Validation Package
17305 Daimler Street
Irvine, California 92614
Office 949.470.2300
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
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Created for customer use only
Proprietary and Confidential
For more information about the data, please contact Cryoport Quality directly at [email protected]
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
SPECIFICATIONS Standard Dry Vapor Shipper
(EXP6)
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Dynamic Holding Time: Up to 10 Days
Holding Temperature: -150°C or colder
Core Technology: Dry Vapor Liquid Nitrogen
Specimen Chamber: 3.1" (79mm) diameter
11.5" (292mm) depth
Storage Capacity: 75 of 1.8 & 2.0 ml vials
15 canes with 5 vial clips
75 cryovials, 2.0 ml
Weight: Dry 9.7 lbs./ 4.4 kg
Charged 18.3 lbs./ 8.3 kg
Domestic Dimensional: 21.07 lbs. / 9.56 kg
International Dimensional: 24.87 lbs. / 11.28 kg
Outer Box: 12" x 12" x 22"
(305 x 305 x 559mm)
IATA Rated for Category B
Up to 10-day dynamic holding time qualified under normal shipping conditions per shipment
Specimen Chamber
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
FEATURES Standard Dry Vapor Shipper
(EXP6)
• Flat bottom for improved handling and
package design
• Lockable vapor plug with aesthetically
appealing Cryoport Blue cap
• Integrated Thermocouple installation tube
• Cabosil fumed silica absorption material
• Streamlined thermocouple lead wire assembly
• Improvement in the average overall hold-time
performance
• Meets ISTA 3A, and ISTA 7E and IATA PI 650Returnable Package Construction
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Rollerboard
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
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SPECIFICATIONS Combo Dry Vapor Shipper
(CXCBO)
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Dynamic Holding Time: Up to 10 Days
Holding Temperature: -150°C or colder
Core Technology: Dry Vapor Liquid Nitrogen
Specimen Chamber: 2.8" (71mm) diameter
11.5" (292mm) depth
Storage Capacity: 75 of 1.8 & 2.0 ml vials
15 canes with 5 vial clips
75 cryovials, 2.0 ml
Combo Box
Top Accessory Tray: 7.25” x 10.5” x 2”May be used for paperwork, medical kits, etc.
Weight: Dry 15 lbs./ 6.8 kg
Charged 20 lbs./ 9.07 kg
Domestic Dimensional: 21.07 lbs./ 9.56 kg
International Dimensional: 24.87 lbs./ 11.28 kg
Outer Box: 12" x 12" x 24"
(305 x 305 x 584mm)
IATA Rated for Category B
Up to 10-day dynamic holding time qualified under normal shipping conditions per shipment
Top
Accessory
Tray
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
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SPECIFICATIONS High Volume Dry Vapor Shipper
(CXHVO)
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Dynamic Holding Time: Up to 10 Days
Holding Temperature: -150°C or colder
Core Technology: Dry Vapor Liquid Nitrogen
Specimen Chamber : 8.5” (215.9 mm) diameter
12.75” (323.85 mm) depth
Storage Capacity: Five 5“x 5” x 2“ cryovial boxes
81 2.0 ml vials per box = 405 vials
Five 5.25” x 5.25“ x 2” cryovial boxes
100 2.0ml vials per box = 500 vials
Six Safepak® bags with 15 5-vial canes per bag
75 2.0ml vials per bag = 450 vials
One Safepak®XL bag (with optional Cryostrap®)
Dimensions of the 7.3” (185.42 mm) diameter
Internal Canister*: 8.6” (218.44 mm) depth*When using for Category A and B substances
Weight: Dry 50 lbs./ 22.7 kg
Charged 71 lbs./ 32.2 kg
Domestic Dimensional: 79.68 lbs. / 36.14 kg
International Dimensional: 94.01 lbs. / 42.64 kg
Outer Container: 22" (558.8 mm) diameter x 27" (685.8mm) tall
IATA Rated for Category B
Up to 10-day dynamic holding time qualified under normal shipping conditions per shipment Specimen Chamber
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
FEATURES High Volume Dry Vapor Shipper
(CXHVO)
• Custom designed, light weight
aircraft grade aluminum
• Vapor plug
• Liquid Nitrogen retention media
• Cryogenic temperatures up to 10
days
• Large payload capacity
• Impervious to External Heat
7MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
The Sliderite™ pallet has two primary
modes that are controlled by the pedals on
either end of the pallet.
Pushing down on the RED pedal puts the
pallet into the stationary mode. In this
mode the pallet will not roll.
Pushing on the GREEN Pedal put the pallet
into the motion mode and allows the pallet
to be rolled about.
SPECIFICATIONS Sliderite® - High Volume
Shipper Palletized (SRHVO)
• The Sliderite® is a mobile pallet developed
to assure that the Cryoport High Volume
Shipper (CXHVO) remains in the upright
position.
• Maintaining this orientation assures that the
shippers validated temperature hold time
can be achieved.
• It also allows for easy mobility of the High
Volume Shipper.
