Automated Vial Capping and Labeling System

The U.S. Food and Drug Administration (FDA) is conducting market research to identify potential contractors capable of providing an Automated Vial Capper Machine and Labeler System. This system is crucial for the preparation of Center for Biologics Evaluation and Research (CBER) Standards, which are essential for quantifying the potency of biological drugs and are used by manufacturers and regulatory agencies. The existing equipment has been discontinued, necessitating a replacement to ensure uninterrupted production and compliance with federal regulations. The required system must have a maximum footprint of 16x5 feet and maintain high operational reliability, with a minimum production rate of 60 vials per minute for 3mL and 5mL vials. Key components include a rotary table, variable speed motor drives, a control panel with a color touchscreen HMI, and a wrap-labeling system. The system must also integrate seamlessly with an automatic tray loader for downstream accumulation and handling. Installation, on-site qualification, training, and optional annual preventative maintenance services are included. The place of performance is the Federal Research Center Building 52/72, Room 5296, 10903 New Hampshire Avenue, Silver Spring, MD 20993. Equipment delivery is expected within 60 days of contract award, with installation, qualification, and training completed within 90 days. The solicitation also outlines requirements for contractor personnel security, packaging and shipping, installation, setup, testing, training, and warranty. The FDA is particularly interested in small business sources but encourages all interested parties to respond with capability statements by June 11, 2026.