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2026 ISTA Forum USA
ISTA CC 201: Introduction to BioPharma Cold Chain Training
The Who, What, Why, Where of Cold Chain
- Basics of a cold chain program
- Attributes of a gold standard cold chain program
- Guiding standards for the industry
- Introduction to the Shipping Qualification Process Flow
- Lessons learned on selecting test labs and suppliers (labs, packaging, recording devices, etc.)
Led by expert ISTA Instructor, Carolyn Williamson, ISTA Pharma Committee Officer.
Get ISTA Packaging Dynamics Professional (ISTA PDP) Certified with this comprehensive in-person training. To receive ISTA’s Packaging Dynamics Professional (ISTA PDP) Certification, you must complete all six PDP courses and pass the corresponding exams. Take the ISTA PDP Certification exams conveniently online through ISTA’s learning platform—complete with full video presentations and course content to help you prepare and succeed. PDP courses included:
- PDP 101: Principles of Distribution Packaging
- PDP 201: Atmospheric & Compression Hazards in Transit
- PDP 202: Shock & Drop Hazards in Transit
- PDP 203: Vibration Hazards in Transit
- PDP 204: Test Laboratory Operations & Instrumentation
- PDP 205: Test Procedures & Enhanced Simulation Testing
Click here to view the full schedule and rates with and without Forum registration.
Led by expert ISTA Instructor Larry Dull, this in-person training is a convenient option to becoming a certified ISTA Packaging Dynamics Professional.
User Requirement Specification to Operational Qualification Training
The How of Cold Chain – Taking the fundamentals of the first class and putting it into practice
- How to create a robust URS
- Highlight both major and minor attributes of a URS
- How to design and implement your OQ process
- Highlight the design qualification tests
- Execution of an OQ protocol
- Documentation
- Test Protocols and Reports
- Temperature Recording Device Settings
- Operational SOP/WIs
- Staff training
- How to select and implement a pre-qualified shipper
- Navigating Change Control to Implement your Qualified System
- Lessons Learned on Implementing a Qualified Shipping System
- Case Studies
Led by expert ISTA Instructor, Carolyn Williamson, ISTA Pharma Committee Officer.
Click here to learn more.
Unveiling the 2025-2035 Horizon – Insights from the PTIS Future of Packaging Global Thought Leader Survey
In an era of accelerating disruption, the 2025 edition of PTIS’s triennial Future of Packaging Global Thought Leader Survey captures the collective foresight of over 150 curated experts from academia, industry associations, and Fortune 500 leaders across the global packaging value chain. This presentation distills key findings projecting transformative trends from 2025 to 2035, spotlighting the dominance of circular economy principles, regulatory pressures, and recovery infrastructure as top forces reshaping packaging strategies.
Drawing on rigorous foresight methodologies, the survey reveals escalating priorities in sustainability—where reusable, refillable, and compostable solutions outpace traditional recycling—fueled by digital innovations like IoT-enabled packaging and AI-driven supply chains. Attendees will explore actionable implications for CPG, manufacturing, and retail sectors, including risk mitigation in volatile markets, consumer-driven demands for eco-transparency, and opportunities for Horizon 3 innovations that integrate packaging into a holistic, value-creating ecosystem.
Join us to gain strategic foresight that equips your organization to navigate complexity, foster resilience, and pioneer sustainable growth in the decade ahead.
Artificial Intelligence is no longer a distant frontier—it’s a daily partner in how we work, innovate, and solve complex challenges. In this session, Bill Green will introduce you to the evolving landscape of AI, with a focus on the transformative potential of Agentic AI—a new paradigm where intelligent agents autonomously plan, execute, and adapt workflows across enterprise environments.
Drawing from IBM’s latest developments in watsonx.ai, Bill will explore how Agentic AI is reshaping digital labor, enabling packaging and logistics professionals to automate repetitive tasks, orchestrate complex decision-making, and accelerate sustainability goals. Attendees will gain insights into:
- The foundational building blocks of enterprise AI: data, models, agents, governance, and assistants.
- How Agentic AI differs from traditional automation and chatbots, offering contextual awareness, dynamic skill sequencing, and intelligent orchestration.
