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Thermal Shipper Handling & Storage Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval. PFIZER CONFIDENTIAL. Page 1 of 23 Thermal Shipper Handling & Storage Current as of November 17, 2020

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Page 1: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 1 of 23

Thermal Shipper Handling & Storage Current as of November 17, 2020

Page 2: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 2 of 23

Change Log

Version History of Changes 01 Initial version 02 Updated formatting and pictures for clarity. 03 Softbox

• Section 5.1 Unpackaging Section:o Step 5, updated with payload box.o Step 6, updated that inspections must be completed

within 5 mins.• Appendix 1, Softbox Diagram updated with payload box.

Aerosafe • Section 5.1 Unpackaging Section:

o Step 7, updated that inspections must be completedwithin 5 mins.

04 Softbox • Section 3.2 Recommendations updated from 1 min to 3

mins for opening thermal shipping container.• Section 5.1 Unpackaging Section:

o Step 6, added information about vial trays not beingout longer than 10 mins.

Aerosafe • Section 3.2 Recommendations updated from 1 min to 3

mins for opening thermal shipping container.• 5.1 Unpackaging Section:

o Step 7, added information about vial trays notbeing out longer than 10 mins.

Page 3: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 3 of 23

Table Of Contents

3.1. Materials ....................................................................................................................................... 5

3.2. Recommendations ........................................................................................................................ 5

4.1. Unpackaging ................................................................................................................................. 6

4.2. Re-Icing ......................................................................................................................................... 9

5.1. Appendix 1: Softbox Medium ULT Parcel Shipper ...................................................................... 14

8.1. Materials ..................................................................................................................................... 16

8.2. Recommendations ...................................................................................................................... 16

9.1. Unpackaging ............................................................................................................................... 17

9.2. Re-Icing ....................................................................................................................................... 20

10.1. Appendix 1: AeroSafe 47L7 ULT Parcel Shipper ......................................................................... 23

Page 4: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 4 of 23

Softbox Medium Thermal Shipper Handling & Storage

Purpose

The purpose of this controlled document is to provide unpackaging and re-icing requirements on the Softbox Medium ULT Parcel Shipper with Dry Ice.

CAUTION: Use of dry ice in confined spaces (small rooms or walk-in coolers) and/or poorly ventilated areas can result in depletion of oxygen resulting in asphyxiation. Exposed skin should be protected from contact with dry ice. Eye protection is recommended (for example, safety glasses).

Appropriate training to be been conducted for personnel handling dry ice and documented within their relevant training system as required.

Scope

This controlled document is applicable to unpackaging and re-icing requirements using the Softbox Medium ULT Parcel Shipper with Dry Ice.

Page 5: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 5 of 23

General Requirements 3.1. Materials

Specification Number Description CD-88557 SPEC – Softbox Medium ULT Parcel Shipper

N/A Insulated (Thermal) Gloves N/A Safety Glasses N/A Carton Sealing Tape N/A Dry Ice Pellets (10 to 16 mm)

3.2. Recommendations

Recommendations (Using Thermal Shipping Container as Temporary Storage)

• The thermal shipping container is a passive (non-compressor) device that contains dry ice as the energy source to maintain the required temperatures when maintained properly as defined by Pfizer instructions. The dry ice in the thermal shipper will deplete over a number of days (duration will vary depending on use and care), which will impact how long the shipper holds the temperatures. This differs from an ultra-low-temperature freezer, an active (electronically powered, compressor-driven) device, which when plugged in, is designed to maintain ultra-low temperatures indefinitely. The longer the thermal shipping container remains closed, the longer it will take for the dry ice to deplete.

• The thermal shipping container should be stored at 15° to 25° Celsius, which is 59° to 77° Fahrenheit.

• The thermal shipping container is qualified with a minimum of 23 kgs of dry ice pellets (10 mm – 16 mm pellets). Upon receipt and after opening, the box should be replenished/inspected with dry ice within 24 hours by adding dry ice to the maximum within the payload insert areas and dry ice pod.

