Advanced Freeze-Dryer Lyophilize

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial items, issued as a Request for Quote (RFQ) by the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR). The FDA requires an Advanced Freeze-Dryer Lyophilizer to support complex generics, biologics, and essential medicine manufacturing and product quality research. The equipment will aid in assessing manufacturing and product quality, and developing science-based regulatory standards, ultimately strengthening the FDA's ability to ensure the safety, efficacy, and quality of lyophilized drugs.

• A "Turn-Key Solution" for a Laboratory Scale R&D Lyophilizer.

• Must be Controlled Ice Nucleation and Foam Drying Ready.

• Features include an ASME rated product chamber, isolation valve, and ports for controlled Ice Nucleation Technology.

• Requires positive pressure transducer for monitoring.

• Integrated control of ice nucleation within an automatic recipe program.

• Automatic backfill and stoppering capability.

• Display of all process parameters on a single interface.

• Barometric Endpoint control and Pirani Gauge/Capacitance Manometer Differential control for end of primary drying.

• Data output for various temperatures, pressures, and product conditions.

• Precise control of vacuum, leak rate less than 15 mTorr per hour.

• Internal condenser with minimum capacity of 28L, temperature controlled.

• Minimum of three shelves with a surface area greater than 0.4 meters square.

• Air-cooled freeze dryer with a minimum of two compressors.

• Precise shelf temperature control (± 0.5°C) between -65°C to 60°C.

• Capable of full load traditional freeze drying with vacuum control (±5mTor).

• Includes a solvent trap for freeze-drying products with organic or co-solvents.

• Rapid defrosting capability.

• Backfilling with inert gas (ideally nitrogen).

• Sample extractor for removing and stoppering vials during operation.

• Noise level not exceeding 70 dB during normal operation.

• Standard electrical plug or NEMA 6-50P plug, compatible with 208V 60Hz, 40 amps outlet.

• Isolation of chamber from vacuum with pneumatic isolation valve.

• Stainless-steel door compatible with sample extractor.

• Standard temperature monitoring with at least 14 wired thermocouples.

• Internal UPS for minimum 20 minutes continued operation.

• Tunable Diode Laser Absorption Spectroscopy (TDLAS) System for vapor flux monitoring.

• TDLAS system must be compatible with and include a Lyoflux TDLAS system and most recent operating system.

• TDLAS system accuracy less than 7% over useful pressure range.

• TDLAS software Windows 11 compatible.

• Includes all necessary hardware and software for installation and operation.

• Minimum one-year warranty, including parts and labor.

• On-site installation, full system hardware, peripherals, software, qualification, and training.

• On-site performance testing.

• On-site training for at least 6 scientists.

• Contract Type: Firm-Fixed-Price.

• FOB Destination: U.S. Food and Drug Administration, Silver Spring, MD.

• Quotes/proposals must be submitted via email to howard.nesmith@fda.hhs.gov.

• Submission Deadline: March 27, 2026, by 1:00 PM Central Time.

• Evaluation Factors: Technical Acceptability and Price. The lowest priced technically acceptable offer will be awarded.

• Offerors must provide sufficient technical information to demonstrate compliance with all requirements.

• Accessibility Conformance Report (ACR) or Voluntary Product Accessibility Template (VPAT) is required for ICT items.

• NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing.

• Small Business Size Standard: 1,000 employees.

• Competed unrestricted, available to Full and Open competition.

• Any catalog number, manufacturer brand name, or proprietary description is used as descriptive only, not restrictive.

• The Government is offering an "as-is" basis for a Trade-In Discount on an existing SP Industries Inc., LyoStar 3 Lyophilizer (Serial Number: 322750). The Government will retain specific components from this unit.

• Alternative solutions will be considered if they meet the Minimum Technical Requirements.

• Offerors must be registered and active in SAM.gov.

• Electronic documents must not contain macros.

• Payment Terms: Net 30 Days After Government Acceptance of Supplies/Services.

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