Sources Sought Notice CDR-2026-133243 final.docx

SOURCES SOUGHT NOTICE

Notice ID: CDR-2026-133243 NAICS Code: 333914

PSC: 6640

1. PURPOSE

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.

2. BACKGROUND

Advanced pharmaceutical manufacturing represents innovative technology with the potential to enhance drug quality, improve manufacturing process reliability and robustness, and increase timely access to quality medicines for the American public. The FDA's research priorities include exploring advanced manufacturing techniques for inhalation drug delivery systems, including manufacturing of spray-dried powder formulations for intranasal and inhalation drug delivery.

3. REQUIREMENT OVERVIEW

The FDA requires a complete semiautomatic Aerosol Propellant Filler system capable of filling pMDIs with traditional and next-generation propellants for inhalation drug delivery in a laboratory setting. The system must meet pharmaceutical-grade standards and support research flexibility.

Key System Components Required:

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: 2,000 kPa (20 bars)

- Compatible with liquified propellants (LPG, DME, HFA)

- Dual-stage filtration system (5 micron pre-filter and 0.1 micron sterile filter) and/or Inlet filter with 150-micron mesh size used as coarse filter

- Pressure gauge on the outlet for pressure control

- All product-contact parts made of stainless steel AISI 304 or 316L Additional Requirements:

Complete sets of spare parts for all system components Special tools for maintenance and operation Material certificates according to EN 10204-3.1 for all stainless-steel product contact parts Delivery within 90 calendar days after contract award Installation, Factory Acceptance Testing, and validation support Comprehensive operator training for up to 6 personnel Minimum 1-year warranty with onsite repair service All shipping, packaging, and delivery costs included Delivery Location:

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

4. INFORMATION REQUESTED

Interested parties should provide the following information to assist the Government in determining the appropriate acquisition strategy:

A. Company Information Complete company name, address, point of contact, phone number, and email address DUNS Number and CAGE Code SAM.gov registration status (Active/Inactive) Business size classification (check applicable box in response template) GSA Federal Supply Schedule information (if applicable) B. Technical Capability Description of relevant experience providing similar pharmaceutical manufacturing equipment Manufacturer relationships and authorized distributor status (if applicable) Technical capabilities to meet the specified requirements Previous contracts with federal agencies (if any) C. Delivery and Support Capability Ability to meet the 90-day delivery requirement Installation and training capabilities Warranty and maintenance support capabilities Factory Acceptance Testing and validation support experience

5. SUBMISSION INSTRUCTIONS

Responses to this Sources Sought Notice must be submitted using the attached SSN Response Form no later than April 14, 2026 @10:00am, to Michele Jackson at Michele.Jackson@fda.hhs.gov Subject Line: Sources Sought Response – XXXX (company name) Aerosol Propellant Filler System

6. DISCLAIMER

This Sources Sought Notice does not constitute a solicitation for proposals, and no contract will be awarded from this notice. The Government will not pay for any information received in response to this notice, nor will the Government compensate any respondent for any cost incurred in developing a response. Responses will not be returned. No reimbursement will be made for any costs associated with providing information in response to this notice or any follow-up information requests.

Respondents will not be notified of the results of the evaluation. A determination by the Government not to compete this requirement based upon responses to this notice is solely within the discretion of the Government.

7. POINTS OF CONTACT

Contracting Officer:

Michele Jackson Email: Michele.Jackson.@fda.hhs.gov

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