Semiautomatic Aerosol Propellant Filler

Project ID: CDR-2026-133243 FederalOpportunitiesSources Sought

Overview

Agency	Food and Drug Administration
Deadline	04/14/26
Posted	03/31/26
Estimated Value	Not Provided
Set Aside	None
NAICS	333914 - Measuring, Dispensing, and Other Pumping Equipment Manufacturing
PSC	6640 - Laboratory Equipment And Supplies
Location	Silver Spring, MD 20993 United States

Description

Primary Latest Change

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

Summary (Newest Update)

Background The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is conducting market research to identify qualified vendors capable of providing a complete semiautomatic Aerosol Propellant Filler system for pressurized metered-dose inhaler (pMDI) formulations. This initiative supports advanced pharmaceutical manufacturing research, which aims to enhance drug quality, improve manufacturing process reliability, and increase timely access to quality medicines for the American public. Work Details The FDA requires a complete semiautomatic Aerosol Propellant Filler system that meets pharmaceutical-grade standards for filling pMDIs with both traditional and next-generation propellants in a laboratory setting. The system must include: A. Pressure Filler System: - Dosing cylinder adjustable from 0.5 - 20 ml - All product-contact parts made of stainless steel AISI 316L - Oil-free execution - Quick-changeable product aggregate - Compatible with 20 mm valve systems - Protection guard with two-hand release mechanism B. Crimper System (Model 2002/021 or equivalent): - Large crimping head for 20 mm valves - Adjustable crimp height and diameter - Adjustable container height and diameter - Stainless steel construction - Oil-free execution C. Crimp Height Measuring Gauge: - Digital display with 0.01 mm resolution suitable for 20 mm opening aerosol containers, supplied with calibration piece and certificate. D. Propellant Pump System (Model 2008/100 or equivalent): - Capacity up to 15 liters per minute, maximum outlet pressure of 2,000 kPa (20 bars) compatible with liquified propellants (LPG, DME, HFA). Features dual-stage filtration system and pressure gauge on the outlet for pressure control, with all product-contact parts made of stainless steel AISI 304 or 316L. Additional requirements include complete sets of spare parts for all components, special tools for maintenance, material certificates according to EN 10204-3.1 for stainless-steel parts, installation support, factory acceptance testing, comprehensive operator training for up to six personnel, a minimum one-year warranty with onsite repair service, and inclusion of all shipping costs. Period of Performance Delivery within 90 calendar days after contract award. Place of Performance U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Testing and Research 10903 New Hampshire Ave., Laboratory WO 64 Rm 1083 Silver Spring, MD 20993

Contacts

Contact name	Michele Jackson
Contact email	michele.jackson@fda.hhs.gov
Contact phone	None
Secondary contact name	Madeline Bryant
Secondary contact email	madeline.bryant@fda.hhs.gov
Secondary contact phone	None