Effectiveness of manual cleaning in a line of oral suspensions

Abstract

The microbiological control of production equipment in the pharmaceutical industry is essential to achieve quality medicines. This is achieved through proper control of the cleaning and disinfection processes of the equipment. Samples were taken by the rinsing method and for the count of microorganisms, the poured plate method containing soy tryptone agar was used. The samples were incubated according to the physiological needs of the microorganisms for a period of 48h at a temperature of 35 ° C. Selective media and gram stain were used for the identification of microorganisms and the Poisson distribution was used to calculate the usual working interval and the alert and action limits respectively.The cleaning and disinfection of the equipment is done manually, associated with this, the large volumes of the same and the places of difficult access can promote microbial growth, the arithmetic means of isolate microorganisms ranged from 7.62 cfu / mL in the transfer pump to 69.28ufc / Ml in the plastic container, which was eliminated from the production process due to the formation of pores that can accommodate microcolonies. Alert, action, and work interval limits were determined for each individual computer taking into account the volume of each. The determination of these limits allows preventive and corrective actions to be taken to reduce the microbial load, thus avoiding the possibility of contamination of the finished product.