Background Heparin flush solution is a sterile preparation of heparin sodium with sufficient sodium chloride to make it isotonic with blood. So far heparin was mainly prepared on wards from concentrated solution (25.000 IU/ml) prior to application.
Purpose To streamline the preparation and provide products that meets all the quality criteria. Information about the desired concentrations and quantities of different concentrations of heparin in saline solution were obtained using a 3-month data collection on hospital wards.
Materials and methods A literature search was made and the conclusions of stability studies were respected and obtained monographs were studied. Materials: Heparin Sodium, injectable grade; Sodium Chloride low in endotoxins, suitable for the biopharmaceutical production. Method of preparation: suitable amount of Heparin Sodium and Sodium Chloride are weighed in sterile glass and dissolved in chilled water (20 °C) for injections. After homogenisation the sample for in process control is taken. The solution is then filtered by 0.2 μm membrane filter in 100 ml Asolvex glass bottles and sterilised by steam sterilisation 15 min by 121 °C.
Results The authors have prepared a series of solutions of various content of Heparin Sodium in 9 mg/ml Sodium Chloride solution. Heparin content was measured before and after filtration and before and after sterilisation. Tests were made in accordance with the European Pharmacopoeia chapter 2.7.5. At the same time the pH value and the content of sodium and chloride was measured. All samples were sent for Sterility testing and testing for Pyrogens.
Conclusions Solutions of heparin in concentrations from 1 IU to 100 IU/ml in sodium chloride solution are stable under sterilisation conditions. No significant decrease in heparin activity during autoclaving cycle at 121 °C 15 min was detected.
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