Mesa Labs is an ISTA Standard 20, Test Standard 7E Thermal Transport Packaging Laboratory
The following information is taken directly from the ISTA in order to understand the ISTA Standard 20, Test Standard 7E. Additional details can be found by accessing the ISTA website here.
Testing Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment. The 7E Profiles are the new standard for thermal transport testing. The ISTA Standard 20 standard includes heat and cold profiles developed from data gathered in real world transport. From design to design and manufacturer to manufacturer, it is very difficult to know if the performance of one ISC is better or worse than another for a particular cold chain challenge. Adoption of the 7E profiles as a global standard addresses this issue.
The following provides guidance for the practical application of ISTA Standard 20, “Design and Qualification of Insulated Shipping Containers (ISC), ”7E, “Thermal Controlled Transport Packaging for Parcel Delivery System Shipment”, and Standard 14, “Thermal Transport Lab Certification”.
ISTA Standard 20, 7E Applicability and Use
Applicability: The ISTA documents outlined here, Standard 20, 7E, and Standard 14 are recommended for use in supporting an FDA regulated organization’s compliance activities relative to the Center for Drug Evaluation and Research (CDER) guidelines on process validation as applied to an insulated shipping container (ISC) thermal performance. Reference the following compliance documents:
- “Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients” ICH, 2001.
- Visit the CDER website.
Use: ISTA documents provide the means to comply with both internal and external quality system requirements through individual (Certified Thermal Professional) certification, laboratory certification (Standard 14), and ISC design qualification (Standard 20).
The documents provide the user with a standardized methodology for demonstrating the performance of an insulated shipping container against a real world set of shipping lane temperature data, which has been statistically analyzed to create a robust thermal profile.
Benefits to Industry of the 7E thermal profile and Standard 20 ISC qualification process:
- What it is — A complete insulated shipping container (ISC) qualification tool for industry application and subsequent regulatory submission, as required.
- What it is not —
– customized shipping lane data
– customized worst case shipping qualification
Who benefits from the ISTA 7E Std 20?
End user, purchaser of ISC designs and products
- Off the shelf, independently certified packaging solution that meets industry requirements with the requisite qualification data to support high value pharmaceutical/biopharmaceutical manufacturers and global regulators.
- Supply chain optimization through selection of the most competitive ISC solution(s) for the most economical shipping lanes.
- Reduction in cost and time to market by selecting pre-qualified ISC designs. Internal resource demands are minimized and focused on product development activities.
- Internal laboratories benefit from improved efficiency in executing thermal performance testing.
Supplier of ISC designs and products
- Supply markets will open up and provide a more level playing field by providing designs which can be compared based on performance data, cost and service levels.
- Facilitates and encourages new product development and innovation as there will exist an industry accepted methodology to demonstrate benchmark thermal performance for new ISC products.
Contract test laboratories
- Industry standardization via ISTA 7E and Standard 20 deployment will increase the demand for independent test laboratories certification activities (Standard 14); and the resultant value of the independent test laboratory within the marketplace is increased.
- Standardization and supporting qualification documentation greatly improves the laboratory’s efficiency in completing high-quality work for their clients.