The New and Improved ISTA Standard 20 v2

The New and Improved ISTA Standard 20 v2

The International Safe Transit Association (ISTA) is a member-driven standards organization. A revised version of ISTA Standard 20 is now available. The original Standard 20 was developed to assist suppliers and users of passive thermal shippers in defining the necessary elements for data packages. When assembled correctly, the data elements are presented in a consistent form by all suppliers and benefit users. They can easily compare their needs with the documented performance of each shipper.

Modality Solutions was proud to play a role in leading ISTA members in the development of Standard 20 v2. Together the team of experts reduced the size and complexity of the original Standard 20. The new version has been simplified, clarified, and streamlined. It benefits both suppliers with an easy to implement approach to documenting shipper qualification.

What Hasn’t Changed in Standard 20 v2? The original guiding principle of Standard 20 has not changed. The premise is still the same — to have an industry standard so that users have a qualified insulated shipper that meets regulatory expectations.

The ISTA Standard 20 v2 process is the same. Some parts are now optional or best practice. User feedback indicated that depending on who qualified a shipper dictated what should be done. Suppliers should not be executing a PQ. End users should perform the PQ. ISTA Standard 20 v2 still incorporates CDER’s principles of validation, and Quality By Design is still a key component of the new version.

What Has Changed in Standard 20 v2? Simplified and streamlined the entire program by reducing the size and number of documents in the entire Standard 20 v2 program: Reduced: Total # of docs from 25 to 15; Reduced: From 45 pages to 26 pages; Reduced: Data package examples from 1000 pages to one 17-page manual; Clarified: Protocol templates by moving from an outline format to a table format; Clarified: Thermal sensor locations by creating a table to precisely specify how many and where thermal sensors shall be located in an ISC — based on the ISC design and payload configuration

Additional Standard 20 v2 Change Highlights: Added flexibility around thermal profiles. Removed qualified air temperature (QAT) to reduce confusion. Parts of the process are now optional depending on who is qualifying an ISC. Now requires a physical test as part of DQ. Clarified that physical testing may take place at an ISTA lab certified to execute ISTA 2B or 3A. Provided clear direction on what to do if a test fails. Removed all company-specific references. Incorporated a process flow diagram to clarify the process flow. Provided more flexibility across the entire Standard to make it easier to use. Tightened up thermal chamber performance requirements so the mean of errors shall not be greater than a (+or-) 1.0°C and no single error greater than a 3.0°C — providing a more accurate test.

At Modality Solutions we strongly recommend you take advantage of Standard 20 v2. Become an ISTA Member. For more information, visit www.ista.org and/or contact ISTA today at (517) 999-3437.