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Is standardization possible in a custom single-use world? 2014 Parker Hannifin Group Corporation. All rights resereved. C www.parker.com/dh-bioprocessing Europe: phone +44 (0)191 4105121 - email: [email protected] North America: toll free 877 784 2234 - email: [email protected] phone +1 805 604 3400 WHAT CHALLENGES DO YOU STILL SEE IN SINGLE-USE IMPLEMENTATION? WHO SHOULD BE SETTING THE STANDARDS? COULD WE GET TO A POSITION WHERE ULDPE COULD BE REGARDED IN THE SAME WAY AS 316 STAINLESS STEEL? (Meaning that so long as the fluid contact layer is ULDPE and it meets an agreed set of criteria, materials would be interchangeable) 45% 59% Validation requirements Time to implement Cost Scaleability Automation 45% 38% 17% 76% 82% 56% 56% 82% YES, BUT 10 YEARS DOWN THE ROAD YES NO WEBINAR: WHAT SHOULD BE STANDARDIZED? Materials (e.g. fluid contact layers) How an assembly is built (e.g.connectivity) Assembly design (e.g. lengths & fittings) Testing & documentation End user QA (11%) Vendors (3%) Regulators (17%) Industry bodies (33%) (e.g. BPOG, BPSA) All of these (36%) 56% 25% 19%
