Attachment 1 _ Revised Statement of Work Specification 75A50326Q00024 Amdend 1.pdf

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STATEMENT OF WORK

Tittle: Pharma Cool Single Chilled Pallet Shipper System

SECTION 1 – BACKGROUND

The Strategic National Stockpile (SNS), Administration for Strategic Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS), maintains deployable inventories of temperature-sensitive Medical Countermeasures (MCMs) that require validated passive cold-chain shipping systems to maintain product integrity during transportation.

Operational Logistics (OL) maintains validated passive cold-chain shipping systems capable of maintaining refrigerated temperatures between 2°C and 8°C during storage, transportation, emergency response operations, and special events. These systems support rapid deployment of MCMs throughout the United States and internationally.

The purpose of this procurement is to acquire passive refrigerated pallet shipping systems and compatible refrigerant assemblies that meet SNS operational, dimensional, and thermal performance requirements while remaining compatible with existing validated packaging and operational procedures where applicable.

SECTION 2 - SCOPE OF WORK

The Contractor shall furnish new passive refrigerated pallet shipping systems including all compatible refrigerant assemblies (gel packs, gel cassettes, or equivalent thermal conditioning media) designed to maintain internal temperatures between 2°C and 8°C during transportation.

Each system shall include all components necessary for operation, including compatible refrigerant assemblies (gel cassettes or equivalent cooling packs), insulation components, assembly hardware, and operating instructions.

The refrigerant assemblies (gel packs, gel cassettes, or equivalent passive cooling media) shall be specifically designed for the proposed pallet shipping system and shall fit securely within the manufacturer's intended locations without modification. The refrigerant assemblies shall support the required internal temperature of 2°C–8°C for a minimum of 120 hours.

The offered system shall be commercially available and capable of meeting the performance requirements identified in this Statement of Work. Where compatibility with existing SNS operational procedures or validated packaging configurations is required, the Contractor shall demonstrate compatibility through manufacturer documentation or equivalent technical data.

SECTION 3 – PERFORMANCE AND REQUIRED SPECIFICATIONS

• Maintain an internal temperature range between 2°C-8°C for a minimum of 120 continuous hours under any external temperatures during transit. operating conditions.

• Operate as a completely passive shipping system. Active refrigeration or electrically powered cooling systems are not acceptable

• The use of Dry Ice to maintain temperature requirements is not acceptable.

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• Must be able to support amount of product that fits on standard 48”X40” pallet

• Be suitable for warehouse storage and rapid deployment.

• Require a maximum of 30-minute to assemble for shipment

• Include all refrigerant assemblies required for operation.

• Include assembly and operating instructions.

• Include recommended conditioning procedures for refrigerant assemblies.

• Include safe handling and disposal instructions.

• Include manufacturer technical support contact information.

• Provide at thermal qualification report

• Provide Summer and Winter operating profile validation

• Provide Quality Assurance/Quality Control procedures and verification documentation

• Provide Assembly and Operating instructions

• Manufacturer product specifications to include manufacture date, manufacturer item/model number and manufacture name will be printed on the container in a visible location when the product is stored in warehouse racking.

Refrigerant/Frozen Assemblies (Gel Packs) The Contractor shall provide refrigerant and frozen gel pack assemblies (to ensure the pallet shipping system keeps product at the proper temperature of 2°C-8°C during the cold-chain shipping process) that:

• Are compatible with the proposed pallet shipping system.

• Fit within the manufacturer's designated locations inside the shipping container.

• Require no modifications or custom fabrication by the Government.

• Are new and unused.

• Have a minimum remaining shelf life of forty-eight (48) months upon delivery.

• Be sufficient in quantity to fully outfit each pallet shipping system.

• Be capable of maintaining the required thermal performance when conditioned and used in accordance with the manufacturer's instructions.

• Include conditioning, storage, reuse, and disposal instructions.

Documentation shall demonstrate that the proposed shipping system satisfies the required performance criteria.

3.1 DIMENSIONAL REQUIREMENTS

Minimum payload capacity:

• Interior volume: 122.6 liters or greater than 2,697 lbs equivalence

• Interior dimensions: 49 in. L × 42 in. W × 45 in. H (minimum)

• Outer Dimensions: At least 62 in. (L) × 54 in. (W) × 62 in. (H) with no dimension exceeding the validated storage or transportation constraints of SNS facilities.

• Exterior dimensions shall not exceed operational warehouse limitations and shall be suitable for transportation on standard freight equipment

• The system shall be compatible with handling and transportation on a standard 48 in. ×

40 in. pallet.

• The ability to reduce the profile footprint (cubic foot) when the item is stored by means of folding or deflating is preferred to maintaining the container in full, ready-to-use size.

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3.2 REFRIGERANT ASSEMBLIES

The refrigerant assemblies shall:

• Be compatible with the offered pallet shipper.

• Be new and unused.

• Have a minimum remaining shelf life of 48 months upon delivery (if stored and maintained in proper temperature).

• Be capable of supporting the required thermal performance.

3.3 INSPECTION AND ACCEPTANCE

The Government will inspect all delivered items for:

• Quantity

• Physical damage

• Completeness

• Documentation

• Shelf life

• Conformance with contract requirements

Items found damaged, incomplete, or nonconforming shall be replaced by the Contractor at no additional cost within a mutually agreed-upon timeframe.

SECTION 4: SHIPPING AND DELIVERY REQUIRMENTS

All contracts for delivery to a SNS location shall have the following shipping requirements:

a. All shipments will include packing slips and contract number.

b. Storage Requirements shall be on all packing lists.

c. No Partial Case or Packages quantities will be accepted unless approved by SNS in advance.

d. No Mixed Lot #'s per Case, Packages, or Pallets will be accepted unless approved by SNS in advance.

e. Product must have at least 12 months of Shelf Life upon delivery.

f. Shelf-life shall be included on all packing lists, inner packaging, and outer case.

g. Item description, NDC/Part number, Lot numbers and quantities shall be included on each

Case, box/package/etc., and the packing list.

h. All pallets are to have the identical TyHi stack pattern except for the final pallet.

i. All product to be delivered on standard 48" by 40" heat treated pallet, not to exceed 60” in height, stretch wrapped and secured to pallet for safe transport.

j. Full case quantities only unless approved by SNS in advance. Final shipment may be less than full quantity.

k. Contractor shall contact the designated point of contact (POC) to schedule delivery appointments.

l. Lot number and part number shall be included on the inner packaging and outer case.

m. Contractor shall contact the designated POC to schedule delivery appointments.

n. No deliveries accepted on weekends without prior approval of the COR/Project Officer.

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SECTION 5: DELIVERY SCHEDULE

Complete shipping addresses will be provided at the time of award by appointed COR

Shipping Locations:

Location Pallet Shipping Systems

Refrigerated (Red) Frozen (Blue)

Mississippi 10 240 240 Texas 3 72 72 Utah 12 288 288 Total 25 600 600

For purposes of preparing shipping estimates, Offerors shall use the following destination ZIP codes:

• Mississippi: 38654

• Texas: 75038

• Utah: 84104

Each Pallet Shipping System requires 24 Refrigerated (Red) and 24 Frozen (Blue) Gel Cassette Assemblies.

Anticipated Period of Performance: September 1, 2026 through December 31, 2026