Automated Dry Heat Diffusion System
Closed Solicitation Posted
- Solicitation number
- 75F40125Q00181
- Agency
- FDA Office of Acquisition and Grant Services Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 334516 Analytical Laboratory Instrument Manufacturing
- PSC
- 6640 Laboratory Equipment And Supplies
- Place of performance
- Silver Spring, Maryland 20993, United States
- Points of contact
-
- Amanda Lusk amanda.lusk@fda.hhs.gov (240) 402-0264
- Nicholas Bisher nicholas.bisher@fda.hhs.gov (240) 402-2773
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services is seeking to procure an Automated Dry Heat Diffusion System with 24 vertical cells for the Division of Product Quality Research (DPQR). This sophisticated scientific instrument will be used to conduct research on transdermal and topical drug product quality and safety, specifically to perform diffusion studies across synthetic and biological barriers. The system must include heated donor and receiver compartments, an automated sampling mechanism, and sensors for direct temperature measurement and control. The solicitation (RFQ No. 75F40125Q00181) was posted on May 16, 2025, with responses due by May 30, 2025. Potential vendors should carefully review the attached government files, including the contract terms and conditions, pricing worksheet, and question submittal form.
The solicitation is not set aside for any specific business category and falls under the NAICS category of Analytical Laboratory Instrument Manufacturing (334516) with a Product Service Code of 6640 for Laboratory Equipment and Supplies. The place of performance will be located in Silver Spring, MD 20993. While specific award value details are not explicitly stated, the procurement is for one (1) Automated Dry Heat Diffusion System to support critical research activities. The system will be used to conduct approximately 96-hour diffusion studies with large numbers of samples and repetitions, enabling researchers to gather valuable data on drug release and permeation. The procurement supports the Center for Drug Evaluation and Research's (CDER) mission-critical objectives of assessing drug product safety, performance, and quality.
Notice text
The Division of Product Quality Research (DPQR) conducts research on assessing the quality and safety of drug products. One of the on-going research activities is to conduct research on assessing the performance, quality and safety of transdermal and topical drug products. These studies are critical in assessing the quality of transdermal and topical drug delivery systems. To support this function, DPQR is requesting the acquisition of one (1) Automated Dry Heat Diffusion System with 24 vertical cells (or equivalent). This Automated Dry Heat Diffusion System will be used to perform diffusion studies that are approximately 96 hours and with large number of samples and repetitions to check the drug release and permeation across synthetic and biological barriers. This Automated Dry Heat Diffusion System and these diffusion studies will provide valuable information regarding safety, performance, and quality of transdermal and drug products and support CDER’s mission critical missions.
The Automated Dry Heat Diffusion System with 24 vertical cells is used for studying the in vitro drug release and diffusion across various synthetic and biological barriers. This diffusion system has a heated donor and receiver compartments of the vertical diffusion cells with an automated mechanism to continuously collect and replace aliquot and whole media samples from all diffusion cells. This automated mechanism should also eliminate and expel any air bubbles that may be formed below the diffusion barrier during dosing and sampling throughout the study duration. This Automated Dry Heat Diffusion System is also equipped with sensors for direct measurement and control of donor and receiver chambers and barrier temperatures throughout the study duration.
Attachments
| File | Type | Posted |
|---|---|---|
| Attachment B - 52-212-5-Contract-Terms-and-Conditions w Deviation.pdf | ||
| Attachment C- RFQ Question Submittal Form.xlsx | XLSX spreadsheet | |
| 5-16-2025 RFQ No. 75F40125Q00181.pdf | ||
| Attachment A - Pricing Worksheet.pdf |
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