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