Attachment 5_TDPs_HHA Op and T Panels with change notes.pdf

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25 Jun 13

TECHNICAL DATA PACKAGE (TDP)

FOR

Operational and Training Panel

Table of Contents:

1. Drawing HHA-0004 (Single Assay Tray)

2. Drawing HHA-JPO-10 (Operational Panel Assembly)

3. Drawing HHA-JPO-10A (Operational 2 Panel Assembly)

4. Drawing 5-15-19324 (Assay Strip Assembly (for reference)) with changes attached

5. Manufacturing Instructions

6. Quality Assurance Provisions

7. Special Packaging Instructions (SPIs)

PJPOHHA-10

PJPOHHA-20

P0-HHA-01UN

Panels - P2

Panels - P3 tuan.pham

Typewritten Text

NOTES:

1. Replace all instances of "W" and "OS" test strips with "NU" and "OU" test strips, respectively.

2. This configuration shall be used for Panels which will be used in the Operational 2 Bio Sampling Kit, NSN 6665-01-616-4590, (P/N: LFI-0-BSK-01V) only.

A

Panels - P5

Changes to drawing 5-15-19324

Assay Strip Assembly

a. Delete “For Quality Assurance Provisions See QAP5-15-19321”

b. Change suggested source of supply From: “SA Scientific, Inc 4919 Golden Quail San Antonio, TX 78240”

To: “BBI Detection Inc.

2312 Vondron Rd Madison, WI 53718-6734”

c. Note 4, change storage temperature from “4o ± 2o degrees celcius” to “5o ± 3o C”

d. Note 7, replace address with:

“Joint Program Executive Office for Chemical and Biological Defense Critical Reagents Program

110 Thomas Johnson Drive, Suite 240 Frederick, MD 21702 301-619-2277”

e. Note 8, delete “After assembly, assay strips shall meet the performance requirements stated in QAP 5-15-19321”

f. Note 13, change to read:

“The assay strips shall have a shelf life of at least 3 years when stored at 2-8o C (36-46o F) and relative humidity of less than 40% or at least 12 months when stored at room temperature at 20-25o C (68-77o F) and non-condensing relative humidity from 5-100%.

During storage at these conditions, the assay strips shall not exhibit any degradation (e.g.

decomposition, deformation, discoloration, and illegible markings.) After storage, assay strips shall be capable of identifying biological agents and simulants by meeting optical requirements in Note 11.”

g. Delete sheet no “1 of 2” at the bottom right-hand side.

h. Under “next assy” block, add “32011932

i. In the Distribution Statement, change the address From: “Commender, U.S. Army Soldier and Biological Chemical Command.

ATTN: PMJBPDS-SFAE-BD…”

To: “Joint Program Executive Office for Chemical and Biological Defense

ATTN: SFAE-CBD-NBC-BDS…”

Panels - P6

Manufacturing Instructions for

Operational and Training Panels

1. The single assay tray (HHA-0004) shall be made from GP-PVC (general purpose poly vinyl chloride) or R-PVC, color clear, thickness: 0.0175”

2. Each panel consists of inserting eight individual HHAs into a single assay tray (Fig. 1)

Figure 1

3. Snap each HHA into the assay tray using the appropriate coded configuration outlined in

Table 1 and illustrated on drawings HHA-JPO-10 and HHA-JPO-10A. Uncoded panels will be prepared in a configuration provided by the Government. Fold the cover over to secure them in place.

Table 1: Panel Configurations

4. Ignore the silica packet (Find no 13) and the pouch (Find No 14) on drawings HHA-JPO-10 and HHA-JPO-10A. Instead use the desiccant and bag specified in the Special Packaging Instructions (SPIs.)

5. Package each panel in accordance with SPI PJPOHHA-10, PJPOHHA-20, P0-HHA-01UN or PLFI-0-BSK-01V*, as applicable. In addition, the sealed bag shall also be marked with the following information. Uncoded panels shall be labeled with agent name instead of agent code. The label shall also include the CRP and DoD insignias.

a. panel name (Operational or Training)

Position Configuration 1 2 3 4 5 6 7 8 Operational Panel

N

LE

W

XR

UC

UL

AB

OS

Operational 2 Panel*

N

LE

NU

XR

UC

UL

AB

OU

Training Panel

Pos

Neg

b. lot number of each individual HHA

c. appropriate agent code and designation

d. date assembled

e. Special Marking: “NOT FOR DIAGNOSTIC USE”.

