VALIDATION OF MICROBIOLOGICAL CONTROL METHOD OF DIAZEPAM - RECTAL SOLUTION 5 MG/2.5ML
Dr. Eva Troja*
ABSTRACT
Bioburden testing is a quality control process used during production to quantify microbial contamination in finished products to ensure the safety of a manufactured product. This study represents validation of bioburden testing of Diazepam rectal solution according to the requirements of European Pharmacopoeia. The aim of this study was to validate the method for bioburden testing capable of detecting any microbiological contamination by spread-plate method of finished product Diazepam 5 mg/2.5 ml – rectal solution which is a pharmaceutical drug product produced in Profarma Sh.a. The plates of casein soya bean digest agar at 30-35 °C for 3 days and the plates of Sabouraud-dextrose agar at 20-25 °C for 5 days were incubated. For the spread-plate method, the manual reading as a method to perform the colony enumeration was used. The recovery rate and a mean count of any of the test organisms were calculated. Growth obtained was acceptable, thus the media tested were considered suitable for use at the method evaluation. The mean count of any of the test organisms was not differing by a factor greater than 2 from the value of the control. The growth of the positive control was visually comparable to the one with sample spiked. Hence, the product passed the bioburden study and did not have inhibitory effect on the microbes/contaminants. The spread-plate method was found to be precise and accurate for enumeration of micro-organisms in rectal solution Diazepam.
Keywords: diazepam, microbiological contamination, bioburden testing, spread-plate method, enumeration.
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