Sterility Test of Reconstituted Ganciclovir Solution for Injection

Abstract

Background: Ganciclovir is an antiviral medication used to treat and prevent of cytomegalovirus (CMV) infection. The manufacturer recommended using it within 24 hours after dilution to reduce the risk of bacterial contamination. However, the dosage used for infant with infection at the Queen Sirikit National Institute of Child Health involves small amounts of the drug, resulting in a large amount of leftover medication. Therefore, a study was conducted to examine the stability of the drug after dilution to extend its shelf life and reduce the loss of drug value. Objective: To study the sterility of the preparation of ganciclovir injection at concentration 5 mg/ml Method: This is an experimental study preparing in a negative pressure isolator inside a cleanroom. Ganciclovir 500 mg was dissolved in 10 ml of sterile water for injection, then further diluted in normal saline for injection up to 100 ml final concentration of 5 mg/ml. The solution was stored in polypropylene bags, sealed with parafilm, and in polypropylene syringes placed in sterile peel pouches. It was stored at temperature 2-8 °C. Sterility was tested using the direct inoculation method, the pH of the solution was measured with a pH meter, and the physical stability was observed visually on days 0, 7, 14, 21, 28, and 35 after preparation. Result: The ganciclovir injection at concentration 5 mg/ml in normal saline solution (NSS) remained free from bacterial, yeast, and mold growth over the 35 days period. The pH value ranged from 10.10 to 10.19, and the physical appearance did not change from the freshly prepared solution. Conclusion: The ganciclovir injection at concentration 5 mg/ml in NSS was prepared in a negative pressure isolator, set up inside a cleanroom. The solution was stored at temperature 2-8 °C in a polypropylene bags or syringe, remaining sterile for at least 35 days.