©2021 Cryoport Systems, LLC | All Rights Reserved Validation Summary Package 1 17305 Daimler Street Irvine, California 92614 Office 949.470.2300 [email protected] MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
Validation Summary Package
1
17305 Daimler StreetIrvine, California 92614
Office [email protected]
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved 2
Created for customer use onlyProprietary and Confidential
For more information about the data, please contact Cryoport Quality directly at [email protected]
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
Standard Dry Vapor Shipper - Specs
3
IATA Rated for Category BUp to 10-day dynamic holding time qualified under normal shipping conditions per shipment
Specimen Chamber
Specifications Standard Dry Shipper
Dynamic Holding Time Up to 10 days
Holding Temperature -150°C or colder
Core Technology Dry Vapor Liquid Nitrogen
Product Line Availability General Purpose
Specimen Chamber 3.1" (79 mm) diameter11.5" (292 mm) depth
Storage Capacity• 2 cryovial boxes with 60 total
vials (30 vials per box)
• 75 of 1.8 & 2.0 ml vials• 15 canes with 5 vial clips• 75 cryovials, 2.0 ml
Weight Dry – 9.7 lb / 4.4 kg; Charged – 18.3 lb 8.3 kg
Outer Box 12" x 12" x 22" (305 x 305 x 559mm)
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
Standard Combo Dry Vapor Shipper - Specs
4
Top Accessory
Tray
Specifications Standard Combo Dry Shipper
Dynamic Holding Time Up to 10 days
Holding Temperature -150°C or colder
Core Technology Dry Vapor Liquid Nitrogen
Product Line Availability General Purpose
Specimen Chamber 2.8" (71 mm) diameter11.5" (292 mm) depth
Storage Capacity• 2 cryovial boxes with 60 total
vials (30 vials per box)
• 75 of 1.8 & 2.0 ml vials• 15 canes with 5 vial clips• 75 cryovials, 2.0 ml
Top Accessory Tray 7.25” x 10.5” x 2”
Weight Dry – 15 lb / 6.8 kg; Charged – 20 lb / 9.07 kg
Outer Box 12" x 12" x 24" (305 x 305 x 584mm)
May be usedfor paperwork, medical kits, etc.
IATA Rated for Category BUp to 10-day dynamic holding time qualified under normal shipping conditions per shipment
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
IATA Rated for Category BUp to 10-day dynamic holding time qualified under normal shipping conditions per shipment
Specimen Chamber
Current High Volume Dry Vapor Shipper – Specs(Phasing out models by end of July 2021)
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Specifications CXHVO & CXHV1SPHU High Volume Shippers
Dynamic Holding Time Up to 10 days
Holding Temperature -150°C or colder
Core Technology Dry Vapor Liquid Nitrogen
Product Line Availability Advanced Therapy Shipper™ & General Purpose
Specimen Chamber 8.5” (215.9 mm) diameter, 12” (304.8 mm) depth
Storage Capacity – Boxes• 405 vials:
Five 5“ x 5” x 2“ cryovial boxes81 vials (2.0 ml) per box
• 500 vials:Five 5.25” x 5.25“ x 2” cryovial boxes100 vials (2.0 ml) per box
AccessoriesMetal Cryovial Box Rack ORSafepak®XL Tyvek Bag with optional Cryostrap®
Storage Capacity – Canes• 500 vials
100 canesFive vials (2.0 ml) per cane
AccessoriesUp to 4 Metal Canisters with 25 canes per canister ORUp to 6 Safepak® Tyvek bags with 15 canes per bag
Storage Capacity – Cassettes• 9 cassettes (up to 11.13” x 6.5” x 0.5”)• Additional quantities depending on
cassette size
AccessoriesMetal Cassette Rack ORSafepak®XL Tyvek Bag with optional Cryostrap®
Weight Dry - 50 lb / 22.7 kg; Charged - 71 lb / 32.2 kg
Outer Container 22" (558.8 mm) diameter x 28" (711.2 mm) tall
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
IATA Rated for Category BUp to 10-day dynamic holding time qualified under normal shipping conditions per shipment
Upgraded High Volume Dry Vapor Shipper – Specs
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Specifications CXHV2 & CXHV2SPHU High Volume Shippers
Dynamic Holding Time Up to 10 days
Holding Temperature -150°C or colder
Core Technology Dry Vapor Liquid Nitrogen
Product Line Availability Advanced Therapy Shipper™ & General Purpose
Specimen Chamber 8.5” (215.9 mm) diameter, 12” (304.8 mm) depth
Storage Capacity – Boxes• 405 vials:
Five 5“ x 5” x 2“ cryovial boxes81 vials (2.0 ml) per box
• 500 vials:Five 5.25” x 5.25“ x 2” cryovial boxes100 vials (2.0 ml) per box
AccessoriesMetal Cryovial Box Rack ORSafepak®XL Tyvek Bag with optional Cryostrap®
Storage Capacity – Canes• 500 vials
100 canesFive vials (2.0 ml) per cane
AccessoriesUp to 4 Metal Canisters with 25 canes per canister ORUp to 6 Safepak® Tyvek bags with 15 canes per bag
Storage Capacity – Cassettes• 9 cassettes (up to 11.13” x 6.5” x 0.5”)• Additional quantities depending on
cassette size
AccessoriesMetal Cassette Rack ORSafepak®XL Tyvek Bag with optional Cryostrap®
Weight Dry - 57 lb / 26 kg; Charged - 77 lb / 35 kg
Outer Container 22" (558.8 mm) diameter x 28" (711.2 mm) tall
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
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.
