Aseptic Processing: Creating Optimal Conditions for Clean Room Design

Welcome to the expert in fight theory, brought to you by benchmark products. A theory in war with seek out experts. In the pharmaceutical and life science industry in order to help our listeners at bad industries. I'm your host, Jenny Parker. And today we have two guests with us. We have Matt Ferren, c f o and c o o, of Benchmark Products, and Mike Kuznicki, President of Seapro. Today's topic revolves around clean room design and construction, a critical aspect of aseptic processing in the pharmaceutical and life sciences. Streets. So let's dive into the discussion. Alright. Well, hi, Jenny. Hi, Mike. It's great to be here today. My name is Matt Ferrant. I joined Benchmark a few years ago. So Benchmark as a business, he's celebrating its thirtieth year this year. And the core of our business is serving the Cleater and production space within the life sciences industry. So our customers are pharmaceutical manufacturers, and cell and gene companies, etcetera. And our focus is on providing cleaning, disinfecting, and PPE products into the cleaner production space within life sciences, as well as things like single use tubing assemblies, and specialty products that are important to the manufacturer and a production of of life science drugs. Good morning, Jennifer. Good morning, Matt. Thank you for that Andrew Notion. My name is Mike. You know, again, I'm the president of Seapro. And we've been in business since two thousand seven. When we started based on a vision of of helping their clients better prepare their facilities for for operations. We noticed a gap in the industry between the architects and the engineers and the owners. That was that was leaving clients with with facilities that were not optimal for their operations. So we we provided our service as a consultant to help bridge that gap between the the owners. And the users of the facilities, and the engineers and architects that are putting these these facilities on paper for them. So at the end of the day, they have a facility that that operates according to their needs and and meets their their requirements of their facilities. We've been we've been involved in in hundreds of clean and construction projects throughout the country and even even into Mexico. Cleaners is is one of the the types of facilities that we we specialize in. We also work with the health care environments, operating rules, Quarantine rooms, isolation rooms as well as high containment facilities and bioresearch facilities and so on. So we specialize in all kinds of critical spaces, critical environments, that that have regulatory needs in particular whether it's a USP or the FDA requirements or even the BMBL as it pertains to high containment biological facilities. Well, mock fantastic quote, with all that experience. And we were supposed to walk up through the depths involved in designing and constructing a clean room? Yeah. Absolutely. Thank you for that. I the the most important part of of the designing, and I'm sure that can attest to this is the initial conversations upfront where where you really have to design your your own what we call the OPR and owner's project requirements. And that that's the document that really defines how the customer, how the client, the end user is ultimately gonna use that facility. It determines the equipment that goes into the space, it determines It determines the finishes in the in the facility. It determines the electrical loads, the mechanical loads. It it's an all encompassing document that really helps helps us define and fine tune how the facility is gonna be used and ultimately designed to sure that that at the end of the day, that facility is the optimal design for for that particular client. Sir, sir Matt, I know that benchmark has just last year, he installed a number of clean rooms and even has plans for expansion. Help me, and our listeners understand how had the selection of the queries being able to grow to benchmark products, The core of benchmarks business is selling into clean room space within life science manufacturing. And as part of that, it's important that products that we sell and produce for our customers are packaged and assembled in in a highly controlled clean environment. We completed a facility move last year, and that facility moved almost tripled our operational footprint, And within our cleanroom production space, as we doubled our cleanroom production space, and also have plans to expand to more than triple the amount of clean room production space that we have today. All with the intent of being able to provide our customers services like cleanroom packaging, for cleanroom, for cleaning products, a single use tubing assemblies that need to be manufactured in a controlled environment you assemble and put together in a controlled environment. And we need the the expectations of our customers as we know these products are going directly into the manufacture of, you know, life saving therapies and pharmaceuticals. Obviously, a clean room of construction isn't always straightforward. So, like, what kind of challenges do you believe come up when planning the new klingon route? Then what advice do you have to overcome the obstacle? Well, Jenny, as I stated earlier, it's important for us to understand