ABSTRACT:
Sterility test is an essential procedure for injectable products in pharmaceutical industries. Penicillinase breaks ß-lactam ring of some ß-lactams. The aim of this study was the application of penicillinase in sterility test and its validation in some injectable ß-lactams. Five different ß-lactamswere solved in fluid Acontaining different dilutions of enzyme. Then, Staphylococcus aureus, Pseudomonas aeruginosa, Bacillussubtilis, Clostridiumsporogenes, Candida albicans and Aspergillusniger were inoculated to fluid A separately, and antibiotic solutions were filtered. Filterswere washed with the same dilution of fluid Awithout microorganisms andput in Fluid Thioglycollate Medium (FTM) and Tryptic Soy Broth (TSB). Media were incubated 3 days for bacteria and 5 days for mold and yeast. Microorganisms grew in the presence of Ceftriaxone and Ceftazidime containing 14286 IU/ml of penicillinase.Meanwhile, Cefazolinrequired to 28571 IU/ml and 85741IU/ml of enzyme was necessary in case of Imipenem-Cilastatin. In the presence ofMeropenem,microorganisms grew just after adding 3×106IU/ml enzyme in solvent washing fluid, and 2×105 IU/ml in media.Our results showed that penicillinase can be used for sterility test of above mentioned antibiotics.Lack of this enzyme can lead to false negative results.