The document discusses challenges in single-use bioprocessing implementation and the possibility of standardization. It presents results of a survey that found the top challenges to be validation requirements, time to implement, and cost. The survey also found that most respondents think that in 10 years, ultra-low density polyethylene could be regarded like stainless steel if a set of criteria are agreed upon. Respondents felt materials, assembly construction, assembly design, and testing/documentation were most in need of standardization.

1. Is standardization possible in
a custom single-use world?
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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%