Study On The Decontamination Method Of Penicillin Workshop

The variety of pharmaceutical markert lead to the universality and urgency about that penicillin dosage forms producing facilities are decontaminated and renovated for non-penicillin solid dosage forms producing.Due to the obvious causing allergy and the purport of inter-contaminate protection according to GMP, the restablish of the scientific and feacible methods which can insure the new variety safe is a problem which must be solved by us. In this article, several parts are studied such as sampling methods in decontaminating course, examing methods to decontamination results, investigation methods to the degree of penicillin and it's interrealated componds, the choice of cleaning reagents and the result of decontaminate experiment, beginning with the analysis to the object of study.There are four parts of studies below.1 The sampling methods during decontamination are studied. It indicated that special method is used for special target Cleanse which is suitable widly and usable simply, can be used enomously to sample for penicillin decontaminated when the recoveray rate about all kinds of material is defined and verified.2 The examing methods to trace- penicillin and it's interrealated componds during decontamination. The limit of examing by miny-organisum culture is lower compared with HPLC, with the advantage of accurate and reliable,suitable for deciding the decontaminate effct in determining the nature. HPLC is used to determining the nature and the quantity.in examing the rest of penicillin's interrealated componds3 The basic train of thought and opration condition are defined.Through the investigation and analysis to the rest degree of penicillin and penicillin's interrealated componds before decontamination, The decontamination condition is designed, penicillin distroied by base solution is tested,the main positions of decontamination and sampling are defined, the thoughts and steps are founded. The carry out of decontamination is prerared by all of these on technic and management .4 The tentative plan that cephalosporin is renovated after decontamination is put forward.It is pointed that the cephalosporin is the best sutibale renovation variety during the deep analysia.The method examing trace-penicillin out of cefazolin is restablished and verified.The limit quantity of penicillin by this method is not higher than 2.5×10-7mg in 1mg cefazolin It is indicated, by the calculate and analysis to the test above, the restablished methods for decontamination in penicillin facility are scientific and feacible,and the safety of cephalosporin renovation after decontamination can be assured.