Attachment 1-Questions Answers.pdf
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- Attached to
- Lyobeads Production System or Equal Federal contract opportunity
- Solicitation number
- 75F40124Q-122109
About this file
This document contains Questions and Answers related to a federal solicitation for a Lyobeads Production System or Equal. The solicitation requires trays that are compatible with a Lyostar 3 freeze dryer, with a minimum of 4 trays to allow full loading of at least two shelves. The trays must be vacuum sealable after freeze-drying, allow collection and storage of the frozen beads, and be cleanable and reusable. There are no specific requirements for Site Acceptance Testing (SAT) or Factory Acceptance Testing (FAT) for the trays. The solicitation is being issued by the Department of Health and Human Services, Food and Drug Administration, Office of Acquisition and Grant Services.
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Text version
Attachment 1 ‐ Questions & Answers 75F40124Q-122109_0001
Lyobeads Production System or Equal
1. Solicitation, section “Minimum Technical Requirements”, page 1, numbers 7, 8, and 10: The specification mentions the need for trays. This does not mention the size or quantity. Please advise.
Answer:
The trays shall be compatible with the loading and shelving system of a lyostar 3 freeze dryer.
A minimum number of trays (4) to allow full loading of at least two shelves of a laboratory scale freeze dryer, specifically a lyostar 3 freeze dryer.
The trays should be vacuum sealable post freeze-dying in a laboratory scale freeze dryer.
The tray shall allow the collection of frozen beads, hold of the beads during freeze drying and post drying storage.
The tray shall be cleanable and reusable
2, Solicitation, section “Minimum Technical Requirements”, page 2, number 17: Can you provide the SAT requirements? Can you provide the FAT requirements?
Answer:
The trays will be evaluated for compliance with the above technical, requirements. There are no specific or added SAT or FAT for these accessories.
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