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%
Opportunities for Standardization in Single-use: Your views at a glance
Apr 15, 2017
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2% Virus Inactivation
6% Virus Filtration
4% Normal Flow Filtration
6% Mixing
19% Final Bulk Filtration & Dispense
9% Cross Flow Filtration
21% Chromatography
34% Bioreactor Operation
2% Virus Inactivation
6% Virus Filtration
4% Normal Flow Filtration
6% Mixing
19% Final Bulk Filtration & Dispense
9% Cross Flow Filtration
21% Chromatography
34% Bioreactor Operation
43%
49%
9%
YES, share completely
Within facilities but notbetween mammalian & microbial
NO, always dedicate to facilities
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] 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 ROADYES 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%
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