Routine Processing
Examples
Option #1
Customer purchases RTS Sterilizer(s) and installs in their own manufacturing facility
Estimated Duration: 1 Month
Syringes are Filled, Assembled & Packaged
Product is loaded into chamber
Product is Exposed ~4-10 Hours (Including Aeration)
Read EPCDs at Day 14
Product is Released
Option #2
Customer purchases RTS Sterilizers and installs at Contract Manufacturing Organization (CMO)
Estimated Duration: 2 Months
Syringes are Filled at Customer Manufacturing Location
Unassembled Filled Syringes are Shipped to CMO
Drug Product is Tested Upon Arrival
Syringes are Assembled and Packaged
Product is Loaded in the Chamber
Product is Exposed 4-10 Hours (Including Aeration)
Read EPCDs at Day 14
Product is Released
Option #3
Customer uses Contract Sterilization
Estimated Duration: 6 Months
Syringes are filled at Customer Manufacturing Location
Unassembled Filled Syringes are Shipped to CMO
Drug Product is Tested Upon Arrival
Syringes are Assembled and Packaged
Syringes are Shipped to Contract Sterilization Facility
Drug Product is Tested Upon Arrival
Product is Loaded in the Chamber
Product is Exposed 4-10 hours (Including Aeration)
Read EPCDs at Day 14
Syringes are Shipped Back to CMO for Final Packaging
Drug Product is Tested Upon Arrival
Product is Released