Parental Drug Association Technical Report No. 72 
Passive Thermal Protection Systems for 
Global Distribution: 
Qualification and Operational Guidance 
An Introduction 
October 14, 2015 
The images and tables are references made from Technical Report No. 72 and property of the PDA. 
This information is not to be duplicated or copied and only for the purposes of this presentation. 
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Introduction to the PDA 
Pharmaceutical Cold Chain Interest Group 
• An overview into the PDA PCCIGs Technical Report No. 72: Passive 
Thermal Protection Systems for Global Distribution: Qualification 
and Operational Guidance.   
• A report for temperature-controlled distribution of 
pharmaceutical and biological products. 
• Information to assist stakeholders in the supply chain to preserve 
the quality, safety, and efficacy of products during distribution.  
• Provide guidance on the types of passive systems, including the 
materials used in their manufacture, characteristics & capabilities 
of these systems,  qualification approach, operational use & reuse 
and options for recycling at the end of the systems’ life. 
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PDA PCCIG Background
1. A Parental Drug Association (PDA) group of volunteers from 
pharmaceutical industry.  
2. PCCIG is focused primarily on Cold Chain Practices. 
3. PCCIG sponsors task forces to conduct gap analyses of 
current cold chain practices, global regulatory and 
pharmacopoeia expectations and best industry practices. 
4. PDA Board of Directors and Science Advisory Board have 
sanctioned this technical report. 
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PCCIG Objectives
Good Distribution Practices 
Temperature Control Management 
Supply Chain Partner Management 
Performance Management 
Communication and Education 
Continuous Improvement 
Regulatory Requirements 
Distribution Control Management 
Import/Export Compliance 
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PDA PCCIG Technical Report No. 72
Passive Thermal Protection Systems for Global Distribution: 
Qualification and Operational Guidance 
1. History 
Timeline 
US & Euro Task Groups merge 
2. Members 
Pharmaceutical & BioPharma 
Service Providers (Cold Chain Solutions) 
Packaging & Passive Protection Manufacturers 
Academia 
Logistics 
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PDA PCCIG Technical Report No. 72
Passive Thermal Protection Systems for Global Distribution: 
Qualification and Operational Guidance 
Technical Report Team 
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PDA PCCIG Technical Report No. 72
Passive Thermal Protection Systems for Global Distribution: 
Qualification and Operational Guidance 
1. Introduction 
What & Why 
Considerations 
2. Glossary of terms 
3. Overview 
Principles 
Understanding types of systems 
Characteristics 
4. Qualification Guidance 
5. Operational Considerations 
6. Conclusions 
7. Appendix & Reference 
What is TPS? 
• Passive T
hermal P
rotection S
ystem 
–Non-powered 
–Insulation or barrier to heat exchange 
–Protection of temperature sensitive freight 
• System components 
–Covering 
–Insulation 
–Phase Change 
Why Choose Passive Protection?
• Energy Savings 
• Simplicity 
• Availability of Active Systems 
• No Mechanical parts to break down 
• Continuous Product Protection 
• Carbon Emission Reductions 
• Less Expensive 
Considerations for choosing TPS?
Regulatory requirements 
Size of load 
Overall cost for distribution 
Availability of systems 
Handling capabilities of stakeholders within the supply chain 
Product protection (stability) data/transport conditions 
Shipment duration   
Environment (e.g., season, prevailing [expected] temperature) 
Available controls along the shipping lane 
Meet customer needs and expectations 
10 
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