Controlled Environments (CE): Can you give us a basic overview of how product can get contaminated, and what the recall process does to the business?
Bob Nase (BN): In particulate management we consider three basic areas where particles can be introduced to a product – people, machinery, and environment. We consider particles as being intrinsic – which means that it arises from the actual container closure system itself, or the drug formulation.
One of the things you don’t want to do is launch a brand new product and have a recall for anything, but shortly after the launch of the product. That could actually kill the product, particularly if there’s a competition out there.
CE: What are the most common reasons for contamination?
BN: Human intervention is obviously a major contributor to particulate, whether you’re talking about the closure system itself or the filling process. Particulates are everywhere and it’s difficult to say one special design is going to solve all our problems. But the more we take the human element out of the process, the better chance we have at mitigating the particulate issue.
Proper training and continued awareness, where workers imagine themselves as particulate, is part of the West training process. Another area that’s very prone to particulate contamination is the amount of static that might be in the air or in the environment. [Regarding] cleanrooms and unilateral air flow – make sure that you don’t block that flow of air from the system or the container system that you’re working with.
CE: How can staff prevent contamination?
BN: Constant awareness of any extraneous movement that you do in the room or the area has to be considered. And anything you bring into the room could in fact contribute to your particulate contamination.
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CE: How often are standards and regulations adjusted, and how can facility managers stay informed about these changes?
BN: In this industry, the term is CGMP and that means current is current thinking, so that changes literally on a daily basis.
To stay current … it requires staying current with the trade – trade shows, publications, continuous knowledge of what’s new, and again, constant awareness of the operation and feedback from the operator and the people who are actually in the process.
We’re always faced with new regulations but it’s more than that — we have to have an understanding of what the current thinking is.
CE: What important steps do you think facility managers often skip or overlook? Are there any unnecessary steps, in your opinion?
BN: One of the things in the last 5-10 years [has been] somewhat of a paradigm shift because when we talk about sterile/aseptic we’re concerned about microorganisms. We would wipe it down with a disinfectant or a sterilant of some sort, and even our validation process is focused more on microbial contamination more than the particulate contamination.
The act of wiping something down from a microbial contamination standpoint could generate particulate contamination, such as the direction that you’re wiping in, etc. Cleaning something from a microbial standpoint could lead to particulate contamination.
Take the worker out of the operations as much as possible. Anything you bring into the room can result in particulate contamination to the environment. Example – if a machine is now functioning and you have to intervene with a mechanic, is that person knowledgeable about what’s being done? If the wrench isn’t cleaned properly it can result in more contamination.
CE: In terms of contamination due to failure to inspect equipment, what steps should a facility manager take to correctly inspect equipment? What should they look for when purchasing equipment?
A facility manager responsible for the design and purchasing of equipment going into controlled environments must consider the materials of construction used in the machinery including isolation of moving parts that are inherent in generating particles. For instance, conveyor systems are notorious for generating particles. They need to pay attention to the proximity of the product to airborne particulate generated by conveyor systems. Whenever there is unilateral HEPA air flow over machinery it should be designed to not impeded or interrupt the air flow. The machinery must be designed to facilitate easy cleaning and ensure that materials of construction are of the proper material to withstand repetitive cleaning and cleaning agents used in the operation. As mentioned earlier, the human intervention of any operation is a primary contributor to particle contamination and systems should be designed to enable easy access to areas, but not disturb the unidirectional flow of air over and around the product.
Bob Nase is VP of Quality Assurance at West Pharmaceutical Services in Exton, Pa. www.westpharma.com
