Data Analysis & Collection
Data Analysis Guidelines: Shock Impact Drop Data
This document details various approaches for analyzing shock and drop data generated by packaged product handling (manual and mechanical) and transport vehicles for use within ISTA testing. The objective is to translate the collected shock and drop data into meaningful laboratory tests, which reasonably and efficiently simulate real-world transportation shock and drop. The methods included in this document range from the more common to alternative approaches that are more theoretical.
Data Analysis Guidelines: Thermal Data
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:
- Ensuring that the OQ profiles have sufficient overall thermal challenge. This is accomplished by using the QT(Min) and QT(Max) metrics.
- Ensuring that the OQ profiles contain appropriate thermal spikes & dips.
Data Analysis Guidelines: Vehicle Vibration Data
This document details a recommended approach in which ISTA analyzes vibration data generated by transport vehicles for use within ISTA testing. The objective is to translate the collected vibration data into accurate and representative Power Spectral Density (PSD) information that can be used in creating laboratory vibration tests, which reasonably and efficiently simulate real-world transportation vibrations.
Data Collection Standards
This document details ISTA’s requirements for measuring atmospheric conditions, shocks/impacts and drops and vibrations generated by transport vehicles occurring during distribution. The objective is to collect data that can be used in creating laboratory tests that reasonably and efficiently simulate real-world transportation conditions.
Online Learning Courses: Distribution Environment Data Collection & Analysis
NEW: ISTA's Distribution Environment Data Collection & Analysis courses provide an in-depth discussion on the collection and analysis of shock & vibration data associated with the transport of products. The course modules include a pre-recorded video presentation and supporting text that provides a dynamic self-paced learning experience.
Pharma Committee Guidelines
ISTA PCG-00 | Catalog Listing & Glossary of Terms
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.
ISTA PCG-01 | Reusable Passive Thermal Packaging System Best Practice Guideline
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. 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.
ISTA PCG-02 | Passive Thermal Packaging System Operational Qualification Best Practice Guideline
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.
ISTA PCG-03 | Thermal Shipping System: Performance Qualification (PQ) and Performance Verification (PV) Best Practice Guideline
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.
ISTA PCG-04 | Thermal Packaging System Ambient Temperature Profile (ATP) Best Practice Guideline
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.
Load Stability Performance Testing of Unitized Packaged-Products for Transit
This document aims to define the current landscape relative to load stability performance testing of unitized packaged-products. Additionally, it provides transparency to the discussions, research and process utilized by ISTA’s workgroup in the development of a qualitative (pass/fail) test method that can be used to predict load stability and horizontal shifting issues on unrestrained unitized packaged-products in transit.
Methodologies For Vibration Testing Packaged-Products
This document lists and details established and newer methodologies for vibration testing packaged products for road distribution. It is intended to provide information on the range of methods available. This information will be of interest to those who wish to review their specification and selection of vibration test methods, and to those who wish to have a better understanding of the methods available.
Practical Application of ISTA Lane Data to Pharmaceutical Cold Chain Strategies
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.
Touchpoints E-retailer Fulfillment
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.
Rack Transport Stability Team
Goal: To produce voluntary industry-wide test procedures and criteria for shipping large IT products on casters, cushioned or regular pallets, and/or shipping crates. If you are interested in becoming an active participant of this important project please contact either Eric Hiser of ISTA 517-333-3437 or John Hayward of Hayward Consulting, LLC 281-221-9379.
Project Description: The goal of the Rack Transport Stability Team is to produce voluntary industry-wide test procedures and criteria for shipping large IT products on casters, cushioned or regular pallets, and/or shipping crates. The project goal is to improve transportation stability for products such as racks and storage systems when shipped, relocated or returned. The project may include test procedures for caster robustness, as well as static and/or dynamic stability. We anticipate gathering information on the ground transportation environment, including trucking and also material handling practices such as fork lifts, pallet jacks or manual handling. Environmental characterization, dynamic studies and modeling should be the basis for the project. The test procedures and criteria should be based on most likely conditions, rather than exceptions.
Participating Team Members: ABF, Allianz, Clemson University, Dell, HP, Huawei, IBM, ISTA, Knurr, McCollister’s, Nelson, Oracle, Smithers, Panduit, Teradata and TransPak.
RTST Mover's Guide
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.