Performance Validation will be attending and exhibiting at the Jan 2017 PDA Midwest Chapter Meeting. The meeting will be held on January 26, 2017 5:30 to 9 PM at the Crowne Plaza in Northbrook, IL.
The topic for the evening is the DuPont™ Tyvek® Case Study:
Manufacture of complex pharmaceuticals requires understanding and mitigation of risk. For biopharmaceuticals or for products that cannot be terminally sterilized, risk to the final product is minimized through control of bioburden or full aseptic processing. In cleanroom environments where this type of processing takes place, a potential source of contamination is particle shedding from human workers. A mechanism to minimize risk from this contamination is through use of appropriate cleanroom protective garments. In aseptic processing areas or in bioburden control areas, these garments are typically sterile. There are many methods used to sterilize garments—all of these methods not only kill micro‐organisms, but can impact the polymers that make up the garments. To better understand the impact of sterilization, this presentation will address common polymer degradation mechanisms. As an example of the impact of sterilization on garments, a case study of evaluation of reusable, woven polyester, cleanroom garment properties as a function of gamma radiation exposure dose will be presented. This can be contrasted against the change in functionality for single‐use garments after radiation exposure. Data showing the impact of radiation on the polymers making up the garments via molecular weight analysis will also be presented. With the physical property information, implications for particulate load in a cleanroom can be considered, and ultimately drive a better understanding of garment properties over their expected service life.
Mike Stires will be representing Performance Validation at this event. Mike is an owner for Performance Validation and a Principal Validation Engineer responsible for oversight of all work originating out of PV’s Illinois office. Have a question on commissioning, qualification or validation? Mike and his team will be available to answer your questions during the networking breaks. Alternatively, you may contact Mike directly via email to schedule a meeting.
We hope to see you at the Jan 2017 PDA Midwest Chapter Meeting!
About Performance Validation – Performance Validation has been serving the life science industries since 1988, and is a nationwide leader in providing commissioning, qualification, and validation services for pharmaceutical, biotechnology, and medical device manufacturers. We live by our Mission, which is to provide our clients with peace of mind, and we have been doing so for more than 25 years.