Abstract

ESTABLISHMENT OF METHOD FOR BIOBURDEN RECOVERY: NON-ANTIBIOTIC ORAL TABLETS (STUDY II)

Mostafa Essam Eissa* and Ahmed Mohamed Mahmoud

Abstract

Determination of the microbiological quality of the final pharmaceutical products is crucial not only to assess the degree of the compliance of the manufacturing process in the pharmaceutical facility to Good Manufacturing Practice (GMP) but also to the safety of the drug to the patients' consumption. If the applied microbiological testing method is not examined for its suitability for microbial enumeration and detection for each product situation a false estimation of bioburden may occur which encounter great risk for both consumer and manufacturer. A risk assessment study using tabular method was performed primarily to identify potential hazard associated with microbial contamination of oral tablets. A survey study for a group of 15 drugs of different non-sterile, non-antibiotic oral tablets from the market were tested for Method suitability (MS) using selected standard strains of bacteria and fungi after ensuring the purity of cultures by miniaturized identification biochemical system (BBL Crystal and API20C AUX) and characteristic morphological appearance. Growth media used in the study are those that passed growth promotion tests. The primary applied technique is the dilution as a mean of sample processing and neutralization of any nonantibiotic antimicrobial activity. Then chemical neutralization is followed if dilution alone could not recover one or more microbes effectively. Dilution technique proved to be adequately effective at 1:10, 1:20, 1:40 and 1:100 (w/v) with the later dilution being the most common for microbial enumeration and the first dilution for specific microorganism detection. No chemical neutralization was needed during the course of the study.

Keywords: Good manufacturing practice, Microbial enumeration and Detection, Nonantibiotic oral tablets, Bioburden, Method suitability, Standard strains.