Sterile Compounding and Contamination Control with Abby Roth

Welcome to Exceeding Your Benchmark, a podcast brought to you by Benchmark Products. Tune in as we explore life science industry relevant topics, discuss industry leading practices, and dive into cutting edge solutions the industry has to offer. This is the Exceeding Your Benchmark podcast. Hello, and welcome to the Exceeding Your Benchmark podcast. I'm your host, Michelle Dawn Mooney, and today we're talking about sterile compounding and contamination control. We have a great guest today. Abby Roth is founder of Pure Microbiology. Abby, thank you so much for being with me today. Thank you for having me, Michelle. Looking forward to getting into the conversation. Before we do, can I ask you to give us a brief bio if you can, please? Sure. Again, my name is Abby Roth, founder of Pure Microbiology. So I do training and consulting mostly for sterile compounding facilities, but I also work with contract labs, certification companies, and others that might serve, that particular industry. So just little bit of backstory. I started my career in a contract microbiology lab, got a lot more involved in sterile compounding around two thousand and eight, twenty ten, when the sterile compounders had to do a lot more environmental monitoring. And then I started in twenty seventeen actually doing more consulting and training for that group and I've been there ever since. So, clearly we have the right person for this conversation today. I do have to ask you before we get started Abby, I couldn't help but notice there is some sort of blue character behind you, and we we talked briefly before we went on camera here. And you told me that this character, which I wanna learn so much more about, pretty much travels with you. So before we go any farther, because I know other people must be asking the same question too. If you're watching this podcast, can you introduce us to them? Sure. So that back there is Petrie the Penicillium, and I end up taking him with me on all of my trips, trainings. It all started kind of because I would go away and my daughter would send a stuffed friend with me, and I'm like, this would be super fun to do it, like, industry specific. So ended up finding, a giant microbe and penicillium is one of my favorite molds. So it was sort of a match, you know, meant to be. And yeah, follow me on Instagram or connect with me on LinkedIn. You'll see him out and about with me at conferences and, other travel work related trips. I love it. And I can't wait for this conversation, Abby, because I don't think I've ever heard of mine as is one of my favorite molds. I didn't even know we were rating molds but here we are. Okay. So where do we begin? Let's start here. Can you explain the difference between traditional drug manufacturing versus compounding with either USP seven nine seven five zero three a oversight or five zero three b compounding. Why would someone opt for compounding versus manufacturing here? So, I think it's important that we just start off with like making a very clear distinction about manufacturing and and compounding. And when we talk about manufactured drugs, those are going to come with FDA approval. They go through a lot of rigorous testing, lot of oversight from different regulatory bodies. And it's coming to you as the patient in, like, the final dosage form. You take it in whatever, you know, version you need to, whether it's orally or intravenous. And it's been made specifically to just let's get it to the patient. When it comes to compounding, we really need the compounded drugs because the manufacturers can't make all of the right dosage forms in the right volumes, in the right concentrations to give to every single patient. Like, our our pediatric population is a great example child and we might need to dilute it to get it to a concentration that's safe for that child. So that's sort of where compounding comes into play here where we're kinda taking, a little bit of art, a little bit of science, and getting the right medication to the patient that they happen to need. So where we have then the difference in the compounding world is we have traditional compounding, which, falls under USP seven ninety seven as the standard that we follow, for practice. And that's kind of your traditional compounding that happens in a hospital setting. It might happen in a community pharmacy right down the street. I have a number of different compounding pharmacies in my area, and they're making something specifically for me based on a prescription for me. The five zero three b or the what we'll call the outsourcing facility, they're basically manufacturing compounds. So they actually fill a really important gap with drug shortages, where if we can't get the manufactured dosage format we need, we can then go to one of these outsourcing facilities to hopefully, get it compounded so that we can, you know, get those medications to patients. So compounding versus manufacturing, what do you choose? Why do you choose it? It all is gonna kinda come down to, is there a commercially available medication available? Great. We give it to the patient. And if there's not, that's where compounding kinda comes into play to fill that gap. So now that we have a little more foundation, I wanna see if we could dive a little deeper. Can you walk us through the difference between category one, two, and