early on what it was project requirements are so that the facility is is appropriately designed and can be maintained. I'm in a cost effective manner to ultimately meet the the needs and the requirements of of the end user, which in this case is, you know, your your cloner manufacturing facility. The challenges are Most people don't fully understand how cleaning needs to be desired and how a clean wound needs to function on its own apart from the use within the space. So a coolant was not just a room that's clean. It's it's a room that's that needs to be designed to keep itself clean, so air changes in In environmental requirements are very crucial in these types of environments, and that includes temperature and humidity control. So it's important that that those those aspects of the environment not be overlooked many times a a a cleaning client or over some of us look for a cleaning, we'll only look at your changes, or we'll only look at the hapa filtration, and they will ignore some of the other critical parameters that really drive the air quality within that space. And make it challenging to to maintain and and keep that facility clean and operational throughout the life cycle of that facility. Well, Mark, you've just mentioned there how critical it is to get a clear and design right. But how did you ensure that the material's used in cleaners construction make the necessary industry stand it by clean remit and contamination control. Although, there there's a lot of considerations that must be taken into account, including the number of people that are working in that facility, the type of work, whether it's an assembly line type of facility or working on top of work surface So even even the airflow within the space, the the directional airflow within in the space is critical because if if you have an area of high activity in one corner of the room, and then and then another area in the room is just used for storage or doesn't have a whole lot of activity going on, you have to treat them as areas separately almost separately within that space to ensure that that the high the the area where the highest level of of particulate is being generated is is scrubbing it air more rapidly. So you may wanna incorporate a higher dense of HEPA filtration at the ceiling above those who incorporate low level returnings in those spaces where it can more quickly draw out that particulate So that's just one example of of how functionality or or traffic patterns within the facility workflow within the facility affects can affect the mechanical design and the airflow within the space. Pressureization is also critical too. You don't want a union space to be negatively pressurized. So you ensure that it's positively pressurized so that it's always pushing out. It's not drawing the dirty contaminated under the doors for the cracks in the crevices within the facility. So pressurization is also a very critical component. Well, like one thing I know a lot of leafness are interested in, what are the potential long term maintenance and operational cost? A third theory with clean room construction, and many significant costs or other things that companies might not consider during the start of a project. And how could those be mitigated? And feel free, Matt, to to chime in. It's officially how being in charge of buying it. Yes, sergeant, as I stated earlier, there there's a lot of different ways to design a clean room in in really the job of the clean room again is is to keep itself clean and to to minimize the the manpower, the the labor required to keep it to to keep the the facility clean in in within the the ISO specification that is required. So, you know, HEPA filtration is obviously critical, but there's there's also numerous ways of doing that within the facility. And in ensuring that that the most efficient method possible is is implemented within the design is is one of the tasks that will be take pretty seriously. A lot of a lot of clean mold facilities will draw their air back to a centralized ventilation system and and push it through large HEPA filtration systems that are very costly to to install and they had costly to maintain. You can also depending upon the outside air requirements of a facility, you can implement localized recirculation, be like we did in case of the benchmark clean here. There wasn't a lot of odds at their requirements, due to the fact that There was a lot of exhaust requirements in the facility because there was no chemical handling. So we were able to use localized recirculation which is much more cost effective, you know, smaller motors to move the air, much more cost effective way to to move the year through the facility to keep itself clean. There's also PPE that a lot of people neglect to consider when they're designing these facilities. PPE is important in ensuring that the particulate and and especially, sterility in the in an aseptic cleaner environment is maintained without administration of the proper PPE, you contaminate your facility every time you give one. So that's a that's a costly endeavor and you guys being min treasures of PPE and and sell that to a lot of clients. I'm sure nobody knows that better than you guys. You also have to consider the the the type of maintenance and cleaning that's required in those facilities in in a septic