SOW- CBER-2026-135296- Final.pdf
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- Solicitation number
- FDA-RFQ-CBER-2026-135296
About this file
This is a Statement of Work (SOW) for the procurement of a benchtop freeze dryer (lyophilizer) system for processing and preserving biomaterials, including hydrogels and biologic-hydrogel combination product components. The system will support critical biomaterial characterization workflows and enable optimization of drying parameters for new formulations under development while eliminating sample transport risks and ensuring reproducibility required for regulatory science applications.
The required benchtop freeze dryer system must meet the following minimum technical specifications: collector temperature of -84 °C or colder, collector capacity of approximately 2.5 liters, stainless steel or PTFE-coated condenser coils, a 12-port drying chamber or manifold, initial flask sets (150 mL and 300 mL), and all necessary tubing, clamps, and adapters for full system assembly. The system must operate on 230V, 50/60 Hz electrical configuration. A compatible vacuum pump is already available in the laboratory and should not be included in quotes. The freeze dryer will be located in a standard laboratory as a benchtop model and will be used to lyophilize aqueous samples in various flask sizes. Delivery is required to Kyung Sung at 10903 New Hampshire Ave, WO 52/72, Room 3248, Silver Spring, MD 20993 (Phone: 240-402-7994), with a period of performance of 12 months from the time of award. No special considerations have been identified for this procurement.
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| File | Type | Posted |
|---|---|---|
| Combined Synopsis Solicitation- FDA-RFQ-CBER-2026-135296- 09.24.2026.pdf |
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Statement of Work (SOW) – Freeze dryer
Part I: General Information
A. Introduction
This document outlines the requirements for procuring a benchtop freeze dryer (lyophilizer) system. This equipment is for processing and preserving biomaterials, including hydrogels and biologic-hydrogel combination product components.
B. Background
Lyophilization is an essential process for the characterization and preservation of novel biomaterials. An in-house freeze-drying capability will support critical biomaterial characterization workflows and enable the optimization of drying parameters for new formulations under development. This system eliminates sample transport risks, reduces processing time, and ensures the high degree of reproducibility required for regulatory science applications.
C. Scope
To obtain a benchtop freeze dryer system that meets all specified technical requirements as described in Part II. The system should include the main freeze dryer unit, a drying chamber, and all necessary accessories for immediate operation with an existing vacuum pump.
D. Technical Environment
The freeze dryer system will be located in a standard laboratory and must be a benchtop model. It will be connected to an existing, compatible vacuum pump. The system will be used to lyophilize aqueous samples in various flask sizes.
Part II: Work Requirements
A. Technical Requirements for a benchtop vacuum plasma system
The proposed system must meet the following minimum technical specifications:
• Collector Temperature: Must reach -84 °C or colder.
• Collector Capacity: Approximately 2.5 Liters.
• Condenser Type: Stainless steel or PTFE-coated coils.
• Drying Chamber: Must include a 12-port drying chamber or manifold.
• Accessories: The system must include an initial set of flasks (e.g., 150 mL and
300 mL), and all necessary tubing, clamps, and adapters for full system assembly.
• Electrical: 230V, 50/60 Hz configuration.
• Note: A compatible vacuum pump is already available in the laboratory and does not need to be included in the quote.
Part III: Supporting Information
A. Place of Performance Shall be delivered to:
Kyung Sung 10903 New Hampshire Ave
WO 52/72, Room 3248 Silver Spring, MD 20993 Phone: 240-402-7994
B. Period of Performance
12 months from the time of award.
C. Special Considerations None.
| B. Background |
| C. Scope |
| D. Technical Environment |
| Part II: Work Requirements |
| Part III: Supporting Information |
| B. Period of Performance |
| C. Special Considerations |
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