In January, the International Safe Transit Assn. (ISTA) and the Parenteral Drug Assn.'s (PDA)/Pharmaceutical Cold Chain Interest Group (PCCIG) will conduct a 56-city performance test in an effort to develop a shipping program that will help life sciences companies satisfy FDA regulations, reports ISTA executive director Ed Church (shown here).
This test follows one conducted last July by ISTA and PDA/PCCIG, in which 56 cities were involved in a parcel shipping test in the U.S., including Puerto Rico, to develop hot profile performance test data based on the ambient temperature ranges found in the distribution environments when shipping to the largest U.S. pharmaceutical distributors. This was accomplished by shipping to 56 United Parcel Service "store fronts" located near each of these distributors.
The University of Florida will examine the results of data recorded on Sealed Air temperature logging tags and then do the same with cold profile data that will be recorded in the January test of the same 56 U.S. locations.
The ISTA/PCCIG test involves sending an empty shipping case to each of the 56 destinations in three separate round trips away from and back to UPS's hub in Louisville, KY. These trips are UPS 2nd-day shipments and therefore can be either air or ground shipments. The temperature logging tags will be used with each trip to record ambient temperatures outside of the box.
"Our work is providing information on what the box is exposed to during distribution, and on what the box is going to [experience] regarding the ambient temperatures outside the box. So that's what is critical in developing a cold chain performance test profile," said Church during an exclusive interview with Healthcare Packaging at the recent Pack Expo Intl. 2008 show in Chicago.
Data collected from the summer and winter shipments will be used to create hot and cold temperature profiles that will replace the current ones in ISTA Procedure 7D, which focuses on thermally controlled transport packaging for parcel delivery shipments. "We want to create a situation where a manufacturer of a cold chain box can test its product against this new ISTA procedure so it doesn't have to go out and do its own testing," said Church.
For life sciences product manufacturers, the test results "will give you a starting point for designing your cold chain package," said Church. "The pharmaceutical or medical device user will ideally be able to buy off-the-shelf packaging that will meet FDA guidelines."
ISTA also believes the information will benefit producers of biologic-based products. "With our various test standards and procedures, ISTA members are conducting shock and vibration tests. There was a general thinking that vibration would be the really bad thing for proteins, and now there's a concern as to whether shock is worse than vibration to these sensitive biologics," noted Church.
He credits Amgen, Eli Lilly, and Abbott, along with other members of the PCCIG Steering Committee, with being at the forefront of temperature-sensitive shipment testing among end-user companies. "Amgen is driving a lot of this as far as pushing the industry along. They are wide open with what they're doing because they believe it benefits the entire industry," he said.
Seeking sponsors
Church explained, "We have spent a considerable amount of money on this project. In addition, we are seeking more sponsors to help reimburse the University of Florida for some of its research time on this if we can. ISTA is looking for funding in the neighborhood of $150,000. That amount would also help us in conducting a similar, though smaller-scale European study."
Corporate sponsorship benefits include the following, according to ISTA's Web site:
• Participation in ISTA 7D test verification using your company's products.
• Free access to all individual lane data: two years for $10,000 sponsors and four years for $15,000 sponsors.
• One free attendee registration to ISTA's Transport Packaging Forum.
• An in-person session to review, first-hand, the results of the analysis of the data collection presented by the project experts.
• Participation in a symposium to provide expertise in the development of packaging to meet the new temperature profiles.
• Participation in a Webinar during the validation of the new hot and cold temperature profiles.
• Opportunity to showcase case studies of successful efforts toward temperature-controlled packaging.
ISTA reports that the financial support will allow it to measure the hot and cold temperatures seen by packages in the parcel delivery distribution environment in the U.S., analyze the data, develop new temperature profiles for use in ISTA 7D, and provide cold chain shippers with technical and educational support. To become a sponsor or to learn more, go to www.ista.org/pages/resources/TemperatureProfileProject.php, or contact Ed Church at 517/333-3437.
--By Jim Butschli, Editor
