Opportunity
SAM #75F40126Q133277
FDA Solicitation for Rocking Bioreactor System with Installation and Support
Buyer
FDA Office of the Associate General Counsel for Administrative Law
Posted
June 04, 2026
Respond By
June 12, 2026
Identifier
75F40126Q133277
NAICS
334516, 541690, 541512
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), is seeking to procure a Rocking Bioreactor System for pharmaceutical quality research. - Government Buyer: - U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR) - Product Requested: - One (1) Rocking Bioreactor System - Must support rocking speed of 2-40 rpm and rocking angle of 2-12 degrees - Temperature control from ambient +5°C to 40°C - Integrated load cells for weight measurement - Gas mixer with O2/CO2 control - Peristaltic pump - Instrument control package with Windows 11 Pro - Software compliant with 21 CFR Part 11 and GAMP 5 - Includes Bag Sensor Adaptor 2.5m assembly, WorkStation software license, and Tube Kit for sterile gas delivery - Services Included: - Installation by certified field technicians (including configuration, calibration, and functional testing) - On-site training - One-year maintenance support post-installation - Notable Requirements: - System must be delivered within 60 days of contract award, FOB destination to FDA/CDER in Silver Spring, MD - All software must comply with FDA regulatory standards (21 CFR Part 11, GAMP 5) - Price must be held firm through September 30, 2026 - No specific OEMs or vendors are named, but the requirements suggest compatibility with leading bioreactor manufacturers
Description
See Attached Combined Synopsis/Solicitation 75F40126Q133277