coolpack - creating value through designing and ......2015/11/07 · insurers, by providing...

Creating value through Designing and Implementing a shipping Lane Qualification

for High-Value Pharmaceutical Products

WORKSHOP B

Alan J. Davis

Chief Operating Officer

K. L. Harring Transportation, LLC

Feb 24, 2015 1

As a known temperature controlled transporter in the life science industry - with numerous years’ experience and a recognized reputation - our mission is to maintain your rigorous requirements by observing both Good Manufacturing Practice (cGMP) and Good Distribution Practice (GDP) protocols.

Our established policies and procedures ensure that your products are handled and managed within the expected parameters you’ve entrusted to us.

From the manufacturer to the final destination, K.L. Harring Transportation, LLC will assure that every effort possible, to maintain your product’s integrity, has been made.

Security

• With pharmaceuticals potentially being an attractive target for cargo thieves, K.L. Harring Transportation, LLC customers are afforded our secure services - which involve multiple layers of security attributes to protect both the security and integrity of their products:

• Asset based carrier since 1978

• Employee drivers (no owner-operators)

• Team drivers (upon request)

• Driver profiles & pictures sent, in advance of arrival

• Route assignments pre-defined with associated risk assessments

• Preauthorized fuel / rest stops

• Covert / overt security technology on all trucks and trailers

• Shipper has visibility (via Secure Transmission) of all driver activity

• GPS geo-fencing with redundant positioning technology

• Off-Route automated notifications

• Door sensor monitoring providing door Open / Close Notifications

• Facility is a 360 degree fenced location / CCTV Security Cameras

• Security guard on duty 7 days a week; facility secured 24hrs daily

• Active membership in the Pharmaceutical Cargo Security Coalition (PCSC)

Feb 24, 2015 2

K.L. Harring Transportation, LLC was awarded

“Best in Security” in 2013

Carrier class <50 Million Dollars in Revenue

Agenda

• Analyzing of your temperature controlled products and their requirements

• Best practices and tools to help organizations realize improvements with easy implementation processes

• Security risk assessment process and risk mitigation

• Security enhancements

• Considering off-the-shelf packaging solutions for products with little stability data

• Case study: Compare passive versus active container qualification

• Choosing a test profile that is appropriate for your shipping channels as part of the overall qualification process

• Designing your packaging for specific products traveling in specific lanes

• Design Qualification – Scope document & user requirements

• Operational Qualification – Chamber and distribution testing

• Performance Qualification – Size, maximum/minimum load, winter/summer

• High volume and frequency of commercial products

• Offset investment requirements for a shipping lane qualification through high volume and frequency of commercial products shipments

• Considering lane qualification for low volume of shipments –Depending on the drugs development stage, lost shipment can be detrimental to the launch of a new product

Feb 24, 2015 3Contents depict opinions of Alan Davis and do not represent any specific company or business practice, and are not all inclusive of best practices and regulatory requirements.

Analyze temperature controlled products & requirements

Key physical attributes

• Required temperatures

• Where & when to place temperature monitors

• Allowable temperature excursions

• Environmental sensitivity• Vibration• Shock• Light• Humidity

• Stability testing

• Expiration dating

• Impact to product if any deviations

• Impact to patient if any deviations

Key security attributes

• Attractiveness for theft

• Where and when to place security monitors

• Replacement time & cost

• Traceability

• Vetting of supply chain partners• 3 PL’s• Warehousing & Distribution Sites• Transportation Service Providers• Terminal operations

• Impact to product if any deviations

• Impact to patient if any deviations

Feb 24, 2015 4

TCSC – Temperature Controlled Supply Chain

Agenda















Feb 24, 2015 5

Industry Best Practices

Parental Drug Association (PDA) http://www.pda.org/home

PCCIG Pharmaceutical Cold Chain Interest Group

Technical Report No. 58

Risk Management for Temperature-Controlled Distribution

2012

Technical Report No. 64

Active Temperature-Controlled Systems: Qualification Guidance

2013

Feb 24, 2015 6

http://www.pda.org/home


• International Air Transport Association• Perishable Cargo Regulations (PCR) http://www.iata.org/publications/Pages/perishable-cargo.aspx• IATA created a Center of Excellence for Independent Validators (CEIV) in Pharmaceutical Logistics with the aim of helping the industry to

improve the transport and handling of pharmaceutical products to meet the requirements of shippers and manufacturers. • The IATA Temperature Control Regulations (TCR) addresses temperature management issues identified by the industry. This manual provides

the requirements and standards for the transportation and handling of pharmaceutical products, including the compulsory use of the Time and Temperature Sensitive Label.

