Validation Summary Package

©2021 Cryoport Systems, LLC | All Rights Reserved

Validation Summary Package

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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]



Standard Dry Vapor Shipper - Specs

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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)



Standard Combo Dry Vapor Shipper - Specs

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Top Accessory

Tray

Specifications Standard Combo Dry Shipper




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.





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




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




Upgraded High Volume Dry Vapor Shipper – Specs

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Specifications CXHV2 & CXHV2SPHU High Volume Shippers













Storage Capacity – Cassettes• 9 cassettes (up to 11.13” x 6.5” x 0.5”)• Additional quantities depending on

cassette size


Weight Dry - 57 lb / 26 kg; Charged - 77 lb / 35 kg

Outer Container 22" (558.8 mm) diameter x 28" (711.2 mm) tall



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




Upgraded Sliderite® Dry Vapor Shipper – Specs

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Specifications CXSR2 & CXSR2SPHU Sliderite® Shippers













Storage Capacity – Cassettes• 9 cassettes (up to 9” x 6.5” x 0.5”)• Additional quantities depending on

cassette size


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



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



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



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



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



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



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



Standard Dry Vapor Shipper – 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 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.



Standard Combo Dry Vapor Shipper – Validation Studies

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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.


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




Current High Volume & Sliderite® Dry Vapor Shippers –Validation Studies

(Phasing out models by end of July 2021)

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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


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




Upgraded High Volume & Sliderite® Dry Vapor Shippers –Validation Studies

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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


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




C3™ Refrigerated Shipper – Validation Studies

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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


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




C3™ Controlled Room Temperature (CRT) Shipper –Validation Studies

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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


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)



Documents

Validation Summary Package