Page 6: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 6 of 23

Recommendations (Using Thermal Shipping Container as Temporary Storage)

• The thermal shipping container should be re-iced every 5 days. • This can help maintain the level of dry ice and the temperature of the

vaccine product. It is recommended that the thermal shipping container not be opened more than 2 times a day, and shouldn’t be opened for more than 3 minutes at a time. If that is followed, the thermal shipping container should then be re-iced every 5 days.

• Local dry ice suppliers should be used for re-icing the thermal shipping container.

• Temperature monitoring devices to be used if thermal shipping container is used as temporary storage. Sites are responsible for obtaining their own temperature monitoring devices to monitor temperatures when using the thermal shipping container as temporary storage. Temperature monitoring devices (probe or probeless) capable of being in a dry ice environment to be used and placed in the location of the vial tray payload area within the thermal shipping container.

• The thermal shipping container should be returned within 20 business days of

delivery, including temperature data logger. • If you receive a Controlant Real-Time Temperature Monitor, it must be

returned with the thermal shipping container. • If you receive a Sensitech Temperature Monitor, it does not need to be

returned.

Procedure

4.1. Unpackaging Responsible Role

Action Step

Operator 1. Before opening the thermal shipping container, make sure the area in which you are working has proper ventilation. Use of dry ice in confined spaces, such as small rooms, walk-in coolers, and/or poorly ventilated areas, can result in depletion of oxygen, resulting in asphyxiation.

2. In a well-ventilated area, open the Outer Corrugated Shipper by cutting the tape on the outside.

Page 7: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 7 of 23

Responsible Role

Action Step

3. Open the lid. Note: One side of the thermal shippingcontainer is permanently affixed so it is recommended to usethe three finger hole die-cut on the foam.

Once the lid is opened the dry ice pod will be seen as illustrated below.

4. While wearing insulated (thermal) gloves, take out the Dry IcePod.

Page 8: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 8 of 23

Responsible Role

Action Step

5. Remove the Payload Box from the thermal shipper by carefully pulling directly upwards with the handles.

6. Once received, the vials should be inspected. Remove the vial trays immediately from the thermal shipping container, inspect, and return to frozen storage within 5 minutes. Store

Page 9: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 9 of 23

Responsible Role

Action Step

in an ultra-low temperature freezer or prepare for use. If shipper will be used as temporary storage for remaining vial trays, immediately re-insert the trays within this five minutes and follow the re-icing instructions. Note: For other activities where just the vial tray must be removed from frozen storage, vial trays should not be at room temperature for longer than 10 minutes before being returned to frozen storage.

*Refer to Recommendations section of this procedure for further details on using the thermal shipping container as temporary storage.

7. If not using the thermal shipping container as temporary storage, insert all components back into the thermal shipping container for return. Dry ice must be discarded in a well ventilated area before considering returning the thermal shipping container.

4.2. Re-Icing Responsible Role

Action Step

Operator 1. Before opening the thermal shipping container, make sure the area in which you are working has proper ventilation. Use of dry ice in confined spaces, such as small rooms, walk-in coolers, and/or poorly ventilated areas, can result in depletion of oxygen, resulting in asphyxiation.

Page 10: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 10 of 23

Responsible Role

Action Step

2. In a well-ventilated area, open the Outer Corrugated Shipperby cutting the tape on the outside.

3. Open the lid. Note: One side of the thermal shippingcontainer is permanently affixed so it is recommended to usethe three finger hole die-cut on the foam.

Once the lid is opened the dry ice pod will be seen as illustrated below.

Page 11: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 11 of 23

Responsible Role

Action Step

4. While wearing insulated (thermal) gloves, take out the Dry Ice Pod.

5. Fill the sides of the payload sleeve with dry ice until it’s equal with the corrugated structure.

Page 12: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 12 of 23

Responsible Role

Action Step

6. Reinsert the Dry Ice Pod and fill with dry ice leaving room between dry ice level and sides of shipper.

7. Close the Dry Ice Pod.

8. Close the Lid, the Outer Corrugated Shipper and reseal with tape.

Page 13: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 13 of 23

Responsible Role

Action Step

Page 14: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 14 of 23

Appendix

5.1. Appendix 1: Softbox Medium ULT Parcel Shipper Note: Approximate weights are based on maximum configuration of dry ice.

