Process 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.

Download STD-7E 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, download the ISTA White Paper "Practical Application Of ISTA Lane Data To Pharmaceutical Cold Chain Strategies".

Contact ISTA Headquarters to purchase.

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

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. Price: $10,000

Package includes:

• All Raw Data collected during 7E Project
• Heat & Cold 144 hr formatted profiles
• Heat & Cold 72 hr formatted profiles

Benefits:

• 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

Standard 20

• 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.

  Price: $10,000

• 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.

  Price: $425

• 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.

  Price: $450

• Each lab seeking to become an ISTA Certified Thermal Transport Lab must make application to ISTA.

  Price: $500

• 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: $500

• 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.

  Price: $500

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

Responsible Packaging by Design

How do you take sustainability considerations into account when designing packaging solutions? The Responsible Packaging by Design (RPbD) Guide is now available to help you. The RPbD Guide is a step-by-step process management standard for the design, testing, and qualification of responsible packaging that meets industry, consumer, and regulatory expectations. It has been developed by industry leaders and vetted by companies, NGOs, and government experts.

Until now, there hasn‘t been a single, unified standard that would ensure that everyone is on the same page, meeting all of the applicable industry and package functional requirements while taking into consideration all the new sustainability initiatives that have been introduced in the past decade. But now there is. Larry Dull, ISTA Lead Instructor

The process provides a framework and guidance for evaluating two or more different packages to:

• Provide appropriate packaging for protecting the product and performing all the other functions of a packaging system
• Minimize product waste through the prevention of damage or spoilage
• Optimize use of materials, energy, and water in production, distribution, and use
• Maximize recovery of materials and energy from used packaging

The protocol provides a data-driven procedure for analyzing packaging systems throughout the life cycle. Eight steps guide the package designer in a Stage-Gate Process, with each stage accompanied by a template to help users gather data and navigate the process.

More information about the RPbD Guide and its underlying processes can be found in the Powerpoint presentation.

In conjunctions with the RPbD Guide, ISTA offers a RPbD training program with a Professional Certificate of Training for those who are interested in learning how to implement the process in their company. Whether you‘re seeking to test the waters, committed to implementing the program, or desiring to obtain a professional certificate, the RPbD training program can help you gain the skills and knowledge you need to build your company‘s reputation as an environmentally and socially conscious corporate citizen – and drive profitability. A full day in-person session followed by a half day web meeting is available. Contact ISTA Headquarters for available dates or to request that a training program be held at your company.

How to Get the RPbD Guide

ISTA Business Primary Members

The RPbD Guide is available as a member benefit at no additional cost under a licensing agreement to ISTA members classified as a Business Primary Location. Individual members, additional locations and university members are not eligible for this benefit. If you are unclear of your ISTA membership classification you may view your profile by logging into the Member Center.

The delegate of the business primary location may download the RPbD Guide at no cost. Simply login to the ISTA website and visit the ISTA Store.

Purchasing the guide

The RPbD Guide is available to non-members for an annual license fee of $750. Simply visit the ISTA Store. Complete the checkout process with your payment and contact information. ISTA will process your order and send you a link to your digital download. You must agree to the licensing agreement before your download is available.