Best QA Practices in Metal Contamination Control
Kris Tompkins was recent interviewed at INTERPHEX 2014 to discuss the importance of inspection systems in the pharmaceutical manufacturing industry. Kris discussed the importance of inspecting raw materials, as well as the final packaged product for any metal contaminants throughout the manufacturing process.
Loma Systems and Lock Inspection have joined forces to become the world’s leading engineering and manufacturing company specializing in metal detection, checkweighing and x-ray inspection systems. With over 100 years of combined experience, our products are uniquely engineered for consistent quality with a low cost of ownership. They have successfully partnered with the world's largest food, pharmaceutical and packaging companies, located in over 100 countries, to comply with product safety standards, weight legislation and retailer codes of conduct.
Todd S: Good afternoon this is Todd and Todd here in New York Life Science Connect radio live on location at Interphex, day two. Todd we have an exciting guest up next but we are just having a good time. It is criminal that we spend so much time here. We are learning so much.
Todd Y: usually you have to pay to go to school and learn things. We get paid to come to school as incredible as this and it is just something.
Todd S: I don’t think it’s over. We have a little more coming our way. I think this next guest is going to teach us some thing or two. Say hello to Kris Tomkins. He is a Pharma Product Manager with Loma Systems and Lock Inspection. Chris welcome to the show.
Chris: Thank you. I am glad to be here.
Todd S: Thank you for stopping by and joining us. Before we get into a conversation around Loma and Lock take a quick few seconds and tell us about you and your background.
Chris: I have been in the industry for seven years. I got started basically working for a supplier, cut my teeth there. Basically our most popular product was metal detectors and so after five years it was a perfect transition for me to get hired direct by Lock Systems. I am doing a great job for them and my experience just falls in with what I have been doing.
Todd S: Outstanding. Loam and Lock; give us a 10,000 foot view. What do you guys do and how do you serve your market?
Chris: Basically how we serve our market is say a company; a brand name pharmaceutical or a generic contract pharmaceutical company well they have to adhere to the FDA. They have a regulation in place called 21C part 11 and specifically parts 210 and 211 that dictate compliance.
For us initially that is the interest, that they need to comply and we need to basically provide product protection, quality assurance and also protect the consumer. That ultimately relieves the company of any liability.
Again that is initially why they come to us but again there is an expertise with it with metal detection. This is just one aspect so they might not be aware of how that works and how to actually configure systems in their production room.
That is where I come in, to basically educate them and also make sure that they are complying.
Todd Y: give us another level on the how, what you were just talking about.
Chris: the how is really what these manufacturers want because there are multiple different ways that you can accomplish something and ultimately not everyone has the knowledge.
That is where my experience comes in. It comes with engineering that we put into our machine. It is having the validation processes, you I2OPQ [sp?]. It is also having a sense of knowledge of how the machine works.
Often times you will put a machine in a production room and it is not going to work right the first time that you turn it on. There is some troubleshooting. There are some diagnostics, product setup and having that experience with Lock and Systems and Loma Systems giving us an edge in that department because it is not as simple as just plugging it in and turning it on.
In a lot of cases there is a different configuration specifically for raising product up. A lot of companies have issues with getting their product up and getting it into their container. A lot of companies will put platforms or use conveyors and typically what I see is that is a no-no.
The FDA will come in and slap them with a warning level. There are risks there. There is cross-contamination risks with tablets falling on the floor, you have dust contamination possibly that could get contaminated with other products.
Some of these companies; if you are doing Advil or you are doing a schizophrenic drug or you are doing an Alzheimer’s drug you just can’t afford to have these products mix getting the wrong product into the wrong packaging. It is a mess.
For me it is about educating them about contamination, educating them about containing a product, having a nice clean execution so that way you are raising your product up, it is contained, you are containing the dust and any residual. There is no cross-contamination and you are getting into your product container without anything falling onto the floor which is a problem for some customers.
As I have mentioned they may not have the proper setup and that is where we come in. That is a critical role, especially for complying.
Todd S: I am not so sure that the random citizen on the street tuned into Life Science’s show that they would be surprised that they are hearing a conversation around metal detection.
I think that could potentially freak some people out. Chris I am just curious; knowing that I would expect those in the industry to be well aware of it. Is that an issue? How much education do you need to do to get people really aware of what is necessary here?
Chris: You would be surprised really the level of education on metal detection. These companies rely on their vendors to educate them. We are just one aspect. If you are managing or directing a facility where you are processing or managing drugs you are really not focused on metal detection.
You are managing a big project and we are just one sliver of that. They really expect us to know the regulation and to tell them what to do. Having that knowledge that I have that is an advantage. That is what they look for so it is something that companies are being faced with more and more because people are finding metal getting into products that never intended to be.
It doesn’t have to be from the product. A lot of products that are upstream are moving parts that are metal that can press together. Naturally you are going to find it but then you would be surprised; it gets worked into their products often.
A lot of times we have to do compression and a packaging. I also recommend customers to do a raw materials stage because it is always good to have the protection.
Todd S: Okay I am going to try to get a little free consulting for our audience here Chris. Give us some ideas about best practice. If I am responsible for this in the plant what should I be doing and looking for?
