ASTM D10 Workshop: Optimizing Packaging Performance

Transcription

1 Pharma Packaging Through Single Parcel Shipments ASTM D10 Workshop: Optimizing Packaging Performance Mahesh Khurana & Sam Upadhyaya 11 th October 2017

2 Content: Project Goals Planning Phase Project Setup Test Setup e-value Shipping Routes Drop Results Orientation Results 2

3 Project Goals: Gather data for Roche temperature controlled single parcel shipments across the global distribution network: 1. Shocks and drops. 2. Package orientation during transit. 3

4 Planning Phase: Planning phase included selection of: Field data collection instrument Representative shipping lanes Test samples Performing pilot shipments Review published literature Supply chain information included dispatch volumes and sales volumes, size and weight ranges for single parcel shipments 4

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6 Test setup We used Lansmont SAVER devices to monitor the shock (3X90 and 3M30+) and the orientation of package (3D15). Two representative packaging configurations representing high and low end of commercial shipments weight & dimensions were made. Small Package: 14 x 10 x lb (5kg) Large Package: 24 x 24 x lb (18kg) Large Small 6

7 e-value calculation The coefficient of restitution (e) is the ratio of final velocity to initial velocity after an object undergoes a collision. Therefore it is possible to calculate the drop height of the package if e is known. EDH is effective drop height, g is acceleration due to gravity, ΔV R is change in velocity. We performed in-lab drop tests at 6 known heights, across multiple orientations with 3 repetitions each in order to reverse calculate e for our package configuration. RESULTS: The e value for both package is calculated to be

8 Shipping Routes Shipping routes were selected in six countries within North America (N A), Europe (EU), Latin America (LATAM) and Asia. Six round-trips shipments were done in each country. Sending sites were Roche distribution center. Receiving sites were selected based: high dispatch volume, mode of transport (air, truck, ferry), geographical location within country Shipments were done using the same method as for commercial Roche shipments Courier service (like Fedex, DHL), dedicated truck etc. 8

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10 Drop data results (drops >7in only) Drop Data Average number of drops for one-way trip globally Small Package Large Package 6 3 Max. drop height, in Drop height at 99% occurrence Drop height at 95% occurrence Mean drop height, in

11 Drop data for Large and Small package 70 Avg. No. of drops per oneway trip Number of Drops Mean Large 6 Mean Small 3 95% Occurrence % Occurrence Max 48.2 Max Drop Heights, inch

12 Top 5 drop heights Drop Data Small Package Large Package Highest drop, in 54.6 Asia 48.2 Asia 2nd highest drop, in 48.0 Asia 39.6 EU 3rd highest drop, in 42.4 Asia 33.7 N A 4th highest drop, in 40.8 Asia 31.9 NA 5th highest drop, in 40.7 Asia 31.3 Asia 12

13 Drop Impact orientation results (drops >7in only) Impact Orientation Small Package Face - Top 2 1 Face - Bottom Face - Sides 5 2 Edge - Top 9 9 Edge - Bottom Edge - Side 9 11 Corner - Top Corner - Bottom Large Package 13

14 Conclusions from drop data Majority of drops were bottom oriented for both packages (60% for small and 65% for large). Average number of drops per one-way trip were 6 for small package and 3 for large package (ASTM D7386 has 18 drops and D4169 has 12 drops). 14

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16 Set-up: Orientation data for Large package SAVER 3D15 was mounted on the Large package to record the orientation of package during the transit. SAVER 3D15 include MEMS technology accelerometers with DC response measurement capability. 3D15 3X90 3M30+ 16

17 Orientation data for Large package Average one-way trip duration (hours) ASIA LATAM N A EU Average % Time on Orientation Top Side Bottom 0 ASIA LATAM NA EU 17

18 Orientation detail: North America Bottom Side Top This graph shows the orientation as factor of time for North America. This graph displays the number of time the orientation changed and duration spent on certain orientation. Each color represents one round trip shipment.

19 Conclusions from orientation data Orientation information is important to evaluate the performance of passive temperature controlled packages. Examples: Thermal packages may experience temperature excursions when orientation is changed. Understand time to failure in different orientation and compare to normal shipping orientation (bottom). 2-8 C is maintained only for 24 hours when package is oriented on side vs. 56 hours when oriented on bottom. 19

20 Doing now what patients need next