• The purpose of the IATA Standard Acceptance Checklist is to inform airlines and ground-handling agents of the minimum checks to execute in temperature sensitive healthcare shipments.

• The Time & Temperature Task Force (TTTF) develops and maintains standards for the procedures, documentation, cargo handling, packaging and acceptance of goods from the healthcare sector, under guidance from the Live Animals and Perishables Board (LAPB).

• US Pharmacopeia http://www.usp.org• USP proposed five new General Chapters on Good Distribution Practices (GDP) in Pharmacopeial Forum 40(2) [Mar.–Apr. 2014]:

• <1083> Good Distribution Practices

• <1083.1> Quality Management System

• <1083.2> Environmental Conditions Management

• <1083.3> Good Importation and Exportation Practices

• <1083.4> Supply Chain Integrity and Security

Feb 24, 2015 7

http://www.iata.org/publications/Pages/perishable-cargo.aspx

http://www.usp.org/


CargoNet http://cargonet.com/about.html

• CargoNet serves supply-chain participants, including manufacturers, logistics companies, retailers, and their insurers, by providing services to help deter theft and increase the chances of recovery.

• CargoNet Recovery Network revolves around a sophisticated and secure database, secondary-market monitoring, and a theft alert system that allows effective and secure data sharing from theft victims to law enforcement.

Rx 360 http://www.rx-360.org/• Mission Statement: "Protect patient safety by sharing information and developing processes related to the integrity of the

healthcare supply chain and the quality of materials within the supply chain."

Feb 24, 2015 8

http://cargonet.com/about.html

http://www.rx-360.org/


Six Sigma DMAIC

• Define the system, the voice of the customer and their requirements, and the project goals, specifically.

• Measure key aspects of the current process and collect relevant data.

• Analyze the data to investigate and verify cause-and-effect relationships. Determine what the relationships are, and attempt to ensure that all factors have been considered. Seek out root cause of the defect under investigation.

• Improve or optimize the current process based upon data analysis using techniques such as design of experiments, mistake proofing, and standard work to create a new, future state process. Set up pilot runs to establish process capability.

• Control the future state process to ensure that any deviations from the target are corrected before they result in defects. Implement control systems such as statistical process control, and continuously monitor the process.

Feb 24, 2015 9


FMEA Risk Assessment

Failure Modes and Effects Analysis

• Map the Process

• Assign ratings for • Severity – rate the severity of the failure• Probability of occurrence – rate the frequency of failure• Probability of detection – rate the ability to detect the failure once it occurs

• Severity can be classified by critical characteristics• Q – the quality or defect rate• C – the price or cost• D – delivery or cycle time• P – the process• S – the safety of the user or producer

Feb 24, 2015 10

Feb 24, 2015 11

Failure Modes and Effects Analysis

Assign team and lead for the project

Map the process

Assign ratings for

Severity

Can be classified by various critical characteristics (each can have a different severity rating)

Q - the quality or defect rate

C - the price or cost

D - delivery or cycle time

P - the process

S - the safety of the user or producer

Probability of Occurrence

Probability of Detection

Description of a worst case shipping lane

Execution of the FMEA

Calculation of the Risk Priority Number

RPN = Severity x Probability of Occurrence x Probability of Detection

Develop corrective and preventive action

Recalculate the RPN

Feb 24, 2015 12

FMEA Ratings

Severity

3 Low risk to product

5 Medium risk to product

7 Product endangered

10 Product lost

Occurrence

1 Unlikely

3 Annually

5 Monthly

7 Weekly

10 Daily

Detection

1 Failure will be discovered before reaching the customer

3 Low chance the potential failure will reach the customer undetected

5 Medium chance the potential failure will reach the customer

7 Unlikely the failure will be detected prior to reaching the customer

10 Current controls will not detect the potential failure

Agenda















Feb 24, 2015 13

Security risk assessment process and risk mitigation

Feb 24, 2015 14Know your supply chains!

