the industry is always a new product development, new package delivery systems and so with every new package delivery system, there are unique interfaces.

                        So like a pre sale syringe, it’s a new delivery system. It’s been around for some time and they're still figuring out but that’s the way to assure quality on this products. So as these delivery systems become more complex or as you use Apetens or these sort of single use solutions, you're going to have a lot more difficultly in assuring quality.

                         So that’s definitely one thing. But the industry is stuck a little bit in using old and traditional methods that you're seeing sort of simple, but they don’t solve the problem, they don’t give reliable data, they're not sensitive enough. And so that’s one of the areas that is so important to have the industry shift to more reliable and quantitative solution.

Todd S:            Well you’ve used the word quantitative in one form or another probably five or six times already in true science and I get all that. Give us another level with detail, what exactly are you doing with the data? What kind of analysis is coming out of the back end that's valuable to me and the customer?

Oliver:             Okay, yes. So right now some of the comments assessment methods if we look at those like the di-test, you might put a product in the blue dye bas and then run a di-test and it will tell you whether pass or fail.

                        You might see blue dye you might not. But its objective. You're just looking at it as a human being and it’s relying on you to use your judgment. But unfortunately human judgment is exactly it’s sort of these grey areas, these grey space. And if you have access methods that’s quantitative that’s looking at a test result.

                        So vacuum the kay, we pull vacuum on the product and monitor that vacuum level and we’re giving you a distinct quantitative results that shows you whether this product is leaking or not.

                        And that quantitative number then you can apply real statistics to it, you can use six sigma principles to evaluate the test method, evaluate your product and have a much level of assurance.

                        If you're just using pass or fail of this blue dye method, that are very subjective and you know using human, sort of human judgment, you're risking that level of assurance and you're injecting people with these products. So it’s about assurance. You want the highest level of assurance that what it takes.

Todd S:            Todd I suspect you and I are both struck by his strong emphasis on scientific approach. And I mean you’ve emphasized emphatically and it is striking. I imagine every organization that's talking about this probably does that, put a price, says on the brochure. But I get a sense it’s a real bigger cultural push on your organization. Is that a fair sentence?

Oliver:             Yeah. I mean the whole industry and in every organization, these are jargon [00:05:48] [inaudible] and so just saying, okay now we are going to switch a method. It’s very difficult to just sort of shift and change and that’s something that’s happening slowly.

                        But the USP or United States Pharmacopeia they're coming out with TR27. It’s a technical report and its identifying specific methods as either probabilistic sort of you know its using judgment or its using some sort of--.

                        There is a probability that you would detect something and methods that are deterministic, that actually definitively tell you, this is what it is. And it gives you a factual statement or factual information as to the quality of the product.

                        So the FDA is shifting, the whole industry is shifting to addressing these spaces. Shifting subjective methods to quantifiable more reliable methods.

Todd S:            Well are there other common things coming out of the FDA for example?

Oliver:             Well I think that certainly more testing is needed. So the FDA is always looking for more testing, hard data, they're looking for reason why you're using certain methods or why you're suggesting that a certain test is appropriate for your products.

                        So if you're doing a CCI method or for vial or syringe, the FDA wants to know, well why you did suggest that this is the right test method for your product? And you have to justify that. And when it comes down to parenterals only the most sensitive and reliable solution are really holding up the master in.

                        So that's something that’s extremely important. The FDA has a keen eye on the data that's being produced, on the methods that are being used.

Todd S:            All right. So let’s summarize. When you're choosing a pass for integrity testing, well review what the important factors are that we should be considering when making that important decision.

Oliver:             Yeah, this is the pharmaceutical space. So there are a variety of applications from the injectable, the actual tablets and capsules, right? And the most important thing is to really start with a definition or understanding as to what is important for your products.

                        So let’s forget tablets and capsules if you're packaging in cold form blister package, there is a reason for that. Its moisture and oxygen sensitive. And so that's something that needs a test method that is moist and oxygen sensitive or testing down to that level.

                        So define and understand what it is that you need to test to, once you’ve established that, only then can you actually launch or deploy a test method that’s going to serve your need. So define and then identify method that will measure the quality or the product that you need to try, right?

Todd S:            INTERPHEX, no small investment and time and effort to be here.

Oliver:             Definitely not.

Todd S:            Why? Why are you here? What do you expect to learn, what do you expect to get out of the show?

Oliver:             There are some new faces, always meeting new people. But I always love a great conversation with people we know from industry coming in always looking for new ideas, new concepts or sharing some of their experiences.

                        So surely about all the conversations that we are having with people, not just the business cards that you collect through the day, some great people on the show.

Todd S:            When we chat with you again and probably maybe INTERPHEX 15, 16, what are some things we will be talking about? What are the hot trends we should be keeping an eye on?

Oliver:             In our space, it’s always about new sensory technology and new developments in test methods. And so every year we are developing new sensory technologies and who knows what's going to be next down the road.

                        Whether its thermography, tomography or other sensory technologies. So that’s really what we should be looking for. And it’s about reliable test methodologies. If you don’t have a reliable test method, you don’t have a test method and that’s, really striving for that.

Todd S:            Outstanding. All right, well 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 PTI Inspection System.

Oliver:             One more thing about PTI System you can visit our website at www.ptiusa.com and certainly we are out there in the interwebs and we can get a hold of me at PTI any time as well. But we are certainly out there always looking for new solution, new application and if you have any questions, just feel free to give us a call.

Todd S:            Oliver Stauffer the chief operating officer with the PTI Inspection Systems. Oliver it’s great to have you thanks for joining us.

Oliver:             Thanks so much.

Todd S:            All right. That wraps this broadcast. On behalf of our guest Oliver Stauffer, my co-host Todd Youngblood, I'm Todd Schnick. Life Science Connect Radio will be right back.