• Outer Dimensions: 24” L x 32” W x 36” H
• Weight: Dry – 92 lbs. / 42 kg
Charged – 121 lbs / 55 kg
8MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
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Dynamic Holding Time: Up to 96 Hours
Holding Temperature: 2°C - 8°C
Core Technology: Phase Change
Specimen Chamber: 8.9” x 8.9” x 8.9”
Weight: 25 lbs./ 11.34 kg
Dimensional Weight 21 lbs./ 9.52 kg
Outer Box: 16" x 14" x 15"
(407 x 356 x 381mm)
IATA Rated for Category B
Up to 96 hour dynamic holding time qualified under normal
shipping conditions per shipment.
SPECIFICATIONS C3™ 2 - 8°C Shipper
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
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Dynamic Summer
Profile Holding Time: Up to 96 Hours
Dynamic Winter
Profile Holding Time: Up to 72 hours
Holding Temperature: 15°C - 2°5C
Core Technology: Phase Change
Specimen Chamber: 8.9” x 8.9” x 8.9”
Weight: 25 lbs./ 11.34 kg
Dimensional Weight 21 lbs./ 9.52 kg
Outer Box: 16" x 14" x 15"
(407 x 356 x 381mm)
IATA Rated for Category B
Up to 96 hour dynamic summer profile holding time qualified under
normal shipping conditions per shipment.
Up to 72 hour dynamic winter profile holding time qualified under
normal shipping conditions per shipment.
SPECIFICATIONS C3™ CRT Shipper
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
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SPECIFICATIONS Data Logger and Data Station
Two Channel USB Temperature Data Logger
Channel 1 Measures Ambient Temperature
Channel 2 Measures Internal Temperature
Manufacturer: Onset Computing
Make: Hobo
Model: U12-014
Calibration Schedule: Annually by third party (NIST traceable
standards)
Standard Sampling Frequency: 5 minutes
The Cryoport Data Station allows for onsite download of the Data
Logger Temperature Tracking Report
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
SPECIFICATIONS Smartpak II®
Condition Monitoring System
Provides real time cellular tracking of location when used in conjunction with the Live View™ service feature (SRV-LIV)
Monitors and also measures the following:
• Temperature
• Orientation
• Shock
• Pressure
• Humidity
• Light
• Battery Life
Size: 5.31” x 2.09” x .55”
Operating Temperature: -20° C to +65° C / -4° F to +140° F
Temperature Measurement Range: -212° C to +100° C
Live View™
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ACCESSORIES
Cryostrap® Material: High-density polyethylene (HDPE)
Dimensions: 3” l x 36.127” h
Holds: 5’ x 5” Cryovial Boxes
Up to 9 Blood Cassettes
Canes Material: Aluminum
Dimensions: .5” diameter x 11.25” tall (12.7 x 285.75 mm)
Storage Capacity: Five 2.0 ml cryovials per cane
Canisters Material: Aluminum
Dimensions: 2.5” diameter x 12” tall
Storage Capacity: 15 Cryocanes with vials
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
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ACCESSORIES (continued)
Safepak® Material: Tyvek – 1073B (medical grade)
Tyvek Bags Dimensions: 5“ l x 23.625” h
(127 x 600 mm)
Safepak®XL Material: Tyvek – 1073B (medical grade)
Tyvek Bags Dimensions: 6.5" l x 5" w x 23.125" h
(165.1 x 127 x 587.4 mm)
Storage Capacity: 1 Box Rack
The Tyvek bags are used for infectious substances and pass IATA
testing for class 6.2 substances. IATA Rated for Category B.
Labels: UN3373, UN2814, UN2900, UN3245, No Not X-Ray,
Exempt Human Substance, Exempt Animal
Substance, Tamper Resistant Serialized Labels.
Miscellaneous: Canisters, Racks, Lifters, Goblets
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
VALIDATION CXCBO Validation Studies
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Infectious Substance Shipping
Regulation/Guidelines: IATA Packaging Instruction 650 (Class 6 – Toxic and Infectious Substances UN 3373)
Testing/Validation Study: Infectious Substance Category B Design Qualification
Conducted by Ten-E Testing Labs
Passed the standards of the DEPARTMENT OF TRANSPORTATION’S TITLE 49 CFR; Category B Infectious
Substance, Section 173.199. This package is also certified under IMDG, and the UN Recommendations on the
Transport of Dangerous Goods.
Reports available upon request
Holding Time Performance
Regulation/Guidelines: ISTA 7E-2010 (Heat) and ISTA 3A-2008 (Thermal and Performance Validation)
Testing/Validation Study: EXP-5 Hold Time Study and Qualification for EXP-5 CXCBO
Protocol:
OQ – Three min loads and three max loads tested in an environmental chamber using ISTA 7E Heat
profiles for 245 hours. ISTA 3A Drop Test Three min and three max loads tested to ISTA 3A Drop Test
specifications.
PQ – Three min loads and three max loads tested with Global Shipping Study.
Results:
OQ – Meets requirements
PQ – Meets minimum 10 day requirement
Validation study available for review during an onsite audit.