in aseptic cleaning facilities, sterility is obviously the key in the end. So there's a lot of a lot cleaning requirements routine cleaning, whether it's weekly or monthly dependent upon your SOPs, those are real hard costs that that need to be considered as as part of the maintenance of the facility. In addition to the simple maintenance of the ventilation system serving that space, They they should not be neglected because when they go down, you lose containment. It's it's a critical critical function of the facility as well. So there's a lot to consider with with long term costs of the facility, but there are ways to to streamline that and and make things more efficient to energy wise. With regards to the mechanical systems in particular? Like Mike said, the priority in the clean room is maintaining cleanliness. We have ISO class sub in rooms and the priority there is maintain particulate levels that are that are below ISO ISO standards. Some of the decisions that are made upfront in the design phase have a direct impact on what your ongoing maintenance cost is gonna look like. And like Mike had said, understanding how how are the filters serviced, how do you make sure that the plenum is properly sized in space so that you don't have to have folks crawling into the plenum to do to do maintenance. Those are all decisions that are made upfront, but have a direct impact on what your ongoing maintenance cost is gonna look like. And then things like gowning protocols, cleaning protocols, those are things that you don't necessarily link to direct maintenance cost, but they have an impact, and the more diligent you are in maintaining your gowning and cleaning protocols, the less of the non routine maintenance and service you're gonna run into. And so those are the things that we've tried to think about as we've worked with Seabroch design our clay room then as we have our gowning protocols and our maintenance schedules lined up to make sure that we we can maintain our cost budget because that's important. But the priority is making sure that the room remains clean. Still keeping on that long term theme. Mike, how can have the needs ensure that a clean room design will accommodate any future changes or expansion. Great question, Jennifer. Thank you for that. In fact, the expansion and and flexibility was a big top of our conversation during the design of your cool name there in leakagehire. We spent a lot of time discussing that, discussing flexibility, discussing future use of the space surrounding that. And one thing we incorporated there was the use of modular cleaner walls and partitions a typical stick built facility whether, you know, with with studs and drywall, creates a lot of dust and debris when you're demoing. So expansion in the future really results in a lot of of contamination of the space and really makes it challenging to to keep that that space clean and and ready for more, you know, expanded her new cleaning space, where a modular system, such as we installed their lincolnshire can be quickly unbolded, taken apart, new will with with mineral contamination of the ceramics space. Minimal dust generation, and then kids just be expanded, maybe relocated. So modular construction provides a lot of flexibility in that regard. Get it you gotta be really careful though when when sizing mechanical systems for expansion because an oversized mechanical system can can lead to played to humidity issues, temperature control issues, a lot of temperature control swings and humidity swings because an an oversized unit that is designed for, you know, future expansion may not be able to accommodate or maybe may not be able to tightly control a smaller space that it that it's currently that was another discussion that that we had with Matt. And Matt made the right choice to to invest in a really high quality mechanical system out there. That provides some linear control of of heating and cooling without getting into, you know, being too oversized to so that it can't serves the current space. So Matt made some very wise choices in regards to future expansion looking forward. It was a result of of some of those great conversations we had going into going prior to construction. Well, on that in our Matt. I'd actually like to know what was your impression of working with Deepgram? Well, Benchmark and SIPRA have actually worked together for a long time. On customer projects work together on customer cleaner and builds and meeting customer expectations that way. With the facility moved that benchmark complete last year, this was the first time benchmark and SIPRA have worked together on a benchmark clateroom. Which has been a really fantastic experience. So one of the fastest growing segments within our industry is clear room supplies, cleaning products, as well as single use tubing assemblies. Benchmark maintains an ISO class seven standard, clean rooms. When we planned our facility move into Lincolnshire, we knew that we needed to maintain an ISO class seven standard within our within our clean rooms. One of the fastest growing segments within our business is clean room supplies, as well as single use tubing assemblies. And we know that our customer expectations in the space that we produce those in is high, and it's a critical need they have, and so we wanna maintain the same