Background: Passive insulated shipping containers (ISCs) are a common way to transport temperature sensitive products through a transport lane. Containers of this type provide thermal protection for the product using various combinations of insulating and phase change materials (PCMs). Each different container packout should be qualified to ensure that it can protect the contents from the varied seasonal thermal exposures within each transportation lane. This is accomplished by testing the container in a thermal chamber using ambient temperature test profiles. Each packout should be challenged with both a cold and a hot temperature test profile. In order to make this qualification meaningful, the ambient temperature test profiles (hereafter referred to as the OQ profiles) must cover the range of the thermal challenges expected in the transportation lane with some probability. One rational way to ensure that the OQ profiles are adequate is to create such OQ profiles using actual ambient temperature data collected from shipments made over the transportation lanes (hereafter referred to as the profiles dataset). This guidance document defines how to create risk-based OQ test profiles based on such a profiles dataset. 

 
The methodology outlined in document (a) contains two parts:

1. Ensuring that the OQ profiles have sufficient overall thermal challenge. This is accomplished by using the Q_T(Min) and Q_T(Max) metrics.
2. Ensuring that the OQ profiles contain appropriate thermal spikes & dips.

 
 

ISTA Data Analysis Guidelines. ISTA's guidance for analysis of Vehicle Vibration Data.

Learn about analyzing vibration data with ISTA Online Learning.  Click here for more: Distribution Data Collection & Analysis (DCA) - International Safe Transit Association (ista.org)

ISTA Data Collection Standards. ISTA's standards for measuring Atmospheric; Shock/Impacts and Drops; Vehicle Vibration.

Learn about collecting and analyzing distribution environment hazard data with ISTA Online Learning.  Click here for more: Distribution Data Collection & Analysis (DCA) - International Safe Transit Association (ista.org)

This data product is the result of an ISTA-sponsored data collection study, completed in 2020, measuring the hazards associated with the transportation modes, storage and handling involved in the distribution of Consumer Packaged Goods (CPGs), including the “last segments”, in the land routes in India within, near and between Jawaharlal Nehru Port (JNP) and New Delhi. Due to complications with collecting shock data in the CPG shipments, we expanded the project to collect shock data from the parcel delivery network.

The purpose of the Parcel Delivery study was to measure the dynamic conditions related to the small parcel (express courier) shipping environment in India. 38 one-way air shipments and four one-way surface shipments between four of the major cities in India (Mumbai, New Delhi, Kolkata and Chennai) using two different courier companies over approximately 43,000 miles were undertaken.

The information included in this data product is as follows:

1. CPG Report and hazard data files (Excel) for vibration and atmospheric data.
2. Parcel Delivery Report and hazard data files (Excel) for shock and atmospheric data.
3. ISTA Data Collection Standards
4. ISTA Data Analysis Guidelines

This data product is the result of an ISTA-sponsored data collection study, completed in 2020, measuring the hazards associated with the transportation modes, storage and handling involved in the distribution of Consumer Packaged Goods (CPGs), including the “last segments”, in the land routes in India within, near and between Jawaharlal Nehru Port (JNP) and New Delhi. Due to complications with collecting shock data in the CPG shipments, we expanded the project to collect shock data from the parcel delivery network.

The purpose of the Parcel Delivery study was to measure the dynamic conditions related to the small parcel (express courier) shipping environment in India. 38 one-way air shipments and four one-way surface shipments between four of the major cities in India (Mumbai, New Delhi, Kolkata and Chennai) using two different courier companies over approximately 43,000 miles were undertaken.

The information included in this data product is as follows:

1. CPG Report (does not include data)
2. Parcel Delivery Report (does not include data)
3. ISTA Data Collection Standards
4. ISTA Data Analysis Guidelines

This document has been prepared by the ISTA Pharma Committee, which is composed of both life science manufacturers, wholesalers, and thermal packaging/monitoring suppliers.  The terms described are considered by this committee to represent current industry consensus of the definitions for common industry terms that have been used in existing and in-development ISTA Pharma Committee guidance documents.

