Automated Vial Capper Machine and Labeler system

The solicitation for an Automated Vial Capper and Labeler system, issued under solicitation number 75F40126Q133944 by the FDA Office of Acquisition and Grant Services within the Department of Health and Human Services, is a total small business set-aside under NAICS code 333993, with a size standard of 600 employees. The procurement is conducted on a lowest price technically acceptable (LPTA) basis, where technical acceptability serves as the sole pass/fail threshold before price is evaluated. The system must be newly manufactured, turn-key, and capable of capping 13mm and 20mm aluminum crimp caps on 3mL and 5mL vials at a minimum rate of 60 vials per minute, with integrated labeling that supports two specific label sizes without barcode requirements. Delivery and installation are to occur at the FDA’s Silver Spring, Maryland facility, with all work subject to stringent security protocols requiring contractor personnel to have valid government-issued identification, be escorted at all times, and comply with parking and access procedures. The system must include installation, installation qualification, operational qualification, performance qualification, and comprehensive on-site training, with a mandatory 12-month warranty covering parts, labor, travel, and preventive maintenance. The contract requires full compliance with Section 508 accessibility standards, necessitating submission of an Accessibility Conformance Report or HHS Section 508 checklist, and adherence to the Buy American Act. All invoice submissions must be electronically filed through the Treasury’s Invoice Processing Platform, with no alternative methods permitted without prior written approval. Contract performance is governed by strict delivery timelines: equipment must be delivered within 196 calendar days of award, with installation and qualification completed by day 226, and an optional three-year post-warranty service agreement is available for annual preventive maintenance and unlimited corrective support. The contractor is responsible for onsite unpacking, visual inspection for damage, and must provide complete operation and maintenance manuals in printed and electronic formats. No shipping charges are allowed, and all deliveries must occur between 9:00 AM and 3:00 PM with 48-hour advance notice. The contracting officer is Nick Sartain, and offers must be submitted via email by 1:00 p.m. Central Time on July 31, 2026. The solicitation includes deviations from standard FAR clauses across multiple areas including commercial item terms