STANDARDS UPDATE. Ed Church President

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1 2012 STANDARDS UPDATE Ed Church President

2 Update Topics Process Standards Standard 20 for the Design and Qualification of Insulated Shipping Containers Responsible Packaging By Design ISTA Test Protocols Random Vibration Investigations ISTA s Data Depot 2

3 ISTA s Response ISTA has released a set of validated thermal testing profiles under ISTA 7E for Parcel Delivery Transport Published Standard 20, the first Global Standard for the design, testing and qualification of packaging solutions for temperature sensitive products (TSP s) Developed by industry experts Has been proven to develop shippers which meet regulatory expectations. 3

4 Standard 20 The purpose of this Standard is to define the process and minimum requirements to design and qualify insulated shipping containers (ISC s) used for the transport and distribution of temperature sensitive products such as drugs and other materials. 4

5 Table of Contents: Templates and Worksheets Document # 0020-MAN 0021-FORM 0022-APPX 0023-APPX 0024-APPX 0025-APPX 0026-APPX Title Design and Qualification Process of Insulated Shipping Containers Insulated Shipper Qualification Program Worksheets Instructions For Use of Protocol, Report and Table of Contents Appendixes Design Protocol Template Design Report Template Design Table of Contents Template Design Data Package: (Example) 0027-APPX 0028-APPX 0029-APPX 0030-APPX 0031-APPX 0032-APPX 0033-APPX 0034-APPX 0035-APPX 0036-APPX Thermal Qualification Protocol Template Thermal Qualification Report Template Thermal Qualification Table of Contents Template Thermal Qualification Data Package: (Example) Physical Qualification Protocol Template Physical Qualification Report Template Physical Qualification Table of Contents Template Physical Qualification Data Package: (Example) Thermal Qualification Verification Protocol Template Thermal Qualification Verification Report Template Data Packages have the same flow and specific areas can easily be found 0037-APPX 0038-APPX Thermal Qualification Verification Table of Contents Template Thermal Qualification Verification Data Package: (Example) 0039-SOP Rules For Determining Significant Figures and the Rounding, Recording and Reporting of #s 0040-APPX 0041-APPX 0042-TPL Document History File Template Document History File: (Example) Insulated Shipper Qualification Program Document Template with Headers and Footers 5

6 Voluntary Standard to Advance Packaging Sustainability Provides a Process for the design, testing and qualification of responsible packaging Written by ISTA s Sustainable Solutions Division Vetted by industry, NGO s and governmental experts It is hoped to develop packages which meet industry, consumer and regulatory expectations. Evaluates different package designs for the same application, for functional and environmental performance ISTA 2011

7 What does RPbD embrace? Functional requirements Environmental performance Financial performance Lifecycle thinking, Full LCA or LCA light Sourcing, production, distribution, use and recovery of materials Sourcing of energy and water used in manufacture The role of packaging in preventing damage or spoilage of product After use value 7

8 8 Steps to Responsible Packaging Step 1. Step 2. Step 3. Step 4. Establishing Project Scope Define Boundaries & Metrics Assessing Impact of Existing Design Determining Impact of Proposed Design Step 5. Step 6. Step 7. Step 8. Selecting the Best Action for the New Design Prototyping and Validating the New Design Assessment, Recommendation & Documentation Design Implementation Understanding which variables create positive impact Includes Development of Master Test Plans First-run pilots Decision stage Qualification repeatability of processes Doc design history Embraces existing roll-out processes Includes damage data gathering/ review Continuous Improvement 8

9 Technical Update ISTA Restructure

10 Technical Division Structure Technical Division Board (Strategic in nature) Currently 13 members Global perspective (6/13 outside USA) Testing Council (Tactical in nature) Up to 19 members Member representatives in all classes Test Series Groups (1, 2, 3 and above) Voting for projects and technical changes within series Workgroups Task specific Member and industry representatives. 10

11 25 Package Performance Tests Procedures Based on TECHNICAL CHANGES made to Procedures, the following are the current VERSION DATES for all ISTA Procedures: 2001: 1A, 1B, 1C, 1D, 1G, 1H 2005: 1E 2006: 2D, 2E 2007: 7D 2008: 3A, 3F, 7A, 7B, 7C 2009: 3E, 4AB 2010: 2F, Project 6-SAMSCLUB 2011: 2A, 2B, 2C, 3B, 3H, 3K 11

12 New Test Projects All new tests since 2002 have been General Simulation Test Series or higher. Project 3B Packaged-Products for Less-Than- Truckload (LTL) Shipment Project 3K- Fast moving consumer goods in the European retail supply chain 6-SAMSCLUB released September

13 Testing Council Current Activity 3-Phase Review of all ISTA Test Procedures Phase 1: Determine which procedures to maintain, which to discontinue (Completed) Phase 2: Comprehensive review for consistency and accuracy within remaining procedures (Underway) Phase 3: Review format and presentation. (2013) Review of Random Vibration Spectra for Air Shipments Expansion of Regional Transport Environment Data Upgrading 4AB Packaged-Products for Shipment in Known Distribution Channels Web-Based Software Application that Generates Enhanced Simulation Test Plans 13

14 Research in Random Vibration Driven by the need and desire for ever more accurate simulations IAPRI Working Group Guidelines for Advanced Vibration Testing Approaches provided to encourage testing laboratories to try/evaluate alternative simulation methods and inform the WG (or the wider packaging community) of their results ISTA s Technical Division is looking at Confidence Levels for testing levels including random vibration and other hazard levels. 14

15 Data, Data and More Data Expansion of Regional Transport Environment Data ISTA s Guide to Data Capture and Analysis Measurement Project Description and Documentation Instrument Mounting Control of Variables Instrument recording setup Data and Analysis Creation of Tests - Lab Simulation ISTA s Data Depot We help with the set up and analysis if you will share data 15

16 Providing Value to our Member Companies through Test Procedures and Industry Standards that Meet Their Needs