Page 15: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 15 of 23

Aerosafe 47L4 Thermal Shipper Handling & Storage

Purpose

The purpose of this controlled document is to provide unpackaging and re-icing requirements on the AeroSafe 47L7 Parcel Shipper with Dry Ice.

CAUTION: Use of dry ice in confined spaces (small rooms or walk-in coolers) and/or poorly ventilated areas can result in depletion of oxygen resulting in asphyxiation. Exposed skin should be protected from contact with dry ice. Eye protection is recommended (for example, safety glasses).

Appropriate training to be been conducted for personnel handling dry ice and documented within their relevant training system as required.

Scope

This controlled document is applicable to unpackaging and re-icing requirements using the AeroSafe 47L7 ULT Parcel Shipper with Dry Ice.

Page 16: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 16 of 23

General Requirements 8.1. Materials

Specification Number Description CD-86218 SPEC – AeroSafe 47L7 Small Parcel Shipper

N/A Insulated (Thermal) Gloves N/A Safety Glasses N/A Carton Sealing Tape N/A Dry Ice Pellets (10 to 16 mm)

8.2. Recommendations Recommendations (Using Thermal Shipping Container as Temporary Storage)

• The thermal shipping container is a passive (non-compressor) device that containsdry ice as the energy source to maintain the required temperatures whenmaintained properly as defined by Pfizer instructions. The dry ice in the thermalshipper will deplete over a number of days (duration will vary depending on useand care), which will impact how long the shipper holds the temperatures. Thisdiffers from an ultra-low-temperature freezer, an active (electronically powered,compressor-driven) device, which when plugged in, is designed to maintain ultra-low temperatures indefinitely. The longer the thermal shipping container remainsclosed, the longer it will take for the dry ice to deplete.

• The thermal shipping container should be stored at 15° to 25° Celsius, which is 59°to 77° Fahrenheit.

• The thermal shipping container is qualified with a minimum of 22 kgs of dry icepellets (10 mm – 16 mm pellets). Upon receipt and after opening, the box shouldbe replenished/inspected with dry ice within 24 hours by adding dry ice to themaximum within the payload insert areas and dry ice pod.

• The thermal shipping container should be re-iced every 5 days.• This can help maintain the level of dry ice and the temperature of the

vaccine product. It is recommended that the thermal shipping containernot be opened more than 2 times a day, and shouldn’t be opened formore than 3 minute at a time. If that is followed, the thermal shippingcontainer should then be re-iced every 5 days.

• Local dry ice suppliers should be used for re-icing the thermal shipping container.

• Temperature monitoring devices to be used if thermal shipping container is usedas temporary storage. Sites are responsible for obtaining their own temperaturemonitoring devices to monitor temperatures when using the thermal shipping

Page 17: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 17 of 23

Recommendations (Using Thermal Shipping Container as Temporary Storage)

container as temporary storage. Temperature monitoring devices (probe or probeless) capable of being in a dry ice environment to be used and placed in the location of the vial tray payload area within the thermal shipping container.

• The thermal shipping container should be returned within 20 business days of

delivery, including temperature data logger. • If you receive a Controlant Real-Time Temperature Monitor, it must be

returned with the thermal shipping container. • If you receive a Sensitech Temperature Monitor, it does not need to be

returned.

Procedure

9.1. Unpackaging Responsible Role

Action Step

Operator 1. Before opening the thermal shipping container, make sure the area in which you are working has proper ventilation. Use of dry ice in confined spaces, such as small rooms, walk-in coolers, and/or poorly ventilated areas, can result in depletion of oxygen, resulting in asphyxiation.

2. In a well-ventilated area, open the Outer Corrugated Shipper by cutting the tape on the outside.

Page 18: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 18 of 23

Responsible Role

Action Step

3. Remove the VIP Lid carefully as the temperature monitorprobe is connected to the Payload Box. Care should be takento not disconnect the probe from the Payload Box.

4. While wearing insulated (thermal) gloves, take out the Dry IceTray.

Page 19: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 19 of 23

Responsible Role

Action Step

5. Remove the Payload Box from the thermal shipper by carefully pulling directly upwards. Care should be taken to not disconnect the probe from the Payload Box.

