MPID No 2_ISDL_dated 2022-04-13.pdf

MPID No. 2 (6910-01-507-5141)

Medical Procurement Number Date 2 13 April 2022

National Stock

6910-01-507-5141 INACTIVE SKIN DECONTAMINATION LOTION

TRAINING Individual Use Pouch, 21 ml, 60s

1. SCOPE. This Medical Procurement Item Description covers a training lotion kit for simulating skin decontamination procedures with the Reactive Skin Decontamination Lotion (RSDL) Kit.

2. SALIENT CHARACTERISTICS.

2.1 Medication. This item is not a medication. It is a

topical lotion containing inert ingredients used to simulate the use of RSDL on skin exposed to chemical warfare agents.

2.2 Requirements.

2.2.1 Shall simulate the application and use of RSDL by

providing the ability to apply an inert lotion to human skin in the same manner as RSDL.

2.2.2 Shall be packaged and applied in the same manner as

the RSDL product, with obvious packaging characteristics that designate the training lotion package as an inert lotion trainer, as specified herein. The training lotion shall be pre-impregnated in a suitable sponge applicator pad; each applicator pad shall be packaged in a heat-sealed 21 ml packet. The packet shall be steel blue in color to contrast with the green color of the active RSDL packet.

2.2.3 Shall meet the following characteristics and

acceptance criteria:

2.2.3.1 Physical examination. Training lotion shall be a

clear, yellow-orange solution similar in appearance to

RSDL.

2.2.3.2 Container closure system: appearance. Shall be

contained within a packet that is verified for general appearance, leak, delamination, fading, rubbing off and legibility of the printed information.

2.2.4 Production conditions and procedures. The

conditions for production of this item shall be as specified herein and, in the contract, or purchase order.

2.2.4.1 ISDL shall be produced and packaged in accordance

with the with the current Good Manufacturing Practices Regulations, 21 CFR Title 21, Food and Drugs, Parts 210 and 211.

2.2.5 Testing of individual filled packets. The

individual filled packets shall be tested and shall have the following properties:

TABLE I – TEST REQUIREMENTS

PROPERTY ACCEPTABLE RESULTS

Heat seal seam strength test

(MIL-STD-3010)

Pass

Peel strength test (MIL-STD- 882)

9.4 lbf machine direction;

14.4 traverse direction

Pressure/Burst (ASTM D 882) 44.8 psi

Vacuum (ASTM D 3078) Pass

Labeling marking of individual pouch (MIL-STD- 3010)

Pass

Tensile strength (ASTM D 882)

23.3 lbf machine direction; 25.0 transverse direction

Tear resistance (ASTM D 1938)

17.3 lbf machine direction and transverse direction

Rough handling (TAPPI T 800) Pass

2.2.6 Training lotion characteristics.

2.2.6.1 Shall be suitable for simulating personnel skin

decontamination on hands, face, neck, limbs, and torso.

2.2.6.2 Individuals shall be able to begin applying

Training Lotion on their hands, face and neck within one minute of simulated contact and complete the decontamination process within 2 minutes of contact.

2.2.6.3 Shall be supplied in three separately packaged

decontamination applicators, each of which shall decontaminate an area equal to or greater than 1300 cm2 on skin or equipment.

2.3 Use of training lotion with other nuclear, biological, or chemical protective material.

2.3.1 CBRN detector compatibility. Shall not degrade the

tactical point detection devices used to evaluate decontamination effectiveness in a field environment.

2.3.2 M291, M295, and M100. Shall not create any

hazardous reaction if contact is made with M291, M295, or M100 decontamination kits.

2.3.3 Equipment compatibility. Shall not interfere with

or damage the operation of equipment that may come in contact with the training lotion during simulated decontamination operations. This includes individual protective equipment, load bearing equipment, individual weapons and crew-served weapons below .50 caliber.

2.3.4 Operation in CBRN gear. Shall be capable of being

operated by ground and aircrew personnel in MOPP 4.

2.4 Shelf life. ISDL training lotion shall have an

unlimited shelf life.

3. Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S.

Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State and local statutes, ordinances, and regulations.

3.1 Recovered materials. The offeror/contractor is

encouraged to use recovered materials in accordance with the Federal Acquisition Regulation (FAR) Subpart 23.4 to the maximum extent practical.

4. QUALITY ASSURANCE PROVISIONS

4.1 Responsibility for inspection. Unless otherwise

specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements, as specified herein. Except as otherwise specified in the contract or purchase order, the contractor may use his own or any other facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specifications, where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements.

4.1.1 Records. Records of examinations and tests

performed by or for the contractor shall be maintained by the contractor and made available to the Government, upon the Government’s request, at any time, or from time to time, during the performance of the contract and for a period of three years after expiration of the supplies to which such records relate.

4.1.2 No company supplying any raw materials to the

contractor or manufacturer will be considered an acceptable facility for the performance of any inspection requirements specified herein.

4.2 Quality conformance inspection.

4.2.1 Lot for inspection. For purposes of this

specification, a lot, batch or control is that single, uniform, and homogenous quantity of the medication produced from one formulation, subjected to the same compounding and manufacturing operation, and filled into final containers.

4.2.2 Sampling for inspection. Sampling for inspection

shall be in accordance with ANSI/ASQ Z1.4. Inspection level S-2 shall be used; acceptable quality level (AQL) shall be 1.0 percent.

4.3 Inspection of packaging. The sampling and inspection

of the packaging, packing and marking for shipment and storage shall be in accordance with the quality assurance provisions of the applicable container specification and the marking requirements of Medical Marking Standard No. 1.

5. Preservation. Preservation shall be military, as specified.

5.1 Unit. Package (PG). One package containing 20

pouches, each pouch containing three packets (60 individual use packets), together with one technical manual, as specified, constitutes one unit. Material shall be packaged as specified herein.

5.1.1 Immediate container. Each immediate container

(individual use packet) shall be opaque steel blue and shall contain one training lotion-impregnated applicator pad. The training lotion shall simulate the decontaminating material and the applicator pad shall be used to apply the lotion and wipe the skin surface to enhance effectiveness of decontamination. The dimensions of the individual use packet shall be 6.0 inches (15 cm) in height, by 4.2 inches (11 cm) in width, by 0.4 inches (1

cm) thickness. Design of the individual use packet shall include notches to permit easy opening and access to the contents.

5.1.2 Pouch. Three individual use packets shall be

supplied in a suitable sealed opaque steel blue pouch that conforms to specifications of the pouch material that has been tested and validated. The unfilled dimensions of the pouch shall be 6.0 inches (15 cm) in height, by 4.2 inches (11 cm) in width, by 1.2 inches (3 cm) thickness. Design of the pouch shall include notches to permit easy opening and access to the contents.

5.1.3 Technical manual. One copy of the technical manual

shall be supplied in a heat-sealed bag conforming to MIL- DTL-117, type III, Class B, style 2; excess air shall be removed from the bag prior to heat-sealing. Design of the bag shall include notches to permit easy opening and access to the contents.

5.1.4 Unit package. Unit package shall be a fiberboard

box conforming to ASTM D 5118, style RSC, grade V3c, class weather resistant. Box shall be supplied with an interlocking partition. Twenty pouches shall be packaged in the box, with 5 pouches in each quadrant, as illustrated in Figure 1. The technical manual shall be placed on top of the pouches. Closure of the box shall be as specified in ASTM D1974, closure method 1D.

5.2 Packing. Packing shall be level A.

FIGURE 1. Configuration of the Unit Package.

TM – See 1.1.3.

3- Training RSDL

5.2.1 Level A. Four units shall be packed in a snug-

fitting exterior (shipping) container designed for a type 2 load and conforming to ASTM D 5118, grade V3c, class weather-resistant. Closure shall be as specified in ASTM D 1974, closure method 1D. Each fiberboard box closure shall be water-resistant as specified in ASTM D 1974.

5.2.2 Packing variation permitted. If the required number

of units to be shipped is less than the number of units specified to be overpacked in an exterior (shipping) container, such units shall be packed in an exterior container of suitable size and design, acceptable to a common carrier, which will insure safe delivery to destination.

