Considerations When Using Advanced Packaging Materials Richard Wood Design Manager, Peli BioThermal

Transcription

1 Considerations When Using Advanced Packaging Materials Richard Wood Design Manager, Peli BioThermal 1

2 Peli BioThermal A Brief History 2

3 Presentation Overview Methods for selecting the most appropriate TCP system Kelvin Hour concept - Benchmarking TCP systems Overview of TCP Design Principles Packaging Materials What makes a TCP System Thermally Robust? Clinical Trials Biological Specimen Return? 3

4 Considerations When Using Advanced Packaging Materials 4

5 Case Study 2 to 8 Shipper Shipments originating Central EU to CIS countries Product temperature to be maintained +2 C to +8 C Shipment durations in excess of 72 hours High likelihood of delays during customs clearance B A 5

6 Case Study 2 to 8 Shipper T Range The original design brief required the TCP systems to be qualified to a broad range of ambient temperatures. HOT MILD COLD 6

7 Control vs. Risk 7

8 T Range Large Small Volume, International Distribution EU Distribution Centre Road Freight Air Freight Customs Clearance Road Freight Remote Destination HOT MILD COLD 8

9 Three TCP options, how do they compare? 4 Day 2 Day 1 Day 9

10 Qualification Performance Review Shipper A Custom Profile Shipper B ISTA 7D Hot Shipper C WHO +43 C Ave Thermal Stress = +20 C Control Duration = 93.5Hrs Thermal Stress Score = 1402K.Hr Ave Thermal Stress = C Control Duration = 58.5Hrs Thermal Stress Score = 1488K.Hr Ave Thermal Stress = +38 C Control Duration = 34.5Hrs Thermal Stress Score = 1311K.Hr 10

11 Kelvin Hours Example Average Thermal Stress x Control Duration = K.Hrs Custom Profile ISTA 7D Hot WHO +43 C Ave Thermal Stress = C Control Duration = 93.5Hrs Thermal Stress Score = 1402K.Hr Ave Thermal Stress = C Control Duration = 58.5Hrs Thermal Stress Score = 1488K.Hr Ave Thermal Stress = +38 C Control Duration = 34.5Hrs Thermal Stress Score = 1311K.Hr 11

12 Ambient Profile Kelvin Hours Performance Matrix Test Duration 24 Hours 48 Hours 72 Hours 96 Hours WHO (+43 C) 888K.Hr 1776K.Hr 2664K.Hr 3552K.Hr ISTA 7D (+30 C) 600K.Hr 1200K.Hr 1800K.Hr 2400K.Hr Custom Profile (+20 C) 360K.Hr 720K.Hr 1080K.Hr 1440K.Hr 12

13 Ambient Profile Kelvin Hours Performance Matrix Test Duration 24 Hours 48 Hours 72 Hours 96 Hours WHO (+43 C) 888K.Hr 1776K.Hr 2664K.Hr 3552K.Hr ISTA 7D (+30 C) 600K.Hr 1200K.Hr 1800K.Hr 2400K.Hr Custom Profile (+20 C) 360K.Hr 720K.Hr 1080K.Hr 1440K.Hr 13

14 Kelvin Hours Performance Matrix Performance Duration 24 Hours 48 Hours 72 Hours 96 Hours 120 Hours +20 C 360K.Hr 720K.Hr 1080K.Hr 1440K.Hr 1800K.Hr Clarifies how the shippers should perform to a specified ambient stress. 3 to C 14

15 Kelvin Hours Performance Matrix Performance Duration 24 Hours 48 Hours 72 Hours 96 Hours 120 Hours +30 C 600K.Hr 1200K.Hr 1800K.Hr 2400K.Hr 3000K.Hr Clarifies how the shippers should perform to a specified ambient stress. 2 to C 15

16 Case Study 2 to 8 Shipper *Stock Image for reference only The TCP vendor designed systems that incorporated two types of Phase Change Material; Water and 5C PCM. 16

17 Case Study 2 to 8 Shipper *Stock Image for reference only The inclusion of Frozen Water into the system helped to achieve impressive durations in Laboratory Qualification 17

18 Case Study 2 to 8 Shipper Considerations when using Frozen Water within TCP systems (maintaining +2 C to +8 C) Water Phase Changes at 0 C (Freeze and Melt) Most often used to absorb heat (Melting Phase) TCP Design requires a thermal gradient to be created to prevent product cold excursions: 1) Use of Insulation Materials (Spacers) H2O (0 C) Temperature Sensitive Payload (+2 C to +8 C) 18

19 Case Study 2 to 8 Shipper Considerations when using Frozen Water within TCP systems (maintaining +2 C to +8 C) Water Phase Changes at 0 C (Freeze and Melt) Most often used to absorb heat (Melting Phase) TCP Design requires a thermal gradient to be created to prevent product cold excursions: 2) Use of Phase Change Material H2O (0 C) PCM (+5 C) Temperature Sensitive Payload (+2 C to +8 C) 19

