- Should the design retrofit an existing door or door frame, or may a new door be procured and modified?
- Which minimum patient-care functions must cross the barrier, and which functions should remain inside the patient area?
- Which door types, dimensions, fire-safety requirements, emergency-egress requirements, and local fabrication capabilities must the system support?
- Which cleaning agents and infection-prevention procedures are mandatory in the intended setting?
- What level of containment performance must be demonstrated, which test methods should be used, and which authority should approve the acceptance criteria?
- Should the transfer chamber incorporate a mechanical interlock to prevent both closures from being opened simultaneously, or could a procedural control be acceptable during early feasibility testing?
- Which medical tubing, cables, connectors, and equipment must pass through the barrier?
- How should unused tubing-port capacity be closed and sealed?