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1.

Introduction

1. INTRODUCTION

The CryoSure

®

system is designed for global shipping and storage of pharmaceutical products, clinical trial

materials, vaccines, cell & gene therapy, biospecimens and specialty medicines that are required to be kept
below -70°C (-94°F).

The CryoSure

®

system uses a unique patented technology combined with dry ice. It is a

reusable

shipping

system which offers both mechanical protection of the shipped product and maintains load space temperature
below -70°C (-94°F) (average between -74°C and -80°C / -101°F and -112°F).

• Maintains temperature control consistently below -70°C (-94°F)

• Suitable for any destination, domestic or international, and by ground or air, covering the entire shipment

duration including delays and customs without the need to re-charge

• Provides mechanical protection during transport by ground or air

The CryoSure

®

system comes in four different sizes, with product space volume from 1 L to 10.8 L. The

temperature control duration is intended to last throughout the shipment without recharging.

These systems will be pre-charged with dry ice at an Envirotainer facility and be delivered to a second location
where temperature-sensitive materials can be loaded into the dewar for transit or storage.

1.1 OVERVIEW

The CryoSure

®

product line consist of four different sizes.

Table 1 Product specification

CryoSure°
system

X1

X2

X5

X11

Autonomous
duration*

>8 days

>21 days

>13 days

>15 days

Average
sublimation rate

0,0055 kg / hour

0,0063 kg / hour

0,010 kg / hour

0,012 kg / hour

Payload opening

Ø 9 cm
(Ø 3.5ʺ)

Ø 9 cm
(Ø 3.5ʺ)

Ø 15.2 cm
(Ø 6ʺ)

Ø 21,3 cm
(Ø 8.4ʺ)

Dry-ice payload

1,2 kg
(2.5 lb.)

3,5 kg
(7.7 lb.)

3,2 kg
(7.2 lb.)

5,5 kg
(12 lb.)

Product payload

1 L
(33.7 oz.)

1.6 L
(55 oz.)

5 L
(170.3 oz.)

11.1 L
(376.3 oz.)

Product space
(DxH)

8,1 x 19,5 cm
(3.2ʺ x 7.7ʺ)

8,1 x 31,9 cm
(3.2ʺ x 12.6ʺ)

14,3 x 31,5 cm
(5.6ʺ x 12.4ʺ)

20,7 x 33,2 cm
(8.1ʺ x 13.1ʺ)

Outer dimensions
of box (WxLxH)

27,5 x 27,5 x 42,4 cm
(10.8ʺ x 10.8ʺ x 16.7ʺ)

30 x 30 x 59 cm
(11.8ʺ x 11.8ʺ x
23.2ʺ)

33,8 x 33,8 x 59 cm
(13.3ʺ x 13.3ʺ x
23.2ʺ)

45,7 x 45,7 x 63,5 cm
(18ʺ x 18ʺ x 25ʺ)

Total weight

(excl. product load)

4,8 kg
(10.6 lb.)

9,9 kg
(21.7 lb.)

11,3 kg
(24.8 lb.)

16,8 kg
(37 lb.)

* When exposed to ISTA 7D summer profile

1 (14)

Doc No:
UM-CRYO-3030

Revision:
2

State:
Released

Release Date:
2021-12-01

Approved By:
hanst

Summary of Contents for CryoSure X1

Page 1: ...X1 X2 X5 X11 Doc No UM CRYO 3030 Version 2 www envirotainer com CryoSure systems User Manual Doc No UM CRYO 3030 Revision 2 State Released Release Date 2021 12 01 Approved By hanst...

Page 2: ...UN3481 information If system is equipped by Envirotainer with a track er the safety sticker will be added from the start 3 3 Monitor the autonomy duration left on your CryoSure system replaces chapter...

Page 3: ...CryoSure system 5 2 3 Cleanliness of product 5 3 USING THE CRYOSURE SYSTEM 6 3 1 Preparing a shipment 6 3 2 Operating instructions 6 3 2 1 Product loading 7 3 2 2 Shipping of loaded product 9 3 2 3 P...

Page 4: ...Intentionally left blank Doc No UM CRYO 3030 Revision 2 State Released Release Date 2021 12 01 Approved By hanst...

Page 5: ...out recharging These systems will be pre charged with dry ice at an Envirotainer facility and be delivered to a second location where temperature sensitive materials can be loaded into the dewar for t...

Page 6: ...nes without sleeves 5 vials cane 70 Canister holding 14 canes with sleeves 5 vials cane CryoSure X5 300 Canister holding 60 canes without sleeves 5 vials cane 200 2 boxes oriented vertically 100 vials...

Page 7: ...and material to be preserved C Product space To place product holder in D Insulating lid Cap and insulating cork used to close the dewar opening while allowing carbon dioxide vapor from sublimating dr...

Page 8: ...2 Safety IMPORTANT Biological materials used with the CryoSure systems are limited to Biological Substance Category B materials specified under UN 3373 and exceptions defined in IATA 3 6 2 2 3 No path...

Page 9: ...inside In normal operation it should not be necessary for users of a pre charged CryoSure system to handle dry ice The interior spaces and surfaces of a pre charged dewar are very cold and users are a...

Page 10: ...2 1 Product loading 2 Shipping CryoSure system 3 2 2 Shipping of loaded product Remove old labels and documents Prepare new labels and documents for cardboard box 3 Receiving CryoSure system and remo...

Page 11: ...s remove the lid Place the lid to one side together with the tracker and probe if any DANGER DO NOT DISCARD THE LID Fig 4 3 Loading the product 3a Lift the product holder by its handle and remove it f...

Page 12: ...5 4 Place the following items back in place 4a lid wearing safety gloves 4b tracker and probe if any 4c top foam A C B B G00007531 8 14 Doc No UM CRYO 3030 Revision 2 State Released Release Date 2021...

Page 13: ...1 Remove or cover all labels on the cardboard box the label of the parcel carrier the dangerous goods label UN1845 where you are notified as consignee Fig 6 2 Apply the labels to the exterior of the b...

Page 14: ...ve it from the dewar 2b Remove the product from the product holder Store or use the product as defined by procedures 3 Prepare the next shipment If loading new product into the dewar follow step 3b an...

Page 15: ...goods label UN1845 where you are notified as consignee the dangerous goods label UN 3373 Fig 9 3 Preparing the documents and labels 3a Remove the folder Return from the cardboard box In the folder you...

Page 16: ...urs of cooling capacity is remaining In addition to cooling capacity remaining DuraWatch also provides Contact details to schedule pickup of the CryoSure system Shipping route information Product deta...

Page 17: ...Intentionally left blank 13 14 Doc No UM CRYO 3030 Revision 2 State Released Release Date 2021 12 01 Approved By hanst...

Page 18: ...Envirotainer AB www envirotainer com Doc No UM CRYO 3030 Revision 2 State Released Release Date 2021 12 01 Approved By hanst...

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