- Real-world use cases in supply chain
- The role of secure models in powering safe, performant, and transparent AI solutions tailored for enterprise needs.
Whether you're just beginning your AI journey or looking to scale intelligent automation across your operations, this session will provide a practical roadmap for integrating AI into your value chain.
ISTA PCW-04 | Introduction to Sustainability in Temperature-Controlled Packaging Whitepaper
Presenters:
- Eduardo Molina, ISTA Pharma Committee Member, Center for Packaging and Unit Load Design, Virginia Tech
- Alison Crawley, ISTA Pharma Committee Member,ThermoSafe
Presenter:
- Carolyn Williamson, ISTA Pharma Committee Vice Chair, Parenteral Supply Chain, LLC
Assessment (LCA) conducted in accordance with ISO 14040 and ISO 14044.
Early‑stage biotechnology companies face unique and rapidly evolving supply chain challenges as they progress from R&D into clinical development and, eventually, commercialization. Each phase carries distinct constraints on speed, cost, quality, and risk tolerance, requiring logistics processes that are not only technically sound but also appropriately scaled to the organization’s maturity. This presentation outlines a practical framework for designing and operationalizing a phase‑appropriate logistics model that can adapt as pipeline complexity, geographic reach, and regulatory expectations expand.
Drawing on more than 35+ years of combined experience supporting biologics, oncology therapies, cell and gene modalities, and global clinical programs, the speakers break down what “fit‑for‑phase” truly means. Topics include defining the right scope of logistics responsibilities, aligning cross‑functional stakeholders, managing increasing cold‑chain and dangerous goods requirements, and avoiding the common illusion that shipments alone represent the full extent of supply chain operations. The session further explores the progression from manual tools to integrated supply chain systems, emphasizing how early data capture and thoughtful vendor partnership strategies lay the foundation for future scalability.
Attendees will learn how to balance executional speed with procedural rigor and what steps are essential during key clinical phase transitions. The presentation concludes with actionable guidance for building resilient, right‑sized processes that remain flexible, cost‑conscious, and capable of supporting both early‑phase uncertainty and long‑term commercial readiness.
We will demonstrate how translating these insights into engineering requirements enables the development of patent pending right-sized, curbside recyclable solutions that deliver validated thermal performance while simplifying pack-out, improving unboxing, and reducing total landed cost. Real-world case studies highlight measurable gains in sustainability (recyclability and carbon reduction), operational efficiency (labor and cube optimization), and end-user satisfaction.
Attendees will leave with a practical framework for embedding the voice of the customer into thermal packaging innovation—turning sustainability from a constraint into a competitive advantage.
The fitted amplitude distributions were combined with measured PSDs to generate route-specific, non-stationary profiles that preserve spectral content and reproduce the observed short-time modulation. These models enable estimation of exceedance probabilities and route-specific severity thresholds to support risk-informed selection of vibration test levels and cushioning, with straightforward alignment to established laboratory procedures and test protocols. The outcome is more realistic laboratory excitation, improved correspondence between laboratory and field performance, and a defensible basis to avoid both unnecessary over-packaging and under-packaging without compromising product protection. Potential applications include automated analytics and reporting, route-aware test selection, predictive risk modelling, and rationalisation of protective-material variants.
This project aims to develop a simplified, cost-effective 2-degree-of-freedom (2DOF) vibration test apparatus that induces rotational motion while mounted on a standard vertical-only Lansmont vibration table. The system will use a pivot-spine structure with elastomeric or spring components of varying stiffness (k) to enable off-vertical axis movement. The research will assess the apparatus’s ability to simulate transport-induced motions using both field and lab evaluations.
OQ testing included thermal mapping under empty and full-load configurations, compressor switchover, genset transition, open-door recovery, and power failure scenarios. Results confirmed stable temperature control during normal operations, with rapid recovery after stress events. Simulated product sensors remained within range throughout, ensuring no impact on product integrity.
PQ testing involved four live shipments between Ireland and Netherlands. All interior and product-simulating sensors maintained temperatures within specification during transit. Excursions occurred only during door openings for unloading and inspection, not during shipment. Visual inspection of 300 bottles confirmed zero defects. A single deviation related to sensor ice accumulation did not affect product temperatures. Procedural updates were recommended to minimize door-open times.
