Attachment 6_TDPs_Biological Sampling Kits.pdf

1 Mar 13

TECHNICAL DATA PACKAGE (TDP)

FOR

Biological Sampling Kit

Table of Contents:

1. Manufacturing Instructions

2. Drawing 5-15-19324 (For Reference) with changes attached

3. Quality Assurance Provision (QAP)

4. Special Packaging Instructions (SPIs)

PJPOBSKT-10

PJPOBSKT-20

P0-BSK-01UN

PLFI-0-BSK-01V

BSK - P1

Manufacturing Instructions for

Biological Sampling Kit (BSK)

1. Each Biological Sampling Kit consists of the following components:

a. One packaged Panel: an Operational Panel, a Training Panel, an uncoded Panel, or a

Special Operational Panel.

b. One Biological Sampling Kit instruction card (10 cm x 10 cm laminated card.)

Card stock shall be 90 lb Index or heavier. (See below for instructions to be printed on card.)

c. Two sterile Dacron fiber tipped plastic applicator swabs, packaged in one envelope (e.g. Fisher catalog no. 22 029 574)

d. One 50 ml conical tube polystyrene containing one 4 ml clear LDPE dropper bottle with white PP closure (e.g. Fisherbrand catalog no. 03-007-16A) containing 4 mls of Assay Buffer (0.1% Triton X-100 and 0.04% Kathon in Phosphate buffered saline (PBS) at pH 7.4. Sterile filtered thru 0.22 μm filter). Assay buffer shall be stored at 2-8 degrees Celsius.

e. The 4-ml Buffer Solution bottle shall be labeled as follows:

“Phosphate Buffered Saline, pH 7.4 Lot #:

Store at 2-8o C (36-46o F) For Environmental Sampling Only Not for Human Consumption Contains Kathon and Triton X-100”

f. Package BSKs in accordance with special packaging instructions PJPOBSKT-10, PJPOBSKT-20, P0-BSK-01UN, or PLFI-0-BSK-01V, as applicable.

BSK - P2

(FRONT SIDE)

BSK - P3

(BACK SIDE)

BSK - P4

BSK - 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…”

BSK - P6

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

BSK - P7

QUALITY ASSURANCE PROVISION (QAP)

for

Biological Sampling Kit (BSK)

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 Biological Sampling Kit manufactured using panel with accepted government-furnished assay strips.

PART I. APPLICABLE DOCUMENTS and INSPECTION EQUIPMENT CODING

DRAWINGS

None

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 biological sampling kits 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 4 Biological Sampling Kit 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 applicable Special Packaging Instructions.

BSK - P8

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 Biological Sampling All components present and correct 20 VI Kit No damage or contamination on any component 20 VI

Label on assay buffer bottle correct and legible 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

BSK - P9

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 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.

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. Components in the kit

BSK - P10

Class Characteristic Sampling Inspection Method Critical

1. None

Major

101 All components present and correct 100% VI

102 No damage or contamination on any 100% VI component

Minor

201 Label on assay buffer bottle correct Level II VI and legible

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.

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.

BSK - P11