Stability study of a screw-port syringe with luer cap for the dispensing of PIVAS for intravenous bolus of finished product injections
Objective To explore the stability of a screw-port syringe with luer cap for the dispensing of pharmacy intravenous admixture service(PIVAS)for intravenous bolus of finished product injections.Methods Application of screw-port syringe with luer cap for intravenous bolus samples of esomeprazole sodium for injection,parecoxib sodium for injection,ambroxol hydrochloride injection at the level of PIVAS laminar flow table;the sealing property was examined by positive pressure method;and the pH value of the sample solution and the changes of the traits were detected at the time points of 0,1,2,4,6,8,and 24 h.Results Each sample injection 20 ml was subjected to a lateral force of 3 N and axial forces of 200 N and 300 N for 30 s with a screw-port syringe with luer cap,and no leakage was observed.Esomeprazole sodium for injection,Parecoxib sodium for injection and ambroxol hydrochloride injection were diluted with 20 ml 0.9%sodium chloride injection using disposable screw syringes with luer cap,respectively.pH values were detected at 0,1,2,4,6,8 and 24 h at room temperature(experimental condition 25℃),and all showed stable results.No significant changes have taken place.Esomeprazole sodium for injection,parecoxib sodium for injection and ambroxol hydrochloride injection were diluted with 20 ml 0.9%sodium chloride injection using a disposable screw syringe with luer cap,respectively.Their clarity and color changes were observed at 0,1,2,4,6,8 and 24 h at room temperature(experimental condition 25℃),respectively.All showed colorless and clear state without color change.Conclusion The dispensing of the drug into an intravenous bolus injection with a screw-port syringe with luer cap within the PIVAS environment is secured for stability and sealing.