Risks Of Pinholes And Leaks In Pharmaceutical Containers
Source: Pfeiffer Vacuum Inc.
Hemi Sagi , President of Advanced Test Concepts (ATC) , recently was interviewed to discuss the risks of a pinhole or a micro leak in pharmaceutical containers and packaging systems. “The idea is to ensure that the package is sterile and a microorganism cannot go through this defect size. Some of our applications include testing of syringes with drugs, cartridges, valves, and similar sterile products” said Sagi. Increasing demands for container closure integrity testing (CCIT) are driven by the FDA guidelines for sterile barrier. ATC specializes in leak testing due to the need for a better method of leak testing methods. Some of the leak testing applications include: blisters, vials , syringes, cartridges and IV bags.
Interview Transcription:
Todd S: Alright, good morning and welcome back to Life Science Connect Radio. I am your host, Todd Schnick, joined by my friend and colleague, Todd Youngblood. Todd, the countdown continues to NYC at Interphex 2014. We're just days away now. We're so excited about getting to this great event.
Todd Y: Yes, days away from us getting another dose of intelligence from this industry, Todd. It's just always endlessly fascinating to me, and I know to you, as well.
Todd S: Yes, it's been fascinating, what we're learning. Leading up to Interphex, Todd, Life Science Connect Radio is continuing our series of great conversations from some fascinating industry leaders, so let's get right to it. On today's show is Hemi Sagi, who's the president of Advanced Test Concepts. Hemi, welcome to the show.
Hemi: Good morning.
Todd S: Good morning. Good to have you. Thanks for stopping by and joining us. Hemi, before we get into our conversation, take a few quick seconds and tell us a little bit about you and your background.
Hemi: Well, I'm an education and mechanical engineer with advanced engineering degrees, specializing in [INAUDIBLE 00:01:19]dynamic. We formed Advanced Test Concepts over 27 years ago. We actively participate in our specialties, leak and flow measurement, and we've been developing this field [INAUDIBLE 00:01:32] in the past over 20-some years, with multiple patents and industry standouts.
Todd S: Todd, methinks Hemi has some experience in this business. Hemi, give us a 10,000-foot view of ATC. Exactly how do you serve your market?
Hemi: First, ATC was established over 25 years ago. We started building a custom test system, that usually is a quality assurance tool to improve the US manufacturing quality control. If you recall, in the late 80s, we were competing with the foreign auto makers and some US auto makers had some quality concerns.
We quickly specialized in flow and leak testing, realizing that the available leak testing method that's out in the market, [INAUDIBLE 00:02:19] environmental and safety requirements for tighter leak specification and the cost that is meeting the competitive edge that US manufacturers need.
In 1998, the FDA established guidelines for the industry for [INAUDIBLE 00:02:36] packaging, [INAUDIBLE 00:02:37] integrity, or we could call it package leak testing. Basically, the concept was to ensure that if you put a sterile drug in a package on a shelf for two years, it would still stay sterile and you wouldn't have to repackage it after two years.
These FDA guidelines became medical requirements in 2008. Since 1998, we have been working on improving our technology to meet this new requirement with some of the largest pharmaceutical companies. This is basically how we [INAUDIBLE 00:03:09] technology and INAUDIBLE 00:03:10] technology that we're presenting in the show today.
Todd Y: Hemi, get a little more specific with a few more examples of applications of this leak testing technology.
Hemi: The application of [INAUDIBLE 00:03:22] technology, or mass extraction technology, or our product, are using multiple industries. The pharmaceutical industry, which Interphex shows is actually covered here – the main application is [INAUDIBLE 00:03:34] application is package integrity testing.
Sometimes they call it container closure integrity testing. Our product detects the existence of a defect or a pinhole. Think of that as a pinhole in a sterile product of, let's say, one micrometer, which is pretty small. It's actually, in the magnitude of [INAUDIBLE 00:03:53] wavelength of light, you cannot see it in a regular microscope. The idea is to ensure that the package is sterile and a microorganism cannot go through this defect size. Some of our applications include testing of syringes, [INAUDIBLE 00:04:08] syringes, with drugs, cartridges, [INAUDIBLE 00:04:11] valves, and similar sterile products.
We also test other pharmaceutical and food packages, like pouches, bottles, blister packs, to make sure that the package provides a sufficient barrier for [INAUDIBLE 00:04:24] of moisture and oxygen [INAUDIBLE 00:04:27] product. Now, all those tests have to be done very quickly, if you really want to do a large sample of tests and you don't want to wait two years.
Of course, before you finish the test, the product shelf life is two years, typically. The method works rather quickly in establishing that there is a defect about given size, yes or no, and what's the value of that, results in [INAUDIBLE 00:04:50] defect size.
For the medical industry, we're testing quite a bit of implanted devices, surgical treatment tools like catheters, to protect against [INAUDIBLE 00:04:59] of body fluids, as well as sterile packaging for these devices. That's in the medical device industry. In the automotive industry, we do a lot of work with the fuel and break safety components, testing them for leakage.
Obviously you don't want to have a car with a leaky break line. We test the engine and transmission for leaks. We also test electronic components that are supposed to protect against water penetration or water [INAUDIBLE 00:05:27].
If you look around, most of the consumer products, or many of the consumer products, need to be leak tested to protect from water [INAUDIBLE 00:05:35] or from [INAUDIBLE 00:05:36] and so forth.
Even your coke bottles have to be leak-tight, because they have high pressure CO2 inside them. We cover quite a range of industry, with multiple products. All of them are based on this micro [INAUDIBLE 00:05:52] technology and [INAUDIBLE 00:05:53] technology we've developed.