6. Open the Payload Box and remove the vial tray.

7. Take out the product for inspection and immediately (within five minutes of opening) store in an ultra-low temperature freezer or prepare for use. If shipper will be used as temporary storage for remaining vial trays, immediately re-insert the trays within this five minutes and follow the re-icing instructions. Once received, the vials should be inspected. Remove the vial trays immediately from the thermal shipping container, inspect, and return to frozen storage within 5 minutes. Store in an ultra-low temperature freezer or prepare for use. If shipper will be used as temporary storage for remaining vial trays, immediately re-insert the trays within this five minutes and follow the re-icing instructions.

Page 20: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 20 of 23

Responsible Role

Action Step

Note: For other activities where just the vial tray must be removed from frozen storage, vial trays should not be at room temperature for longer than 10 minutes before being returned to frozen storage.

*Refer to Recommendations section of this procedure forfurther details on using the thermal shipping container astemporary storage.

8. If not using the thermal shipping container as temporarystorage, insert all components back into the thermal shippingcontainer for return.

Dry ice must be discarded in a well ventilated area beforeconsidering returning the thermal shipping container.

9.2. Re-Icing

Responsible Role

Action Step

Operator 1. Before opening the thermal shipping container, make sure thearea in which you are working has proper ventilation. Use of

Page 21: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 21 of 23

Responsible Role

Action Step

dry ice in confined spaces, such as small rooms, walk-in coolers, and/or poorly ventilated areas, can result in depletion of oxygen, resulting in asphyxiation.

2. In a well-ventilated area, open the Outer Corrugated Shipper by cutting the tape on the outside.

3. Remove the VIP lid, Item A.

Page 22: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 22 of 23

Responsible Role

Action Step

4. While wearing insulated (thermal) gloves, take out the Dry Ice Tray, Item B as required to get better access to the Scaffolding to begin re-icing.

5. Fill the Scaffolding, Item D of the shipper with dry ice to the top of the scaffolding.

6. Reinsert the Dry Ice Tray, Item B on top of the Payload Box, Item C. Fill the Dry Ice Tray, Item B with dry ice to the top.

7. Add the VIP Shipper Lid, Item A back on top.

8. Fold the outer corrugated flaps and reseal shipper with tape.

Page 23: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 23 of 23

Responsible Role

Action Step

Appendix

10.1. Appendix 1: AeroSafe 47L7 ULT Parcel Shipper Note: Approximate weights are based on maximum configuration of dry ice.

Page 24: Thermal Shipper Handling & Storage

Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.

PFIZER CONFIDENTIAL.

Page 24 of 23

Page 25: Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.PFIZER CONFIDENTIAL.

Shipping & Handling OverviewCurrent as of November 6, 2020

Page 26: Thermal Shipper Handling & Storage

3

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.PFIZER CONFIDENTIAL.

Direct Shipment to Points of Vaccination

*COVID Vaccine supply chain model is a drop ship direct from Pfizer manufacturing sites to the designated locations by the governments. Markets with no Pfizer commercial legal entity: Product ownership transfer at port of entry for governmental customer importation and in-market distribution

Controlant Reusable

RTM Logger

• Each thermal shipper has reusable GPS enabled temperature monitoring device which will be enabled when the shipper is packed.

• All shipments will be tracked via the onboard GPS monitoring device to ensure end-to-end distribution within required temperatures.

• Shipments will be executed under the management of Pfizer Quality processes and controls to ensure that upon ownership transfer, product has arrived under acceptable conditions.

• Temperature records of the shipments can be shared with upon request.

Pfizer has designed a distribution model which is built on a flexible just in time system to ship the vaccine from manufacturing site and/or storage facility directly to the points of vaccination.

Direct Shipments* to Vaccination Center by Transport Courier Temperature & Location Tracking During Transportation

Thermal Shippers may have slight differences depending on manufacturer.

Page 27: Thermal Shipper Handling & Storage

4

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.PFIZER CONFIDENTIAL.

