The Definition of Patient Safety and Implementing Technologies (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 the definition of patient safety and how to implement new technologies into upgraded facilities.

Jornitz: Patient safety is paramount for any processes which you see in the pharmaceutical/biopharmaceutical industry, meaning when, when we, our aim, our ultimate aim is to create therapies for patients who are, you know, ill, sick people, we want to cure, we want to have treatments, we want to have therapies, we produce medicines for them. And these medicines need to be free of contaminations. These medicines are there to heal a person and not to endanger a person. So patient safety in that regard means we need to elevate the safety and quality of these products, the processing of these products, the facilities where these products are produced, and so that we don't have any contaminations within the product, which could, again, potentially endanger or kill the patient. And so when we talk about increasing or enhancing patient safety, within my presentation at the PDA/FDA conference, I'm talking there about new technologies, where we see that they are older technologies, for example, in a critical field step, which could create a potential risk or higher risk of contamination. And when we see advancements in technologies, which say, closed systems are isolated by first systems, they enhance the environment or the protection of that fluid, the protection of that critical step, and, therefore enhance the patient safety. And I think, ultimately, we see the developments in the airline industry, we see the developments in the car industry, we also need to develop and enhance our technologies within our industry constantly. And so within that presentation, I talk about these new technologies, and be kind of like the technology scout for the industry and make suggestions and bring forward some creative ideas and some new technologies, which have these creative, creative ideas encompassed.

Jornitz: Well, that's a very good question. I think the one part, which I found very astonishing, when we had the Aging Facility Task Force, we had, you know, we submitted a survey to the industry. And it was very interesting, we segregated it into analytics process and facility. Analytics, number one, was very much neglected. It was not the first line of defense, but it was, there was really not even a motivation by a lot of people joining this type of that group, that group in the Aging Facility Task Force. The other part, which we found also very surprising was the technology scouting question. We asked the question- are you actually do technology scouting? And it was very interesting to see that, you know, the level of technology scouting is very low. And so I think when I give that type of presentation, I'll want to highlight that there are much better technologies out there, there are technologies out there which take the human factor, which is the highest contamination, so it's really out of some of the processes. And we should utilize these technologies. So for example, single use process technology is a really good technology because it's a it's a good first barrier against, you know, the environment, the typical environment out there. So it's a trunk, it's a closed system, you can use a set of connections to, again, half the product, not getting in contact with the outside world. It's a very good technology. It's a very good positive technology, but it needed 20 years to be adopted mainstream in the industry. So what I want to highlight is there is new technology out there. And what I also want to highlight is that we are too slow to adopt new technology.