Todd S: Wow, you cover a lot of industry than I thought. You know, there's been some recent FDA recalls, due to the seal integrity issues, Hemi. Why is that happening, and how do we avoid those?
Hemi: I cannot say that I am familiar with all the cases of recall and the root causes. Some of them are not necessarily public domain information. We know that some of them has to do with glass products, like a sterile glass syringe or glass vial that cracks. Due to that, you have the risk of either glass particulate or field contamination coming from the outside into the product, losing its sterility capability, or sterility property, I should say.
Most of the food and drug manufacturers are still using inadequate and pretty old test methods, such as bubble tests and what we call [INAUDIBLE 00:06:46] tests, or di-penetrate testing. This is a subjective test method that are really dependent on an operator to visually make decisions, and they're simply not sensitive enough to detect micrometer-sized pinholes.
The correct way to ensure consumer safety and avoid expensive recalls are, step one, start from the very beginning, from packaging development, to qualify the design and the manufacturing process to meet your expectation.
Then start, when you do the product qualification, use this [INAUDIBLE 00:07:19] technology for tighter leak spec, and then when you go into the production system, protect yourself from equipment malfunctioning and so forth, and use a non-destructive test method, like mass extraction, to test high speed or high [INAUDIBLE 00:07:36] or 100 percent inspection. This is a non-destructive method for the product we're testing. It can be sold out.
Todd Y: Hemi, talk a little bit more about that. So many leak testing technologies destroy the packaging in the process of the test. Talk about the value of that non-destructive method that ADT can provide.
Hemi: In the guideline, the 2008 requirement from the FDA for sterile products or physical testing methods, one of the requirements is to do a non-destructive testing. There are few advantages to that. One, to test a product can be shipped to the customer, verified and to be safe and meeting the container closure integrity specification intended for that product.
Theoretically, it's nice if you can test 100 percent of the product you get in your hands, so that you know they are good before you ship them out. Obviously you cannot do that if you do it with the destructive testing. You will ship nothing, right? The second approach, when do a research and development of a product and product qualification, if you use a destructive method, you basically use the evidence.
In order to keep the evidence around, or the sample around, so you can analyze what went wrong. The third advantage, a lot of the newer drugs are bio drugs, very expensive, [INAUDIBLE 00:08:57] drugs that are grown. That process may take three to six months, just to manufacture those drugs. You cannot afford now to throw away those samples, because they're very expensive and you don't have many of them.
It's a cost and [INAUDIBLE 00:09:10] issue, especially if you do high percentages of dose, so you want to reuse those. Since the method is non-destructive now, we can entertain the idea of increasing the sampling rate from few for a lot to many a lot, up to 100 percent inspection. There obviously is clear advantage to a non-destructive approach.
Todd S: Hemi, what advice do you have to offer? When a manufacturer is getting ready to source, or a container closure integrity testing system, or CCIT system, what advice do you have to offer them, when they're making that sourcing decision?
Hemi: First, I would suggest [INAUDIBLE 00:09:46] of that. I develop a product strategy, from early package development through product qualification, through production phase. In other words, develop what you want to do based on the criticality of the product.
If it's a cosmetic cream, that, if it's contaminated and nobody cares about it, that's one worry. But if it's a sterile product that goes right into your blood stream, it may be a different story, especially for patients that are already sick and weak. You need to look on your safety considerations and how severe you want to address that.
You need to have a product strategy design, early on, from the time you decide to develop a package [INAUDIBLE 00:10:24] through production phase to time you ship to your customer. It then starts by looking at a non-destructive method, as we discussed prior to that.
Then continue with a simple question: what is the maximum pinhole that this product can have without risking the product functionality and safety? In all business, everything leaks. It's just a matter of how big is the hole, even things that you don't believe we can measure leakage through them, that you see that [INAUDIBLE 00:10:52] non-leaking.
Ask yourself, “What is the smallest pinhole that I can reasonably and effectively protect against, that will still keep my product safe and functional as it’s intended to?” Then, once you define that, then define your leak tightness or container closure integrity tightness requirement.
Look for equipment that could do better than that, in case you need to tighten up the spec in the future. Don't start with equipment that that's all it can do, in case in the future you need to change it.
Start early, from the product packaging design through its design testing qualification, and all the torture path that you go to qualify a big product with market with qualification tests, and finally, through testing in your production line, and then that part of that strategy, do you want to do high speed sampling, low speed sampling, or 100 percent inspection?
Todd S: Gosh, Todd, when you hear a guy like him, you say that everything that leaks, it's just a matter of how big of a problem it is, it makes you comforted that there's a guy like Hemi out there, thinking on these things.
Todd Y: Yes, I want to keep those pinholes teeny tiny.
Todd S: I'm with you on that. Hemi, I hate to say it, this has been a really fascinating conversation, but we're out of time. Before we let you go, how can people get in touch with you, and where can they learn more about ATC?
Hemi: Please visit our webpage at www.ATCInc.net, and look us up at the Advance Test Concepts. We're located in Indianapolis, Indiana, in the Hoosierland, the Midwest of the USA.
Todd S: Alright, Hemi Sagi, he's the president of Advanced Test Concepts. Hemi, it was a real pleasure. Thanks for stopping by and giving us some time.
Hemi: Thank you. Have a great day.
Todd S: You too. That wraps today's show. We'll enjoy seeing you at Interphex in New York City, March 18th through the 20th, and you can catch Life Science Connect Radio, broadcasting live from Booth 1265. On behalf of today's guest, Hemi Sagi, my cohost, Todd Youngblood, I'm Todd Schnick. We'll see you soon on Life Science Connect Radio.
Pfeiffer Vacuum Inc.
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