Safety and technological hygiene in production of active pharmaceutical ingredients

Abstract

Practical implementation of the principles of safety and technolog ical hygiene is carried out with proper organization of production design and operation of equipment under specific operating conditions. To solve biosafety issues at the stage of production design the features of technological hygiene require consideration, where a subject of production is personnel and the environment. Production of active pharmaceutical ingredients using the biotechnology and based on it pharmaceutical production have a significant impact on actions on safety and personnel hygiene, and actions to protect the environment. To ensure the product quality, personnel safety and environmental protection two basic types of actions are required - correct design of the production and proper design and operation of equipment. A methodology and principles of project activities, design and operation of equipment of technologies of active pharmaceutical ingredients for the production of immunobiological drugs were developed. An essential element of the design, production and operation of the equipment is compliance with Good Manufacturing Practices (GMR) when using clean premises