Automated Vial Capper Machine and Labeler system with post-warranty service agreement options

The Food and Drug Administration is seeking an automated vial capper and labeler system to replace aging equipment at the Division of Biological Standards and Quality Control, which plays a critical role in preparing reference standards for biological products including vaccines. These standards are essential for accurately measuring the potency of biologics and are used globally by manufacturers, regulatory agencies, and the FDA for mandatory lot-release testing before products can be approved for public use. The procurement includes full installation, onsite qualification, and comprehensive training to ensure seamless integration into existing workflows and compliance with regulatory requirements. The system must support the high-precision, sterile preparation of standards critical to ensuring the safety and efficacy of biological drugs. In addition to the core equipment, the contract offers optional annual onsite preventative maintenance services to ensure long-term reliability and operational continuity. The point of contact for both program and contracting matters is Nick Sartain, reflecting a single point of accountability for the procurement. This acquisition underscores the FDA’s ongoing commitment to maintaining the integrity of the biological product approval process through modernization of essential production infrastructure.