three compounded sterile preparations or CSP products? How do facilities determine beyond use date, and why is that critical? So with the new version of USP seven ninety seven that, came out, we first saw it in twenty twenty two, we have what are called compounding categories. And the whole purpose of these are to kind of describe the different levels of where you can prepare the medication and, the different, again, beyond you states that you can assign to it. So we're sort of breaking things out in a, like, risk stratification of category one CSPs have the least amount of regulatory needs associated with it, versus the category three. So it kinda puts it on like a quality spectrum of if you're doing category one CSPs, we can do it in what's called a segregated compounding area. And it's really just a primary engineering control, or as we like to call them hoods in a room where we do compounding. And there's not a whole lot of other quality elements that come into play versus the other two, category two and category three, where we're working in what's called a clean room suite, where we really have a lot of engineering controls, HEPA filtered air, a number of other different requirements to ensure the safety of those, medications that are being prepared. So when it comes to beyond use states, it's really gonna come into where are you preparing it? And are you doing additional testing to make sure that it's going to be safe for the patient? So USP provides beyond use dates that we are, allowed to use and choose, and really what we choose is gonna base on be based on the safety to the patient. Yeah. Of course. Safety is top priority. So what roles do primary and secondary engineering controls play in maintaining a sterile compounding environment? What are the best practices for segregated compounding area? So the different engineering controls as we have primary and secondary. So primary would be the actual area where we're compounding and preparing that medication. And we'll call that the PEC as we have so many acronyms, in, you know, both the manufacturing and the compounding world. And then the secondary engineering control or the SEC could be either the clean room or that segregated compounding area that I mentioned. So with these engineering controls, especially the hoods themselves and the rooms like the clean room, we have HEPA filtered air. We have pressure differentials. We have a certain number of air changes per hour that are required. There's specific, guidance for particle counts that we need to follow. So, really they end up giving us that safe environment to be able to again, prepare these, compounds for patients. Now, the segregated compounding area sounds a little bit scary when I say we're just gonna put a hood in a room and we don't have HEPA filtration and we don't have pressure differentials and we don't have some of those, other engineering controls to kinda help mitigate contamination. But that's where those compounding categories kinda tie back in here where if we are preparing in a segregated compounding area and it's what we call category one, it's the shortest beyond use dates. So that means that those drugs can only be stored at room temperature for up to twelve hours or in a refrigerator up to twenty four hours before they can be given to a patient. We get longer beyond use dates when we have a clean room suite. Now with that segregated compounding area, as long as we're keeping it clean and following the chapter requirements, we'll be in good shape to use that space. There are so many factors that come into play here. Can you explain the importance of proper garb when entering a clean room for sterile compounding? What common mistakes do people sometimes make in sterile compounding settings? Yeah. So, I mean, garb is critical. We as people are gonna be the dirty things entering these compounding areas. And covering ourselves helps with preventing shedding of particles, shedding of microorganisms. So it's really critical to garb in order to maintain the cleanliness of the compounding environment. Some of the mistakes that, you know, we might see and maybe that's not even really a mistake, But, USP seven ninety seven, the chapter that gives us the direction on what we're supposed to do, it's a minimum standard. So it kinda sets the, like, base level of this is the least amount that you need to do, which means you can always do more. And I guess where I would maybe call it a mistake is organizations not choosing to do more than what's required. Good example of this is that chapter basically just says we need to wear, like, a gown to go in. We're not fully covering legs, you know, with the garbing material, but we shed a lot of skin cells. We drop hair. Like, we shed microorganisms, so encapsulating us the best that we can in a, like, as we call them, bunny suits or a coverall. Right? That's gonna be kind of a best practice. So I think with sterile compounding, it's maybe not so much mistakes when it comes to garbing, but it's not doing enough. We can do so much more and sort of mimic what goes on in the GMP world, with our garbing, to really help with contamination control. So, we talk about hand washing a lot, especially if you're a parent. You know, there's a lot of conversations there, right? But it is definitely important with what we're talking about here. So, tell us more about the importance of hand