Comparison of Penicillinase and β–lactamase enzymes invalidation of sterility test in some of injectable β–lactam antibiotics

Background and Aim : Sterility test is an essential test for injectable products in pharmaceuticalindustries. In this test, inhibition effect of materials must be neutralized. β- lactamases break β–lactam ring of some antibiotics such as Cephalosporins, Carbapenems, etc. The aim of this studywas to apply penicillinase and LacbusterTM-S (betalactamase) enzymes in sterility test and theirvalidation in some of injectable β–lactam antibiotics such as Cefazolin Sodium, CeftriaxoneSodium, Ceftazidime Sodium Carbonate, Cefotaxime Sodium, Imipenem-Cilastatin andMeropenem with Sodium Carbonate.Methods : One gram/L peptone from meat (fluid A) including different dilutions of enzymes wereinoculated with S. aureus, P. aeruginosa, B. subtilis, C. sporogenes, C. albicans and A.nigerseparately. Then, above mentioned antibiotics were solved in prepared fluid A, filtered and washedwith the same dilution of Fluid A. Filters put in FTM and TSB with the same dilution of enzymes.Media were incubated ۳ days for bacteria at ۳۰-۳۵ ºC and ۵ days for mold and yeast at ۲۰-۲۵ ºC.Results : Our results showed growth of mold and yeast were seen in enzyme free media containingantibiotics. In this study we found that ۱۴۲۸۶ Unit/ml of penicillinase were needed to breakCefazolin (۰.۵gr), Ceftriaxone, Ceftazidime and Cefotaxime (۱gr), while, sterility test ofImipenem-Cilastatin validated with ۸۵۷۴۱ Unit/ml penicillinase concentration in solvent, washingfluid and media. Furthermore, there were ۳× ۱۰۶ Unit/ml in solvent, washing and ۲ × ۱۰۵ Unit/mlin media for meropenem, but these amount were decreased to ۲۰۰IU for β–lacII (Lacbuster).Conclusion : Lesser use amount and long lasting form of enzyme (freeze dried power) are twoadvantages of LacbusterTM-S.

کلیدواژه ها:

β–lactam ، β- lactamase ، Sterility test ، Validation