Semiautomatic Aerosol Propellant Filler

Statement of Work (SOW)

To procure a complete semiautomatic aerosol propellant filling system, including accessories, installation, validation support, training, and warranty services, for use in pharmaceutical inhalation product development and manufacturing research.

• Furnish all labor, materials, equipment, transportation, supervision, and other resources for a semiautomatic aerosol propellant filling system.
• Deliver, install, test, and provide user training for the equipment at the FDA facility.

Pressure Filler System:

• On-column design, stainless steel pneumatic control enclosure.
• Adjustable dosing cylinder (0.5 mL to 20 mL), diaphragm shut-off valve, oil-free operation.
• Product-contact components from AISI 316L stainless steel.
• Includes filling head insert, container centering device, two-hand safety guard, special tools, and spare parts.

Crimper Assembly:

• On-column design, stainless steel pneumatic control enclosure.
• Large crimping head suitable for 20 mm valves, oil-free operation.
• Adjustable crimp height, diameter, container height, and container diameter.
• Includes crimping tong, two-hand safety guard, container centering device, special tools, and spare parts.

Crimp Height Measuring Gauge:

• Suitable for 20 mm openings, digital display, calibration piece and certificate included.

Propellant Pump Assembly:

• Capacity up to 15 liters/minute, max outlet pressure 2,000 kPa.
• Compatible with HFA, LPG, and DME propellants.
• Includes inlet filter, outlet pressure gauge, special tools, spare parts, hose kit, and filter unit.

Contractor Responsibilities:

• Packaging, handling, transportation, shipping, delivery, installation, operational testing, FAT documentation, validation documentation and support, user training, manuals, and warranty support.

• Period: Date of Award through One (1) Year After Award.

• Place: U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research, Silver Spring, MD 20993.

• Contract Type: Firm-Fixed-Price (FFP) purchase order.

• Delivery: Within 90 Calendar Days After Award.

• Minimum one-year warranty covering parts, labor, travel, onsite repair, and technical support.

• Response to service requests within two business days.

• Government has 30 working days for inspection and verification post-installation and testing.

• Acceptance contingent on operational status, meeting contract requirements, completed training, and received documentation.

Solicitation / RFP / RFQ

This is a Request for Quotation (RFQ) for commercial products, prepared in accordance with FAR Part 12 and FAR Part 13 procedures. The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Testing and Research (OTR), requires the purchase, delivery, installation, validation support, training, and warranty of a Semiautomatic Aerosol Propellant Filler for PMDI Two-Stage Formulation. This requirement supports FDA research in advanced pharmaceutical manufacturing and inhalation drug delivery systems.

• Semiautomatic Aerosol Propellant Filler for PMDI Two-Stage Formulation

• Purchase, delivery, installation, validation support, training, and warranty

• The document does not explicitly state the contract type or period of performance.

• Questions Deadline: Submit all questions in writing via email to Michele.Jackson@fda.hhs.gov no later than June 15, 2026, at 9:00 AM Eastern Time. Questions received after this date may not receive a response.

• Quotation Submission Deadline: Submit quotations electronically to Michele.Jackson@fda.hhs.gov no later than June 22, 2026, at 11:00 AM Eastern Time.

• Subject Line for Quotations: Include "[Company Name] 75F40126Q00231/CDER-2026-133243 Quote" in the subject line.

• The RFQ is marked as "IS NOT A SMALL BUSINESS SET ASIDE."

• This request utilizes FAR Revolutionary FAR Overhaul clauses and provisions available at Acquisition.gov.

• Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

• Standard Form 18 (Rev. 6-95) is the prescribed form.

Form / Attachment / Pricing Sheet

This document is Attachment II, a Pricing Schedule, intended for bidders to detail their proposed pricing for the items associated with the opportunity. Bidders should use this schedule to input unit prices and calculate extended prices.

• CLIN (Contract Line Item Number): Identifies specific items or services.
• Description: Details the item or service (e.g., Semiautomatic Aerosol Propellant Filler System, Crimper Assembly, Warranty).
• Quantity: The number of units required.
• Unit: The unit of measure (e.g., EA for Each, LOT).
• Unit Price ($): The price per unit (to be filled by bidder).
• Extended Price ($): The total price for the CLIN (Quantity * Unit Price), to be calculated by the bidder.
• Manufacturer, Model Number, Country of Origin, Comments: Additional fields for specific item details.
• Total Price: The sum of all Extended Prices.

This pricing schedule is critical for bidders to accurately quote their costs for the required goods and services. It directly impacts the proposal submission and will likely be a key component in the evaluation process. Bidders must complete this sheet with their proposed pricing for all CLINs.

Form / Attachment / Pricing Sheet

This document is Attachment III, the Past Performance Reference Form. It is designed for offerors to provide details about their past performance on previous contracts. This information will likely be used by the government to evaluate the offeror's ability to successfully perform the current requirement.

