ISTA Standard 20 Offers Standard Test Method
With the new ISTA Standard 20, ISTA is providing a standard for thermal and physical testing of insulated shipping containers (ISCs) that includes a set of standard global thermal profiles—ISTA 7E profiles—for testing container performance.
Testing laboratories will be certified for validating packaging under Standard 20, following a comprehensive validation process for ISC design, testing, and verification. ISCs tested and validated under Standard 20 are then reviewed and certified by ISTA for performance under the standard.
EnviroCooler (Huntington Beach, CA) has announced ISTA-certification of its EnviroCooler Ice-Lockers as the first ISCs certified under the standard. The standard will make the selection of regulatory-compliant shipping solutions easier for industry by allowing “apples-to-apples” comparisons of ICSs’ performance, says Rod Derifield, president, EnviroCooler.
“By having a true industry standard to comply with, and a certification path independent of the ISC manufacturer and the biopharma companies, comparability can be performed in a more meaningful fashion, “ Derifield says.
“For the biopharma industry, this will ultimately result in the best and most cost-effective solutions being highlighted and used. For the supplier, both big and small, it will be a path to a more level playing field in which to compete,” he adds.
Derived from a three-year shipping lane study, the 7E thermal profiles represent real world “shipping environments” based on conditions experienced in trucks, air carriers, and storage facilities.
Although some ISC providers and biopharma firms have aligned in favor of the standard, industry has yet to respond with broad consensus since the standard was formally announced in September.
“For us as providers to the industry, we want to make sure we are providing a quality product that will serve the industry and our customer base,” says Bill Hingle, marketing director, TCP Reliable/Cryopak (Edison, NJ).
“We think it is too soon to tell whether this will be recognized as a universally acceptable standard by the entire industry both domestically and internationally.
“More time will be required for concurrence that this standard can be implemented on a wide scale. We need to understand and thoroughly vet the approach that was taken in developing the [thermal] profiles,” Hingle says.
“[Ultimately,] customers will tell you if they want this or not based on their individual requirements,” he adds.