Application of Penicillinase in Validation of Sterility Test in Some Injectable β-Lactam Antibiotics Behoftadeh Fatemeh1, Mojtahedi Ali2,*, Hooshmandi Elham3 1Department of Biology, Rasht Branch, Islamic Azad University, Rasht, Iran 2Department of Microbiology, Faculty of Medicine, Guilan University of Medical Sciences, Rasht, Iran 3Department of Pathobiology, Faculty of Veterinary, Rasht Branch, Islamic Azad University, Rasht, Iran *Corresponding Author E-mail: mojtahedii.ali@gmail.com, mojtahedi@gums.ac.ir
Online published on 20 December, 2018. Abstract Sterility test is an essential procedure for injectable products in pharmaceutical industries. Penicillinase breaks βlactam ring of some β-lactams. The Aim of this study was the application of penicillinase in sterility test and its validation in some injectable β-lactams. Five different β-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 of Meropenem, 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. Top Keywords Antibiotics, Penicillinase, Sterility test, Pharmaceutical. Top |