Attachment 4_TDPs_HHAs.pdf
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- Solicitation number
- W911SR_24_R_0008
About this file
This document appears to be a set of manufacturing instructions for Hand Held Assay (HHA) products that are part of a federal contract opportunity.
The instructions detail the specifications for manufacturing the HHA devices, including cutting the lateral flow immunoassay card stock, assembling the components in a temperature and humidity controlled environment, labeling the devices, packaging them in barrier bags with desiccant, and shipping the individual HHAs. Key requirements include maintaining appropriate environmental conditions, using proper personal protective equipment, and securing government approval for any engineering changes.
The related federal contract opportunity is for the assembly, manufacturing, storage, and distribution of Defense Biological Product Assurance Office (DBPAO) products. The solicitation number is W911SR_24_R_0008, issued by the Department of the Army Materiel Command, Army Contracting Command Aberdeen Proving Ground.
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Text version
Hand Held Assay Drawings and Specifications
Table of Contents:
1. Drawing HHA-0001- Assay Assembly
2. Drawing HHA-0002- Assay, Front
3. Drawing HHA-0003- Assay, Back
4. Drawing Assay-strip- Assay Strip Assembly
5. HHA Manufacturing Instructions
HHA manufacturing instructions
Hand Held Assay (HHA) Manufacturing Instructions:
1. Each individual HHA requires the Lateral Flow Immunoassay (LFI) card stock be cut to the specifications provided in the Assay-Strip drawing.
2. Manufacturing shall take place in a humidity and temperature controlled, 20 to 25 degrees Celsius, assembly room that can maintain less than 40% humidity with ASHRAE efficiency of 90-95% filtration.
3. Personnel shall wear protective gloves, lab coat, and full hair coverage apparel.
4. The LFI strip is positioned into the bottom half of the HHA assay carrier.
The strip shall be positioned membrane side up and the sample delivery pad should be placed under the sample delivery well. The carrier specifications are provided in drawing numbers HHA-0001, 0002, and 0003.
5. Secure the plastic carrier by pressing the top and bottom halves together (figure1).
6. Label each coded HHA with the appropriate agent code, the strip lot number, and the assembly date. Uncoded HHAs will be labeled with agent name, the strip lot number and the assembly date.
7. Package individual HHA into a 3 x 4.5 inch barrier bag (MIL-DTL-117) with one desiccant (MIL-D-3464).
8. Closure of the barrier bag shall be accomplished by heat sealing. Heat sealing shall be accomplished in accordance with the barrier bag manufactures instructions. Excess air shall be removed from the barrier bag prior to heat sealing.
9. Label barrier bag with the appropriate agent code, the strip lot number, and the assembly date. Uncoded HHA will be labeled with agent name, the strip lot number and the assembly date.
10. Individual HHA assays shall be shipped in accordance with delivery orders.
11. The Contractor shall not implement engineering changes, or deviations which affect Government controlled documents (e.g. engineering drawings), without prior Government approval.
HHA manufacturing instructions
Figure 1
| HHA TDP TOC |
| HHA 0001 |
| HHA 0002-1 |
| HHA 0002-2 |
| HHA 0003-1 |
| HHA 0003- 2 |
| Assay strip |
| 20080103 HHA assembly instruct |
File details come from the government source that posted it. Updated .