SAM #CDR-2026-133243

FDA Market Research: Semiautomatic Aerosol Propellant Filler System for Pharmaceutical Research

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is seeking information from qualified vendors for a complete semiautomatic Aerosol Propellant Filler system to support advanced pharmaceutical manufacturing research. - Government Buyer: - U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Testing and Research - Products/Services Requested: - Complete Semiautomatic Aerosol Propellant Filler System (quantity: 1) - Pressure Filler System (dosing cylinder 0.5-20 ml, stainless steel AISI 316L, oil-free, compatible with 20 mm valves) - Crimper System (Model 2002/021 or equivalent) - Crimp Height Measuring Gauge (digital display, 0.01 mm resolution) - Propellant Pump System (Model 2008/100 or equivalent, capacity up to 15 L/min, max 2000 kPa, compatible with LPG, DME, HFA) - Complete spare parts and special tools - Material certificates per EN 10204-3.1 - Installation, factory acceptance testing, validation support - Operator training for up to 6 personnel - Minimum 1-year warranty with onsite repair service - Unique/Notable Requirements: - All components must be pharmaceutical-grade and compatible with a range of propellants (LPG, DME, HFA) - Delivery required within 90 days of contract award - Includes installation, validation, and comprehensive operator training - Minimum 1-year warranty with onsite repair - No specific OEMs or part numbers are mandated; equivalent models are acceptable - Place of performance and delivery: FDA Office of Testing and Research, Silver Spring, Maryland

Description

This is a Sources Sought Notice only and shall not be construed as a solicitation or as an obligation on the part of the Government to acquire any products or services. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification relative to NAICS code [Insert Code] in support of market research.

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is seeking information from qualified vendors capable of providing a complete semiautomatic Aerosol Propellant Filler system for pressurized metered-dose inhaler (pMDI) formulations to support advanced pharmaceutical manufacturing research.

This notice is issued solely for information and planning purposes and does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This notice does not commit the Government to contract for any supply or service.  

Please review the attached Sources Sought Notice (SSN) and respond using the attached SSN response form on or before April 14, 2026@10:00 am to Michele Jackson at Michele.Jackson@fda.hhs.gov 

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