Improving Facilities in an Efficient Manner (PDA/FDA Joint Regulatory Conference 2023)

In part of the session "Upgrading and Updating Aging Facilities: Quality and Business Advantages" at the PDA/FDA Joint Regulatory Conference, Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses how to upgrade facilities in an efficient manner and other highlights from his presentation.

Jornitz: You can implement, you know, new technology within existing processes, we've seen that that some of the older processes can be refurbished, at least if it's only certain stages within the process. I mean, ultimately, what comes immediately to mind is always the filling system, which is the most critical system. But also, when it comes to, you know, new enhanced technologies, when it say, let's say, infiltration, that you have new enhanced sterilizing grade filters, you can at least bring them into the intermediate steps, for example, within the bio processes and gain enhancement in regard to total throughput and flow rates, you can utilize very specific processing steps to improve the efficiencies, you can also reduce when it comes to single use process technology, for example, what we see is that certain cleanroom classifications in some of the upstream processes could be reduced and therefore, you start reducing energy costs or your operating costs. You can also have some new cleanroom technologies, for example, you will utilize, which will reduce or process intensify. And therefore, you gain much more compact footprint. So I think you cannot go out there and say, "Well, I will now enhance my entire process immediately have an existing process, I think that's pretty much impossible, because you actually bite off too much. And you might suffocate on that bite." But if you do in stage improvements, and if you look back into preventative maintenance, for example, when it comes to improvement, or when you go into new facility designs, look at the new facility designs, bring the new technology into the new facility design. And then also on that side, though, having said this, don't reinvent the wheel over and over again, when you have a good state of the art facility and process in your new processes. Also try to clone the sales processes so that you gain much higher efficiencies. And you also know where are the downfalls, where the upswings, learn more from on these types of designs.

Jornitz: So ultimately, what I show is, you know, the typical building of contamination control strategies. And a lot of the focus is, you know, testing, testing, testing, quality measurements, etc. But the foundation of control contamination, control strategy is the facility and process design, as well as training people and doing the appropriate process validation of these processes. And I think that's one focus, which we also need to look at is what can be done, and we got to that foundation, we need to have the foundation done appropriately and build on something solid instead of quicksand. And so you cannot test quality into your into the process, you cannot test quality into a product. And that's the lesson and the learning philosophy in our industry for decades. Having said this, you know that and that's the reason why I'm preaching on that foundation that we gained the right processes, and the right facility designs. And then you know, you have the controls on top of that built on that foundation. Having said this, we also recently saw that, you know, when you look at annex one, for example, there's previous posterization integrity testing, I mean, a test integrity test after the sterilizing grade filter, your last barrier in front of the foul line is sterilized and then you do integrity tests. And you manipulate the downstream side of that sterile filtrate side of the filter. That testing quality into your product, in my opinion, with a manipulation of the filtrate side, sterile filtrate side, a higher risk. So it seems like we talk about contamination control strategies, and specifically focus groups and annex one. And next we know there's a there's, in my opinion, risk elevation. So I think there's still a lot of work which needs to be done on discussing together with the suppliers, with the consultants, with the industry, and with the regulators of how we can improve these processes to a build a better foundation, and then build the right controls and do not over build these type of controls so that we start testing quality into your product.