Detection of Microbial Contamination in quality control of Ophthalmic Preparations by PCR

INTRODUCTION Contamination of pharmaceutical preparations by micro-organisms continues to be a matter of concern to the pharmacists. From the beginning it has been an official requirement that parenteral preparations shall be sterile. More recently a number of serious infections in the eye in Britain and elsewhere have resulted in the further requirement that all preparations used in the eye should be sterile. Side by side with this has been a greater appreciation of the need to control microbial contamination and to establish microbial standards for Pharmaceutical products. Sweden who traced an outbreak of Salmonellosis to tablets containing the drug of natural origin and who also found large number of enterobacteriaceae in number of tablets of synthetic drugs; other reports have also been published in different countries. These undoughtedly laid to standards being set or recommended in Sweden and other countries of Europe limiting the level of microbial contamination in individual materials or in Pharmaceutical products, similar standards are being proposed in the USA. Thus in Sweden all corticosteroids preparations must be sterile, and with certain qualifications, it is recommended that no preparation should have a viable microbial count greater than 100/gm or ml, in Britain the BPC requires that salmonellae shall be absent from carmine, the USPXVII gave a series of microbial limit test and in the USPXVIII several standards are set, including a modified specification for the total bacteria count in gelatine (not more than 5000/gm) and Escherichia coli absent from 10gm, a limit of 100 bacteria per ml for the various magnesia and alumina suspensions (But not for their dried preparations) Water shall be of the US public health service standard for potable water. Escherichia coli and salmonellae shall be absent from starch, and Salmonellae absent from powdered Digitalis Thyroid. Pharmaceutical preparations, which are checked for the presence of microbial contamination, are given below;2 Research Article