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
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VALIDATION EXP6 Validation Studies
Infectious Substance Shipping
Regulation/Guidelines: IATA Packaging Instruction 650 (Class 6 – Toxic and Infectious Substances UN 3373)
Testing/Validation Study: Infectious Substance Category B Design Qualification
Conducted by Ten-E Testing Labs
Passed the standards of the DEPARTMENT OF TRANSPORTATION’S TITLE 49 CFR; Category B Infectious
Substance, Section 173.199. This package is also certified under IMDG, and the UN Recommendations on the
Transport of Dangerous Goods.
Reports available upon request
Holding Time Performance
Regulation/Guidelines: ISTA 7E-2010 (Heat) and ISTA 3A-2008 (Thermal and Performance Validation)
Testing/Validation Study: EXP-6 Hold Time Study and Qualification for EXP-6 Standard Shipper
Protocol:
OQ – Three min loads and three max loads tested in an environmental chamber using ISTA 7E Heat
profiles for 245 hours. ISTA 3A Drop Test Three min and three max loads tested to ISTA 3A Drop Test
specifications.
PQ – Three min loads and three max loads tested with Global Shipping Study.
Results:
OQ – Meets requirements
PQ – Meets minimum 10 day requirement
Validation study available for review during an onsite audit.
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
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VALIDATION CXHVO Validation Studies
Infectious Substance Shipping
Regulation/Guidelines: IATA Packaging Instruction 620 (Class 6 – Toxic and Infectious Substances UN 2814 and UN 2900)
IATA Packaging Instruction 650 (Class 6 – Toxic and Infectious Substances UN 3373)
Testing/Validation Study: 1H2 Infectious Substance Category A Design Qualification
Conducted by Ten-E Testing Labs for Chart Industries
Resulting UN Marking for EXP5 1H2 / Class 6.2 / ** / USA / +AA7309
Reports available upon request
Holding Time Performance
Regulation/Guidelines: ISTA 7E and 7D (Thermal Performance Validation)
Testing/Validation Study: Cryoport High Volume Dry Vapor Shipper Validation Package
Prepared by MJ Consulting
Conducted by WestPak, Inc.
Protocol:
OQ – Three min loads and three max loads tested in an environmental chamber using ISTA 7E Heat
profiles for 245 hours
PQ- ISTA 3A Drop Test Three min and three max loads tested to ISTA 3A Drop Test specifications, 17
drops from 12 to 24 inches each package.
TQV – Three min loads and three max loads shipped using standard carrier to determine holding time
Results:
OQ – Passed 315 Hours
PQ – Passed
TQV – Passed 334 Hours
Validation study available for review during an onsite audit.
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
VALIDATION C3™ 2-8°C Validation Studies
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Infectious Substance Shipping
Regulation/Guidelines: IATA Packaging Instruction 650 (Class 6 – Toxic and Infectious Substances UN 3373)
Testing/Validation Study: Infectious Substance Category B Design Qualification
Conducted by Ten-E Testing Labs
Passed the standards of the DEPARTMENT OF TRANSPORTATION’S TITLE 49 CFR; Category B Infectious
Substance, Section 173.199. This package is also certified under IMDG, and the UN Recommendations on the
Transport of Dangerous Goods.
Reports available upon request
* For blood bags only
Holding Time Performance
Regulation/Guidelines: ISTA 7E-2010 and ISTA 3A-2008 (Thermal and Performance Validation)
Testing/Validation Study: C3™ Hold Time Study and Qualification for C3™
Protocol:
OQ – Three min loads and three max loads tested in an environmental chamber using ISTA 7E
Summer & Winter profiles for 245 hours. ISTA 3A Drop Test Three min and three max loads tested to
ISTA 3A Drop Test specifications.
PQ – Three min loads and three max loads tested with Global Shipping Study.
Results:
OQ – Meets requirements
PQ – Meets minimum 96 Hour requirement
Validation study available for review during an onsite audit.
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020
VALIDATION C3™ CRT Validation Studies
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Infectious Substance Shipping
Regulation/Guidelines: IATA Packaging Instruction 650 (Class 6 – Toxic and Infectious Substances UN 3373)
Testing/Validation Study: Infectious Substance Category B Design Qualification
Conducted by Ten-E Testing Labs
Passed the standards of the DEPARTMENT OF TRANSPORTATION’S TITLE 49 CFR; Category B Infectious
Substance, Section 173.199. This package is also certified under IMDG, and the UN Recommendations on the
Transport of Dangerous Goods.
Reports available upon request
* For blood bags only
Holding Time Performance
Regulation/Guidelines: ISTA 7E-2010 and ISTA 3A-2008 (Thermal and Performance Validation)
Testing/Validation Study: C3™ Hold Time Study and Qualification for C3™
Protocol:
OQ – Three min loads and three max loads tested in an environmental chamber using ISTA 7E
Summer & Winter profiles for 245 hours. ISTA 3A Drop Test Three min and three max loads tested to
ISTA 3A Drop Test specifications.
PQ – Three min loads and three max loads tested with Global Shipping Study.
Results:
OQ – Meets requirements
PQ – Meets minimum 96 Hour requirement (Summer Profile)
– Meets minimum 72 Hour requirement (Winter Profile)
Validation study available for review during an onsite audit.
MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020