SAM #75F40126Q00091

FDA Seeks Bathless Dual Dissolution System with Autosampler and Software for San Juan Lab

The FDA San Juan Medical Products Laboratory is seeking to replace its obsolete dissolution bath systems with a modern, bathless dual dissolution system. - Government Buyer: - Food and Drug Administration (FDA), San Juan Medical Products Laboratory (SJNLMP), under the Department of Health and Human Services - Products and Equipment Requested: - Dual bathless dissolution system (2 dissolution instruments, 115V) - Integrated autosampler (Parent/Child configuration) - Two filter systems (one per bath) - Controller software and PC workstation (Windows 11, 21 CFR Part 11 compliant) - Cables and accessories (including USB/RS232 communication hub) - User manuals and consumables for training - Services Requested: - Onsite installation and setup by factory-certified personnel - Installation and operational qualification (IQ/OQ) documentation - Onsite familiarization training for 3-5 users - Preventative maintenance visits (minimum two, including one during warranty) - Warranty service (minimum three years, covering parts, labor, travel, software updates, and one preventative maintenance visit) - Unlimited technical support (phone/email with OEM-certified engineers) - Unique and Notable Requirements: - System must be bathless, dual configuration, and include serialized instrument components - Compliance with cGMP/cGLP, ISO/IEC 17025:2017, ISO 9001:2008, and 21 CFR Part 11 - Must support protocols from USP, FDA, DOD SLEP, and FCC programs - Delivery and installation required within 6-8 weeks after award at the FDA San Juan facility - Total small business set-aside under NAICS 334516 - No specific OEMs or part numbers are mentioned, but the system must be installed and supported by factory-certified personnel

Description

The FDA San Juan Medical Products Laboratory (SJNLMP) requires the replacement of its obsolete dissolution bath systems used for routine sample analysis. The replacement system must maintain compliance with cGMP/cGLP, ISO/IEC 17025:2017, ISO 9001:2008, and 21 CFR Part 11 standards for analytical equipment under existing accreditation.

The laboratory analyzes medical product samples using established protocols from USP, FDA internal programs, the Department of Defense Shelf-Life Extension Program (DOD SLEP), and the Federal Contract Compliance (FCC) program. To maintain modern analytical capabilities, SJNLMP requires a bathless dual dissolution system with an integrated autosampler, PC workstation, controller software, and serialized instrument components, as the previous system has been discontinued by the manufacturer.

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