Risk of Reusables in the Aseptic Processing Area I - The world leader in serving science

Including: • Facility Design • Process Design • Personnel Training and Gowning • Cleaning and Disinfection • Environmental Monitoring • Process Simulation Lifecycle-Management-for-Near-Sterile-Facility-Contamination-Control-Programs/ . [...] b) Prevents chemical and particulate contamination of the product during the process and prior to disinfection. [...] • Quat inactivation (Quaternary Ammonia disinfectants) • Where storing? Dock? Mold? • Washing/Drying Process: • Destruction of microfibers • Overloading washers don’t allow for proper agitation/rinse • High heat used to speed up drying • Validating/managing cycles • When is too many? Source: Contec Inc. [...] Single Use Risk Reusable Risk Source raw materials and incoming Contamination burden on the used garments, mops, or wipers bioburden can vary widely and can lead to inconsistent quality levels in the relaundered materials Qualified Supplier Are materials segregated? Cross contamination? Control of the process How do you verify the contamination has been cleaned from the washer itself? Chain of cus. [...] • Equivalent Pore Diameter – The air pressure to determine the relative pore size of the garment.