global® Blastocyst Fast Freeze® Kit

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CE Marked (CE 0086)

GFV5-005, 1 kit (5 ml)

Indications for Use   For cryopreservation of blastocysts.
Storage and Shelf Life   Store at 2-8°C and protected from light. One (1) year from the date of manufacture.
Disposal Consideration   Treat or dispose of waste material in accordance with all local state/provincial, and national requirements. Dispose with laboratory waste.
Composition   1 X 5 ml vial of Fast Freeze® Solution 1 (green cap)
1 X 5 ml vial of Fast Freeze® Solution 2 (blue cap)
2 X 5 ml vials of Fast Freeze® Solution 3 (white cap)
10 X Universal GPS® dishes

Base Components: Sodium Chloride, Potassium Chloride, Calcium Chloride, Potassium Phosphate, Magnesium Sulfate, Sodium Bicarbonate, Glucose, Lactate Na Salt, Sodium Pyruvate, Amino Acids, EDTA, Phenol Red, HEPES, Human Serum Albumin* (20 mg/ml), Gentamicin Sulfate* (10 μg/ml), *from therapeutic-grade source material

global® Blastocyst Fast Freeze® Solutions 1, 2, and 3 contain increasing concentrations of glycerol and ethylene glycol together with the base components.
Instructions for Use  

Link to global® Blastocyst Fast Freeze® Kit IFU

Quality Control Specifications  
Assay (performed for each Sbatch) Specification
pH – Fast Freeze® Solution 1 7.1-7.5
pH – Fast Freeze® Solution 2 7.1-7.5
pH – Fast Freeze® Solution 3 7.1-7.5
Osmolality – Fast Freeze® Solution 1 1400-2000 mOsM
Osmolality – Fast Freeze® Solution 2 4900-6600 mOsM
Osmolality – Fast Freeze® Solution 3 7800-10600 mOsM
Endotoxin (LAL) – Fast Freeze® Solution 1 < 1.0 EU/ml
Endotoxin (LAL) – Fast Freeze® Solution 2 < 1.0 EU/ml
Endotoxin (LAL) – Fast Freeze® Solution 3 < 1.0 EU/ml
Sterility Test (bacterial and fungal screen, SAL 10–3) PASS
Mouse Embryo Assay (% re-expanded blastocysts at 24 h of culture) > 80%
Universal GPS® Dishes  
Endotoxin (LAL) < 20 EU/device
1-cell Mouse Embryo Assay (% expanded blastocysts after 96 h) > 80%

Precautions and Warnings
  1. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
  2. Caution: The user should read and understand the Instructions for Use, Precautions and Warnings, and be trained in the correct procedure before using global® Blastocyst Fast Freeze® Kit for cryopreservation of human blastocysts.
  3. Warning:.The long term safety of blastocyst cryopreservation on children born from this procedure is unknown.
  4. Warning: This kit is not intended to be used for the cryopreservation of human oocytes, or for human embryos that have not yet reached the blastocyst stage of development.
  5. Not to be used for injection.
  6. Do not resterilize.
  7. Do not use the product if:
    • the product packaging appears damaged or if the seal is broken
    • the expiry date has been exceeded
    • the product becomes discolored, cloudy, or shows evidence of particulate matter
  8. This product contains human serum albumin, a derivative of human blood. The human serum albumin used in the preparation of this product has been heated at 60°C for ten hours.
    Contains: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes. It is strongly recommended that every time that global® Blastocyst Fast Freeze® Kit is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
  9. global® Blastocyst Fast Freeze® Kit contains the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
  10. To avoid problems with contamination, practice aseptic techniques.
  11. Use freezing straws appropriate for blastocyst cryopreservation procedures and follow the manufacturer’s instructions for labeling, handling and heat-sealing the straws.
  12. The global® Blastocyst Fast Freeze® Kit is intended for single use only (the cryopreservation of the blastocysts from one patient on one day). Discard any unused product after opening.