or
Reagents
5% Albumin (human), USP
10% Dextran 40, USP
Bacterial culture bottles (aerobic and anaerobic)
Supplies
Cell Wash/Infusion Bag Set (Transplant Set) (included with HEMACORD)
Sterile Disposable Syringes: 3 mL, 30 mL and 60 mL
Sterile tubing
18 gauge injection needles
Sterile gloves
Hemostats
Sterile small plastic zipper-lock bags
Alcohol prep pads
Iodine swab sticks
Sampling site couplers
Tubes for cell counts, progenitor assays (optional)
Protective cryogloves
Transfer pack containers 300 mL
Instructions for preparation for infusion
2 VERIFICATION OF PRODUCT IDENTITY
HEMACORD is shipped frozen in a steel canister that is contained in an insulating foam sleeve. HEMACORD must be kept at or below -150° C, either inside the container used for shipping (Dry-Shipper) or in a Liquid Nitrogen (LN2)-cooled storage device at the Transplant Center (recommended).
The bar-coded ID label of the product, affixed to the canister, is visible after removing the styrofoam sleeve (Figure 1).
Figure 1
a.Check the HEMACORD ID label to confirm its identity with the ID of the expected product as soon as it is received.
b.Wearing protective cryogloves, transfer the HEMACORD from the Dry-Shipper to the vapor phase of a LN2 storage tank.
c.Use the canister opening tool to pry canister open at top and bottom, as shown below in Figures 2 and 3.
Figure 2.
Figure 3.
d.Work carefully to avoid damaging the frozen plastic product bag.
e.Check the bar-coded label on the product against your records to verify that the bar-coded and visually-readable printed number absolutely conforms to the information previously provided and the documentation included with the HEMACORD product.
f.Document this check on the “Unit Receipt Form” document received with the product.
NOTE:
If there is any error or ambiguity with regard to the product ID, close the canister and keep the product at LN2 temperature. Immediately advise the staff of the New York Blood Center, Inc. (NYBC) and the transplant physician. Do not proceed until the problem is resolved. If your LN2 storage tanks have no space to store the product in its canister and insulated sleeve, add LN2 to the NYBC dry-shipper to maintain the product frozen until a completely satisfactory determination is made.
3 METHOD
3.1 Preparation of Thawing Solutions
a.Prepare the thawing solution (also called reconstitution solution) at room temperature, mixing equal volumes of 10% Dextran 40 and 5% human albumin, in a biological safety cabinet. The final concentration in the thawing solution is 5% Dextran 40 and 2.5% human albumin.
b.Attach an 18 gauge needle to a 30 cc syringe. Draw approx. 12.5 mL of 10% Dextran 40 and approx. 12.5 mL of 5% human albumin into the syringe. The contents of this syringe are to be used for diluting the cell suspension after thawing.
c.Fit 18 gauge needles to three 60 mL syringes. Draw 30 mL of 10% Dextran 40 and 30 mL of 5% human albumin into each syringe. Two of these 60 mL syringes will be used in steps “l” and “o” in section 3.4 of this procedure. The third syringe will be used in step “l” of section 3.5.
d.Alternatively, prepare the thawing solution in a 300-mL transfer bag by adding, using syringes, 150 mL 10% Dextran 40 and 150 mL 5% albumin.
3.2 Thawing HEMACORD
Wearing protective cryogloves, remove the canister with HEMACORD from the LN2 cont |