* The Operational 2 Panel is not an end item but will be a component of the Operational 2 Bio Sampling kit (SPI PLFI-0-BSK-01V)

6. Sample labels are provided in Figures 2, 3 and 4.

Figure 2 (Label for Operational Panel)

P o s i tio n 1 2 3 4 5 6 7 8

T y p e N LE W X R UC U L AB O S

Lot 11201 11143 12071 12012 7243 12013 12073 8031

Assembled 0 5/ 00

NOT FOR DIAGNOSTIC USE

Figure 3 (Label for Operational 2 Panel)

P o s i tio n 1 2 3 4 5 6 7 8

T y p e N LE NU X R UC U L AB O U

Lot 11201 11143 12071 12012 7243 12013 12073 8031

Assembled 0 5/ 00

NOT FOR DIAGNOSTIC USE

Figure 4 (Label for Training Panel)

Position 1 2 3 4 5 6 7 8

T ype POS N EG N EG N EG N EG NEG NEG NEG

Lot 6015 5161 5161 5161 5161 5161 5161 5161

Assembled 05/00

NO T F O R D IAG NO S T IC USE

Training

QUALITY ASSURANCE PROVISION (QAP)

for

Hand Held Assay Panels

DISTRIBUTION STATEMENT D. Distribution authorized to the Department of Defense and U.S. DOD contractors only, critical technology, determination made 28 November 2007. Other requests shall be referred to U.S. Army, JPEO for Chemical Biological Defense, Office of JPM for Biological Defense Systems, ATTN:

SFAE-CBD-BD-BDS, Aberdeen Proving Ground, MD 21010-5424.

WARNING - This document contains technical data whose export is restricted by the Arms Export Control Act (Title 22, U.S.C., Sec 2751 et seq.) or the Export Administration Act of 1979, as amended (Title 50, U.S.C., App 2401 et seq.). Violations of these export laws are subject to severe criminal penalties.

Disseminate in accordance with the provisions of DOD Directive 5230.25.

Note: This Quality Assurance Provision (QAP) only applies to panels manufactured using accepted government-furnished assay strips in tested and approved Hand Held Assays.

PART I. APPLICABLE DOCUMENTS and INSPECTION EQUIPMENT CODING

DRAWINGS

HHA-0004 - Single Assay Tray HHA-JPO-10 - Operational Panel Assembly HHA-JPO-10A - Special Operational Panel Assembly

STANDARDS

MIL-STD-1916 – DoD Preferred Methods for Acceptance of Product

INSPECTION EQUIPMENT CODING

AD – Army designed special acceptance inspection equipment CD – Contractor designed special acceptance inspection equipment CE – Commercial inspection equipment

VI – Visual inspection

PART II. QUALITY PROVISIONS

1. First Article Inspection.

a. Sample Quantity. Contractor shall produce 50 hand held assay panels of each type using the same methods, materials, equipment, and processes as will be used during regular production. The first article samples shall be submitted for inspection and approval in accordance with the terms of the contract.

Panels - P10

b. Inspection procedure. This inspection applies to each of the 4 panel configurations.

From the 50 samples above, 20 random samples shall be used for the first article inspection as described in Table 1; the remaining 30 samples shall be used for the packaging inspection as specified in the applicable Special Packaging Instructions.

c. Acceptance criteria. If any sample item fails to comply with any of the applicable requirements, the first article sample shall be rejected.

Panels - P11

Table 1 First Article Inspection

Component Drawing no. Requirement Sample Inspection Note Size Method

Storage and No degradation* during storage 100% CE** Manufacturing (storage condition shall not be out of the 2o - 8o C Condition (36o - 46o F) range and less than 40% RH for more than

8 consecutive hours)

No degradation* during manufacturing 100% CE** (assembly room shall not be out of the 20o - 25o C (68o - 77o F) range and less than 40% RH for more than 8 hours) of possible power failure and loss of environmental control Assay tray HHA-0004 Top and bottom snap-fit together 20 VI Correct color (clear) 20 VI

No flash 20 VI Assembled Panel Panel and HHAs free of visible contamination 20 VI

Correct hand held assay position on panel 20 VI○

Label present and correct 20 VI HHAs installed correctly (label ends up) 20 VI

* Degradation includes material decomposition, deformation, discoloration, and illegible markings

