Attachment 3_TDPs_JPS Carrier Box.pdf

15 Jan 13

TECHNICAL DATA PACKAGE (TDP)

FOR

Joint Portal Shield (JPS) Carrier

Table of Contents:

1. Drawing PAR3-PC3 (Top, Assay)

2. Drawing PAR3-PC1 (Bottom, Assay Strip Carrier)

3. Drawing PAR3-PC2 (Box, Carrier)

4. Drawing PAR-ASSAY (Par Assay Cartridge)

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

6. Drawing 32014013

7. Drawing 32011936 (with change noted in item 2 on Manufacturing Instructions)

8. Manufacturing Instructions

9. Quality Assurance Provision (QAP)

10. Special Packaging Instructions (SPIs)

PJPOPAR-10

PJPOPAR-20

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…”

Manufacturing Instructions for JPS Carrier Box Assembly

1. Color for the carrier bottom (PAR3-PC1) and carrier box (PAR3-PC2) shall be black.

2. Drawing 32011936, Note 3, change part no from “Dev.#8475 Transfer Adhesive to

“ARCLEAN 90420”

3. The JPS Carrier assembly consists of the top carrier (PAR3-PC3), bottom carrier (PAR3-PC1), assay strips (5-15-19324), desiccants (32014013), and membrane (32011936.) Assemble assay strips and desiccants onto bottom carrier prior to ultrasonic weld the bottom carrier with top carrier. Strip positions on carrier assembly shall be provided by the government after contract award. Use similar manufacturing process for the JPS carrier assembly as used for the JBPDS carrier assembly (TDP 5-15-31917)

4. Label completed carrier assembly with permanent ink to include: part number, date of manufacture, and manufacturer cage code. Location and method at manufacturer discretion but shall not affect operational performance.

5. Insert 15 completed carrier assemblies into the JPS Carrier box (PAR3-PC2) to make up the JPS Box Assembly. There will be 2 configurations of the JPS Box Assembly: Operational and Training. The JPS Box Assembly –Operational (P/N JPOPAR-10) shall consist of 15 operational carrier assemblies inserted; and the JPS Box Assembly-Training (P/N JPOPAR-20) shall consist of 15 training carrier assemblies inserted. An illustration of a JPS carrier and box assembly is shown in Figure 1 below.

6. Label each completed box assembly with appropriate markings (use similar format to the JBPDS Box markings.)

7. Package the JPS Box Assembly in accordance with special packaging instruction PJPOPAR-10 or PJPOPAR-20 as applicable.

8. Storage shall be at 5o ± 3o C at relative humidity of less than 40%.

9. The Carrier Box Assembly and its internal components shall have a shelf life of at least 3 years when stored in their original package at 2-8o C (36-46o F) and relative humidity of less than 40% or at least 12 months when stored in their original package at room temperature at 20-25o C (68-77o F.) and non-condensing relative humidity from 5-100%. During storage at these conditions, the box assembly and its internal components shall not exhibit any degradation (e.g. decomposition, deformation, discoloration, and illegible markings.”

QUALITY ASSURANCE PROVISION (QAP)

for

JPS Carrier Box Assembly

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 JPS carrier box assembly manufactured using accepted government-furnished assay strips.

PART I. APPLICABLE DOCUMENTS AND EQUIPMENT CODING

DRAWINGS

PAR3-PC1 - Bottom, Assay Strip Carrier PAR3-PC2 - Box, Carrier PAR3-PC3 - Top, Assay PAR-ASSAY - Par Assay Carrier 32014013 - Desiccant Strip 32011933 - Assay Strip Assembly 32011936 - Membrane, Carrier Sample Well

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 the following carrier box assemblies 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.

