Semiautomatic Aerosol Propellant Filler

The U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) has issued a Sources Sought Notice to identify qualified vendors capable of providing a complete semiautomatic Aerosol Propellant Filler system for pressurized metered-dose inhalers (pMDI) to support advanced pharmaceutical manufacturing research. This market research notice is not a solicitation or binding commitment but serves to gather information on potential sources and their size classifications under NAICS code 333914. The required system must include a pressure filler with adjustable dosing cylinders (0.5-20 ml), stainless steel AISI 316L components compatible with 20 mm valve systems, a crimper system with adjustable settings and digital measurement capabilities (0.01 mm resolution), and a propellant pump system with 15 liters per minute capacity and 2,000 kPa maximum outlet pressure. Vendors must also provide spare parts, maintenance tools, material certificates, comprehensive operator training for up to six personnel, Factory Acceptance Testing support, and a minimum one-year warranty with onsite repair service. Responses using the provided SSN Response Form must be submitted to Michele Jackson at Michele.Jackson@fda.hhs.gov on or before April 14, 2026 at 10:00 AM, and respondents should include company information, technical capability details, delivery capabilities, and relevant experience with similar pharmaceutical manufacturing equipment.

This notice carries no set-aside designation and does not identify any incumbent contractors or current suppliers. No contract award value or budget range has been disclosed in this market research phase, and the government will not reimburse vendor response costs. The system must be delivered within 90 calendar days of contract award to the FDA's Silver Spring, Maryland facility, establishing a critical timeline for interested parties to assess their manufacturing and logistics capabilities. Interested vendors must confirm their ability to meet the specified technical requirements, provide pricing for individual line items, detail their installation and training services, describe warranty coverage terms, and outline any value-added services they can offer. The government emphasizes that this notice does not constitute a promise to issue a Request for Proposal or award any contract, making this an exploratory phase to evaluate market capacity and identify qualified sources for potential future procurement actions.