ISTA THERMAL STANDARDS
Standard 20, Test Standard 7E and Thermal Lane Data Package
The First Global Method for Standardizing the Establishment of Insulated Shipping Container Performance.
They’re All About:
Data and Processes
Processes that are Science Based
Processes that are Industry Standards
- STD-0020 — ISTA Standard 20 Revision 2 is process standard developed by pharma industry experts. It is a design and qualification process that provides the structure and path to design, test, verify and independently certify a specific Insulated Shipping Container (ISC) for use. It sets the minimum requirements for qualifying insulated shippers and has been proven to develop shippers which meet regulatory expectations. Included with Standard 20 is the Standard 7E set of global thermal profiles.
- STD-7E — Testing Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment. The 7E Profiles are the new standard for thermal transport testing. The 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 that another for a particular cold chain challenge. Adoption of the 7E profiles as a global standard addresses this issue.
- Click here to download the overview
- Thermal Lane Data Package — Experimental data was collected during summer and winter test campaigns for the development of ISTA 7E Heat and Cold Profiles. Data were collected during round-trip shipments over 82 different lanes using a parcel service company. ISTA Lane Data represents the most comprehensive thermal information about small parcel shipping. This large data set can be used to create real world "what if" simulations of the performance of thermal packaging with real instances. For more information on how the data can be used click here to download the ISTA White Paper “PRACTICAL APPLICATION OF ISTA LANE DATA TO PHARMACEUTICAL COLD CHAIN STRATEGIES.
- Contact ISTA Headquarters to purchase.
- Become an ISTA Certified Thermal Professional (CTP) Click here for more information
- Become an ISTA Certified Thermal Transport Laboratory Click here for more information
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”.
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 a 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 —
End user, purchaser of ISC designs and products
- Off the shelf, independently certified packaging solution that meets industry requirements with the requisite qualification 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.
Thermal Lane Data Package: Experimental data was collected during summer and winter test campaigns for the development of ISTA 7E Heat and Cold Profiles. Data were collected during round-trip shipments over 82 different lanes using a parcel service company.
- All Raw Data collected during 7E Project
- Heat & Cold 144 hr formatted profiles
- Heat & Cold 72 hr formatted profiles
- Use as a source document as part of your overall cold chain strategy development.
- Develop your own lane profiles for normal and exceptional (extreme) shipping conditions.
Experimental data was collected during summer and winter test campaigns using Temperature Acquisition Shippers (TASHs). Data were collected during round-trip shipments over 82 different lanes using a parcel service company.
Standard 7E - Testing Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment. The 7E Profiles are the new standard for thermal transport testing. The standard includes heat and cold profiles developed from data gathered in real world transport. All the lane data gathered are available for purchase through ISTA.
ISTA Member Price: $1,000.00 Non-Member Price: $1,500.00 Click here to purchase
Standard 20 is a design and qualification process for insulated shipping containers. It is a comprehensive set of requirements to achieve a certified package according to ISTA 7E. The companion document, STD-0014, details specifics of audit requirements for thermal transport lab certification. Includes ISTA 7E Temperature Profiles. Contact ISTA Headquarters to purchase.
Each lab seeking certification based on ISTA 7E shall have a Certified Thermal Professional Level I. Lab personnel can achieve Level I certification by passing an online test. Each lab shall have at least one CTP Level I.
Each lab seeking certification based on ISTA 7E shall have a Certified Thermal Professional Level II. Level II status is a two step process, including an online “pre-test” and an in-person training session with a Certified ISTA Thermal Transport Auditor. The CTP Level I and II can be the same person.
Each lab seeking to become an ISTA Certified Thermal Transport Lab must make application to ISTA.
Each lab seeking to become an ISTA Certified Thermal Transport Lab must then apply for an audit. Submission of a pre-audit checklist is required to schedule an audit. After successful review, an on-site audit is scheduled.
Price: No Charge
The Certified ISTA Thermal Transport Auditor conducts the audit based on the requirements of STD-0014. The possible audit results are: (1) Certified, (2) Not Certified – pending remedial actions, or (3) Not Certified.
Price: $2,500 + Auditor Travel Expenses
Thermal Transport Package Certification requires an application filing. A certified package signified that the shipper has been qualified to all the requirements of ISTA 7E. The ISTA Thermal Transport certification mark can then be applied to the shipper and marketed as an ISTA 7E certified package.
ISTA Certified Auditors
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.
Independent ISTA Certified Auditors:
VP Sales & Technology, Life Packaging Technology, LLC
President, Life Packaging Technology, LLC