Carrier Box Assembly Configuration Qty JPS Carrier (Operational) 45 JPS Carrier (Training) 45 Total: 90

b. Inspection procedure. From the First Article samples above, use the following for the FAT inspection. For each configuration, a.) 10 carrier box assemblies shall be used for the first article inspection as described in Table 1. Some sub-components shall need to be inspected prior to next assembly; b.) 2 carrier box assemblies shall be used for the Performance (destructive) test. Of the 2 carrier box assemblies, 2 random carrier assemblies from each box shall be subject to the Performance test specified in Part IV;

c.) the remaining shall be used for the packaging test as specified in applicable Special Packaging Instructions. A breakout of the samples used for the FAT inspection is as below:

Configuration # of unit for # of unit for # of unit for Total Inspection Performance packaging per Table 1 test (part IV) inspection

JPS Carrier (Operational) 10 2 30 42 JPS Carrier (Training) 10 2 30 42

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

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 Box Assembly, Identification markings legible and correct 10 boxes VI 10 boxes for each configuration Carrier Assemblies 15 Carriers assemblies installed correctly 10 VI (with 15 carriers Date of Manufacture (DOM) matches strip lot DOM 10 VI◊ inserted) Carrier code matches marking on rear of box 10 VI○

Carriers snap fit into place inside box 10 VI Correct color: black 10 VI

◊ DOM on marking label martches government-provided DOM of strips used

○ Codes match government-provided color code chart and strip position

Box, Carrier PAR3-PC2 Flatness within tolerance (not to exeed 0.020") 10* CE Rear lock height (30 x 0.030 +0.002/-0) 10* CE Free of flash 10* VI All other dimensions 10* CE

Correct color: black 10* VI

* Select 10 random boxes from the FAT samples produced.

Carrier Assembly, Identification legible and correct 100% VI Assay Strip Free from contaminants, smudges, scratches & fingerprint 100% VI (with 10 strips Desciccant strips and Membrance visible and correct 100% VI

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

** An automated monitoring system with recorder and alarm shall be used to notify personnel installed) Correct color of bottom carrier assembly: black 100% VI No bubbles, creases, wrinkles in sample well 15** VI Overall height, 0.170 ± 0.005 15** CE Assay strip position correct 15** VI□

□ Assay strip position matches government-provided strip position table ** Select 15 random samples from each of 2 carrier configurations (operational and training)

Assay Strip 5-15-19324* Free of visible contamination, loose fibers 100% VI Assembly

* Inspect prior to assembly onto assay strip carrier Top, Assay PAR3-PC3* Free of visible contamination 100% VI No scratches or stray marks 100% VI

Flatness within tolerance (not to exeed 0.020") 30** CE Warp/bend that would prevent assembly 30** VI No flash 30** VI

* Inspect prior to assembly onto assay strip carrier ** Select 30 random samples from quantity required for FAT samples

Membrane, 32011936* Free of visible contamination 100% VI Carrier Sample Length and width 30** CE well (L: 4.492+0.010/-0, W: 0.750+0.010/-0)

* Inspect prior to assembly onto assay strip carrier ** Select 30 random samples from quantity required for FAT samples

Bottom, PAR3-PC1* Free of visible contamination 100% VI Assay Strip Carrier No scratches or stray marks 100% VI

Flatness within tolerance (not to exeed 0.030") 30** CE Wall thickness (0.040") 30** CE Warp/bend that would prevent assembly 30** VI No flash 30** VI Color color: black 30** VI

* Inspect prior to assembly onto assay strip carrier ** Select 30 random samples from quantity required for FAT samples

Desiccant Strip 32014013* Desiccant not exposed or spoiled 30** VI Mass: 75g ± 10% 30** CE Length: 3.99 ± 0.21, Width: 0.63 ± 0.03, H: 0.085 max 30** CE

* Inspect prior to assembly onto assay strip carrier ** Select 30 random samples from quantity required for FAT samples

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. At each change in assay strip lot, a new lot identification shall be assigned. 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 carriers 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 2 configurations.

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. Box Assembly, Carrier Assemblies (with 15 carrier assemblies inserted)

Critical

1. Identification markings 100% VI legible and correct inspection

Major 101 15 carrier assemblies 100% VI installed correctly

102◊ Date of Manufacture (DOM) Level IV VI matches strip lot DOM

103○ Carrier code matches marking Level IV VI on rear of box

104 Carriers snap fit into place Level II VI inside box

Minor

201 Correct color Level I VI

◊ DOM on marking label matches government-provided DOM of strips used.

