Attachment 1_Insulated Shipping Containers Specs.pdf

ATTACHMENT 1

INSULATED SHIPPING CONTAINERS

Specification Requirements:

The containers shall maintain contained product at a temperature range between -25°C and -15°C for up to 96 hours under ISTA 7D Winter and Summer testing.

Refrigerants or Phase Change Materials (PCM) must perform to validated requirements when stored in freezer temperatures between -15°C and -25°C ensuring consistent temperature performance for the payload without the need for ice, dry ice or gel packs.

All Refrigerants or Phase Change Materials will be stored and conditioned inside of freezer units and inside of Insulated Shipping Container (ISC).

ISC cannot be reenergized or loaded with additional PCM once sealed, in order to satisfy the up to 96-hour requirement

The ISC outer shell must last a minimum of 5 routine round-trip shipments before significant deterioration (vendor must supply inspection requirements for reuse)

ISC must be of sufficient strength and integrity to withstand normal handling during storage or shipment.

An end user operation instructions card or sheet shall be provided for each unit purchased.

In final manufactured state, all materials making up the ISC are to be non-hazardous.

End user directions for safe disposal and any associated material risks by end user shall be provided, if applicable.

Preventative maintenance and other maintenance requirements shall be provided.

The containers shall have Thermal Isolation Chamber (TIC), a removable thermal liner containing Phase Change Material, which can be frozen in preparation for frozen shipments.

TIC must utilize Phase Change Material with a freeze/thaw threshold for the necessary temperature range to maintain constant temperature.

The containers must have replaceable Vacuum Insulated Panels rather than foam for insulation.

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

The containers must have a maximum of 5-minute setup time.

Products shall have at least 48 months of shelf life remaining at time of delivery.

Approximate payload dimensions/dimensional requirements:

Small (Sm): have usable payload space of 5.9”L x 5.9” W x 5.9” H Medium (Med): have usable payload space of 8.9”L x 8.9” W x 8.9” H Large (Lg): have usable payload space of 12” L x 12” W x12” H

ISC payload dimensions must accommodate additional space inside and on top of payload area of the height of 1 inch.

Validation Requirements:

ISTA 7D Winter and Summer Protocol will be followed and documented to ensure that the container can maintain the set standards mentioned.

ISTA 7D Winter and Summer profile testing vibration testing (full and empty payload) drop testing on all six sides and side corners (full and empty payload) drop and vibration testing is to be done on the ISC’s in its ambient state with no payload drop and vibration testing is also to be done on the ISC’s in its frozen state with no payload and full payload

Air and product temperature simulations during testing Pre-qualified, validated to the satisfaction of the government to the following stipulations:

o ISTA 7D Winter and Summer Protocol for a minimum of 72 hours at temperatures of -25°C and -15°C o Payload area empty o Tested and Thermal Mapped to an accuracy of ≤ 0.1°C

Thermal Mapped temperature probed on bottom, Middle, and Top of payload area o Allow for qualification and validation inputs from Government including monitoring of testing and format of contractor’s final qualification and validation reporting.