** An automated monitoring system with recorder and alarm shall be used to notify personnel

○ Hand Held Assay position matches position indicated on label

Panels - P12

2. Conformance inspection.

a. Lotting. A lot shall consist of the items produced by one manufacturer, at one plant, from the same materials, under essentially the same manufacturing conditions, and at essentially the same time. Lot number format shall be in accordance with MIL-STD- 1168. The contractor shall also record the lot numbers of the other components used in each lot of panels produced.

b. Sampling. Attribute type normal inspection sampling in MIL-STD-1916 shall be used.

c. Inspection characteristic. Three classes of characteristics are covered in this QAP. These are: critical characteristics, major characteristics, and minor characteristics, as defined in

MIL-STD-1916.

d. Inspection. Inspection shall consist of examination and test of all the characteristics contained in the Classification of Characteristics of this QAP. Every item in the lot shall be inspected for critical and selected major characteristics. If an item is found that does not conform to a characteristic inspected 100%, the non-conforming item shall be removed from the lot. For each of the other characteristics in Part III, failure of any sample item to conform to the characteristic shall be cause for rejection of the lot represented. The following inspections apply to each of the Panel configuration.

Classification of Characteristics.

a. Storage and Manufacturing conditions

Class Characteristic Sampling Inspection Method Critical

1. No degradation* during 100% inspection CE** storage (storage condition shall not be out of the 2o – 8o C (36o – 46o F) range and less than 40% RH for more than 8 consecutive hours)

2. No degradation* during 100% inspection CE** manufacturing (assembly room shall not be out of the 20o – 25o C (68o – 77o F) range and less than 40% RH for more than 8 hours.

* Degradation includes material decomposition, deformation, discoloration, and illegible markings.

** An automated monitoring system with recorder and alarm shall be used to notify personnel of possible power failure and loss of environment control.

b. Assay Tray (Drawings HHA-0004)

Panels - P13

1. None

Major

101 Top and bottom snap-fit together Level III VI

Minor

201 Correct color (clear) Level II VI

202 Free of flash Level II VI

c. Assembled Panel

1. None

Major

101 Panel and HHAs free of visible 100% VI contamination

102○ Correct hand held assay position Level IV VI

103 Label present and correct Level III VI

104 HHAs installed correctly Level III VI (label ends up)

○ Hand Held Assay position matches position indicated on label

Minor

None

PART III. CERTIFICATION REQUIREMENTS

Inspection equipment. Inspection equipment used to perform the examinations and tests in this QAP should be designed, documented and maintained by the contractor using ISO 10012 as guidance, including any fixtures necessary to accommodate the test procedures.

Panels - P14

Inspection equipment should incorporate the appropriate measurement capability, precision and accuracy to assure rejection of nonconforming product. Equivalent inspection equipment standards may be accepted when such alternative(s) provide an equivalent or better level of quality, and provided they have been described in a written proposal, which has been approved by the Government.

