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	URL / File Path
	http://www.ista.org/Documents/ISTA%20001%20Tech%20 ...

Document ID ISTA - 001 Revision

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ISTA Document - 001

Purpose

The Protocol will develop baseline standards for hot and cold profiles per PDA Test Report #39. This data will be used to create a composite profile tool that is representative of the typical conditions encountered by packages during these shipments. The profiles will be used to statistically create the exposure conditions for lab testing of transport packaging

Scope

The scope of this protocol includes sending specially constructed data recording packages in triplicate on “round trip” shipments made within the continental U.S. These shipments will originate at the Midwestern hubs of a specified carrier. The outer terminus of the shipments will be to cities and towns that have “storefronts” operated by the carrier within the vicinity of pharmaceutical wholesalers. There will be two seasonal campaigns to include hottest and coldest months of ambient temperatures. Selection criteria of the shipments will be based on proximity of a wholesaler that would receive actual shipments as well as the availability of a nearby storefront at which to return the data recording packages to the hubs. These termini will be determined in consultation with the freight companies as well as referencing the climactic data as it is presented in the ASHRAE book of Fundamentals

The historical temperature history for the wholesaler locations were reviewed per ASHRAE to determine the time periods that experience the warmest and coldest extreme months of ambient temperature. After review of the temperature history it was determined that the average hottest month across the United States is July, while the coldest month is January.

Responsibilities

ISTA
   • Write Protocol

ISTA Work Group and PCCIG Steering Committee
   • Review and Approve Protocol
   • Review and Approve Specifications
   • Review and Approve SOP’s
   • Review and Approve Lane Reports
   • Review and Approve Final Report

Procedures

TEST PROCEDURE


1.0 DISCUSSION

   1.1 Analysis of 164 shipping lanes
   1.2 Hot and Cold Profiles
   1.3 Profiles at 90%, 95%, and 99% confidence levels


2.0 ACCEPTANCE CRITERIA

   2.1. A minimum of 95 % of the shippers must have data.

Hyperlink

	URL / File Path
	http://www.ista.org/Documents/ISTA%20002%0Wholesaler� ...

Document ID ISTA - 002 Revision

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You have to decide during what period of time you are going to conduct the environement sampling of the ambient temperature packages see during distribution.

Purpose

The purpose of this specification is to list known pharmaceutical wholesaler locations (Table 1) and the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) hottest and coldest months listed for each location.

Scope

This data shows that July is the hottest month in most locations and January of each year on average is the coldest.

Procedures

This protocol is for hot and cold temperature so the zip code locations of the 56 Major Wholesaler Distribution Centes in the US were compared with the American Society of Heating, Refrigeration and Airconditioning Engineers (ASHRAE) monthly temperature studies for those locations.

Hyperlink

	URL / File Path
	http://www.ista.org/Documents/ISTA%20003%20Shipping ...

Document ID ISTA - 003 Revision

Last Reviewed Next Review

United Parcel Service Store Front Location List

Purpose

The purpose of this specification is to list known UPS “storefront” points that are in the same geographic locations as pharmaceutical wholesalers listed in ISTA – 001. The total lanes in this report number 164. That is made up of 82 shipments from an Envirocooler location in Louisville, KY to a “Store Front and 82 shipments from the “Store Front back to the Envirocooler location in Louisville.

Procedures

Obtain a list of all the possible UPS StoreFront locations and sort them by zip code. Compare the Pharmaceutical Wholesaler zip codes with those that have a UPS store front within 200 miles. You then select a single store front location zip code that finds a Wholesaler and Store Front in the same zip code.