• The Sliderite® is a mobile pallet developed to assure that the Cryoport High Volume Shipper 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.
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Sliderite® High Volume Palletized Shipper
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
IATA Rated for Category BUp to 10-day dynamic holding time qualified under normal shipping conditions per shipment
Upgraded Sliderite® Dry Vapor Shipper – Specs
8
Specifications CXSR2 & CXSR2SPHU Sliderite® Shippers
Dynamic Holding Time Up to 10 days
Holding Temperature -150°C or colder
Core Technology Dry Vapor Liquid Nitrogen
Product Line Availability Advanced Therapy Shipper™ & General Purpose
Specimen Chamber 8.5” (215.9 mm) diameter, 12” (304.8 mm) depth
Storage Capacity – Boxes• 405 vials:
Five 5“ x 5” x 2“ cryovial boxes81 vials (2.0 ml) per box
• 500 vials:Five 5.25” x 5.25“ x 2” cryovial boxes100 vials (2.0 ml) per box
AccessoriesMetal Cryovial Box Rack ORSafepak®XL Tyvek Bag with optional Cryostrap®
Storage Capacity – Canes• 500 vials
100 canesFive vials (2.0 ml) per cane
AccessoriesUp to 4 Metal Canisters with 25 canes per canister ORUp to 6 Safepak® Tyvek bags with 15 canes per bag
Storage Capacity – Cassettes• 9 cassettes (up to 9” x 6.5” x 0.5”)• Additional quantities depending on
cassette size
AccessoriesMetal Cassette Rack ORSafepak®XL Tyvek Bag with optional Cryostrap®
Weight Dry - 102.5 lb / 46.5 kg; Charged - 121.25 lb / 55 kg
Outer Container 32" (812.8 mm) W x 35" (889 mm) H x 24" (609.6 mm) L
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
C3™ Refrigerated Shipper - Specs
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Specifications C3™ Refrigerated Shipper
Temperature Range 2°C to 8°C
Duration Up to 96 hours
Product Line Availability General Purpose & Advanced Therapy Shippers™
Cooling Technology TIC Panel Cooling
Volume: 12 L
Weight 22 lb / 9.98 kg
Payload Size Imperial 8.9” x 8.9” x 8.9”
Payload Size Metric 226 x 226 x 226 mm
Outer Dimension Imperial 16” x 14” x 15”
Outer Dimension Metric 407 x 356 x 381 mm
IATA Rated for Category BUp to 96 hour dynamic holding time qualified under normal shipping conditions per shipment
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
C3™ Controlled Room Temperature (CRT) Shipper - Specs
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Specifications C3™ CRT Shipper
Temperature Range 15°C to 25°C
Duration Up to 96 hours (summer profile)Up to 72 hours (winter profile)
Product Line Availability Advanced Therapy Shippers™
Cooling Technology TIC Panel Cooling
Volume: 12 L
Tare Weight 22 lb / 9.98 kg
Payload Size Imperial 8.9” x 8.9” x 8.9”
Payload Size Metric 226 x 226 x 226 mm
Outer Dimension Imperial 16” x 14” x 15”
Outer Dimension Metric 407 x 356 x 381 mm
IATA Rated for Category BUp 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
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
Data Logger & Data Station - Specs
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Two Channel USB Temperature Data Logger Channel 1 Measures Ambient TemperatureChannel 2 Measures Internal Temperature
Manufacturer: Onset Computing
Make: HoboModel: 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. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
Smartpak II® Condition Monitoring System - Specs
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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
Operating Temperature: -20° C to +65° C / -4° F to +140° F
Temperature Measurement Range: -212° C to +100° C
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
Accessories
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Cryostrap® Material: High-density polyethylene (HDPE)Dimensions: 3” l x 36.127” hHolds: 5” x 5” Cryovial Boxes
Up to 9 Blood Cassettes
Canes Material: AluminumDimensions: .5” diameter x 11.25” tall (12.7 x 285.75 mm)Storage Capacity: Five 2.0 ml cryovials per cane
Canisters Material: AluminumDimensions: 2.5” diameter x 12” tallStorage Capacity: 15 Cryocanes with vials
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
Accessories (Continued)
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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 Safepak® & Safepak ®XL bags have been developed to be used in the safe transport of IATA rated Category B infectious substances in Cryoport equipment when used in conjunction with a primary package which meets the 95kPa pressure requirement.