Conclusion: Combined OQ and PQ results demonstrate that the Freezer Container reliably maintains ultra-low temperatures under controlled and real-world conditions, supporting its qualification for pharmaceutical distribution requiring stringent temperature control.
This project seeks to bridge the gap between consumer insights and packaging innovation. The enhanced AI framework will provide more precise identification of packaging failure points related to distribution, a deeper understanding of consumer interactions with packaging, a refined sentiment analysis model capable of detecting nuanced consumer emotions, and a scalable AI approach that integrates text and image-based data for a holistic evaluation of packaging performance. The project builds upon the 2024 Forum presentation but introduces significant advancements. While the earlier work focused primarily on sentiment analysis of Amazon reviews to highlight packaging issues, this new phase incorporates deep learning for image-based damage detection and emotion-aware sentiment analysis. These enhancements will allow for a more robust, multi-dimensional evaluation of packaging performance during distribution, using both text and image data from consumer feedback.
This project addresses the need to identify potential sustainable alternatives to expanded polystyrene foam (EPS) insulated containers used for shipping live ornamental fish. Florida’s ornamental aquaculture industry, the largest in the nation with $172 million in sales in 2021, relies heavily on EPS for its insulation and structural stability. However, increasing legislative restrictions on EPS due to environmental concerns, coupled with fluctuating availability and rising costs, could pose a significant challenge to ornamental fish producers. This project evaluates the performance of alternative packaging materials using mechanical and thermal tests. This introductory project aims to generate key results to help the long-term resilience of Florida’s ornamental aquaculture industry in an evolving regulatory landscape.
Walmart’s scale and omnichannel strategy demand a supply chain that is faster, smarter, and more resilient. To meet these expectations, Walmart is deploying automation across its next-generation distribution centers, leveraging advanced systems from Symbotic, Knapp, Witron, and proprietary Walmart Automation technologies. These facilities integrate robotics, automated storage and retrieval systems (AS/RS), and AI-driven orchestration to handle millions of cases with unprecedented precision and throughput.
This presentation will explore how automation—from receiving and storage to picking, palletizing, and outbound—reshapes packaging requirements and industry standards. Automation introduces new dynamics that packaging engineers must address: tighter dimensional tolerances for robotic gripping, reinforced corrugate strength for high-speed conveyance, and standardized labeling for machine vision systems. Packaging that once accommodated manual handling must now withstand automated sequencing, and rapid sortation without compromising product integrity.
Key discussion points include:
• Automation Architecture: How Walmart’s automated ecosystem creates a seamless, high-throughput environment that reduces dwell time and labor dependency.
• Packaging Implications: Why automation demands precise carton dimensions, consistent case weights, and ISTA protocol updates to mitigate risks such as robotic clamp pressure and automated drop hazards.
• Industry Ripple Effect: The cascading impact on suppliers, testing laboratories, and packaging material innovation as automation becomes foundational to retail logistics.
Attendees will gain insight into Walmart’s automation roadmap and collaborative opportunities to develop packaging solutions that thrive in an automated supply chain. By aligning packaging design with automation capabilities, the industry can unlock efficiencies that benefit retailers, manufacturers, and consumers alike.
The presence of air gaps, variable placement, and uneven surface contact alters heat transfer pathways and can result in non-uniform temperature distribution within the packaging system. Therefore, optimizing cold-chain performance requires consideration not only the total refrigerant mass but also pack size, geometry, and spatial distribution inside the container. The results of thermal experiments studying these factors will be presented.
This session will focus on recent activities/updates from:
- Pharma Growth update
- US Pharmacopeia (USP) Packaging and Distribution Expert Committee,
- Parenteral Drug Association (PDA),
- Asia-Pacific Economic Cooperation (APEC),
- International Organization for Standardization (ISO),
- International Air Transport Association (IATA),
- BioPhorum Operations Group (BPOG),
- Healthcare Distribution Alliance (HDA).
The aim of the study has been threefold: (a) review of the existing reduction techniques for converting shock/drop data into laboratory test protocols, (b) propose a suitable workflow for translating field data into laboratory test protocols, (c) verify the proposed new test protocols against existing protocols and where possible against the field data.