Know your supply chains!

Feb 24, 2015 15

Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements

11 California Puerto Rico Air apparatus ambient corrugated shippers on pallets

12 Puerto Rico Mexico Air apparatus ambient corrugated shippers on pallets cross border through El Paso, TX

21 New York Puerto Rico Air API 2°C to 8°C Dry Ice refrigerant in corrugated shippers transit through Boston

22 Puerto Rico Belgium Air API 2°C to 8°C Dry Ice refrigerant in corrugated shippers transit through Amsterdam for VAT

23 Puerto Rico Italy Air API 2°C to 8°C Dry Ice refrigerant in corrugated shippers transit through Amsterdam for VAT

31 Ohio Puerto Rico Air widgets ambient corrugated shippers

32 Puerto Rico Belgium Air widgets ambient corrugated shippers transit through Amsterdam for VAT

33 Puerto Rico Italy Air widgets ambient corrugated shippers transit through Amsterdam for VAT

41 Belgium Puerto Rico Air WIP 1 2°C to 8°C Air shipper unit uses dry ice as a

refrigerant and D-cell batteries to power

the fans and controller.

transit through Amsterdam for VAT

42 Italy Puerto Rico Air WIP 1 2°C to 8°C Air shipper unit uses dry ice as a




43 Puerto Rico Texas Air WIP 2 2°C to 8°C Air ULD pallet shipper unit uses dry ice as

a refrigerant and D-cell batteries to power


transit via wide body through Florida airport to Texas

44 Texas US DC Truck FG 2°C to 8°C Temperature controlled truck

Know your supply chains!

Feb 24, 2015 16


51 Puerto Rico Mexico Air WIP 1 2°C to 8°C Air shipper unit uses dry ice as a



cross border through El Paso, TX

52 Belgium Mexico Air WIP 1 2°C to 8°C Air shipper unit uses dry ice as a




53 Italy Mexico Air WIP 1 2°C to 8°C Air shipper unit uses dry ice as a




54 Mexico Scotland Air / Ferry

/ Truck

WIP 2 2°C to 8°C Air ULD pallet shipper unit uses dry ice as



Truck transit cross border to airport El Paso, TX;

temperature control truck to origin airport Dallas, TX

(or alternate airport Houston, TX); flight to destination

airport Schiphol, Amsterdam; transit via temperature

controlled truck on ferry to UK; temperature

controlled truck to destination in Scotland

55 Scotland Japan Air FG 2°C to 8°C Air ULD pallet shipper unit uses dry ice as



56 Scotland Belgium Truck FG 2°C to 8°C Temperature controlled truck. Truck / ferry

Security risk assessment process and risk mitigation

Feb 24, 2015 17Know your supply chains!

Risk Assessment

• New York to Boston to Puerto Rico

Feb 24, 2015 18


21 New York Puerto Rico Air API 2°C to 8°C Dry Ice refrigerant in corrugated shippers transit through Boston

Feb 24, 2015 19


21 New York Puerto Rico Air API 2°C to 8°C Dry Ice refrigerant in

corrugated shippers

transit through Boston

Process Step Key Process Input Potential Failure Modes Potential Failure Effects Severity Class Potential Causes Occurrence Current Process Controls Detection RPN

Truck arrives for

loading

Truck is

scheduled and

dispatched

Truck late for pick up Delayed shipment 3 D Equipment breakdown,

Communications error,

Driver lost, etc.