Labels: UN3373, UN3245, No Not X-Ray, Exempt Human Substance, Exempt AnimalSubstance, Tamper Resistant Serialized Labels.
Miscellaneous: Canisters, Racks, Lifters, Goblets
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
Standard Dry Vapor Shipper – Validation Studies
15
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 QualificationConducted by Ten-E Testing LabsPassed 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.
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 specificationsPQ – Three min loads and three max loads tested with Global Shipping Study
Results:OQ – Meets requirementsPQ – Meets minimum 10 day requirement
Validation study available for review during an onsite audit.
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
Standard Combo Dry Vapor Shipper – Validation Studies
16
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 QualificationConducted by Ten-E Testing LabsPassed 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.
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 hoursISTA 3A Drop Test Three min and three max loads tested to ISTA 3A Drop Test specificationsPQ – Three min loads and three max loads tested with Global Shipping Study
Results:OQ – Meets requirementsPQ – Meets minimum 10 day requirement
Validation study available for review during an onsite audit.
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
Current High Volume & Sliderite® Dry Vapor Shippers –Validation Studies
(Phasing out models by end of July 2021)
17
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 QualificationConducted by Ten-E Testing Labs for Chart IndustriesResulting UN Marking 1H2 / Class 6.2 / ** / USA / +AA7309
Holding Time Performance
Regulation/Guidelines: ISTA 7E and 7D (Thermal Performance Validation)
Testing/Validation Study: Cryoport High Volume Dry Vapor Shipper Validation PackagePrepared by MJ ConsultingConducted by WestPak, Inc.
Protocol:OQ – Three min loads and three max loads tested in an environmental chamber using ISTA 7E Heat profiles for 245 hoursPQ- 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 packageTQV – Three min loads and three max loads shipped using standard carrier to determine holding time
Results:OQ – Passed 315 HoursPQ – PassedTQV – Passed 334 Hours
Validation study available for review during an onsite audit.
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
Upgraded High Volume & Sliderite® Dry Vapor Shippers –Validation Studies
18
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 QualificationConducted by Ten-E Testing Labs for Chart IndustriesResulting UN Marking 1H2 / Class 6.2 / ** / USA / +AA7309
Holding Time Performance
Regulation/Guidelines: ISTA 7E (Thermal Performance Validation)
Testing/Validation Study: Cryoport High Volume Dry Vapor Shipper Validation PackagePrepared by MJ ConsultingConducted by WestPak, Inc.
Protocol:OQ – Three min loads and three max loads tested in an environmental chamber using ISTA 7E Summer profile for 240 hoursPQ – ISTA 3A Three min and three max loads tested to ISTA 3A Drop Test, Random Vibration, Random Vibration, Drop Test PQ – ISTA 3B Three max loads tested to ISTA 3B Shock (sequence), Vibration, Shock (sequence)TQV – Three min loads and three max loads shipped using standard carrier to establish commodity protection and shipper durability
Results:OQ – Passed (≥360 hours)PQ – PassedPQ – PassedTQV – Passed
Validation study available for review during an onsite audit.
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
C3™ Refrigerated Shipper – Validation Studies
19
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 QualificationConducted by Ten-E Testing LabsPassed 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.*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 specificationsPQ – Three min loads and three max loads tested with Global Shipping Study
Results:OQ – Meets requirementsPQ – Meets minimum 96 Hour requirement
Validation study available for review during an onsite audit.
MKT-124 Rev. G DCN-1301 Effective Date: 05/26/2021
©2021 Cryoport Systems, LLC | All Rights Reserved
C3™ Controlled Room Temperature (CRT) Shipper –Validation Studies
20
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 QualificationConducted by Ten-E Testing LabsPassed 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.*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 specificationsPQ – Three min loads and three max loads tested with Global Shipping Study
Results:OQ – Meets requirementsPQ – 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. G DCN-1301 Effective Date: 05/26/2021