Mack Powers (00:07):
Okay. I’m here with Tom Whitely today. We’re talking about contamination in pharmaceutical facilities. Contamination really can be catastrophic, and we work with companies to help them solve contamination issues and get their manufacturing facilities back on track. So Tom, tell us how you’ve been engaged with clients in the past when they call you and say, “Hey, we’ve got a contamination issue. We need your help.”
Tom Whiteley (00:31):
A lot of times, customers will come to us and they know they’ve got a contamination issue, but they may or may not know exactly where it is. So we’ll help them determine that as well as go through and define what pieces of equipment have issues and where the scope of boundaries of the issue are. So we can focus in on what pieces of equipment need to be addressed going forward with the issue.
Mack Powers (00:59):
All right. So most of the time, they’ve identified probably where the contamination was. They’ve been able to do some technical analysis. And then so once they’ve presented that to you, where do you go from there?
Tom Whiteley (01:12):
There’s two things and they sometimes happen in sequence and sometimes happen one after the other, but we’ll go in and help them figure out how it got into the system. A lot of times, they know it’s in the system and what it is and where it’s at, but they don’t really know how it got there. So we’ll come in and help them with that and figure out how it got established in the system. Most places are already doing CIP, COP, whatever, they’re doing some sort of cleaning already. So not just how it got in the system, but how it got established, whether there’s a design issue or there’s a manufacturing deficiency between how they’re handling their parts or something like that and the manual processes.
Tom Whiteley (02:00):
So we’ll help them figure out how it got into the system and got established. And then the other thing we’ll come in and do is figure out how to get rid of it in the short term, as far as if it’s established in there, you’ve got to do something more than your typical CIP. So we’ll come in and figure out, based on what bug they’ve got or what contamination issue they have, what the best approach for removing. If it’s a biofilm, or spore, or something like that, removing that from the system and making sure the system’s at a clean zero state before we move anything else. And that all happens pretty quickly. That’s really the biggest thing to get them back up and running.
Mack Powers (02:44):
That makes sense. And so you’re working generally with the manufacturing team and the quality team at the companies that we’re doing business with?
Tom Whiteley (02:51):
Yeah. Yes. And then that’ll work with the manufacturing quality team. And then sometimes, we end up bringing engineering in from a process design if it’s piping. But at the end, we’ll come back in and help them close out the CAPA or the whatever corrective actions they need, be it piping or handling changes with how they do their manual stuff. If they’ve got dead legs, if they’ve got things that could be improved that are causing the issue, we’ll figure out how it got in there and how to prevent it from getting back into there, so that they don’t end up in the same place they are.
Mack Powers (03:37):
That’s right. Well, that’s very helpful. Well, we know this is a very critical component for food and beverage manufacturers, for pharmaceutical companies, for biotechnology companies. And so thanks for helping us understand the process and how we go about fixing these problems and getting companies back on track. That was very informative. So thanks.
Tom Whiteley (03:58):
Yep. You’re welcome.