3 Carrier dispatcher, GPS 1 9

Truck is loaded and

departs

Truck transports and

delivers to airport

facility

Shipment re-iced if

required

Airport facility loads

on aircraft

Aircraft transports

to destination

airport

Aircraft unloaded at

destination airport

Shipment re-iced if

required

Truck arrives for

loading

Truck transports to

destination

Destination unloads

and receives

shipment

Risk Mitigation

• Transportation Service Provider Vetting

• Contracts

• Quality Agreements

• On site audits

• Key contacts

• Primary carrier & back up carrier strategy

• Escorts

• Electronic monitoring

• DNET (Depart No Earlier Than) times

Feb 24, 2015 20

Risk Mitigation

• Planned routes

• GEO Fencing

• Planned safe stops

• Event Escalation Procedures

• RFI & RFP events

• FMCSA Safety Scores http://csa.fmcsa.dot.gov/

• 200 mile Red Zone from origin & destination

• Last mile delivery

• Know your customer

Feb 24, 2015 21

http://csa.fmcsa.dot.gov/

Risk Assessment

• Ohio to Puerto Rico

Feb 24, 2015 22



Feb 24, 2015 23



Process Step Key Process Input Potential Failure Modes

Potential Failure

Effects Severity Class Potential Causes Occurrence Current Process Controls Detection RPN

Truck arrives for

loading

Truck is

scheduled and

dispatched



Driver lost, etc.


Truck is loaded and

departs


delivers to airport

facility


on aircraft

Aircraft transports

to destination

airport


destination airport

Truck arrives for

loading

Truck transports to

destination

Destination unloads

and receives

shipment

Risk Mitigation


• Contracts


• On site audits

• Key contacts


• Escorts



Feb 24, 2015 24

Risk Mitigation

• Planned routes

• GEO Fencing








Feb 24, 2015 25


Risk Assessment

• California to Puerto Rico

Feb 24, 2015 26


11 California Puerto Rico Air apparatus ambient corrugated shippers on pallets

Feb 24, 2015 27


11 California Puerto Rico Air apparatus ambient corrugated shippers on

pallets

Process Step Key Process Input Potential Failure Modes Potential Failure Effects Severity Class Potential Causes Occurrence Current Process Controls Detection RPN

Truck arrives for

loading

Truck is

scheduled and

dispatched



Driver lost, etc.


Truck is loaded

and departs

Truck transports

and delivers to

airport facility

Airport facility

loads on aircraft

Aircraft

transports to

destination

airport

Aircraft unloaded

at destination

airport

Truck arrives for

loading

Truck transports

to destination

Destination

unloads and

receives

shipment

Risk Mitigation


• Contracts


• On site audits

• Key contacts


• Escorts



Feb 24, 2015 28

Risk Mitigation

• Planned routes

• GEO Fencing








Feb 24, 2015 29


Risk Assessment

• Mexico to Scotland

Feb 24, 2015 30



/ Truck










Feb 24, 2015 31

550 miles El Paso to Dallas

250 miles Dallas to Houston

El Paso

Miami

Boston

San Juan

Aguadilla

Feb 24, 2015 32

Hook of Holland to Harwich ferry

Feb 24, 2015 33


54 Mexico Scotland Air / Ferry / Truck WIP 2 2°C to 8°C Air ULD pallet shipper

unit uses dry ice as a

refrigerant and D-cell

batteries to power the

fans and controller.

Truck transit cross border to airport

El Paso, TX; temperature control

truck to origin airport Dallas, TX (or

alternate airport Houston, TX); flight

to destination airport Schiphol,

Amsterdam; transit via temperature

controlled truck on ferry to UK;

temperature controlled truck to

destination in Scotland

Process Step Key Process Input

Potential

Failure

Modes Potential Failure Effects Severity Class Potential Causes Occurrence Current Process Controls Detection RPN

Air ULD pallet

shipper sourced

Air ULD pallet

shipper

preconditioned

Air ULD pallet

shipper loaded

Truck arrives for

loading

Truck is

scheduled and

dispatched

Truck late

for pick up

Delayed shipment 3 D Equipment breakdown,


Driver lost, etc.