Panels - P15

Figure 1 panel temp.pdf

HHA TDP TOC

HHA 0001

HHA 0002-1

HHA 0002-2

HHA 0003-1

HHA 0003- 2

Assay strip

20080103 HHA assembly instruct

Panel_Operational-Training.pdf

Panel TOC

HHA-0004

HHA-JPO-10

20080103_panel_ assembly_instructions

SPI HHA panels

TDP - Panel.pdf

Figure 1

TDP - Panel.pdf

Figure 1

QAP - Panel.pdf

FAT Table-Panel.pdf

Sheet1

QAP - Panel.pdf

FAT Table-Panel.pdf

Sheet1 temp panel.pdf

Figure 1

TDP - Panel_alonepdf.pdf

HHA TDP TOC

HHA 0001

HHA 0002-1

HHA 0002-2

HHA 0003-1

HHA 0003- 2

Assay strip

20080103 HHA assembly instruct

Panel_Operational-Training.pdf

Panel TOC

HHA-0004

HHA-JPO-10

20080103_panel_ assembly_instructions

SPI HHA panels

TDP - Panel.pdf

Figure 1

TDP - Panel.pdf

Figure 1

QAP - Panel.pdf

FAT Table-Panel.pdf

Sheet1

QAP - Panel.pdf

FAT Table-Panel.pdf

Sheet1 temp panel.pdf

Figure 1

QAP - Panel.pdf table.pdf

FAT Table-Panel.pdf

Sheet1

TDP - Panel_new.pdf

Figure 1

FAT Table-Panel.pdf

Sheet1 panel temp.pdf

Figure 1

TDP - Panel-revised.pdf

Figure 1 panel temp.pdf

HHA TDP TOC

HHA 0001

HHA 0002-1

HHA 0002-2

HHA 0003-1

HHA 0003- 2

Assay strip

20080103 HHA assembly instruct

Panel_Operational-Training.pdf

Panel TOC

HHA-0004

HHA-JPO-10

20080103_panel_ assembly_instructions

SPI HHA panels

TDP - Panel.pdf

Figure 1

TDP - Panel.pdf

Figure 1

QAP - Panel.pdf

FAT Table-Panel.pdf

Sheet1

QAP - Panel.pdf

FAT Table-Panel.pdf

Sheet1 temp panel.pdf

Figure 1

TDP - Panel_alonepdf.pdf

HHA TDP TOC

HHA 0001

HHA 0002-1

HHA 0002-2

HHA 0003-1

HHA 0003- 2

Assay strip

20080103 HHA assembly instruct

Panel_Operational-Training.pdf

Panel TOC

HHA-0004

HHA-JPO-10

20080103_panel_ assembly_instructions

SPI HHA panels

TDP - Panel.pdf

Figure 1

TDP - Panel.pdf

Figure 1

QAP - Panel.pdf

FAT Table-Panel.pdf

Sheet1

QAP - Panel.pdf

FAT Table-Panel.pdf

Sheet1 temp panel.pdf

Figure 1

QAP - Panel.pdf table.pdf

FAT Table-Panel.pdf

Sheet1

TDP - Panel_new.pdf

Figure 1

FAT Table-Panel.pdf

Sheet1 panel temp.pdf

Figure 1

TDP - Panel wo drawings.pdf

Figure 1

27 February 2024

CHANGE NOTES FOR

Changes to drawing 5-15-19324 Assay Strip Assembly

(page 6 of OP and T Panel TDP 2013)

1. Keep Quality Assurance Provision, pages 10-11

a. Delete “For Quality Assurance Provisions See QAP5-15-19321”

2. Keep SA Scientific for Source of Supply

b. Change suggested source of supply From: “SA Scientific, Inc

4919 Golden Quail San Antonio, TX 78240”

To: “BBI Detection Inc.

2312 Vondron Rd Madison, WI 53718-6734”

3. Note 4 applies

c. Note 4, change storage temperature from “4° ± 2° degrees Celsius” to “5°C ± 3°C”

4. Note 7 change address to New address as of 27 February 2024.

d. Note 7, replace address with:

“Joint Program Executive Office for Chemical and Biological Defense Critical Reagents Program 110 Thomas Johnson Drive, Suite 240 Frederick, MD 21702 301-619-2277”

New address as of 27 February 2024:

“Joint Project Lead, CBRND Enabling Biotechnologies (JPL CBRND EB) Defense Biological Product Assurance Office (DBPAO) 110 Thomas Johnson Drive, Suite 300 Frederick, MD 21702 301-619-2277”

5. Note 8 applies

e. Note 8, delete “After assembly, assay strips shall meet the performance requirements stated in QAP 5-15-19321”

6. Note 13 applies

f. Note 13, change to read:

“The assay strips shall have a shelf life of at least 3 years when stored at 2°C-8°C (36°F- 46°F) and relative humidity of less than 40% or at least 12 months when stored at room temperature at 20°C-25°C (68°F-77°F) and non-condensing relative humidity from 5%- 100%. During storage at these conditions, the assay strips shall not exhibit any degradation (e.g., decomposition, deformation, discoloration, and illegible markings).

After storage, assay strips shall be capable of identifying biological agents and simulants by meeting optical requirements in Note 11.”

7. Delete “SHEET 1 OF 2” at bottom right corner of VENDOR ITEM DRAWING section.

g. Delete sheet no “1 of 2” at the bottom right-hand side.

8 h. applies

h. Under “next assy” block, add “32011932

9. Distribution Statement D is near the bottom, middle section of drawing

i. In the Distribution Statement, change the address

From: “Commender, U.S. Army Soldier and Biological Chemical Command.

ATTN: PMJBPDS-SFAE-BD…”

To: “Joint Program Executive Office for Chemical and Biological Defense

ATTN: SFAE-CBD-NBC-BDS…”

To: “Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense

ATTN: SFAE-CBD”