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 Stored until Sterilization Slot is Available

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

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