Contract Manufacturing: Orchestrating the Dance

PhM: Are you mainly talking about paper or electronic records?

M.C.: Right now we’re just looking to improve our paper records. Those paper records do not go into the aseptic fill zones. But it’s all the work that surrounds that effort that I’m speaking of. I’ve been in the industry for a while. Electronic records has been on the radar for a lot of companies, and as many advantages as it brings you, there are also challenges. It’s definitely something we’re going to do in the future, but it’s not on the near horizon.

PhM: What are some of the new technologies that you believe in that ensure sterility in a facility?

M.C.: I’m a big supporter of isolator technology. We have some of this technology that we’re already using where we completely keep the operator out of the process, and raw materials are sterilized in line and any openings, closings, aseptic connections or additions of API are done with the operator using glove ports. Moving from open-fill operations to more of a RABS or isolator technologies—there are always improvements that DPT and other companies are looking at.

PhM: You have a background with BioVigilant Systems and rapid microbial method technologies—how will this play into your work?

M.C.: The experience I had with BioVigilant was a good one, and it opened my eyes to rapid microbial methods. There’s definitely a place for those technologies in the near future, but like any technology you have to understand how it applies to your product. Part of what I was working on with BioVigilant was helping customers to understand that. It’s not one-size-fits-all, but there’s definitely a place for real-time understanding of what those particles are, and the potential for those particles to be any type of bioburden nature that could be affecting your product. It’s definitely technology that’s on the horizon that we’ll look at, as we move into more of the small-volume parenteral business.

PhM: Will you look at RMM more for process, for environment, or for both?

M.C.: Both. As you start to move into a RABS or isolator technology, rapid methods really come into play. Not that they’re not as important with your typical aseptic fill lines, but there’s also a better understanding of what could be contributing to your counts. It could be product, it could be environment, it could be gown material, anything. I believe in the rapid method technology, I believe in BioVigilant, but really for us at DPT it’s a matter of understanding how we can best utilize the technology in making our products the best that they could be.

PhM: Do see the synergies that rapid methods have with Lean?

M.C.: I do. Again, it’s a matter of understanding them in a level of detail that’s happening at all different companies now. We need to understand how these rapid methods will help us from a resource perspective or from a leaning out perspective. In some instances there may be no difference, or may actually require more in terms of resources or expenditures because some of the rapid methods that are out there are not all in one, they’re not all-inclusive. In the position I’m in, it’s all about patient safety, and. making sure we take care of our customers The lean part is important, but if we can see the rapid methods ensuring the quality of our product, then that would really be the rate-determining step.

PhM: An issue that has increased in importance for contract facilities is the possibility of product cross-contamination. What kinds of things are you focused on?

M.C.: Any time you run more than one product in a facility, let alone any fill zone or fill line, we spend a lot of time, effort, and money making sure our validation activities are of the highest level to ensure that the previous product can be 100% removed from the process before we can move into the next product. As far as improvement goes, I would say that DPT has that part of the business well-defined and that’s basically a benchmark and staple of the company.

PhM: Are you surprised by how many manufacturers struggle with the issue of cross-contamination?

M.C.: That’s a good question. Sure, it surprises me, but to some extent, no, because we see it happen over and over again. We all get the newsletters and go on the FDA web site. Our compliance folks at DPT are very good about communicating current trends. It happens too much in industry not to make it forefront in our minds to make sure that it never happens to us.

PhM: You said that you’re operating more of a team concept in implementing Lean. What are some of things you see the operators picking up on and appreciating?

M.C.: They’re all linked together. One thing that I talked about when I joined the company is these small teams that work together so that the redundancy or headcount is already built into that team, so that we’re not having to pull people from other lines or teams to backfill to meet a production schedule.

That doesn’t mean that we don’t spend a lot of time and effort on cross-training. It’s absolutely critical that we cross-train our people to not only give them the breadth and understanding of what we do, but to give us the flexibility to make our products. At the same time, we’re building in that flexibility and cross-training so that we can be lean and so that the folks who are operating that particular fill area or zone are very experienced and can repeat that process, batch after batch. That’s the key for a high-quality product is to manufacture in a repeatable way. As you know, that’s a benchmark of GMP manufacturing.

With that said, it plays right into the Lean Six Sigma concept, which means that you are making that product with the least amount of time wasted. The phrase I use is “the orchestration of the dance.” How you make a product from compounding to filling to packaging all needs to be orchestrated in a well-defined way. Everybody knows they’re role, they’re trained in that role. Folks are already preparing for the fifth, sixth, seventh step right now, so that if I have a 30 or 45 minute mix time, I’m already preparing for the next several steps in my process, so that there’s absolutely no delay, the product’s moving through as it should be, and errors are reduced.