KryoSure® Cryopreservation Bags

KryoSure Cryopreservation Bags are designed to safely freeze and protect your valuable biologics at temperatures as low as -200°C.

General Information

KryoSure Cryopreservation Bags are made from the highest quality USP Class VI fluorinated ethylene propylene (FEP) material. They provide durability, transparency and high flexibility at a broad temperature range of -200°C to +200°C. This outstanding durability allows for storage in mechanical freezers, vapor phase freezers or direct immersion in liquid nitrogen.

 

Product Documents
Order Information
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Name
 
 
KryoSure® Cryopreservation Bags
FEP Material
 
 
  • Fluorinated ethylene propylene (FEP) film; 5 mil (.005”)
  • USP Class VI compliant
  • Hydophobic nature of FEP offers enhanced retrieval of contents
  • Optically clear, transmits UV, visible and IR light
  • Non-immunogenic; FEP material has no extractables, compliant with USP <661>
Tubing
 
 
Pre-attached PVC tubing leading to a female luer port (typically y-tubing with additional sterile docking tube); USP Class IV material
Animal-derived component free
 
 
Film and ports are animal-derived component-free (ADCF)
Products
 
 
KryoSure® Blood Component Freezing Bags:
20-F, 60-F, 120-F, 180-F
KryoSure® Vaccine Freezing Bag: 6-F

KryoSure® Cryopreservation Bags

Features

  • Rounded corners provide maximal product retrieval after cryopreservation and reduce the risk of sharp ice points that can damage the bag
  • Non-reactive with virtually all chemicals and biologics, including DMSO and DMF
  • Large label pocket allows easy readability of content information
  • ISO-compliant FEP spike port with septum protected from external contamination by an integral tear-open tamper evident cover (allows for safe, quick and gentle removal of cells)
  • Blood Component Freezing Bags: Unique number engraved into the label pocket and etched into the fill tube in three places provides unalterable segments for cross-identification. Each segment contains approximately 0.15 ml and may be stored in the large, integrally attached label pocket

Applications

  • Sterile and safe cryopreservation of biological fluid and suspension at temperatures as low as -200°C

Category

Vaccine Freezing Bag*

Blood Component Freezing Bag

Name

KryoSure® 6-F

KryoSure® 20-F

KryoSure® 60-F

KryoSure® 120-F

KryoSure® 180-F

Capacity

6 ml

50 ml

200 ml

480 ml

625 ml

Order Number

3360 (Pack of 10)

3361 (Pack of 10)

3362 (Pack of 10)

3363 (Pack of 10)

3364 (Pack of 10)

Volume Range

0.1-6 ml

5-20 ml

40-60 ml

50-120 ml

100-180 ml

Freeze volume
(at 1 cm thick)

6 ml

20 ml

60 ml

120 ml

180 ml

Inside Surface Area
(2 sides)

40 cm²

144 cm³

255 cm³

362 cm³

445 cm³

Outside Dimensions

16 cm x 5.1 cm

33 cm x 7.6 cm

36.2 cm x 12.7 cm

40.6 cm x 12.7 cm

43.7 cm x 12.7 cm

Length with Label Folded

 

21.4 cm

24.3 cm

28.7 cm

31.8 cm

Label Pocket Size

 

11.9 cm x 7.6 cm

11.4 cm x 12.7 cm

11.4 cm x 12.7 cm

11.4 cm x 12.7 cm

Features

Tubing with Pigtail End

1 Needle Access

1 Septum Exit Port

Y-Tubing

1 Female Luer Port

1 Pigtail End

1 Pinch Clamps

1 Exit Spike Port

Single Tubing with Female Luer Port

2 FEP Exit Spike Ports

Single Tubing with Female Luer Port

2 FEP Exit Spike Ports

Single Tubing with Female Luer Port

2 FEP Exit Spike Ports

 

* The unique design of the KryoSure® Vaccine Freezing Bag allows for closed system sterile transfer and aseptic recovery of sterile contents such as cellular vaccines, donor lymphocyte infusions (DLI) and other small volume, clinical and industrial applications.

Documents

Regulatory Support

We offer the following to assist you with your regulatory approval process:

  • Comprehensive documentation (e.g. Technical and Regulatory Information Overview (RIO))
  • cGMP declaration and cGMP and compliance to 21CFR8201 on Data Sheets and Certificates of Conformance, 510K Cleared
  • Made from the highest quality USP Class VI materials
  • Separate Certificate of Sterilization for each lot
  • Change notifications prior to relevant changes

Customized solutions can be provided to meet special compliance needs.

Please contact our Regulatory Support Team for all your regulatory requests & questions:
Phone:     +49 761 88 88 9 – 302
Email:      regulatorysupport@cellgenix.com

 

Regulatory Resources


121CFR820: Quality System Regulations for Medical Devices of the Code of Federal Regulations of the United States

Publications

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