washing, hand hygiene, critical concern, especially as personnel are taking off their garb as they leave the clean room. Yeah. So hand washing kinda ties in. It's a chapter requirement. We're required to do at least thirty seconds to the elbow. So hand hygiene is really critical, you know, to what we are are doing. And we have a concern not only about people entering the the compounding space through the anteroom, which is where the sink is to wash hands, but we also have a concern about, like, people exiting at the same time people are entering and ensuring that as I'm going in, I'm washing hands, I'm garbing, that that person exiting is not gonna be contaminating my garb as I'm gonna go in to do do compounding. So we really have sort of this dynamic, space where compounding occurs, where there's people in and out of that clean room all day. And we're trying to mitigate contamination risks, by developing proper hand hygiene and garbing practices, and also just the order and flow of hand hygiene and garbing, to eliminate some of those potential contamination risks. So what are the best practices that you would say for cleaning and disinfecting compounding facilities? What type of cleaning agents then are required there? There's again, chapter sets the minimum standard and it's like, we can always do a little bit more if if we need to. So we have some requirements for what I'll call a daily clean and also then a monthly clean. The daily clean, that would be things like high touch surfaces, the sink in the anteroom, the floors throughout the clean room. We're told to use an EPA registered one step disinfectant cleaner. So we're pretty much looking for an agent that can clean and disinfect that surface, in one step, but it doesn't tell us what it needs to be able to kill for that daily clean. Really, we're just looking, does it kill bacteria? Is it bactericidal? That's great. And for most locations, that might be all they need. But, you know, depending on how busy your clean room is, you might benefit from swapping out that bactericidal disinfectant cleaner for a sporocytial disinfectant cleaner, you know, once a week to sort of help knock down any spore forming bacteria that might be present, which would be my friend back there, right? So, molds and other spore forming bacteria will create spores. And sometimes we need a stronger chemical or agent to knock down those organisms. Now, when it comes to that monthly clean that I mentioned, like this is literally the entire clean room has to be cleaned with a sporocytal agent. So we're taking no chances at that point. Like top to bottom, every sort of nook and cranny is gonna be cleaned with an agent that's gonna be able to destroy spores, which is really sort of what we need on a a once a month basis to get ourselves back to sort of ground zero on a cleanliness standpoint. Is environmental monitoring required and how is this done if so? Yeah. So environmental monitoring, there's a couple different, kind of segments of that that are required by seven ninety seven. So when we think of environmental monitoring, we wanna think of monitoring the entire clean room environment. So things that would be included would be temperature and humidity and pressure differentials. So there are requirements for tracking and monitoring those. And then the total particle counts, that we wanna kind of be looking for, that gets done every six months when our certifier comes to do our ISO classification for our clean room and say, hey, yeah, you meet this certain air cleanliness based on the number of particles that are present. You're good. And then the last big chunk of environmental monitoring is for the viable microorganisms, where we are looking for bacteria, yeast, microorganisms where we are looking for bacteria, yeast, mold, what's present. And, you know, we do have to collect air and surface samples in the clean room. Depending on the category you compound, that will dictate how frequently you need to do that monitoring. But, you know, again, it's following the chapter requirements for frequency. It provides us with incubation parameters on how to incubate, and then also, action levels, meaning like how many bacteria and mold are too many. And if we've exceeded that level, like, what do we need to do in order to remediate that potential excursion? Hard to cram all of the knowledge that you have with all this in a short podcast episode. But, unfortunately, we are almost out of time. As we're getting ready to wrap things up, Abby, any final thoughts? I just I think wanna leave you with, you know, if you're not familiar with compounding, it is essential to patient care. Even though we have drug manufacturers that do an amazing job of of getting our patients what what they need, we are never gonna be able to live without compounding. It it's a necessity. Abby Roth, founder of Pure Microbiology. Abby, thank you for your time. Lots of knowledge. As I said, there are a lot of things to discuss and, appreciate you being here today. Thank you so much. I appreciate it. And I wanna thank all of you for tuning in and listening to the Exceeding Your Benchmark podcast, of course, brought to you by Benchmark Products. And if you would like to find out more about Benchmark, you can visit benchmark products dot com. I'm your host, Michelle Dawn Mooney. Thanks again for joining us. We hope to connect with you on another podcast soon.