CanadaBuys #W6369-26-A112

Feasibility Assessment for HI-6 DMS and Atropine Sulfate Reconstitution Autoinjector Device (RAD) for Canadian Forces Health Services

The Canadian Department of National Defence (DND), through the Canadian Forces Health Services (CFHS), is seeking specialized services to assess the feasibility of manufacturing HI-6 DMS and atropine sulfate drug products in a reconstitution autoinjector device (RAD) for military use. - Government Buyer: - Department of National Defence (DND), Canadian Forces Health Services (CFHS), Materiel Acquisition and Support Specialist, D Svcs C 3-5-4 - OEMs and Vendors: - Kaleo, Inc. (OEM and pre-identified supplier of the RAD platform) - Products/Services Requested: - Feasibility assessment services for manufacturing HI-6 DMS (500 mg ± 25%, dry chamber) and atropine sulfate (2 mg/mL, 1 mL, liquid chamber) in a dual-chamber reconstitution autoinjector device (RAD) - Project management, analytical method development, material processing and performance assessments - Mixing and drug delivery modeling - Sterilization impact assessment - Unique or Notable Requirements: - Use of an existing, regulatory-compliant RAD prototype - Device must support dual-chamber design for separate storage and reconstitution of HI-6 DMS and atropine sulfate - Compliance with Good Manufacturing Practices (GMP) - Documentation of device mechanism, workflow, and regulatory approval for military use - Deliverables include analytical method summary, formulation prototype performance, mixing/drug delivery model, and sterilization impact assessment reports - Contract duration is 12 months, with specific deliverable deadlines - Subject to multiple trade agreements

Description

The Department of National Defence (DND), specifically the Canadian Forces Health Services (CFHS), requires testing and evaluation of the feasibility of manufacturing HI-6 DMS and atropine sulfate drug products in a reconstitution autoinjector device (RAD). The scope involves conducting a feasibility assessment using an existing prototype of a RAD configured with HI-6 DMS (dry chamber, 500 mg ± 25%) and 1 mL atropine (2 mg/mL) in the liquid chamber. The work includes project management, analytical method development, material processing and performance assessments, mixing and drug delivery model, and sterilization impact assessment. The contract duration is 12 months.

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