Developing Cold Chain

Shipping Practices
Getting Started

Tom Meier – Henry Schein Inc

 Key Initial Steps

Review USP 1079

Determine item storage and shipping data
Insure proper storage conditions
Evaluate your transportation network
Develop and establish ambient profiles
Selecting and qualify packaging
 Item Details
The most challenging data to collect
Storage and shipping requirements can be
different
Understand excursions
Record all contacts and information
Use manufacturer data as an advantage
Build data base to support customer inquiries
 Storage Considerations
Ambient – Refrigerated – Frozen
Monitor all coolers/freezers
Insure 24/7/365 power source
Develop emergency back up plan
Monitor facility ambient temperatures
Maintain records
Evaluate Transportation Network
Determine Transportation Methods Used
– Truck
– Parcel
Air
Ground
Establish shipment transit times
– Same Day
– 1 Day
– 2 Days
– More
Evaluate Transportation Network
Carrier Performance and Capability
– Expect ↑ 98% on ground parcel service
– Look for isolated service pockets
– Does equipment meet your needs
– May need special contract addendums
Network Changes
– Stay alert to carrier routing changes that will
impact your network profile
 Develop Network Profile
Location of shipment in relation to total
transit time
– Results can and will vary by carrier, service
type and region
Multiple locations add to complexity
– use worst case scenario
Develop Network Ambient Profile
Duration and range of temperatures packages
are exposed to in transit
Number of profiles impacts packaging
– Mild
– Hot
– Cold
– Extreme (Hot and/or Cold)
Measure exposure temps in your network
– Temp / Time indicators
– Ensure data integrity
– Don’t stop
Temperature Monitoring Devices
Data Loggers
TempTale4 (Single Use Only)
Sensitech

iButton (Repeated Use)

Maxim (Dallas Semiconductor)
 Network Ambient Profile:
HOT (Exposure Limits: (Lower = 27C/80F, Upper = 38C/100F)
Exposed Temp. Low Limit High Limit

45

40
DegreesC

35

30

25

20
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37
Time of Day

Packed-out in In UPS Out for

HS facility 1st HUB Delivery

In UPS Trailer & In UPS

in Transit to 1st 2nd HUB
HUB
In Transit to If not delivered
2nd HUB Return to HUB
 Packaging Options

Cardboard
Temperature controlling “bags”
EPS coolers with gel packs
Formed containers inside corrugated
Pre-Qualified packaging systems
Temperature controlled enviro containers
Packaging Options Examples
Pre-Qualified Shippers
(for 2˚C - 8˚C)
 Pack-out Protocol
Hot Conditions, Large Container, Max. Load

Henry Schein; EPS(Large): Max Load: Hot Ambient

18 x Propofol Vials
4 Frozen x 24 oz Gels Packs & 4 Frozen x 16 oz Gels Packs
Exposure Limits: (Lower = 27C/80F, Upper = 38C/100F)
45 Test No. 05232006.4E Project No. 2441

40

35
E
30
S
Temp Deg C

25

20
8.2C @29.75Hr
M
15

10

0
0 6 12 18 24 30 36 42 48
Product Probe (In Center) ProductHours
Probe (along side) Ambient Probe 1
Ambient Probe 2 2 Deg C 8 Deg C
Pack-out Diagram
Hot Profile – Large Cooler

Lid

Frozen 24oz

(2) Wall Pads

Core Box

Wall Pad

Frozen 16oz

Large Cooler
Temperature Monitoring Devices
Excursion Indicators

MonitorMark™
Time/Temperature Tag
3M Health Care

ColdMark™
Freeze indicator
IntroTech Inc, St. Paul, Minnesota
Labels
 Summary
Read USP 1079
Continuous monitoring of network and
storage ambient conditions
Qualify packaging process
Remember why this is important