Product Packaging Overview

2 mL Type 1 glass preservative-free

1. Primary Packaging 2. Secondary Packaging“Single Tray”

3. Tertiary Container: Thermal Shipper

• 2 mL type 1 glass preservativefree multi-dose vial (MDV)

• MDV has 0.45 mL frozen liquiddrug product

• 5 doses per vial after dilution

• Single tray holds 195 vials• 975 doses per tray• A smaller tray, containing 25 vials (125

doses) is in development withestimated availability in early 2021

• Minimum 1 tray (975 doses) or up to 5 trays (4875 doses) stacked in a payloadarea of the shipper

• Payload carton submerged in dry ice pellets• Thermal shipper keeps ULT -75+15°C (-103° to 5°F) up to 10 days if stored at

15°C to 25°C (5° to 77°F) temperatures without opening• Thermal shippers are reusable and designed to be a temporary storage containers

by replenishing dry ice.

Item Description

Dry Ice Pod

Payload (Vial Trays)

Inner Lid

Payload Box

Outer Carton

1

2

3

4

5

Thermal Shippers may have slight differences depending on manufacturer.

Page 28: Thermal Shipper Handling & Storage

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.PFIZER CONFIDENTIAL.

Dry Ice ProcurementCurrent as of November 6, 2020

Page 29: Thermal Shipper Handling & Storage

3

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.PFIZER CONFIDENTIAL.

US Dry Ice Assessment Summary

Capacity/Capability Review

Assessment Criteria• Availability – liquid CO2 and dry ice market capacity relative to vaccine dry ice need• Delivery support – geographic coverage and service models

Outcomes• CO2 and dry ice quantity is back to pre-COVID levels• US manufacturers ~2.5 million tons of dry ice per year

o Vaccine dry ice need is 1-2% of market total• Three industrial gas companies are able/willing to deliver dry ice to up to 10K Vx centers

o Airgas, Continental Carbonic, and Linde have 1,000s of locations in the US and existing accounts with most hospitals/ universities (Suppliers stated preference is to directly service PoU)

Vaccine Center Considerations

Service Set Up• Order to deliver will take 1 to 4 weeks• Centrally coordinated top-off dry-ice delivery may increase lead time and complexity.• Indicative cost is ~$1 per pound (+/- 50%) and is dependent on location, quantity

delivered, and container type • Handling in accordance with safety and procedural guidance

Page 30: Thermal Shipper Handling & Storage

4

Logistics and Handling Information Intended for the Use of State Immunization Units, Current as of November 2020, Subject to Change. Specifications and assumptions are subject to change. No claims with respect to safety or efficacy are intended to be made prior to regulatory approval.PFIZER CONFIDENTIAL.

Company

Product details

• Standard Pellets sizes approximately ½‘’ – ¾” diameter

• Regular Pellets ¾” diameter• Rice Pellets: ¼” diameter• Blasting Pellets 1/8” diameter

• Regular Pellets ¾” diameter• Rice Pellets: ¼” diameter• Blasting Pellets 1/8” diameter

• Regular Pellets ¾” diameter• Rice Pellets: ¼” diameter• Blasting Pellets 1/8” diameter

Logistics 15 production facilities and 50 distribution centers across the United States.

500,000 customers in North America served through direct delivery, distribution centers, retail stores, and e-commerce solutions.

• Over 300 locations in the US• Operations in 44 US states.

• Over 300 locations in the US• Operations in 44 US states.

Contact David JoynerNational Carbon Dioxide Product [email protected]

Airgas has set up a call center and a website link for vaccine centers to submit requests.Airgas Dry Ice Contact UsPhone: 1-800-329-0010

Jen GrussDirector Strategic [email protected](515)-689-1440

Dennis HarrisPresident Continental [email protected]

Francisco GarciaExecutive Vice President Operations [email protected]

US Dry-Ice Provider Contacts

Page 31: Thermal Shipper Handling & Storage

Dry Ice Safety Awareness Training

SAMPLE

Page 32: Thermal Shipper Handling & Storage

Training Outline

• What is Dry Ice?

• Hazards

• Handling• Personal Protective Equipment

• Storage

• Disposal

• Transportation

• Emergency Response

• Summary

Page 33: Thermal Shipper Handling & Storage

SAMPLE

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SAMPLE

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SAMPLE

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SAMPLE

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SAMPLE

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SAMPLE

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SAMPLE

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SAMPLE

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SAMPLE