Requirements_for_Freeze_Dryer.docx

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Attached to
Freeze Dryer Federal contract opportunity
Solicitation number
APHIS-VS-PR-16-805216
Issued by
Department of Agriculture Animal and Plant Health Inspection Service Headquarters Headquarters Administrative Service Headquarterss Division

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Revision_2_Rfq_Attachmt_1___805216.docx DOCX document
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Requirements for Freeze Dryer for NVSL- DBL- BMRT The Freeze Dryer must be able to accommodate:

•Minimum of two ml vial with 1 ml fill volume.
•Maximum of 50 ml vial with a 25-30 ml fill volume.
•There will be other size vials and fill volumes but will fall between the above stated minimum and maximum sized vials.

1. The Freeze Dryer will need to be thimble fitted into a Hepa-filtered air handling system for room exhaust and needs to have a .2 µm filter attachment for air entering the system. (Any air leaving the system and entering the system needs to be filtered.)

2. The Freeze Dryer will need 8 to 12 square feet in product area.

3. Software that allows for user friendly applications in the areas of Function and Leak testing, real time monitoring, recipe creation, maintenance, and useable data for Quality Assurance. Manuals that can be used as references.

4. Will need to have Capacitance manometer.

5. Pirani Vacuum Gage

6. Isolation Valve.

7. Needs to have the capability of being decontaminated with Chlorine dioxide gas.

8. Needs to have a minimum of 10 product monitoring probes.

9. Freeze Dryer Validation information for Quality Assurance.

10. Need to have product trays for each shelf.

11. Needs to be movable, so that the unit can be moved away from wall for easy access to back panel for maintenance or repair.

12. Needs to have a hydraulic stoppering system.

File details come from the government source that posted it. Updated .