Semiautomatic Aerosol Propellant Filler

Form / Attachment / Pricing Sheet

This document is a response template for a Sources Sought Notice (SSN) regarding a Semiautomatic Aerosol Propellant Filler for pMDI's (CDER-2026-133243). It is designed to collect detailed information from potential vendors about their company's capabilities, business status, and technical qualifications related to the specified requirement.

• Company Identification: Legal name, DBA, address, website, size, and registration details (UEI, CAGE, SAM.gov status).
• Business Size & Certifications: Classification as small or other-than-small business, recommended NAICS code, size standard, annual revenue, employee count, and any relevant socioeconomic certifications (HUBZone, SDB, 8(a), SDVOSB, VOSB, WOSB, EDWOSB).
• GSA Federal Supply Schedule (FSS) Information: Details on existing GSA contracts, availability of requested equipment/services on schedule, and pricing.
• Technical Capability: Confirmation of ability to provide the complete system, including specific capabilities for pressure filler, crimper, crimp height measuring gauge, and propellant pump systems, as well as additional components like spare parts and material certificates.
• Delivery & Installation: Ability to meet delivery timeframes, provide onsite installation services, and conduct operator training.
• Warranty & Maintenance: Details on warranty coverage, included services (testing, calibration, materials), and extended warranty options.
• Pricing Information: Estimated pricing for CLINs, basis of pricing, and validity.
• Subcontracting & Teaming: Information on anticipated use of subcontractors and existing teaming arrangements.
• Attachments Checklist: Required documents to be submitted with the response.
• Submission Instructions: Deadline (April 14, 2026, 10:00 am), submission method (email to Michele Jackson), and required email subject line.
• Certifications: Understanding of the SSN's nature and certification of response accuracy.

This template guides potential bidders on the specific information required to demonstrate their capability to fulfill the requirement for a semiautomatic aerosol propellant filler. Completing this form accurately is crucial for the government's market research and potential future solicitation planning. Bidders must provide detailed responses regarding their technical, delivery, warranty, and business qualifications.

Sources Sought Notice

This notice is for market research purposes only to identify potential qualified sources for a semiautomatic Aerosol Propellant Filler system. The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is seeking information on vendors capable of providing this system for advanced pharmaceutical manufacturing research, specifically for pressurized metered-dose inhaler (pMDI) formulations. This is not a solicitation, and no contract will be awarded based on responses.

The FDA requires a complete semiautomatic Aerosol Propellant Filler system for filling pMDIs with traditional and next-generation propellants in a laboratory setting. The system must meet pharmaceutical-grade standards and include:

• Pressure Filler System: Adjustable dosing cylinder (0.5-20 ml), stainless steel (AISI 316L) product-contact parts, oil-free, compatible with 20 mm valve systems.
• Crimper System: Large crimping head for 20 mm valves, adjustable settings, stainless steel, oil-free.
• Crimp Height Measuring Gauge: Digital display (0.01 mm resolution), suitable for 20 mm containers.
• Propellant Pump System: Capacity up to 15 L/min, max pressure 2,000 kPa, compatible with LPG, DME, HFA, dual-stage filtration.

Additional Requirements: Spare parts, special tools, material certificates (EN 10204-3.1), delivery within 90 days, installation, Factory Acceptance Testing (FAT), validation support, operator training (up to 6 personnel), and a minimum 1-year warranty with onsite repair.

Delivery Location: FDA, CDER, Office of Testing and Research, 10903 New Hampshire Ave., Laboratory WO 64 Rm 1083, Silver Spring, MD 20993.

Interested parties should provide:

• Company Information: Name, address, POC, DUNS, CAGE Code, SAM.gov status, business size classification, GSA Schedule info.
• Technical Capability: Experience with similar equipment, manufacturer relationships, technical capabilities, previous federal contracts.
• Delivery and Support Capability: Ability to meet 90-day delivery, installation/training capabilities, warranty/maintenance support, FAT/validation experience.

Submit responses using the attached SSN Response Form to Michele Jackson (Michele.Jackson@fda.hhs.gov) no later than April 14, 2026, 10:00 AM. The subject line should be: "Sources Sought Response – XXXX (company name) Aerosol Propellant Filler System."

This notice is for information and planning purposes only and does not commit the Government to a contract. No costs incurred in responding will be reimbursed.