HTF

HTF  

CE Marked (CE 0086)

GMHT-100, 100 ml
GMHT-250, 250 ml
GMHT-500, 500 ml

Indications for Use  

Culture of cleavage-stage human embryos (Day 1 to Day 3).

     
Storage and Shelf Life   Store at 2-8°C and protected from light. Ten (10) weeks from the date of manufacture. For best results, use within four (4) weeks.
     
Composition  

A bicarbonate-buffered medium replete with glucose, lactate, and pyruvate is required to support the growth and development of human embryos in vitro.

Sodium Chloride, Potassium Chloride, Calcium Chloride, Potassium Phosphate, Magnesium Sulfate, Sodium Bicarbonate, Glucose, Lactate Na Salt, Sodium Pyruvate, Phenol Red, Gentamicin Sulfate* (10 μg/ml), *from therapeutic-grade source material  

     
Recommendations for Use   For a full and detailed recommended protocol of use for HTF please contact us at customerservice@lifeglobal.com.
     
Quality Control Specifications  
Assay (performed for each batch) Specification
Physicochemical Tests  
pH (with 5% CO2) 7.2-7.4
Osmolality 280-292 mOsM
Biological Tests  
Endotoxin (LAL) < 0.5 EU/ml
Sterility Test (bacterial and fungal screen, SAL 10–3) PASS
Biological Assays  
1-cell Mouse Embryo Assay (% expanded blastocysts at 96 h of culture) > 80%
Special Note on the CO2 Concentration in the Incubator: In most cases, a 5-7% concentration of CO2 in the incubator will produce a pH of 7.2 to 7.4 in HTF. However, the exact concentration of CO2 required to produce the optimum pH of approximately
7.30 (7.27-7.33) depends on several factors, including the physical characteristics of incubator and the altitude. Consequently, we strongly recommend that each laboratory determine and use the concentration of CO2 that is required to produce a pH of 7.30 in
HTF.
     
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 the HTF for the Culture of cleavage-stage human embryos (Day 1-3).
  3. Not to be used for injection.
  4. Devices are not intended for resterilization.
  5. 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
  6. HTF contains the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
  7. To avoid problems with contamination, practice aseptic techniques.
  8. Discard unused medium within 7 days of opening. Do not use after expiry date.