To this end, we first evaluate the field data based on the existing ISTA data analysis guidelines (based on Sheehan’s method). We conclude that this results in rather harsh test profiles that is not representative of real world conditions. We propose modifications and generate profiles which could better represent the field data. These profiles are then verified in the laboratory setting using decoy packaging similar to the ones used during field data collection. This is done partly by comparing the damage incurred by the packages when tested with the generated profiles (including ISTA 3A), and partly by comparing the damage observed in the laboratory to that in the field. The damage evaluation utilises RISE damage coefficient method that provides a somewhat objective means of comparing the damage incurred during testing of the different profiles.
Containerized cargo losses at sea often originate well before a vessel departs—driven by preventable breakdowns in documentation, packing/stuffing, weight verification, stowage planning, and securement. This session follows the end-to-end container transit lifecycle (pre-transit, transit, post-transit) to help shippers, forwarders, carriers, terminals, and insurers identify where risk is introduced and how it can be controlled. Attendees will review the principal onboard loss drivers across four categories: physical damage (e.g., misdeclared weights, improper lashing, vessel motion, poor stowage decisions), environmental exposure (saltwater, condensation, humidity, temperature extremes, contamination, loss overboard), fire (misdeclared/undeclared dangerous goods, lithium-ion battery events, containment challenges), and theft/security (port/terminal theft, inland/drayage theft, seal tampering, and cyber intrusion).
For the packaging community, this trend introduces a new application: shipping a perishable, biologically active payload, packaged by the patient rather than a trained operator, through ambient courier networks. Diagnostic specimens are inherently dynamic—temperature excursions during transit can drive analyte degradation, intracellular-extracellular exchange, hemolysis, and other issues, all compromising the fidelity of the laboratory result to the patient's true physiological state at the time of collection.
The diagnostics field has responded with a range of strategies: dried specimen formats that are inherently more temperature-resistant, engineered shippers with phase-change materials or battery-powered temperature control, and laboratory approaches that account for ambient transport and address specimen changes analytically post-hoc. Each carries tradeoffs in cost, analyte menu, and diagnostic performance. This talk examines how to characterize the thermal profiles specimens actually experience, map those profiles to analyte stability endpoints, and derive design criteria—motivating the use of ISTA thermal conditioning profiles for validating home-collection diagnostics end-to-end.
The rise of AI has brought significant complexity and miniaturization to data center hardware. Components in servers and switches are now smaller, denser, and structurally more intricate. As cloud services and AI become central to everyday life, hardware failures due to shock and vibration can have real-world consequences.
AI is also expanding into fields like edge computing, autonomous vehicles, and robotics. Hardware designed for data centers may soon power these technologies, making shock and vibration testing critical to their long-term reliability.
For more than 7 years, Google Cloud has been investigating real world random vibration conditions, trying to come up with the most accurate random vibration profiles for shock and vibration testing of Google's data center hardware, and the best way to understand their failure modes. This work was released as a part of Google's Open Source Random Vibration Test of Off-the-Shelf Data Center Hardware project, which includes:
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Google's world wide field data measurement, analysis, and lab replication methods
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State of the art 3D strain, motion, deformation, and pressure measurement techniques for data center hardware
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High-speed microscopic motion analysis of critical microelectronics components
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Margins and fatigue analysis in the context of global transport and handling
This project was launched at the 2024 OCP Global Summit, and shared through the project's GitHub repository. The project aims to encourage future collaboration and make random vibration testing universally accessible and useful to the broader community.
Through strategic partnerships, targeted educational outreach, and industry-focused programs, the ISTA Pharma Committee aims to raise awareness, generate excitement, and support the next generation of talent for Cold Chain professions within the Life Sciences industry. These efforts are essential to meeting the growing demand for skilled professionals in this critical area of pharmaceutical logistics.
Heat-induced degradation of polymeric packaging materials can lead to the formation of leachable, posing risks to the safety and stability of packaged products. This study aims to mitigate thermal degradation by incorporating suitable additives into common packaging polymers used in the pharmaceutical industry: HDPE, LDPE, and PP. The additives were selected to modify the polymers’ melting and degradation, thereby reducing leaching potential during product processing and storage.
