Gil Y. Roth04.02.08
Aseptic Boot Camp
By Gil Y. Roth
For more than 30 years, the University of Tennessee College of Pharmacy has conducted "A Hands-On Training Program in Aseptic Processing." This 40-hour lecture and lab course "provides a comprehensive overview of the fundamental concepts of the preparation of aspetically produced sterile products," according to its literature.
To gain some perspective on the challenges of aseptic processing and the training issues it involves, I spoke with one of its invited lecturers, Eugene T. Polini. A customer technical service representative for West Pharmaceutical Services, Mr. Polini has spoken at UT's program for a number of years and refers to it as "Aseptic Boot Camp."
For more information on the Aseptic Processing training program at University of Tennessee, visit cop.utmem.edu/parenterals. --GYR
To gain some perspective on the challenges of aseptic processing and the training issues it involves, I spoke with one of its invited lecturers, Eugene T. Polini. A customer technical service representative for West Pharmaceutical Services, Mr. Polini has spoken at UT's program for a number of years and refers to it as "Aseptic Boot Camp."
For more information on the Aseptic Processing training program at University of Tennessee, visit cop.utmem.edu/parenterals. --GYR
Contract Pharma: Tell me about UT's aseptic processing training program and your involvement with it.
Eugene Polini: One of the primary directives we've always had in this business is continuing education. The technology in our field moves so quickly, we need continuous education to keep current.
This course brings people who have little or no experience in the sterile fill area up to speed with current GMPs, new trends in aseptic processing and more. I've been going to it for five or six years. We're there to provide that well-rounded background to handle work in a sterile fill area.
CP: Once someone's up to speed, how tough is it keep pace?
EP: Well, back when I started in this industry, 20 years ago, an old, seasoned packaging engineer at Upjohn told me, "Don't worry about it, Gene. After 10 or 15 years in this business, you'll start to get the hang of it!"
And he was right! There are such large bodies of knowledge required to be competent in this business: you need microbiology, analytical chemistry, pharmacology, and on and on to really be effective in this area. After 10 or 15 years, you start to understand what is required to get a successful project underway.
CP: How much of that experience can one individual feasibly build up to, and how much requires a solid team?
EP: There are individuals in this industry who are just amazing, and know so much about the business, but you just can't beat a team approach with this. One expert can easily be outdone by a determined, knowledgeable team.
CP: What are some of the recent trends that you see in aseptic processing?
EP: The Quality by Design (QbD) guidance that just came out from the FDA is a good example of a large body of knowledge that needs to be understood and digested by the participants. When you make your next submission, the FDA in theory will be looking at it with an eye toward QbD. One of the products that we offer [West's VeriSure™ components, with verified extractables] is right in line with QbD, but almost every 18 months there's a new guidance from the Agency that you need to stay on top of. If you don't, you put FDA approval of your product at risk.
CP: So as a supplier to the industry, how much of your role involves educating and training potential customers?
EP: I just spent a week on the road, doing just that. We're educating people on what QbD means, and how what we do plays into the needs of the next generation of pharmaceutical products. I spend a lot of time training clients as well as conducting in-house training to keep our own people up to speed.
It's not just about keeping abreast of new technologies. People also need to be aware of older technologies if they want to build up those bodies of knowledge that aren't available in college courses or other parts of industry. So we do a lot of training, in addition to UT's program.
West also takes its experts to customers, conducting seminars at a client facility or a central site where many clients can attend. We talk about our new developments, regulatory issues on the market and new technologies that are in use.
CP: How connected is your company (and industry in general) with the Agency as it develops new aseptic guidances?
EP: West's regulatory department is in contact with the FDA on a weekly -- if not daily -- basis. We're also part of the Parenteral Drug Association (PDA), which has influence on how new guidances develop.
The PDA provides a strong industry presence to work with the FDA so the agency hear its constituents' concerns and expert opinions. An individual from a pharmaceutical company approaching the Agency may not have as strong a voice as a professional organization would.
CP: How are aseptic processing technologies affecting facility design?
EP: We've been seeing a slow evolution -- more than a decade now -- away from sterile rooms into locally controlled environments (LCEs), a contained area for filling and stoppering. Nobody's putting in the old traditional sterile room anymore. They're putting in RABS [Restricted Access Barrier Systems] or LCEs inside a class 100,000 area. These systems maintain better sterility than the old class 100 rooms.
CP: Does that change how your company supplies its components?
EP: Companies look to West to provide ready-to-use components in bags that can be mated to the alpha-beta ports in their LCEs. So we see the need for ready-to-use components growing every day, and we're meeting that need with a number of programs. However, the industry is conservative and change advances at a measured pace.
CP: Because of the heightened regulatory burden, I assume?
EP: People in the industry are cautious and that is reflected in the regulatory environment. There are lives at stake, so this conservative environment is appropriate.
The FDA is composed of pharmacologists who were trained in the same places as the pharmaceutical people who are running these companies. We were all trained basically the same way.
CP: In places like the UT program?
EP: Yes. What I hear from industry, before management at big pharmaceutical companies will let employees set foot in their sterile fill areas, they send them to the University of Tennessee program for a week. It's like their basic training to get into that sterile area.
It can be surprising for some people when they get into this profession to discover how complex it is. I tell them not to worry about it, just like that engineer told me.
CP: I'm sure there's plenty of nervousness among people entering that scenario for the first time.
EP: It's difficult enough to do the things you need to do in the aseptic area. But to wear all the required protective clothing, masks and gloves -- that makes it even more difficult. The techniques alone are difficult to master.
We have a gentle way of reminding people that one slip in technique can be fatal to a patient.
CP: It must be tough to build up that level of fear and dread in someone and then expect them to get their techniques down.
EP: We want to instill respect for the process and for the importance doing our jobs correctly has for patients who depend on drug products. It is difficult to have a pharmacologist point out that you may have injured somebody by passing your hand over a sterile vial. Those lessons you need to learn in a training course, not on the job.
Gil Y. Roth has been the editor of Contract Pharma since its inception in 1999.