Chris: The best practice is that you want to be conducting sample tests on our machines. I would advise at least three times per run because you want to be testing periodically and more frequently is the better.
What will typically happen is that you will test the machine at some point and if you test at the end what if it doesn’t pass? Now what do you do with that batch? Do you just throw it out, re-work it? You want to be more precise.
That is where I think our machines also have advantages because we electronically store everything in that machine so companies can access that information. If something gets through a metal detector they know when it did, who the operator was, the time, the date and again this is all 21CRFO related so this is stuff that they have to have electronic records for signatures and it protects them.
At the same time they need to keep track of that and our machines have that built in storage capacity and it is really an easy way to do it. A lot of people don’t want a lot of technology in the production floor because of the fear of security, locking them out and then stuff getting broken.
You are not working in some spot where everything is nice and easy flow. This is a rush job. You are trying to crank out the production. Everyone is working hard and working fast. Stuff gets slammed around.
Just to stick a flash drive in, download the data, stick it in your PC and store it that is what I advise. Besides that I mean I would say to stick to the combination system. We do tablet de-dusters. We integrate them into one machine. I really think that minimizes the footprint right there and gives you that clean execution that you are looking for to get into your drum.
Again, if you eliminate cross contamination I think that is something that a lot of countries get flagged for as I travel.
Todd S: Chris talks about the products that you are showcasing here at Interphex.
Chris: We are showcasing a bio-line system which is popular. We stock this unit in 6x12 and mount. This is something that typically a customer has packaging and they want a metal detector. That is what we are most likely referring them to.
We also have our pharmaceutical unit which is the product line that I manage. It is very important as I just mentioned through everything with the regulation with the pharmaceutical unit we are getting down to very small contaminates.
That is the advantage; spotting those before packaging because a packaging metal detector may not find it. The last thing that you want is packaging to go out when you have contamination.
That is why the FDA mandates now that everything in a compression room has a metal detector in it. That is why we are featuring that machine. To be honest it really has great features that other machines don’t have. I think that is an advantage.
Todd Y: I already know part of the answer to the question that I am about to ask you and that part of an answer is that guys with as much knowledge as you have about what the issues are and how to address them but talk more about Loma Lock and what sets you apart.
Chris: What really sets us apart is that our support is really unbelievable and I can tell you that has been our feather in our cap for years. I can tell you that big companies do big user requirements around our machine which means that they specified that the facilities globally will buy our machine.
I can tell you that even generics now are getting into doing extensive validation on our machines and that is globally as well. What sets us apart is validation to having features on our machine that have direct visual signal.
An operator can set up the machine in real time. For any product signal, any type of interference if it is vibration electro-magnetic they can see that right away and they can compensate for it.
It is in real time. There is no getting the lap top out. I don’t think anyone in a production room or in that level is going to have a lap top. They would just break every day. Honestly those guys really aren’t trained for that and probably don’t even use a lap top if they had to.
For us you can teach a monkey to do it. It is really simple and user-friendly. It is a really quick tool for them to set up product and once I show people how to do that it is like the light bulb goes off.
We do demonstrations all of the time. For everyone listening to do trials and we do free demonstration. Contact me and we can set that up.
Todd S: Chris when we sit down with you and say Interphex 2016 what will be some of the new innovations and advances in technology that we may be talking about then? Do you know what trends we should be looking for?
Chris: I have an idea in my head of what I would like to see. I would definitely like to see enhanced activity settings we always want to push it to get smaller and smaller particles.
We are working in product development; again I am product developing products for Loma and Lock Inspections. We are going to see that. We are going to see some design changes. Part of my role is really delivering customer feedback to that upper management, the manufacturing because a lot of times companies may feel like their voices aren’t heard.
For me I am very honest with the feedback. I would like to be good in all areas not just support and service. I want to be good with performance of the machine. Typically now with the competition you have to be across the board the best in everything.
We are going to be working with sensitivity, design changes that are going to limit breakages, failures and we are trying to eliminate. It is about preventative instead of waiting for a cure. We are trying to be a step ahead.
That is going to happen. As far as when that is going to happen; as far as 2016 we are looking pretty good.
Todd S: Youngblood I am never going to take for granted again popping a pill. I have to tell you that I feel better every day with that activity. Chris I hate to say it but we are out of time.
Before we let you go how can people get in touch with you and find out more about Loma and Lock?
Chris: They can go to our website online at www.Lockinspection.com. They can also find me on LinkedIn which you can easily just search for me. My cell phone and my email Kthomkin@lockinspection.com. I would be glad to talk to you, help you out and in whatever way possible demonstrations, trials or if you have questions and just want some general knowledge I can obviously email you any product information that you need.
Todd S: Okay, Kris Tomkins Pharma Product Manager with Loma System and Lock Inspections. Dude, come out of your shell a little bit next time. It was great to have you. Thank you for stopping by.
Chris: Thank you Todd and Todd.
Todd S: Okay well that wraps this segment. On behalf of our guest Kris Tomkins, my co-host Todd Youngblood I am Todd Schnick with Life Science Connect Radio live coverage from Interphex. We will be right back.