Freeze Dry System- Brand Name or Equal -Brand Name and Equal (BNE)

Notice of Combined Synopsis/Solicitation. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. The NAICS for this requirement is: 334516. The government is not obligated to make an award. The Government is not obligated to pay costs incurred by the Contractor during quote preparation and quote submission. Background: The U.S. Food and Drug Administration (FDA) laboratory requires a benchtop freeze dryer (lyophilizer) system to support ongoing scientific research and sample preservation activities. Lyophilization (freeze-drying) is a critical process used to preserve the stability and integrity of biological samples, pharmaceuticals, and other moisture-sensitive materials by removing water content through sublimation under vacuum. The required system must achieve a collector temperature of -84 °C or colder to accommodate samples with lower freezing points, including those containing organic solvents. The system must be configured for 230V/50-60 Hz operation consistent with the FDA laboratory's electrical infrastructure. Minimum Performance Requirements/Salient Characteristics: This is a Brand Name or Equal requirement. Products other than the aforementioned are acceptable but shall meet all the salient characteristics contained in the Minimum Technical Requirements below: All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated prior to purchase: General The contractor shall provide One (1) benchtop freeze dryer (lyophilizer) system meeting the following minimum technical specifications, including all required accessories, tubing, clamps, adapters, and standard warranty necessary for full system assembly and operation: • Collector Temperature: -84 °C or colder (to accommodate samples containing organic solvents such as acetonitrile or methanol) • Collector Capacity: Approximately 2.5 liters of ice capacity before defrost cycle • Condenser Type: Stainless steel or PTFE-coated coils (corrosion-resistant construction) • Drying Chamber: 12-port drying chamber or manifold for simultaneous multi-sample processing • Accessories: Initial set of flasks (150 mL and 300 mL), all necessary tubing, clamps, and adapters required for full system assembly • Electrical: 230V, 50/60 Hz configuration Place of Performance: The prospective vendor should provide insured shipping of equipment to: U.S. Food and Drug Administration, Attn: Kyung Sung 10903 New Hampshire Ave, Building 52/72. Room 3248 Silver Spring, MD 20993 Period of Performance: Performance begins on the date of formal government acceptance and continues through the end of the manufacturer's warranty period. Quotes are due by email on or before September 28 2026, by 12:00 P.M. (Eastern Standard Time) and should be sent to brandon.rafus@fda.hhs.gov.

• NAICS334516
• PSC6640

• SOW- CBER-2026-135296- Final.pdf

  .pdf112 KBNot yet available
• Combined Synopsis Solicitation- FDA-RFQ-CBER-2026-135296- 09.24.2026.pdf

  .pdf335 KBNot yet available

• Brandon Rafus
  brandon.rafus@fda.hhs.gov