Attachment_4_-_HHA_Drawings_Specs.pdf

15 Jan 13

TECHNICAL DATA PACKAGE (TDP)

FOR

Hand Held Assay (HHA)

Table of Contents:

1. Manufacturing Instructions

2. Drawing HHA-0001 (Assay Assembly)

3. Drawing HHA-0002 (Assay, Front)

4. Drawing HHA-0003 (Assay, Back)

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

6. Quality Assurance Provision (QAP)

7. Special Packaging Instructions (SPIs)

P1-HHA-01B

P1-HHA-02B

P1-HHA-04B

P1-HHA-01T

P1-HHA-02T

P1-HHA-01R

P1-HHA-03T

P1-HHA-01S

P1-HHA-02S

P1-HHA-02V

P1-HHA-01V

P1-HHA-03B

P1-HHA-04S

P1-HHA-03S

Manufacturing Instructions for Hand Held Assay (HHA)

1. Each Hand Held Assay assembly consists of an assay front (drawing HHA-0002), assay back (drawing HHA-0003), and a Lateral Flow Immunoassay (LFI) strip (drawing 5-15- 19324.) The assay front and assay back shall be made from ABS plastic (acrylonitrile butadiene styrene), color white.

2. The Lateral Flow Immunoassay (LFI) strips are to be furnished by the government.

3. The LFI strip is positioned into the bottom half (assay back) of the HHA carrier. The strip shall be positioned membrane side up and the sample delivery pad should be placed under the sample delivery well.

4. Secure the plastic carrier by pressing the top and bottom halves together (figure 1.)

5. 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.

6. Package HHAs in accordance with special packaging instruction P1-HHA-XXX as applicable.

Figure 1.

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…”

QUALITY ASSURANCE PROVISION (QAP)

for

Individual Hand Held Assay (HHA)

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 hand held assays manufactured using accepted government-furnished assay strips.

PART I. APPLICABLE DOCUMENTS AND INSPECTION EQUIPMENT CODING

DRAWINGS

HHA-0001 - Assay Assembly HHA-0002 - Assay, Front HHA-0003 - Assay, Back 5-15-19324 - Assay Strip 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 70 individual hand held assays 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.

b. Inspection procedure. This inspection applies to each of the Hand Held Assay configuration. From the 70 individual HHAs above, 30 random samples shall be used for the first article inspection as described in Table 1; 5 random samples shall be used for the Performance Test specified in Part IV; and 30 shall be used for the packaging inspection as specified in 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

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 Front HHA-0002○ Dimensions, L: 2.750, W: 0.800, H: 0.152 30 CE Correct color (white) 30 VI

No flash 30 VI Assay Back HHA-0003○ Dimensions, L: 2.750, W: 0.800, H: 0.115 30 CE

Correct color (white) 30 VI No flash 30 VI

Assay Assembly HHA-0001 Identification legible and correct 30 VI Free from contaminants, smudges, scratches & fingerprint 30 VI Correct strip orientation in assembly 30 VI Agent code/agent name on label matches correct strip used 30 VI◊

Assay Front and Back snap fit tightly 30 VI Assay Strip 5-15-19324○ Free of visible contamination and loose fibers 30 VI Assembly

○ Inspect prior to next assembly ◊ Agent code/agent name matches government-provided color code chart

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

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

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 Hand Held Assay 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 Front (Drawings HHA-0002) (Inspect prior to next assembly)

Critical

1. None

Major

101 Dimensions Level III CE L: 2.750, W: 0.800, H: 0.152

Minor

201 Correct color (white) Level II VI

202 Free of flash Level II VI

203 All other 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

c. Assay Back (Drawings HHA-0003)

101 Dimensions Level III CE L: 2.750, W: 0.800, H: 0.115

201 Correct color (white) Level II VI

202 Free of flash Level II VI

203 All other 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. Assay Assembly (Drawing HHA-0001)

101 Identification legible and correct 100% VI

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

103 Correct strip orientation in assembly Level IV VI

104○ Agent code/agent name on label matches Level IV VI correct strip used

105 Assay Front and Back snap fit tightly Level III VI

201 None

○ Agent code/agent name matches government-provided color code chart.

e. Assay Strip Assembly (Drawing 5-15-19324)

None

101 Free of visible contamination 100% VI

102 No loose fiber 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: ABS plastic HHA-0002 and HHA-0003

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 individual hand held assay is a simple, antibody-based assay used to presumptively identify biological warfare agent. It can be used one time to identify one biological agent. A small water sample is deposited into the sample well for sampling.

Liquid will flow through the strip. A colored line in the Test mark will appear to indicate the presence of agent. A colored line in the Control area will appear to indicate the assay is working properly.

2. HHA Assembly Performance Test. The purpose of this Performance Test is to insure the assay strip is still functioning after being assembled into the hand held assay assembly. 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 individual HHA to reach 35-400 C before conducting test. Test is conducted by adding 100µL of dilution buffer to sample wells. Assay should run within 15 min ± 15 seconds.

2.2 Visual Control Line. Allow dilution buffer and individual HHA to reach 35-400 C before conducting test. Test is conducted by adding 100µL of dilution buffer to sample wells.

a) The optical density of the control line shall be at least 450 scanner units

b) The strip shall not exhibit a test line (this applies to non-training HHAs only)

c) Control line is located in the correct position within the assembly