Developed by members of the ISTA Pharma Committee, this technical white paper discusses the use of reusable passive thermal packaging systems for temperature-controlled distribution of pharmaceutical and biological products.  The intent of this information is to establish an aligned industry best practice for the use of reusable packaging to transport temperature-sensitive medicinal products.  The level of detail beyond the suggested industry best practice is the decision of the primary stakeholders of the temperature-sensitive product, based on risk acceptance.  Thus, the examples given are for demonstration purposes only and may be more or less detailed than what is discussed in this paper.
 
This white paper provides specific guidance on the types of materials used in passive thermal packaging systems, the qualification of a reusable system, the return logistics and refurbishment service management, and refurbishment and inspection details

Developed by members of the ISTA Pharma Committee, this technical white paper discusses the operational qualification of passive thermal packaging systems for temperature-controlled distribution of pharmaceutical and biological products.  The intent of this information is to establish an aligned industry best practice for the operational qualification testing of passive thermal packaging to transport temperature-sensitive medicinal products.  The level of detail beyond the suggested industry best practice is a decision, based on the risk acceptance of the primary stakeholders of the temperature-sensitive product.  Thus, the examples given are for demonstration purposes only and may be more or less detailed than what is discussed in this paper.

Developed by members of the ISTA Pharma Committee, this best practice guidance document provides an overview of the performance qualification (PQ) and performance verification (PV) processes for thermal shipping systems used for local and global transport of temperature-sensitive product shipments. The objective of this technical guidance is to establish an aligned industry best practice for the execution of PQ/PV processes following the completion of the thermal operational qualification (OQ). The content and examples provided in this document are to be used for general industry guidance and awareness to drive a standardized best practice approach for the execution of PQ/PV processes.

Developed by members of the ISTA Pharma Committee, this best practice guidance document was established to align industry best practices for the selection, development and comparison of ATPs for use in the thermal qualification testing of thermal packaging to transport temperature-sensitive medicinal products. This collaborative effort between life science companies and solution providers resulted in a mutually beneficial and harmonized best practices guideline to aid the industry in comparing, investigating and implementing agile compliant solutions.

The ISTA Pharma Committee and Lane Management Working Group have prepared this white paper to (1) introduce the concept of Lane Management, (2) establish a definition for Lane Management and (3) provide an overview of the lifecycle approach to Lane Management.  There are various industry guidance documents on the transport of temperature-sensitive products but there are no industry guidance or position documents on the topic of Lane Management. 

The ISTA Pharma Committee and Shipping & Distribution Risk Assessment Working Group have prepared this white paper to provide an overview for developing a Shipping and Distribution Risk Assessment (RA) for the distribution of temperature-sensitive product shipments. The team sought to define the critical aspects associated with completing a shipping and distribution risk assessment; from establishing/understanding the user requirement specifications (URS) through implementation. The content and examples provided in this document are to be used for general industry guidance and awareness to drive a standardized best practice approach for conducting Shipping and Distribution Risk Assessments.

The objective of this white paper is to provide an awareness of the tools that are currently available for performing thermal modeling/simulation, including the characterization of a thermal model, and to discuss the use cases that these tools are currently used for. The white paper concludes with how thermal modeling/simulation could be used within the temperature-controlled supply-chain in the future.

ISTA Whitepaper: Load Stability Performance Testing of Unitized Packaged-Products for Transit

The Rack Transport Stability Team (RTST) collaboratively developed a Mover's Guide with the objective of documenting safer handling practices for large information technology rack products such as servers and storage systems. As one of the project milestones, the intent of the Mover's Guide is to raise awareness of business partners and carriers of the potential for personal injury and/or financial loss during transport of racks. The Guide communicates and emphasizes new and existing safe handling procedures, with the goal to eliminate incidents going forward.

ISTA TouchPoints, E-retailer Fulfillment publication is a summary of detailed questions that were addressed by e-retailers coupled with an analysis of how the insight could be leveraged during the packaging design process in conjunction with laboratory testing.