Lyobeads Production System or Equal   2

Background
The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is conducting market research to identify potential contractors capable of providing a Lyobeads Production System or an equivalent product.

This initiative is led by the Center for Drug Evaluation and Research (CDER) to enhance the manufacturing process of pharmaceuticals, particularly in improving the storage stability of moisture-labile vaccines, biologics, and diagnostics. The FDA aims to leverage advanced manufacturing technologies to ensure timely access to quality medicines for the American public.

Work Details
The requirement is for a Lyobeads Production System or Equal, specifically a Millrock Technology Lyobeads Production System, part # BeadLab 10K, with a quantity of 1. The system must meet the following minimum technical requirements:
1. Fully automated micro dispensing unit.
2. Capability to produce customizable beads with specific volume.
3. Accurately dispense volumes as low as 4 microliters with high repeatability.
4. Dispensing precision of 3% or less.
5. Accurately dispense 5 – 30 microliters of formulation as a single drop.
6. Rapidly freeze dispensed liquid formulation.
7. Holding tray designed to reduce sticking of frozen beads.
8. Compatible bead container for laboratory scale dryers and ease transfer to lyophilizer.
9. Design that minimizes operator exposure to liquid nitrogen.
10. Vacuum sealable tray or bead tray.
11. Capability to produce at least 10,000 beads per hour.
12. In-process tuning of bead volume and shape.
13. Multiple printing modes.
14. Easily scalable design.
15. High consistency in shape and size accuracy of 2%.
16. Pause and resume dispensing functionality.
17. Factory acceptance test (FAT) and site acceptance test (SAT) documentation post-installation.
18. Dewars or accessories for monitoring nitrogen levels included.
19. All necessary accessories for safe operation and transfer of beads included.
20. Required hardware and software for operation provided by vendor.
21. Warranty covering parts and labor for at least one year included.
22. Vendor responsible for all costs related to system crating, shipping, delivery, installation, and on-site training for at least six scientists.

Period of Performance
Delivery, installation, and on-site training shall be completed no later than 90 calendar days after receipt of contract award.

Place of Performance
U.S. FDA – Center for Drug Evaluation and Research, WO Campus, 10903 New Hampshire Ave., Bldg. 64, Rm.1075, Silver Spring, MD 20993.