5.2.3 Unitization. Material shall be unitized as

specified in the contract or purchase order.

5.3 Marking.

NOTE: Although the NSN is required on the immediate container and on the pouch containing 3 immediate containers, as shown in Figures 2 and 3, the unit of issue for this item is a Package (PG) containing 60 immediate containers.

5.3.1 Immediate container (individual sealed packet).

Immediate container (individual sealed packet). Each immediate container (individual sealed packet) shall be marked in permanent black upper-case lettering. Markings shall be legible and water-resistant. The front of the immediate container shall be marked as illustrated in figure 2; the reverse of the immediate container shall be marked as illustrated in Figure 3.

FIGURE 2. Immediate Container Markings.

(FRONT)

5.3.2 Sealed pouch containing 3 immediate containers.

Each sealed pouch containing 3 immediate containers shall be marked in permanent black upper-case lettering.

Markings shall be legible and water-resistant. The front of the pouch shall be marked as illustrated in Figure 4;

the reverse of the pouch shall be marked as illustrated in Figure 5

FIGURE 3. Immediate Container Markings.

(REVERSE)

FIGURE 4. Pouch markings.

(FRONT)

5.3.3 Unit package. Each unit shall be marked as

specified in Medical Marking Standard No. 1 for military material. In addition, marking shall include the bar-coded NSN in code 39 format together with the human readable interpretation. Marking shall also include the date of manufacture prefixed by “MFD”, and inspection/test date.

FIGURE 5. Pouch markings.

(REVERSE)

5.3.4 Exterior (shipping) container and unitized load.

Each exterior (shipping) container and unitized load shall be marked as specified in Medical Marking Standard No. 1.

All markings shall be permanent, legible, and water-resistant, as specified in section V.C. of Medical Marking Standard No. 1. Marking shall include the date of manufacture prefixed by “MFD”, and inspection/test date.

5.4 General.

5.4.1 Exterior (shipping) container. Exterior (shipping)

container (see 2.1 and 2.2) shall be of minimum tare and cube consistent with the protection required and shall contain equal quantities of identical stock numbered items to the greatest extent practicable.

6 Sources of referenced documents.

6.1 The Federal Food, Drug and Cosmetic Act is available

from the Food and Drug Administration, Washington, DC 20204, http://www.fda.gov/.

6.2 ASTM Standards are available for purchase from ASTM

International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, http://www.astm.org/cgi-bin/SoftCart.exe/index.shtml?E+mystore.

6.3 Military/Federal specifications, standards and

handbooks are available from Defense Automation and Production Service, Bldg 4D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, http://assist.daps.dla.mil/quicksearch/.

6.4 Medical Marking Standard No. 1 is available from

Defense Supply Center Philadelphia, ATTN: DSCP-FSFB (Packaging), Bldg 6A South, 700 Robbins Avenue, Philadelphia, PA 19111-5092, DSCP.Packaging@dla.mil. This document is also available online at:

http://www.dla.mil/LandandMaritime/Offers/Services/ TechnicalSupport/Logistics/Packaging/MedicalPack1.aspx

Statement of Work Cold Chain Requirements

1. Contractor shall ensure the Reactive Skin Decontamination Lotion will be maintained at 15-30 degrees C while in transit to customer. Qualified packaging procedures must be submitted with the Contractor's proposal for review and acceptance by the government. Procedures must include a suitable temperature monitoring device (suitability will be verified by the Government).

2. Accompanying each shipment will be instructions for the customer on operating the temperature device and reporting suspected failures back to the Contractor. The Contractor will coordinate with customers on suspected failures to determine product efficacy.

3. The Contractor shall prepare and submit a quarterly report to the Contracting Officer outlining the total number of shipments, total number of shipment failures, expected causes, and the resulting number of reshipments.

Statement of Work- ECAT Procedures

I. Electronic Catalog (ECAT) System

The contractor agrees to use the ECAT system to display its catalog for the items awarded. The contractor agrees to let all authorized users of the system view any information displayed in the system. ("Authorized Users" are defined as agencies with either a ".GOV" or ".MIL" Internet address.)