expectations on ourselves with critical needs. So when we began the planning process, we talked to Mike and the Cipro team to say, And we know what we need to do in the room and we know kind of the general size. We think we know the general size, but we don't know how to build and how to design a clean room. Mike said, the owner's project requirement, the OPR meeting and document that we engaged initially in was critical to the whole project. And we found that the discussion with Seapro was fantastic. They led us through, okay, here's what we here's what benchmark. Here's what we we want from a clean room space and the types of products we're gonna be producing in there and the number of people that are gonna be working there. But from there, just deciding things like, what's the mechanical system? How big does the room need to be? How do you design the the hepa filters to be appropriate? What types of materials to use on on flooring and walls, all that. Without the help of sepro and expertise that they brought, we really would have been lost at whole design process. So we can't be understated the importance of getting those initial design requirements nail down and do it correctly and do it well. And Cipro really has the expertise that helped us go through that design phase. They helped us to size the mechanical system properly. They helped us pick out the the things like flooring and hepa filters, things like that. And then from there, as the design kind of wrapped up, we say, okay, now we know what we need to do. We also then engaged Cpro to help us with project management to help us build this this clean room. And Cpro came in with just fantastic project management team and took it from design all the way to completion and certification, which was important for us because we wanted a third party certification on our our isoclast sonar clean room. And Cipro took the lead and worked really well with both us as a as a customer, but also the other contractors that we had working in space as well in the from the design phase to when those playrooms were complete, really, we were on on time and on budget through the whole project, which was which was important for us as we're removing facility. You know, one thing that we talked about earlier is thinking about future expansion and how do you think about designing a room today knowing that tomorrow your needs may be different. And like Mike had said, that's a big that's a big question for us because we expect that we're going to nearly triple the clean room space that we have over the next few years. So Mike and T really helped us kind of think through, okay, what are the decisions that we need to make now with this cling room to know that we can expand down down the road. Some things you have to build just for the room you have. The mechanical system is an example. We had to design it for the room that we have today. But laying out kind of the flow within the room, laying out where in the facility, do we do we install these groans? Decisions like that have a big impact then on your ability to expand down the road. And we felt that working with the Cpro team really that they provided the expertise and the knowledge to help us kinda define what that is gonna look like. And then take the project from beginning to end and just really a great team, both expertise, but also just great people to to work with through the whole project. And if I could add to that real quick, if you remember, man, a lot of our discussion was the wrong product for in in how you're moving raw materials in in in in package product out. So when you talk about expansion, you have to make sure that your future, you you your current transfer out of your your product doesn't go into the next corner and then you're gonna build. So we talk a lot about about that process and what that's gonna like in the future of the potential location for future, you know, cleaning space. And we even incorporated, you know, transfer hatches or pass throughs to ensure that that equipment that is moving in and and final product that is moving out doesn't get contaminated. It's handled and doesn't violate the integrity. Of the Kungrin space as you're opening and closing doors and rolling in and out at carts and so on. So there's a there's a lot of those details that they're ruining to those early discussions around the OPR. And really helped us to to finalize that design part of the to swing any hand what they asked they say. In which which is important. It's a it's a lot cheaper to make changes on paper than it is once the wall start going up. So I'm heading those preparatory meetings up front are crucial to the process. Yes. I fully agree. Holy agree. Well, on that night, I bring the city end to be in fightful discussion on clear room design and construction. We'd like to thank our guests, Mike Kazinski, President then of Sipro, and that's Sharon, CFO, and COO, a benchmark product for sharing their expertise and valuable insights. We hope that this discussion has shed some light on the critical aspects of clean room signing construction, and the challenges and opportunities that companies might face in the field. We invite you to join us for our next episode of expert insights where we'll continue bringing thought provoking captions with industry leaders. For watching.