Truck is loaded and

departs


delivers to airport

facility

Shipment re-iced if

required


on aircraft

Aircraft transports

to destination

airport


destination airport

Shipment re-iced if

required

Truck arrives for

loading

Truck transports to

destination

Destination unloads

and receives

shipment

Destination unloads

Air ULD Pallet

shipper and receives

shipment

Return Logistics of

Air ULD Pallet

shipper is executed

Risk Mitigation


• Contracts


• On site audits

• Key contacts


• Escorts



Feb 24, 2015 34

Risk Mitigation

• Planned routes

• GEO Fencing








Feb 24, 2015 35


Risk Assessment

• Italy to Mexico

Feb 24, 2015 36






Feb 24, 2015 37

Feb 24, 2015 38


53 Italy Mexico Air WIP 1 2°C to 8°C Air shipper unit uses

dry ice as a refrigerant

and D-cell batteries to

power the fans and

controller.

cross border through El

Paso, TX


Potential

Failure

Modes

Potential Failure


Air shipper unit sourced

Air shipper unit preconditioned

Air shipper unit loaded

Truck arrives for loading Truck is scheduled and

dispatched

Truck late

for pick up



Driver lost, etc.


Truck is loaded and departs

Truck transports and delivers to

airport facility

Shipment re-iced if required

Airport facility loads on aircraft

Aircraft transports to interim

airport

Aircraft unloaded at interim

airport


Shipment stored at interim

airport

Aircraft loaded at interim

airport

Aircraft transports to

destination airport

Aircraft unloaded at destination

airport


Truck arrives for loading

Truck transports to destination

Destination unloads and

receives shipment

Destination unloads Air shipper

unit and receives shipment

Return Logistics of Air shipper

unit is executed

Risk Mitigation


• Contracts


• On site audits

• Key contacts


• Escorts



Feb 24, 2015 39

Risk Mitigation

• Planned routes

• GEO Fencing








Feb 24, 2015 40


Risk Assessment

Feb 24, 2015 41

• Italy to Puerto Rico






Feb 24, 2015 42


42 Italy Puerto Rico Air WIP 1 2°C to 8°C Air shipper unit uses

dry ice as a refrigerant

and D-cell batteries to

power the fans and

controller.

transit through

Amsterdam for

VAT


Potential Failure

Modes

Potential Failure


Air shipper unit sourced

Air shipper unit preconditioned

Air shipper unit loaded

Truck arrives for loading Truck is scheduled and

dispatched

Truck late for pick

up



Driver lost, etc.


Truck is loaded and departs

Truck transports and delivers to

airport facility


Airport facility loads on aircraft

Aircraft transports to interim

airport

Aircraft unloaded at interim

airport


Shipment stored at interim

airport

Aircraft loaded at interim

airport

Aircraft transports to

destination airport

Aircraft unloaded at destination

airport


Truck arrives for loading

Truck transports to destination

Destination unloads and

receives shipment

Destination unloads Air shipper

unit and receives shipment

Return Logistics of Air shipper

unit is executed

Risk Mitigation


• Contracts


• On site audits

• Key contacts


• Escorts



Feb 24, 2015 43

Risk Mitigation

• Planned routes

• GEO Fencing








Feb 24, 2015 44


Agenda















Feb 24, 2015 45

Security enhancements• Control Tower concepts

• Security protocols

• Intelligence analysis of potential for thefts or diversion

• Robust SOP’s• Training

• Education

• Contingency plans

• 3rd party monitoring• On time performance

• Return logistics of reusable packaging

• GPS tracking• Adherence to planned route

• Driver & vehicle security protocols

• Temperature monitoring• Centralized standard process for procurement of temperature monitors

• Centralized repository of data

• Participation in industry organizations• PCSC Pharmaceutical Cargo Security Coalition http://www.pcscpharma.com/

• HDMA Healthcare Distribution Management Association http://www.healthcaredistribution.org/

http://www.healthcaredistribution.org/publications/hdma-recommendations-for-securing-pharmaceutical-storage-facilities

• Health and Personal Care Logistics Conference http://www.hpclcnet.org/

Feb 24, 2015 46

http://www.pcscpharma.com/

http://www.healthcaredistribution.org/

http://www.healthcaredistribution.org/publications/hdma-recommendations-for-securing-pharmaceutical-storage-facilities

http://www.hpclcnet.org/

Agenda















Feb 24, 2015 47

Good, Fast, or Cheap

Fast

CheapGood

Pick Any Two

Low QualityPay For Quality

Low Priority

Requirements

Feb 24, 2015 48

Considering off-the-shelf packaging solutions for products with little stability data

Positive Attributes

• CQ Component Qualification

• DQ Design Qualification

• OQ Operating Qualification

• PQ Performance Qualification

• Time line

• Cost

• Risk

Additional Consideration• Does supplier managed

components and process meet or exceed your requirements• Quality• Environmental impact• Supply chain

• Time line• Cost• Risk

Feb 24, 2015 49

Agenda















Feb 24, 2015 50

Case study: Compare passive versus active container qualification

Passive Attributes

• Payload size

• Thermal mass (liquid, solid, etc.)