II. Electronic Price and Product Catalog

1. The contractor shall submit and maintain an Electronic Price and Product Catalog(s) listing all items available to customers when placing an order for items contained in any contract contained in the ECAT ordering system. The submission of the data shall be by excel spreadsheet or in a delimited file as follows:

Mandatory Fields for Catalog Submission

Item Part Number Manufacturer Part Number Unit of Sale Items Per Unit of Sale Unit Price (contract price) Delivery Lead Time Days Product Name Product Description Manufacturer Name Product Type Code Hazardous Indicator Controlled Indicator Cold Chain Indicator Minimum Order Quantity Multiple Order Quantity Country of Origin List Price Other Federal Agency Price Category Discount Code

2. Part Number, Unit of Sale, Items per Unit of Sale and the Manufacturer's Name are used as the Item Identifiers in the catalog. These four fields combined shall form a unique product line item, unable to be duplicated.

3. Hazardous Indicator attribute will be defined as items that have been determined to be hazardous under Federal Standard 313. This attribute is a logical field in the ECA T application, and contractors are mandated to populate this attribute with a "Y" for any items that are classified as hazardous material.

4. All products requiring FDA approval prior to award will have their approval prior to addition to the catalog, when applicable.

5. Using the attributes cited above, the contractor will populate their catalog submissions with appropriate designations. Although not required, the following fields are available for input and recommended if applicable: Alternate Product Identifiers, such as

Universal Product Number, National Stock Number, and National Drug Code, Volume Discounts.

6. Future enhancements may include the following and are recommended when feasible: Graphic Image File (GIF), Joint Photographic Experts Group (JPEG). Contractors are encouraged to provide any additional information that will assist customers in identifying products and understanding specific features of any product.

III. Order/Confirmation/Delivery

1. The Contractor shall accept individual delivery orders on a daily basis from the ordering facilities. The contractor shall package each delivery order separately for shipment to the delivery point cited on the electronic delivery order in accordance with the packaging requirements of the item specifications.

2. The contractor shall provide an electronic order acknowledgment, which confirms orders at the line item level within 24 hours. Order acknowledgments may be transmitted 24 hours a day, 7 days a week. Any orders received after 5:00 p.m. Contractor's local time shall be treated as orders received the next business day.

3. The contractor shall specify the delivery lead-time for each item in their catalog. Direct deliveries shall be made between the hours of 8:00 am. and 4:00 p.m., local time of the receiving facility, Monday through Friday, excluding federal holidays and weekends. All deliveries shall be made by traceable means.

4. DLA Troop Support is exploring alternative methods for expediting shipments to overseas activities. The contractor may be directed to use third-party shippers for these purposes.

IV. Supplier Order Management (SOM)

1. ECAT offers a browser-based supplier interface to allow offers to respond to orders without using EDI transactions. The procedures contained in the Supplier Order Management guide shall apply and are incorporated in this solicitation by reference. The guide is available upon request.

2. The contractor will receive an e-mail notification of any new orders. The Contractor must then log into ECAT, with a user ID supplied by DLA Troop Support, to view the order(s). The Contractor shall acknowledge the order (s), provide an estimated shipping date, shipping company and tracking number within the ECA T software, which in tum will update the customer's status.

3. The contractor shall be able to submit an invoice in accordance with SOM procedures or by using Wide Area Workflow (WAWF). Although the Government will assist in resolving invoice problems, the Government will not be responsible for invoices submitted in error or not according to protocol. The Government shall pay the contractor 15 days after receipt of a valid invoice.

Payment will be made via electronic funds transfer (EFT) to the contractor's financial institution.

4. At the time of implementation, the contractor must provide the Static Internet Protocol (IP) address(es) of those individual(s) who will be logging into ECAT.

Profile information will also be required for the individual/Group receiving the e-mail notification of new orders. This will include but is not limited to, name, phone number, fax number and e-mail address. The Contractor shall also provide their Company Logo in .jpg or .gif formats.