Výrobní prostředí jako významný faktor ovlivňující kvalitu farmaceutických produktů

Abstract

The aim of this bachelor thesis is to describe the monitoring of cleanrooms in pharma-ceutical company. This thesis describes the cleanroom, it´s history and classification. Furthermore, the work deals with the systematic data collection, ie. Monitoring which is carried out in the company. This monitoring includes measuring of particles number, temperature, relative humidity, flow direction and the number of air exchanges and microbial monitoring. There is also disclosed a monitoring system for production and packaging of Nasal sprays and non-sterile products. finally, the thesis describes the heating and air conditi-oning, instrument for measuring of particle Solair 5100 and also deals with the proposal for improvement.