Automated Vial Capper Machine and Labeler system

The U.S. Food and Drug Administration’s Office of Acquisition and Grant Services is seeking market information for an Automated Vial Capper Machine and Labeler System to be deployed at the Federal Research Center in Silver Spring, Maryland. This sources sought notice, identified as CBER-2026-133944, is not a solicitation but a market research tool aimed at determining the availability of small business manufacturers capable of supplying U.S.-made equipment that meets strict technical and regulatory requirements. The system must handle 3 mL and 5 mL vials with 13 mm and 20 mm aluminum crimp caps at a minimum throughput of 60 vials per minute, fit within a 16 x 5 feet footprint, and feature a 4.3-inch color touchscreen HMI with variable speed control, consistent capping torque, and precise labeling placement. Equipment must operate on standard 115-volt, 60 Hz, single-phase power with clean compressed air at 30 psi or as specified, and include installation, onsite qualification, and training with no separate shipping charges. The machine must support Factory Acceptance Testing, and the contractor must submit Installation and Operational Qualification protocols for FDA approval prior to execution, followed by Performance Qualification using actual production materials. Responses must demonstrate, not merely assert, technical capability through detailed documentation including ISO certifications, technical specifications, product brochures, and three years of past performance providing similar systems. Respondents must identify their business size status under U.S. socioeconomic programs such as Small Business, Veteran-Owned, or Woman-Owned, and include their SAM Unique Entity ID. If the product is sourced from a different manufacturer, that entity’s information must also be provided. The system must comply with Section 508 accessibility standards and include an Accessibility Conformance Report based on the Voluntary Product Accessibility Template Version 2.0, and must adhere to Buy American and Made in America requirements with full disclosure of manufacturing origin. Contractors must comply with stringent FDA facility access protocols, including Real ID or U.S. government-issued passport authentication, White Oak campus parking access, mandatory escorting by FDA staff at all times, and strict adherence to security procedures at designated entry points. Delivery must be coordinated 48 hours in advance and occur between 9 AM and 3 PM on the FDA campus, with full installation and validation completed within 90 days of award and an anticipated 12-month warranty period beginning September 2026. The government