Semiautomatic Aerosol Propellant Filler

The U.S. Food and Drug Administration, through its Center for Drug Evaluation and Research and Office of Testing and Research, is seeking a semiautomatic aerosol propellant filler system for use in research on pressurized metered-dose inhalers utilizing both traditional and next-generation propellants. The requirement is for a complete system, including the base unit, a 2002/100 crimper assembly, a crimp height measuring gauge, a propellant pump package with filters and spare parts, as well as comprehensive support services such as factory acceptance documentation, validation support, installation, operator training, and a one-year warranty covering onsite repairs. The system must meet strict material standards, with all product-contact components constructed from AISI 316L stainless steel and accompanied by EN 10204-3.1 material certifications. The equipment must feature a two-hand safety protection guard and be delivered to a specified laboratory at the FDA facility in Silver Spring, Maryland. Delivery and installation must be completed within 90 calendar days of award, with training finalized within five business days after installation, and full acceptance by the Government must occur within 30 working days following installation and operational testing. The procurement follows FAR Part 12 and Part 13 procedures under an LPTA source selection process, meaning award will go to the technically acceptable offeror with the lowest evaluated price, provided past performance is acceptable or neutral. All quotations must be submitted electronically by June 22, 2026, and must include a completed Buy American Act Compliance Certification, SAM registration status, Unique Entity Identifier, detailed compliance matrix, product literature, country of origin disclosures, Trade Agreements Act compliance, and past performance references. The offeror must hold pricing firm for 120 days after submission and comply with all contractual clauses including those addressing whistleblower rights, internal confidentiality prohibitions, electronic invoicing via the Treasury’s IPP system, information and communication technology accessibility, key personnel, and anti-lobbying requirements. Invoices must be submitted electronically and include a detailed invoice log addendum, certification of service delivery, and supporting documentation for any labor or cost-reimbursement line items.