20 Case Study 2 to 8 Shipper Considerations when using Frozen Water within TCP systems (maintaining +2 C to +8 C) System creates a Thermal Balance when sufficient external heat is melting the Water. If too much or too little heat is transferred the system is likely not to perform as per the system s qualification. H2O (0 C) PCM (+5 C) 20

21 Case Study 2 to 8 Shipper Considerations when using Frozen Water within TCP systems (maintaining +2 C to +8 C) 4 Configurations Each one with different H2O / PCM volumes. Created pack-outs capable of maintaining product temperatures: Across all External Ambient Conditions Over the Transit Durations expected H2O (0 C) PCM (+5 C) H2O (0 C) PCM (+5 C) H2O (0 C) PCM (+5 C) H2O (0 C) PCM (+5 C) 21

22 Case Study 2 to 8 Shipper T Range *Stock Image for reference only Multi-configurations required to cover wide operating temperature range. HOT MILD COLD 22

23 Case Study 2 to 8 Shipper *Stock Image for reference only Which is the best one to use for each shipment? 23

24 Case Study 2 to 8 Shipper Shipper design / selection method not robust enough for the variable shipping lanes Customer found it very difficult to predict what ambient conditions may be experienced Product temperature excursions were experienced frequently 24

25 Case Study 2 to 8 Shipper Performance Examples Dual PCM Systems 35 WATER + PCM Graph_1 35 Ch:1 'C Ch:2 'C Ch:10 'C Ch:11 'C Ch:12 'C Ch:13 'C WATER + PCM Graph_ Ch:1 'C Ch:2 'C Ch:10 'C Ch:11 'C Ch:12 'C Ch:13 'C U U L L 0 00:00:00 2 days 12:00:00 5 days 00:00:00 (Elapsed Time - Quick plot) Minor interval = 12:00: :00:00 3 days 00:00:00 6 days 00:00:00 (Elapsed Time - Quick plot) Minor interval = 14:24:

26 Case Study 2 to 8 Shipper Dual PCM Systems WATER + PCM Graph_ Ch:1 'C Ch:2 'C Ch:10 'C Ch:11 'C Ch:12 'C Ch:13 'C U L :00:00 3 days 00:00:00 6 days 00:00:00 (Elapsed Time - Quick plot) Minor interval = 14:24:

27 Shipping system needs to be more robust. How can this be achieved? Solution? Materials selection is key! 27

28 Thermally Robust Design VIP Insulation PCM (+4 C) 28

29 Thermally Robust Design 29

30 Thermally Robust Design 30

31 Thermally Robust Design 31

32 Clinical Trials Return of Biological Specimens from Investigator Sites? A B 32

33 Clinical Trials Return of Biological Specimens? How do you choose the shipping solution? What regulations do the shippers have to comply with? Who specifies the shipping solution? 33

34 Clinical Trials Return of Biological Specimens? An Idea What if the shipping systems that were used to transport the CT material to the investigator sites could be used to ship Biological Specimens back to the Laboratories? 34

35 Clinical Trials What would the systems have to Re-useable? Yes be capable of? 35

36 Clinical Trials What would the systems have to be capable of? Re-useable? Yes Temperatures Ranges? Outbound: +2 C to +8 C Inbound: <-20 C? +2 C to +8 C? +15 to +25 C? 36

37 Clinical Trials What would the systems have to be capable of? Re-useable? Yes Temperatures Ranges? Outbound: +2 C to +8 C Inbound: <-20 C? +2 C to +8 C? +15 to +25 C? Durations? Outbound: 96 hours? Inbound: 48 / 72 / 96 hours? 37

38 Clinical Trials What would the systems have to be capable of? Re-useable? Yes Temperatures Ranges? Outbound: +2 C to +8 C Inbound: <-20 C? +2 C to +8 C? +15 to +25 C? Durations? Outbound: 96 hours? Inbound: 48 / 72 / 96 hours? Regulatory Compliance? Outbound: EU GDP? Inbound: UN3373 / Hazardous Materials? 38

39 Clinical Trials What would the systems have to be capable of? Re-useable? Yes Temperatures Ranges? Outbound: +2 C to +8 C Inbound: <-20 C? +2 C to +8 C? +15 to +25 C? Durations? Outbound: 96 hours? Inbound: 48 / 72 / 96 hours? Regulatory Compliance? Outbound: EU GDP? Inbound: UN3373 / Hazardous Materials? 39

40 Wish to learn more? Come and see us at our booth 40

41 Thank you for your time Questions? Peli BioThermal +44 (0)