SES105b - Decontamination for CCS: How to Design Decontamination for Upgraded CCS

At the last Aseptic Conference, FDA regulators again mentioned they embrace new technologies.
Three case studies that showcase adoption of new technologies are mainly discussed in this presentation.

1. Retrofit of old-school isolators using rapid bio-decontamination technology, Ultra Decon Retrofit is a trend in the industry. It usually means update traditional clean booth to RABS. We integrated new technologies into 15-year old isolators to improve its productivity.

2. Scalable Cell Processing Barrier Systems for ATMP
With half suit that can rotate 360°, GMP Incubator, rapid decontamination of cell package and other integrated technologies, this barrier systems achieve robust contamination control and production scale-up for ATMPs.

3. Continuous bio-decontamination/electron beam hybrid system for RTU transfer
RTU transfer with validated contamination control has been difficult. New concept, which combines benefit of hydrogen peroxide decontamination and electron beam sterilization, is introduced in the presentation.