• Min / Max payload

• Vibration, shock, humidity

• Coolant – dry ice, gel, pcm

• Winter / Summer profile• Pack out configuration• Year-round qualification

Active Attributes

• Mode – ground, air, ocean

• Payload size

• Min / Max payload

• Vibration, shock, humidity

• Control unit – dry ice, mechanical compressor, combo, other

• Winter / Summer performance• Pack out configuration• Year-round qualification

Feb 24, 2015 51


Passive Attributes

• Storage space required

• Assembly effort required

• Pre-conditioning required

• Customer friendly

• Return logistics

• Data loggers inclusion• Single use• Multiple use

Active Attributes

• Availability• Rolling stock• Storage space required• Multi-compartment

• Pre-conditioning required

• Facility friendly

• Return logistics

• Calibration of data loggers

Feb 24, 2015 52


Passive Attributes

• Physical size & weight• Surcharges for oversize or

dimensional weight• Disposal• Reuse / change control• Failures

• Preconditioning• Pack out• Other

• Risk assessment

Active Attributes

• Physical size & weight

• Surcharges for oversize or dimensional weight

• Disposal of residue dry ice

• Reuse / change control

• Failures• Exhaust power source• Mechanical issues

• Risk assessment

Feb 24, 2015 53

Agenda















Feb 24, 2015 54

Choosing a test profile appropriate for your shipping channels as part of the overall qualification process

Historical Data

• Least reliable

• Higher risk of temperature excursion• Mode

• Hand offs dwell time

• Transit time

• Temporary storage

• Most expensive

Actual Data

• Most reliable

• Lower risk of temperature excursion• Mode

• Hand offs dwell time

• Transit time

• Temporary storage

• Least expensive

Feb 24, 2015 55

Choosing a test profile appropriate for your shipping channels as part of the overall qualification process

• Supplier provided profile

• Modified profile

• Additional considerations• Infrastructure of supply chain

• Volatility of unplanned route deviations• Replenishment of coolants or electrical energy required

• Availability of environmental testing chambers for multiple tests• Analysis of test data• Modifications of packaging• Additional testing

Feb 24, 2015 56

Agenda















Feb 24, 2015 57

Designing your packaging for specific products traveling in specific lanes

• Packaging sourced in another region may be impractical for your region• Transit times

• Costs

• Volume may drive a strong business case for custom tailored packaging• Advantages may be outweighed by complexity of

• Operator training

• Different components assembly

• Pre-conditioning time and method differential

• Quality system

Feb 24, 2015 58

Agenda















Feb 24, 2015 59

Design Qualification – Scope document & user requirements

• Identify product temperature and packaging requirements• Storage• Transportation

• Mode• Transit time

• Allowable excursions

• Payload size and configuration• Product thermal mass

• Solid• Liquid• Gas• Gel, etc.

• Tolerance to shock, vibration, light, humidity, etc.

Feb 24, 2015 60


• Capabilities for available testing • Competency of personnel

• Testing chambers and equipment

• Reputation and certifications

• Regulatory requirements

• Company specific requirements

• Customer specific requirements

• Quality Agreement

• Quality Management System & Change Control

Feb 24, 2015 61


• Tests may be simulated in a laboratory environment• Actual supply chain performance may be very different due to volatility of

environmental factors and packaging• Heat, light, shock, vibration, humidity• Operator error in pre-conditioning and/or assembly• Transit time volatility, unplanned route deviations

• Protocol to include scope of requirements and testing process• Certify test was performed as per approved Protocol• Change control for design or operational changes• Prove repeatability with multiple tests• Acceptance criteria

