Validation Stability Study of Hypodermic Sterile, Plastic Disposable, Syringes

Abstract

This study describes the stability of chemical and physical properties of single-use polypropylene syringes under elevated temperature and relative humidity. 300 pieces of syringes were kept in a controlled room for six months under temperature of 40°C and relative humidity of 70%. Samples were analyzed to test the physiochemical properties to determine the stability of those properties under conditions mentioned above also to determine the shelf life of the syringes. Chemical results, concentration of reduced substances in sample solutions for the six months were: 0.2mL, 2.5 ml, 1.2 mL, 0.9 mL and 2.1 mL. The average was concentration results theof reduced substances during the six months were 1.66 ml. Chemical results, alkalinity in samples solutions for the six months in a row were : 0.1 mL, 0.08 mL, 0.24 mL,0.19 mL and 0.16 mL. The average of the alkaline properties results of the of samples solutions during the six months were 0.16 mL. The absorption results on the UV spectrophotometer of the samples in the range of 220 nm respectively were: 0.002, 0.077, 0.054, 0.046 and 0.159. The concentration results of the absorbed substances on the UV spectrophotometer of the samples in the range of 360 nm respectively were: 0.01, 0.003, 0.005, 0.008 and 0.066. The average of concentration of the absorbed material during the six months was combined of the range of 220 nm and 360 nm was 0.0354. Physical results such as determining the volume and stability of the syringes in the samples were as follows: 4.99 ml, 4.96 ml, 4.99 ml, 4.98 ml and 4.94 ml respectively for six months. The average volumes of samples results after the six months were 4.97 ml. The physical results also are no change in the shape of the syringe and no discoloration in polypropylene used in the manufacture of single-use plastic syringes despite no ideal storage conditions. The ideal storage conditions should not exceed 30°C and 60% relative humidity for medical and pharmaceutical consumers.