ISTA Releases Standard 20

With Article Contributors:

Ed Church, President, ISTA
Karen Greene, ISTA Certified Auditor, Life Packaging Technology
Jim Cox, ISTA Certified Auditor, MJ Enterprises Inc.

Designing, building, and maintaining a cGMP-compliant biopharmaceutical supply chain is one of the greatest challenges facing the industry. Part of the challenge is figuring out how to ship temperature-sensitive pharmaceuticals (TSPs) safely and compliantly around the world, meeting the standards required by all regulatory bodies. Regulatory requirements include proving a selected insulated shipping container (ISC) can repeatedly hold designated product loads in acceptable temperature ranges throughout its supply chain.

Up to now, individual organizations were left to determine the level of performance testing, leading to the use of different testing profiles, protocols, and differing proofs of performance.

Feedback from industry and regulatory bodies over the past 10 years has underlined the need for one global standard that details the minimum thermal and physical testing an ISC should undergo to determine its proof of performance. International Safe Transit Association (ISTA) has responded to this feedback and has invested, over a four-year period, in the development of not only one standard, but also one certification process through which the ISCs will be certified: ISTA Standard 20.

The 7E Roadmap from ISTA.

Scheduled for release in September of this year, ISTA Standard 20 includes ISTA Standard 14, the process and procedure for ISC thermal testing laboratories to be certified to perform the design and testing; and ISTA 7E, a standard for validating ISCs to be certified by ISTA as “ISTA 7E Certified” ISCs. ISTA Standard 20 also contains the first set of statistically validated global thermal profiles, developed from a three-year study of real shipping-lane data. The ISTA 7E Thermal Profiles will replace current Thermal Profile Guidance Document ISTA 7D.

ISTA Standard 20 details not only the minimum thermal and physical testing an ISC should undergo to determine its proof-of-performance rating, but also provides a specific and proven ISC development and qualification process to meet global compliance requirements. This qualification process represents best-demonstrated practices for the cGMP-compliant TSP supply chain. Standard 20 contains, in template format, all the documentation requirements of a full Design Qualification (DQ) and Operational Qualification (OQ) package. 

Certification Process
Once an ISC has been designed and qualified in accordance to Standard 20 by an ISTA-Certified Thermal-Transport Laboratory, the results will be submitted to ISTA for independent review and performance certification. If the documentation and results are approved, a certification mark for that ISC will be issued by ISTA.

To ensure compliance to ISTA Standard 20, ISTA has appointed independent ISTA-certified auditors. They will not only provide training and auditing services for laboratories wanting to become an ISTA-Certified Thermal-Transport Laboratory so they can qualify ISCs under Standard 20, but they will also review the ISC qualification packages that are submitted to ISTA to be certified as ISTA 7E performance certified.  Only ISTA members may receive ISTA certification.

Benefits to Industry
ISTA Standard 20 is the culmination of the investment of a consortium of ISTA, industry, supplier, and university representatives, allowing unbiased and independent critique and affording demonstrated real-world applicability. ISTA Standard 20 will remove the subjectivity from the ISC qualification process. There will now be one standard for thermal and physical testing of ISCs, which will allow “apples-to-apples” comparison of ISC performance, making the selection of regulatory-compliant shipping solutions easier for the industry.

The 7E Flowchart from ISTA.

The value to industry is a reduction in time, resources, and money required to design, qualify, and validate ISC performance. These benefits can be realized by selecting those ISCs that have been ISTA 7E certified. ISTA will maintain a database of ISTA 7E certified ISCs that will detail the specifics of the ISC and its certified performance. 

ISTA’s new 7E thermal performance standard represents additional forward momentum in the continuous improvement process of cold-chain management, specifically for high-value temperature-sensitive-pharmaceuticals. The value of statistically significant thermal-profile data combined with a well-vetted ISC qualification process cannot be underestimated.

For further information or to request an information brochure, please email ista@ista.org. Contact details for the ISTA Certified Auditors can be obtained from the ISTA Web site, www.ista.org.

International Safe Transit Association (ISTA) focuses on the specific concerns of transport packaging. ISTA test procedures define how packages should perform to ensure protection of their contents. Use of ISTA test procedures reduces risks in the transport environment and increases confidence in the safe delivery of a tested packaged-product. ISTA developed the concept of package performance testing and certification over 60 years ago and today its test procedures and certification programs are at the forefront of transport packaging. ISTA members include shippers that manufacture and distribute products, carriers that provide the distribution means, organizations that supply packaging materials and services, and testing laboratories that perform packaged-product performance tests.

ISTA helps members control costs, damage, and resources during the distribution of packaged-products by:

• Creating and publishing packaged-product test procedures.
• Certifying packaging laboratories, packaged-products and professionals.
• Providing education, training, and support.

ISTA would like to thank formally its sponsors and members of the ISTA Standard 20 Project Steering Committee for all their contributions, expertise, and support: Don Wilson, Amgen; Paul Harber, Eli Lilly & Company; Brian Wallin, Amgen; Rod Derifield¸
EnviroCooler LLC; Jim Cox, Temptrip; William Pelletier, University of Florida; and Jason Masingo, UPS. 0