Feb 24, 2015 62

Agenda















Feb 24, 2015 63

Operational Qualification – Chamber and distribution testing

• Protocol defines user requirements

• Acceptance criteria determines pass / fail testing results

• Analysis determines level of risk

• Ensure testing equipment is capable of providing testing criteria• Pre-condition

• Ramp up temperatures

• Ramp down temperatures

• Temperature spikes

• Accurate data monitoring and collection

Feb 24, 2015 64

Operational Qualification – Chamber and distribution testing

• Proper conditioning of components prior to assembly for test

• Define minimum & maximum payloads for testing

• Determine proper placement of data logging probes

• Set testing chamber controller to required test parameters

• Execute test & analyze results• Determine any design changes to improve results• Execute next test

• 3 tests with consistent acceptable results generally establishes repeatability of performance

• Issue qualification report

Feb 24, 2015 65

Agenda















Feb 24, 2015 66

Performance Qualification – Size, maximum/minimum load, winter/summer

• Determine Winter Season – maximum and minimum load

• Determine Summer Season – maximum and minimum load

• Determine representative supply chains to conduct test shipments based on Supply Chain Experience

• Issue testing protocol including placement of data loggers

• Execute test shipments & evaluate results

• Issue report• Redesign recommendations

• Consistency and repeatability of results as per acceptance criteria

Feb 24, 2015 67

Agenda















Feb 24, 2015 68

High volume and frequency of commercial products

Feb 24, 2015 69

Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements Annual Shipments

Volume

11 California Puerto Rico Air apparatus ambient corrugated shippers on pallets 26

12 Puerto Rico Mexico Air apparatus ambient corrugated shippers on pallets cross border through El Paso, TX 26

21 New York Puerto Rico Air API 2°C to 8°C Dry Ice refrigerant in corrugated shippers transit through Boston 12

22 Puerto Rico Belgium Air API 2°C to 8°C Dry Ice refrigerant in corrugated shippers transit through Amsterdam for VAT 12

23 Puerto Rico Italy Air API 2°C to 8°C Dry Ice refrigerant in corrugated shippers transit through Amsterdam for VAT 12

31 Ohio Puerto Rico Air widgets ambient corrugated shippers 24

32 Puerto Rico Belgium Air widgets ambient corrugated shippers transit through Amsterdam for VAT 24

33 Puerto Rico Italy Air widgets ambient corrugated shippers transit through Amsterdam for VAT 24

41 Belgium Puerto Rico Air WIP 1 2°C to 8°C Air shipper unit uses dry ice as a



transit through Amsterdam for VAT 104




transit through Amsterdam for VAT 104

43 Puerto Rico Texas Air WIP 2 2°C to 8°C Air ULD pallet shipper unit uses dry ice as



transit via wide body through Florida airport to Texas 104

44 Texas US DC Truck FG 2°C to 8°C Temperature controlled truck 104

51 Puerto Rico Mexico Air WIP 1 2°C to 8°C Air shipper unit uses dry ice as a



cross border through El Paso, TX 104

52 Belgium Mexico Air WIP 1 2°C to 8°C Air shipper unit uses dry ice as a









/ Truck










104

55 Scotland Japan Air FG 2°C to 8°C Air ULD pallet shipper unit uses dry ice as



52

56 Scotland Belgium Truck FG 2°C to 8°C Temperature controlled truck. Truck / ferry 52

Agenda















Feb 24, 2015 70


Fast

CheapGood

Pick Any Two


Low Priority

Requirements

Feb 24, 2015 71

Agenda















Feb 24, 2015 72


Fast

CheapGood

Pick Any Two


Low Priority

Requirements

Feb 24, 2015 73

Creating value through Designing and Implementing a shipping Lane Qualification for High-Value Pharmaceutical Products

Questions?

Thank you!

Alan J. Davis

K. L. Harring Transportation, LLC

[email protected]

717-933-5992

www.KLHARRING.com

Feb 24, 2015 74

mailto:[email protected]

http://www.klharring.com/

coolpack - creating value through designing and ......2015/11/07 · insurers, by providing...

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