Each instance of the form requests the following information:

• Solicitation Number
• Offeror Name
• Reference Contract Number
• Contract Title/Description
• Customer/Agency Name
• Customer Point of Contact (Name, Email, Telephone)
• Contract Type
• Period of Performance
• Contract Value
• Description of Similarity to This Requirement
• Whether installation services were provided (Y/N)
• Whether training services were provided (Y/N)
• Whether the contract was completed successfully (Y/N)

Bidders must complete and submit this form accurately to provide evidence of their past performance. The details provided, particularly the description of similarity to the current requirement and the success of the past contract, will be crucial for the government's evaluation of the offeror's qualifications and past performance.

Form / Attachment / Pricing Sheet

This document is Attachment VII, a Buy American Act Compliance Certification required for Solicitation Number 75F40126Q00231, "Semiautomatic Aerosol Propellant Filler for pMDI Two-Stage Formulation." Offerors must complete and submit this certification with their quotation to comply with FAR 52.225-1 and FAR Subpart 25.1.

• Section 1: Offeror Information: Requires company name, UEI, SAM registration status, POC details, and date.
• Section 2: End Product Information: Requires offerors to list each product, its country of origin, manufacturer, and indicate if it qualifies as a domestic end product under the Buy American Act for each CLIN (0001-0007).
• Section 3: Certification Statement: Offeror certifies that end products are domestic (manufactured in the U.S. with >60% domestic components) or lists exceptions. It also warns of penalties for false certifications and the government's right to verify origin.
• Section 4: Buy American Act Exceptions Reference: Provides information on non-availability, unreasonable cost, public interest, and resale exceptions for reference.
• Section 5: Signature Block: Requires authorized signature, printed name, title, company name, and date.

Completing this form accurately is crucial for proposal submission. Failure to submit a completed and signed Buy American Act Compliance Certification may render the quotation technically unacceptable and ineligible for award. Bidders must carefully identify their products' origins and domestic component percentages to ensure compliance or properly document any exceptions.

Solicitation / RFP / RFQ

This is a Request for Quotation (RFQ) for a Semiautomatic Aerosol Propellant Filler for pMDI Two-Stage Formulation, including delivery, installation, validation support, training, and warranty. The U.S. Food and Drug Administration (FDA) requires this equipment for research in advanced pharmaceutical manufacturing and inhalation drug delivery systems.

• Semiautomatic Aerosol Propellant Filler System

• 2002/100 Crimper Assembly

• Crimp Height Measuring Gauge

• Propellant Pump Package with Filters, Hoses, Spare Parts and Accessories

• Factory Acceptance Documentation and Validation Support

• Installation and Training

• One-Year Warranty Coverage Including Onsite Repairs

• Delivery and installation must be completed within 90 calendar days after award.

• Equipment must meet all salient physical, functional, and performance characteristics identified in Attachment I – Statement of Work (SOW).

• Term of Contract: Date of award through one year after award.

• Place of Performance/Delivery: U.S. Food and Drug Administration, Silver Spring, MD.

• Evaluation is based on Lowest Price Technically Acceptable (LPTA).

• Factors: Technical Acceptability (Pass/Fail), Past Performance (Acceptable/Neutral/Unacceptable), Price.

• Quotations must be submitted electronically to Michele.Jackson@fda.hhs.gov.

• Quotation Deadline: June 22, 2026, at 11:00 AM Eastern Time.

• Offerors must hold pricing firm for 120 calendar days after quotation closing.

• Questions Deadline: June 15, 2026, at 9:00 AM Eastern Time.

• Full and Open Competition (No set-aside).

• Offerors must be registered in the System for Award Management (SAM).

• This solicitation is for a "Brand Name or Equal" product. Offerors proposing an equal product must provide detailed specifications, literature, brochures, drawings, and datasheets to demonstrate compliance.

• Key attachments include the Statement of Work (SOW), Pricing Schedule, Past Performance Reference Form, and Brand Name or Equal Compliance Matrix.

Form / Attachment / Pricing Sheet

This document is a compliance matrix for "Brand Name or Equal" requirements, intended for bidders to detail how their proposed product meets or exceeds the specified features. Bidders must indicate compliance (Y/N) and provide a description of their compliance, referencing supporting literature or page numbers.

• Requirement: Lists specific features and capabilities for a product (e.g., "Pressure filler with column and base plate," "AISI 316L product-contact components," "One-year warranty with onsite repairs").
• Comply (Y/N): A field for bidders to mark whether their offering meets the requirement.
• Offeror Description of Compliance: A field for bidders to explain how their product complies.
• Reference to Literature/Page: A field for bidders to cite where in their documentation the compliance can be verified.

This matrix is crucial for bidders responding to a "Brand Name or Equal" solicitation. It guides them in demonstrating that their proposed product is equivalent to or better than the specified brand name item by systematically addressing each listed requirement. Failure to adequately complete this matrix may impact proposal evaluation.