Request for Information No. - [Mid-Energy Electron Beam (eBeam) Systems] Redacted

Expected external dose rates at 10 cm from surfaces/slots during operation in unrestricted areas. Explain radiation-monitoring approach, if any can be provided. - Facility requirements: electrical power drop required (kVA), cooling capacity required (kW, flow, inlet temperatures to eBeam machine), exhaust flow required to outside (in order to maintain negative pressure in product path through process zone), ambient environment restrictions (temperature and humidity limits), options for anchoring to floor, required floor-loading capacity under shield, required clearance for largest system crate or component to be brought into installation area.

4.4 Controls, Data, and Cyber/Connectivity

- Human-machine interface / programmable logic controller (HMI/PLC) platform, alarm/interlock architecture.
- Data logging (all dose-relevant critical parameters; run-record reports available), audit trails, user-access control.
- Interfaces: Ethernet/Industrial Protocol (IP), Open Platform Communications Unified Architecture (OPC UA), Modbus, etc.
- Remote-support-connectivity solution and cybersecurity considerations.

4.5 Testing Support and Validation

- Factory Acceptance Test (FAT), being performed at Supplier facility. List typical acceptance criteria, include power-efficiency tests, as well as demonstration of variations/control/recording of all dose-relevant critical eBeam system parameters affecting sterilization. - Site Acceptance Test (SAT), being performed at customer site. List typical acceptance criteria. - Commissioning approach and support through Installation Qualification (IQ) and Operational Qualification (OQ).
- Dosimetry process support for measurements on eBeam system (recommended procedures, holders, beam control of critical parameters for characterizing impact on dose). - Documentation packages typically provided to assist process validation for sterilization. - Support for regulatory engagement through Process Qualification (PQ).

4.6 Project Execution and Schedule

- Typical lead time from contract to FAT.
- Typical time from FAT completion to SAT at customer site in USA. - Major project phases, including required (if any) phase-gate approvals and customer responsibilities.