Four panelists introduced new guidelines to help manufacturers in shipping pharmaceuticals/biopharmaceuticals through the distribution chain during the 8th Cold Chain Distribution for Pharmaceuticals Global Forum Sept. 22 in Philadelphia. The presentation focused on the International Safe Transit Assn. Standard 7E and Standard 20.
According to an ISTA document, Standard 20 “details the process and procedure for Insulated Shipping Containers (ISCs)’ Thermal Testing Laboratories to be certified to perform the design, testing, and validation of ISCs to be certified by ISTA as ISTA 7E-Certified.”
The ISTA 7E procedure refers to a set of thermal shipping profiles. The 7E Converter is a program that allows companies to enter their current data, click a button on their computer, and receive a prediction of thermal performance of their ISC.
ISTA President Edward Church, who moderated the panel discussion, recalled, “We first started talking about industry needs in this area about five years ago at a meeting in San Diego for the Pharmaceutical Cold Chain Interest Group” within the Parenteral Drug Assn. “After years of research and testing, today we announce the first set of validated thermal testing profiles for 7E, which will replace 7D, and the first global standard for thermal testing labs.”
In the August 2010 issue of “Ista views™” the association thanked several key individuals and companies for their involvement in developing 7E and Standard 20. Three of those contributors served as panelists at the Philadelphia Cold Chain event:
• Dr. Jim Cox, chief technology officer for MJ Enterprises Inc. and ISTA Certified Auditor.
• Paul J. Harber, associate engineering consultant, Global Packaging Technology & Development, Eli Lilly & Co., Indianapolis.
• Rod Derifield, president, EnviroCooler LLC.
Cox explained that 7E’s “primary importance is to be used as a testing profile.” Testing used to develop 7E involved acquiring winter and summer profiles for shippers in 82 different shipping lanes in which Temperature Acquisition Shippers (TASH’s) were sent from Louisville to a UPS store located near 156 primary pharmaceutical distributor locations, then sent back.
The test involved the use of TurboTag® monitors from Sealed Air. Cox said six of the monitors were placed on each TASH. Testing included three readings per hour, for three successive weeks in July 2008 for the summer profiles, and in January/February 2009 for the winter profiles. In all, Cox said, there were 885,000 temperature measurements taken. “The resulting profiles are a good representation of parcel shipping environment and our study goals were achieved,” he told the audience.
ISTA provides a “How to Start UP with Standard 20 ISTA 7E Roadmap” that lists prices for the various procedures and certifications involved.
Church noted that a future phase for the standards could involve testing in Europe. He pointed out that testing must be done in cooperation with industry, and noted that income from the sales of its programs are used to invest in additional research.