○Codes match government-provided color code chart and strip position table.

c. Box, Carrier (Drawing PAR3-PC2)

Critical

None

101 Flatness within tolerance Level III CE

102 Rear lock height, Level III CE

30 x 0.030 +0.002/-0

201 Free of flash Level I VI

202 All dimensions not categorized * CE as Major

* Inspect the first 10 consecutive pieces per mold cavity. Re-inspect after each 100,000 pieces are produced on a cavity and after each tool change.

d. Carrier Assembly, Assay Strip (with 10 assay strips installed)

Critical

1. Identification markings 100% VI legible and correct inspection

101 Free from contaminants, smudges, 100% VI scratches & fingerprint

102 Desiccant strips and membrane Level II VI visible and correct

103 No bubbles, creases, wrinkles Level II VI in sample well membrane

104 Overall height, 0.170 ± 0.005 Level III CE

105□ Assay strip position correct Level IV VI

201 Correct color of bottom carrier assembly Level I VI

202 No stray marks Level I VI

□ Assay strip position matches government-provided color code chart and strip position table

e. Assay Strip Assembly (Drawing 5-15-19324) (Inspect prior to next assembly)

101 Free of visible contamination 100% VI

102 No loose fiber Level II VI

f. Top, Assay (Drawing PAR3-PC3)

102 No scratches or stray marks 100% VI

103 Flatness within tolerance Level II CE

(not to exceed 0.020)

104 Warp/bend that would prevent Level III VI assembly

201 No flash Level II VI

g. Membrane, Carrier Sample Well (Drawing 32011936)

102 Width 0.750 +0.010/-0 Level II CE

103 Length 4.492 +0.010/-0 Level II CE

h. Bottom, Assay Strip Carrier (Drawing PAR3-PC1)

102 No scratches or stray marks 100% VI

103 Flatness within tolerance Level II CE (not to exceed 0.030”)

104 Wall thickness (0.040”) Level II CE

105 Warp/bend that would prevent assembly Level III VI

106 Correct color Level II VI

201 No flash Level II VI

i. Desiccant Strip (Drawing 32014013)

101 Desiccant not exposed or spoiled Level I VI

102 Mass: 75 g ± 10% Level I CE

103 Length: 3.99 ± 0.21 Level II CE

104 Width: 0.63 ± 0.03 Level II CE

105 Height: 0.085 max Level II CE

201 Bag not torn or damaged Level II VI

PART III. CERTIFICATION REQUIREMENTS

Certification shall be required for each characteristic specified below and shall include actual examination and test results when required herein. Results of examination and tests shall be on file at the contractor’s facility and shall be available to the Government for review.

NUMBER CHARACTERISTIC TO COMPLY WITH

401 Material: Top, Assay Strip Carrier - 32011935 Lexan™ thermoplastic 402 Material: Membrane, Carrier Sample Well - 32011936 403 Material: Desiccant strip – silica gel 32014013

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.

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.

PART IV. PERFORMANCE/DESTRUCTIVE TEST

1. Intended use. The carrier box assemblies are boxes which contain trays of carrier assemblies. The carrier box assemblies are used by and interface with the Identifier subsystem of the Joint Portal Shield (JPS.) The assay strips within each carrier assembly are inoculated by a liquid, optically scanned by the Identifier and analyzed to determine the presence or absence of specific biological agents.

2. Box Carrier Assembly Performance test. The purpose of this Performance test is to insure the assay strip is still functioning after being assembled into the carrier assembly. It also insures the fit and interface between the box carrier assembly and the Joint Portal Shield system. This test is required for the First Article Test only and is not required for the production lot acceptance test. However, if one or more components in the production lot changes since first article inspection, or if the manufacturer, materials or process associated with the component(s) changes, this Performance Test will need to be re-verified.

2.1 Flow Rate. Allow dilution buffer and carriers to reach 35-400 C before conducting test. Test is conducted by inserting the carrier box assembly into the JPS and inoculating each assay trip on the carrier with 115µL of dilution buffer on sample wells.

Assay shall run within 15 min ± 15 seconds.

2.2 Visual Control Line. Allow dilution buffer and carriers to reach 35-400 C before conducting test. Test is conducted by inserting the carrier box assembly into the JPS and inoculating each assay trip on the carrier with 115µL of dilution buffer on sample wells.

The optical density of the control line shall be 0.175