Methods
DSC was used to evaluate thermal transitions specifically the onset, peak melting temperatures, and enthalpy of fusion to assess the influence of additives on the polymers' crystallinity and stability. TGA will subsequently be conducted under oxygen and nitrogen atmospheres to examine the thermal stability and decomposition of the modified materials.
Results
Preliminary DSC results revealed enhanced thermal properties across all modified polymers. Modified HDPE exhibited onset temperatures of 125-128 °C and peak melting temperatures of 138-139 °C, with enthalpy values of 195-215 J/g, indicating improved crystalline stability. LDPE with additives samples displayed onset around 115-116 °C and peak melting between 120-125 °C, with enthalpy ranging from 105-125 J/g. PP and its additive-modified forms exhibited higher onset (140-152 °C) and peak melting temperatures (160-165°C), indicating greater structural order and heat resistance.
Discussion
These results demonstrate that additive incorporation effectively enhances polymer thermal resilience, suggesting a viable strategy for mitigating heat-induced extractables formation. Ongoing TGA analysis will provide complementary insight into the materials’ degradation and oxidative stability.
Updates will be provided on ISTA’s research to establish a standard methodology to generate draft test blocks for shock and vibration from field data, as well as research conducted through the ISTA Advocate Research & Value Delivery Program and ISTA-funded research grants.
Gain insights on all the new resources ISTA is developing that will help you and your company design effective packaging that minimizes product damage and optimizes resource usage.
- R. David Lebutt Award
- Emerging Leader Award
- Outstanding Student Award
Historical temperature profiles from diverse shipping lanes were incorporated into the simulations, enabling virtual testing of more than 20 pallet configurations under realistic transport conditions. This digital approach allowed benchmarking of insulation strategies and facilitated rapid design iterations without reliance on extensive physical testing. The optimized solution, involving the use of thermal covers and refined distribution routes, has already yielded substantial cost savings and is projected to deliver more annually.
This work highlights how computational modeling can accelerate decision-making, reduce experimental burden, and provide confidence in product performance across extreme global shipping scenarios. The established workflow serves as a scalable platform for future cold-chain initiatives and demonstrates the broader potential of digital modeling in advancing sustainable and cost-effective packaging solutions.
Using life cycle assessment (LCA) tools aligned with ISO 14040 standards and the EcoImpact-COMPASS platform, the research evaluates packaging systems across their entire lifespan, from raw material production and manufacturing to transport, washing, return logistics and end-of-life. The analysis captures multiple impact categories, including energy use, greenhouse gas emissions, water consumption, and material resource demand.
The results reveal that the environmental performance of reusable systems depends heavily on operational factors such as the number of reuse cycles, return logistics efficiency, washing energy, and regional recycling infrastructure. By identifying where and when RPCs reach their breakeven point, the study provides a practical decision framework for companies considering reusable packaging programs.
These findings help stakeholders make informed, data-driven choices that balance sustainability goals with cost and supply chain efficiency ensuring that reusable systems deliver measurable environmental benefits without adding unnecessary complexity or burden.
The complexity of temperature lane mapping, qualification, and management is dramatically increased for wholesale distributors shipping thousands of products on hundreds of lanes. Additionally, there are additional challenges when manufacturers are evaluating freight forwarders.
This presentation will review the recently published USP general chapter and peer reviewed article to cover the USP proposed guidance. This presentation will also cover a case study of a wholesale drug distributor in the United States and a medical device distributor in Canada. The presentation will cover how lanes from multiple distribution centers were chosen out of hundreds of lanes and thousands of customer designation addresses. The presentation will cover data ingestion into Tableau Dashboards, use of risk management criteria, and evaluation against all lane data to establish a rationale to match worst-case mapped lane data and group lanes not mapped with executed lanes. Quality plans to address risks and to identify additional lanes that need to be mapped.
ISTA PCW 06 | Temperature Monitoring Whitepaper
Presenter:
- Mark Maurice, ISTA Pharma Committee Board Member, Sensitech
Presenter:
- Richard Peck, ISTA Pharma Committee At Large Board Officer, RP Pharma Consulting Ltd
Presenter:
- Mark Maurice, ISTA Pharma Committee Board Member, Sensitech
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