Value Stream — Vaccine Fill-Finish Suite
Bulk drug substance to released pallet on a sterile suite running twenty lots a week, where an eight-hour aseptic changeover and the fourteen-day sterility hold leave flow efficiency near 2%.
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title "Vaccine fill-finish — bulk substance to released pallet"
supplier "Bulk drug substance (Building 4)"
# Demand is in LOTS, not doses: every process box below is a lot operation,
# so quoting takt per dose would compare a batch step to a unit rate.
customer "National distribution centres" demand: 20/week
available 120h/week # three shifts, five days
control "MES campaign scheduler"
process "Thaw + pooling" { ct: 95m; co: 40m; uptime: 88%; operators: 3; shifts: 3; fpy: 99% }
wait 6h # bioburden result before filtration
process "Sterile filtration" { ct: 55m; uptime: 84%; operators: 2; shifts: 3; fpy: 98% }
inventory 12 lots
process "Aseptic filling + stoppering" { ct: 210m; co: 8h; uptime: 72%; operators: 6; shifts: 3; fpy: 97% }
wait 4h
process "Capping + visual inspection" { ct: 140m; uptime: 90%; operators: 8; shifts: 2; fpy: 93% }
inventory 9 lots
process "Labelling + secondary packing" { ct: 85m; co: 55m; uptime: 92%; operators: 5; shifts: 2; fpy: 99% }
wait 14d # sterility test incubation, not negotiable
process "QP release" { ct: 45m; operators: 2; fpy: 96% }
info "Campaign plan" from customer to control electronic
info "Executed batch record" from "Aseptic filling + stoppering" to control electronic
info "Release certificate" from "QP release" to customer electronic