RFQ 75F40126Q00091 Dual Dissolution

Form / Attachment / Pricing Sheet

This document is Attachment 2, a pricing sheet for the "Dual Dissolution System with AutoSampler and SW" opportunity. Bidders should use this sheet to provide cost information for the specified equipment and materials.

• Equipment Purchases: Includes line items for Dissolution System, AutoSampler, Filter System, Operation Software, Workstation, Cables, Installation, Qualification, Training, Travel, and Shipping. Quantities and Unit Prices are to be filled in, with Total Cost calculated.
• Material/Supplies: A section for listing additional items with fields for Item Name, Quantity, Unit Price, and Total Cost.
• Total Cost: A summary field for the overall cost.

This pricing sheet is critical for bidders to accurately calculate and submit their proposed costs for the required equipment and any associated materials. It directly impacts the financial proposal and evaluation of the opportunity.

Statement of Work (SOW)

To procure a modern, fully functional dual dissolution bath system with an autosampler and software to replace an existing obsolete system that is over 15 years old and has been discontinued by the manufacturer.

The contractor will provide all resources to supply a dual dissolution bath system with autosampler and software. This system will be used for routine sample analysis of medical product samples, maintaining cGMP/cGLP, ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR Part 11 standards.

• Dissolution Instruments: Two bathless 115V dissolution instruments, each with six spindle drives, color touch screen, quick change paddles/baskets, automatic height adjustment, twelve wireless RTD shaft assemblies (serialized/certified), two RTD power packs, twelve paddle blades (serialized/certified), 1L amber glass vessels (serialized/certified), and twelve vessel covers.

• Autosampler: 115V autosampler with precision syringe pumps, optimized pathway (<5 mL internal volume), capability to sample from two dissolution baths (same or different methods), six positions, media replacement/recycling, 100 method storage, multiple user security, and time point sampling as soon as 5 minutes.

• Autosampler Filter System: Two filter systems (one per bath), capable of utilizing 25 mm syringe filters, two 8-position test tube racks, two 8-position HPLC vial racks, two connection cables (RS-232), twelve sample probes, twelve 90-degree elbow fittings, 2 packs (100 each) filter disks (45 μm), and 2 packs glass test tubes (16 mm x 100 mm).

• Controller Software and Workstation: PC station with Monitor (Win 11), one license, capable of controlling dissolution baths, autosampler, and programming. Must be 21 CFR Part 11 compliant. Includes USB Communication Hub and Cables (USB and RS232).

• Delivery and Installation: System installation within 90 days of award, including inside delivery, setup, cleanup, and necessary supplies. Installation by factory-certified personnel, including IQ/OQ and performance verification.

• Documentation: IQ/OQ electronic documentation of software and hardware, instrument and software user manuals, and installation/operation qualification documentation.

• Training: Onsite familiarization training for 3-5 users.

• Period of Performance: Begins upon contract award and continues for three years from formal government acceptance (or OEM warranty period).

• Place of Performance: Food and Drug Administration, San Juan Medical Products Laboratory, 466 Fernandez Juncos Ave, San Juan, PR 00901-3223.

A minimum of a 3-year limited warranty for parts and labor from date of formal government acceptance. Includes unlimited telephone/e-mail support, on-site response within 72 hours if needed, all non-consumable items, factory-certified replacement parts, engineer labor/travel, software updates, and one subsequent preventative maintenance visit.

• Equipment must be newly manufactured.
• Vendor must provide a minimum of a three-year manufacturing warranty.
• Instrument operators must have access to a technical representative call center.
• Vendor must provide proof of installation qualification/operation qualification (IQ/OQ) certification.
• Vendor must handle inside delivery, unpacking, and disposal of packaging materials.

Solicitation / RFP / RFQ

This Request for Quotation (RFQ) is for the purchase of a Dual Dissolution Bath System with Autosampler and Controller Software for the Food and Drug Administration (FDA), San Juan Medical Products Laboratory (SJNLMP). The system will replace existing obsolete dissolution bath systems used for routine sample analysis.

• The system must comply with cGMP/cGLP, ISO/IEC 17025:2017, ISO 9001:2008, and 21 CFR Part 11 standards.

• It must be a bathless dual dissolution system with an integrated autosampler, PC workstation, controller software, and serialized instrument components.

• Specific components include: Dual Bathless Dissolution Instruments (six spindle drives, RTD shaft assemblies, paddle blades, glass vessels), 115V Autosampler (six sampling positions, media recycling, storage for 100 methods), Autosampler Filter System, and Controller Software/Workstation.

• The system must be new, unused equipment. Refurbished, remanufactured, or previously used units are not accepted.

• A minimum three-year limited warranty covering parts, labor, and technical support is required.

• Onsite installation, delivery, setup, and training are required.

• The anticipated Period of Performance (POP) is a one (1) year base period.

• Delivery, installation, and training shall occur within 6-8 weeks after contract award.

• The contract will be a firm-fixed-price.

• Quotations must be submitted in two volumes: Technical (excluding pricing) and Price.

• The Technical volume should include specifications, work schedule, warranty, and delivery timeline.

• The Price volume should include the completed pricing schedule and cost breakdown.

• Offerors must clearly identify the manufacturer, model number, and country of manufacture for the proposed system and all major components.

• Questions must be submitted via email by May 5, 2026, by noon EST.

• Quotations are due by the date and time listed in SAM.gov.

• Evaluation will be based on Technical and Price, which are approximately equal in importance. Non-price factors combined are approximately equal to price.

• This requirement is solicited as a total small business set-aside.

• The NAICS code is 334516 (Analytical Laboratory Instrument Manufacturing) with a size standard of $41.5 million.

• Offerors must comply with the Buy American-Supplies provision.

• The Contracting Officer is Iris Johnson (Iris.Johnson1@fda.hhs.gov).

• The Contract Specialist is Erika Crawford (Erika.Crawford@fda.hhs.gov).

• Invoices must be submitted electronically through the U.S. Department of Treasury's Invoice Processing Platform (IPP).