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
• 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 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
Industry Best Practices
• 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
Industry Best Practices
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
Industry Best Practices
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
Industry Best Practices
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
• 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 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
refrigerant and D-cell batteries to power
the fans and controller.
transit through Amsterdam for VAT
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
the fans and controller.
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
Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements
51 Puerto Rico 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
52 Belgium 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
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
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
55 Scotland Japan Air FG 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.
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
Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements
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
Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements
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
Risk Assessment
• Ohio to Puerto Rico
Feb 24, 2015 22
Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements
31 Ohio Puerto Rico Air widgets ambient corrugated shippers
Feb 24, 2015 23
Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements
31 Ohio Puerto Rico Air widgets ambient corrugated shippers
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
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
• 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 24
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 25
Risk Assessment
• California to Puerto Rico
Feb 24, 2015 26
Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements
11 California Puerto Rico Air apparatus ambient corrugated shippers on pallets
Feb 24, 2015 27
Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements
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
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
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
• 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 28
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 29
Risk Assessment
• Mexico to Scotland
Feb 24, 2015 30
Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements
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
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
Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements
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,
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
Destination unloads
Air ULD Pallet
shipper and receives
shipment
Return Logistics of
Air ULD Pallet
shipper is executed
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 34
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 35
Risk Assessment
• Italy to Mexico
Feb 24, 2015 36
Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements
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
Feb 24, 2015 37
Feb 24, 2015 38
Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements
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
Process Step Key Process Input
Potential
Failure
Modes
Potential Failure
Effects Severity Class Potential Causes Occurrence Current Process Controls Detection RPN
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
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 interim
airport
Aircraft unloaded at interim
airport
Shipment re-iced if required
Shipment stored at interim
airport
Aircraft loaded at interim
airport
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
Destination unloads Air shipper
unit and receives shipment
Return Logistics of Air shipper
unit is executed
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 39
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 40
Risk Assessment
Feb 24, 2015 41
• Italy to Puerto Rico
Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements
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
Feb 24, 2015 42
Lane # Origin Destination Mode Commodity Temperature Shipper Design Special requirements
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
Process Step Key Process Input
Potential Failure
Modes
Potential Failure
Effects Severity Class Potential Causes Occurrence Current Process Controls Detection RPN
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
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 interim
airport
Aircraft unloaded at interim
airport
Shipment re-iced if required
Shipment stored at interim
airport
Aircraft loaded at interim
airport
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
Destination unloads Air shipper
unit and receives shipment
Return Logistics of Air shipper
unit is executed
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 43
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 44
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 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
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 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
• 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 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
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Case study: Compare passive versus active container qualification
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
Case study: Compare passive versus active container qualification
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
• 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 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
• 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 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
• 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 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
Design Qualification – Scope document & user requirements
• 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
Design Qualification – Scope document & user requirements
• 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
• 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 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
• 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 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
• 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 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
refrigerant and D-cell batteries to power
the fans and controller.
transit through Amsterdam for VAT 104
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 104
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
the fans and controller.
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
refrigerant and D-cell batteries to power
the fans and controller.
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
refrigerant and D-cell batteries to power
the fans and controller.
cross border through El Paso, TX 104
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 104
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
104
55 Scotland Japan Air FG 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.
52
56 Scotland Belgium Truck FG 2°C to 8°C Temperature controlled truck. Truck / ferry 52
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 70
Good, Fast, or Cheap
Fast
CheapGood
Pick Any Two
Low QualityPay For Quality
Low Priority
Requirements
Feb 24, 2015 71
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 72
Good, Fast, or Cheap
Fast
CheapGood
Pick Any Two
Low QualityPay For Quality
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
717-933-5992
www.KLHARRING.com
Feb 24, 2015 74