Automated Vial Capper Machine and Labeler system

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Biologics Evaluation and Research (CBER), requirement for Automated Vial Capper Machine and Labeler system. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required supplies. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort. The associated North American Industry Classification System (NAICS) Code is- 333993 - Packaging Machinery Manufacturing; the applicable Small Business Size Standard is 600 employees. Statement of Work (SOW) Purchase of Automated Vial Capper machine and Labeler system Part I: General Information A. Objective Procurement of Automated Vial Capper machine and Labeler system including installation, onsite qualification, training and optional annual onsite preventative maintenance service. This equipment is used for the preparation of Center for Biologics Evaluation and Research (CBER) Standards in support of vaccines and other biological products submitted for licensure and/or other regulatory decisions. B. Background Division of Biological Standards and Quality Control (DBSQC) serves as a Standards Preparation facility for CBER. This procurement is for the purchase of a replacement Capper and Labeler system to maintain critical production capabilities. These Standards are essential for quantifying the potency of biological drugs and are used by manufacturers during product development and production, as well as by international regulatory agencies and the FDA for mandatory lot-release testing prior to approving biological drugs for public distribution. The Capper and Labeler system is intended to store CBER Reference Standards and Reagents, specifically for capping and labeling of various sized glass vials containing these critical biological products. The existing equipment has been discontinued by the manufacturer, making a replacement necessary to ensure uninterrupted production of these essential reference standards. Continued production is required to maintain compliance with Code of Federal Regulations 610.60-65 and 812.5. This acquisition supports critical mission of CBER under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act to safeguard the safety, efficacy, and quality of biological products that protect public health. C. Scope This procurement is for the purchase of Automated Vial Capper machine and Labeler system for Division of Biological Standards and Quality Control (DBSQC). Part II: Work Requirements See technical specifications for automated Vial capping and labeling system. Maximum Footprint for Capper Machine and Labeler System: 16 x 5 feet. The system should maintain high operational reliability and uptime during production periods. Variable speed control capability must be provided to match production requirements and workflow demands. The equipment must demonstrate consistent capping torque and labeling placement accuracy to ensure product quality and regulatory compliance. Container handling shall be designed for gentle operation to prevent container damage during processing. The system must operate effectively in a temperature-controlled laboratory environment with appropriate humidity levels. Rotary Table Construction: Aluminum frame or equivalent durable frame material, with stainless steel external coverings or equivalent cleanable exterior surfaces Guide Rails: Stainless steel guide rails and center hub Support System: Anti-friction ball bearing supports with stainless steel pads Height Adjustment: Adjustable stainless steel threaded legs, or equivalent leveling mechanism, to support equipment leveling and integration with adjacent equipment; quoted configuration provides an adjustable height range of 33"–37". Cabinet: Integrated stainless-steel cabinet, or equivalent cleanable enclosure, with access panels for maintenance; cabinet shall fit within the overall 16 x 5 system footprint Base Frame: 30" with leveling feet Utilities and Controls Power Requirements: Compatible with 115-volt, 60 hertz, 1-phase facility power, with adequate motor capacity to operate the integrated capper / labeler line at a minimum of 60 vials per minute for 3 mL and 5 mL vials using 13 mm and 20 mm aluminum crimp caps Drive System: Variable speed motor drive system capable of maintaining stable vial handling, capping, and labeling throughput at a minimum of 60 vials per minute, and supporting line start-up, stoppage, and changeover conditions. Air Supply: Requires clean compressed air utility, with minimum pressure of 30 psi or as specified by the manufacturer. CBER/FDA will provide clean compressed air at the installation site; the contractor/system manufacturer shall identify connection, pressure, and consumption requirements and connect/configure the equipment during installation. Control Panel: Capable of supporting labeler configuration with multiple conveyor drives as required by system design Interface: A minimum of 4.3" color touchscreen HMI with pushbuttons, or equivalent operator interface, providing clear visibility and manual control during production. HMI Mounting: HMI shall be mounted on the conveyor or system frame on the operator side of the equipment, in a location that provides clear visibility and safe, unobstructed access to controls during production; final location shall be confirmed during design or installation Production Rate: Minimum of 60 vials per minute Conveyor: Low friction chain conveyor with adjustable guide rails, minimum 3¼" wide or as required to accommodate specified containers Contain…