Description
For processing and freezing 25 mL of cryopreserved, concentrated cord blood stem cells by the method developed at the New York Blood Center. 1, 2*Each sterile set consists of two transfer bags and a two-compartment, three-dimensional 25 mL freezing bag joined by integral tubing and two connector lines (one spike and one luer).
- Two transfer bags, 200 and 150 mL. The 200 mL transfer bag concentrates primary stem cell-rich plasma while the 150 mL transfer bag receives the supernatant plasma from the concentrated stem cells. 1, 2**
- Freezing bag is compatible with liquid nitrogen (LN2) storage. The three-dimensional bag design ensures a homogenous, controlled freezing rate for maximum cell viability.
- Freezing bag is uniquely compatible with the use of DMSO/Dextran and liquid nitrogen storage in ThermoGenesis Corporation's BioArchive* System.
- Freezing bag's two separable compartments allow for a 4:1 division of contents, allowing a consistent volume aliquot for ex vivo cell expansion.
- Freezing bag is compliant with AABB Standard for integral segments cryopreserved with product, enabling confirmatory testing prior to transfusion.
- Addition of cryopreservative solution can be accomplished by either gravity feed or syringe pump.
- 1. Rubinstein, P.; Dobrila, L.; Rosenfield, R.E.; Adamson, J.W.; Migliaccio, G.; Migliaccio, A.R.; Taylor, P.E.; Stevens, C.E. Processing and Cryopreservation of Placental/Umbilical Cord Blood for Unrelated Bone Marrow Reconstitution. Proc Natl Acad Sci USA. 1995, Oct 24;92(22):10119-22.
- Fraser, J.K.; Cairo, M.S.; Wagner, E.L.; McCurdy, P.R.; Baxter-Lowe, L.A.; Carter, S.L.; Kernan, N.A.; Lill, M.C.; Slone, V.; Wagner, J.E.; Wallas, C.H.; Kurtzberg, J. Cord Blood Transplantation Study (COBLT): Cord Blood Bank Standard Operating Procedures. Journal of Hematotherapy. 1998, 7(6):521-61.
*BioArchive is a registered trademark of ThermoGenesis Corporation.
Specifications
| Product No. | 791-02, 791-02U |
| Description | Transfer/Freezing Bag Set |
| Fill Volume Range | Up to 200 mL in transfer bag 1; up to 150 mL in transfer bag 2; up to 25 mL in freezing bag |
| Port Configuration | Vented needle; in-line spike; in-line luer; (2) multi-use sampling ports; (2) pinch clamps |
| Materials of Construction | 200 mL Transfer Bag: Polyvinyl chloride (PVC) with tri (2-ethylhexyl) trimelliate (TEHTM) plasticizer; 150 mL Transfer Bag: Polyvinyl chloride (PVC) with di (2-ethylhexyl) phthalate (DEHP) plasticizer; Freezing Bag: Ethyl vinyl acetate, a copolymer of polyethylene; Tubing: Ethylene vinyl acetate |
| Bag Size(s) | 200 mL Transfer Bag: 17.53 cm length x 11.43 cm width (6.9 in. length x 4.50 in. width); 150 mL Transfer Bag: 14.86 cm length x 7.62 cm width (5.85 in. length x 3.0 in. width); Freezing Bag: 8.84 cm length x 7.04 cm width x 0.74 cm depth (3.48 in. length x 2.77 in. width x 0.29 in. depth) |
| Sterilization | Gamma |
| Packaging | Individually packaged in a plastic pouch; 24/box |
| Shelf Life | 3 years |
| Traceability | Lot number |
| Regulatory Status | FDA 510(k) cleared: 791-02 CE marked: 791-02U 791-02U : Canadian medical device license # 101446 791-03U : Canadian medical device license # 91523 |
| Compatible with Other Bags | 791-03, 791-03U |
Applications
Application
For processing and freezing 25 mL of cryopreserved, concentrated cord blood stem cells by the volume reduction method developed at the New York Blood Center.Advanced Bag Designs Meet Rigorous Industry Standards
Cord blood stem cells have been effectively used in the treatment of more than 70 malignant and non-malignant diseases, including sickle cell, leukemia, non-Hodgkin's lymphoma, other forms of cancer, life-threatening anemias, and autoimmune diseases. As a key supplier to the cord blood banking industry, Pall provides a full range of bag sets that are used to prepare the cord blood stem cells for treatment. Pall's collection and processing sets are manufactured to cGMP using validated manufacturing processes that ensure safe, consistent and reliable product performance. Each bag is 100% inspected prior to release and is fully traceable by lot number. Pall's bag sets are uniquely designed to facilitate closed system processing of cord blood stem cells by the volume reduction method developed at the New York Blood Center.1 Volume reduction maximizes limited storage space while closed system processing minimizes sample loss and reduces the risk of contamination during handling. This method results in a high quality sample available for transplantation.Assessment of stem cell content and viability after long-term storage is a critical step prior to a successful transplantation. International standards recommend storing a cell sample attached to a unit of cord blood for quality control testing. Pall's freezing bag includes sufficient tubing for the preparation of segments, enabling a sample aliquot to be cryopreserved with the final product. Using a tube segment for quality control testing prior to transplantation reduces the risk of contamination during the thawing process and provides critical information needed to predict treatment success.
For disease treatments or patient populations that require a higher cell dose to be transplanted, Pall's advanced freezing bag design divides the sample into two compartments, facilitating transfusion of 80% of the stem cells while retaining 20% of the stem cells for ex vivo cell expansion. Scientific advances in our ability to amplify stem cells will greatly expand the applications for hematopoietic stem cells from cord blood.
1. Rubinstein, P.; Dobrila, L.; Rosenfield, R.E.; Adamson, J.W.; Migliaccio, G.; Migliaccio, A.R.;Taylor, P.E.; Stevens, C.E. Processing and Cryopreservation of Placental/Umbilical Cord Blood for Unrelated Bone Marrow Reconstitution. Proc Natl Acad Sci USA. 1995, Oct 24;92(22):10119-22.
Type
Blood Filters
Ordering Information
| Product Code | Product Code (Europe, Canada) | Description | Packaging |
|---|---|---|---|
| 791-02 | 791-02U | Transfer/Freezing Bag Set | 24 units/case |
*Note: Pall Product Code 791-04U is intended for use with Pall Product Code 791-02U (Transfer/Freezing Bag Set), and is available in Europe only.
To Order, Contact:
Pall Medical
Tel: 877.367.7255
Fax: 888.556.7337
uscustomerservice@pall.com
Pall Europe Ltd
Europa House, Havant Street
Portsmouth, PO1 3PD England
Tel: +44 (0)23 9230 3452
Fax: +44 (0)23 9230 3324
Biosvc@Pall.com
Pall Canada
Pall Canada Ltd.
3450 Ridgeway Drive, Unit 6
Mississauga, ON L5L 0A2
Canada
United States
Pall Medical
25 Harbor Park Drive
Port Washington, NY 11050
Phone: 516-484-3600
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