MPID No 3_RSDL_dated 2022-04-13.pdf

MPID No. 3 (6505-01-507-5074)

Medical Procurement Number Date 3 13 April 2022

National Stock

6505-01-507-5074 REACTIVE SKIN DECONTAMINATION LOTION

(RSDL), Individual Use Pouch,21 ml,60s

1. SCOPE. This Medical Procurement Item Description covers Reactive Skin Decontamination Lotion (RSDL). The RSDL is intended to remove or neutralize chemical warfare agent and T-2 toxin from the skin.

2. SALIENT CHARACTERISTICS.

2.1 Medication. Shall be a topical lotion containing a free oxime dissolved in a mixture of polyethylene glycol, monomethyl ether, and water. RSDL will be used to decontaminate skin exposed to chemical warfare agents.

2.2 Requirements.

2.2.1 The RSDL lotion shall be pre-impregnated in a suitable sponge applicator pad, 2 inches x 3.9 inches x 0.4 inch. As an alternate, the applicator pad may be 3.9 inches x 3.9 inches x 0.4 inch. Each applicator pad shall be individually packaged in a heat-sealed polyethylene-lined aluminum foil pouch. The foil pouch is covered by two (2) polyethylene layers to insure the pouch’s robustness and to facilitate coloring and labeling of the finished pouch and to permit easy opening of the package when wearing CW protective clothing.

2.2.2 Shall be cleared for use by the U.S. Food and Drug

Administration (FDA) for application on unbroken skin of hands, face, neck, limbs, and torso.

2.2.3 Shall reduce toxic effects of warfare agents; HD, Soman (GD), VX on skin to a level better than the M291 SKD and T-2 mycotoxins equal to the M291 SDK.

2.2.4 Shall meet the following characteristics and acceptance criteria:

2.2.4.1 Physical examination. RSDL shall be a clear, yellow-orange solution.

2.2.4.2 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.

2.2.4.3 pH. Shall have a pH in the range of 10.35 to 10.85.

2.2.4.4 DAM concentration. Shall have a DAM concentration between

0.78 percent and 1.10 percent.

2.2.4.5 Dimethyl glyoxime (DMG) concentration. Shall have a DMG concentration of less than or equal to 0.1 percent.

2.2.4.6 Assay/reactive capacity. Shall have a concentration of the active ingredient, Potassium 2,3 –Butanedione Monooximate (KBDO), between 13.2 percent and 16.2 percent.

2.2.4.7 Unknown impurities. Any impurities arising from the

degradation of the active ingredient (KDBO) shall be monitored to the following limits:

- Reporting Threshold: < 0.05 percent

- Identification Threshold: < 0.10 percent

- Qualification Threshold: < 0.15 percent

2.2.5 Production conditions and procedures. The conditions for production of this item, as established by the FDA, shall be as specified herein and in the contract or purchase order.

2.2.5.1 RSDL shall be produced and packaged in accordance with the requirements of the US FDA 510 (K) clearance (K023969).

2.2.6 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

(ASTM F88-00)

Pass

Peel strength test

9.4 lbf machine direction; 14.4 traverse direction

Pressure/Burst (MIL-STD-1916) 44.8 psi

Vacuum (MIL-STD-810F) Pass

Labeling marking of individual pouch (MIL-STD- 810F)

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 (MIL-STD-810F) Pass

2.2.7 RSDL characteristics.

2.2.7.1 Shall be suitable for personnel skin decontamination on hands, face, neck, limbs, and torso.

2.2.7.2 Exposed individuals shall be able to begin applying RSDL on their hands, face and neck within one minute of contact and complete the decontamination process within 2 minutes of contact.

2.2.7.3 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 Product effectiveness. Shall reduce toxic effects of warfare agents; HD, Soman (GD), VX on skin to a level better than the M291 SKD and T-2 mycotoxins equal to the M291 SDK.

2.4 Use of RSDL with other nuclear, biological, or chemical

protective material. Product must have been type classified by the US DoD to have met the requirements of paragraphs 2.4.1, 2.4.2, 2.4.3 and 2.4.4.

2.4.1 CBRN detector compatibility. RSDL shall not degrade the tactical point detection devices used to evaluate decontamination effectiveness in a field environment.

2.4.2 M291, M295, and M100. Shall not create any hazardous reaction if contact is made with M291, M295, or M100 decontamination kits.

2.4.3 Equipment compatibility. Shall not interfere with or damage the operation of equipment that may come in contact with the decontaminant during normal decontamination operations. This shall include individual protective equipment, load bearing equipment, individual weapons and crew-served weapons below .50 CALIBER.

2.4.4 Operation in CBRN gear. Shall be capable of being operated by ground and aircrew personnel in MOPP 4.

2.5 Shelf life. Shall have a shelf life of not less than 5 years (60 months)when stored in controlled conditions of 15 deg C to 30 Deg C.

2.5.1 Delivery. Not more than 6 months shall have elapsed from the date of manufacture to the date of delivery to the Government.

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), with one technical manual placed in the box, 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 olive green and shall contain one lotion-impregnated applicator pad. The lotion shall be 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.

5.1.2 Pouch. Three individual use packets shall be supplied in a suitable sealed opaque olive green pouch. The unfilled dimensions of the pouch shall be 6.0 inches (15 cm) in length, by 4.2 inches (11 cm) in width, by 1.2 inches (3 cm) thickness.

5.1.3 Technical manual. One copy of the technical manual shall be enclosed within each package.

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 D 1974, closure method 1D.

5.2 Packing. Packing shall be level A, as specified.

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, class weather-resistant. Closure shall be as specified in ASTM D 1974, closure method 1D. Each fiberboard box 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.

FIGURE 1. Configuration of the Unit Package.

TM – See 1.1.3.

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.

5.3.2 Temperature Monitoring

5.3.2.1 Time Temperature Indicator (TTI). Each immediate container (individual sealed packet) shall have an approved Type TTI device permanently affixed to the front, visible to the user. The TTI shall be applied at the point of manufacture and affixed above the TTI user marking as illustrated in Figure 2.

5.3.2.2 Shipping Temperature Monitoring Device. Each exterior (shipping) container shall have an industry acceptable, government approved temperature-monitoring device in the cargo space, set to monitor 15° - 30° (59° - 86° F) while in transit.

FIGURE 2. Immediate Container Markings(FRONT)

5.3.3 Sealed pouch containing 3 immediate containers. Each three-sided 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)

5.3.4 Unit package. Each unit shall be marked as specified in Medical Marking Standard No. 1, except marking shall include the bar-coded NSN in code 39 format, with human readable interpretation.

Marking shall also include the date of manufacture prefixed by “MFD”, inspection/test date and the legend: “STORAGE TEMPERATURE –15° and 30° C (59° and 86° F).

5.3.5 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”, inspection/test date and the legend: “STORAGE TEMPERATURE –15° and 30° C (59° and 86° F).

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.

FIGURE 5. Pouch markings. (REVERSE)

5.4.2 Cold Chain Management packaging. Exterior (shipping) container shall be packaged utilizing qualified packaging supplies and a validated packaging protocol designed to maintain 15° - 30° (59° - 86° F) while in transit to all locations, both domestic and overseas.

5.4.3 “SURGE ITEMS” Product ships within 75 days of order receipt, surge capacity minimum must be 30,024 RSDL for up to 6 months. 5,504 packages per month for 6 months; total delivered amount in 6 months:

33,024 packages. For delivery in bulk to DoD Depot location, CONUS only.

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