In the process of drug production, it is necessary to prevent the pollution of particles and microorganisms in the air and cross pollution. The clean room is a controllable indoor environment to meet the requirements of high cleanliness production environment, and its stable operation is an important guarantee for the clean production of pharmaceutical enterprises.
Industry said, correct and reasonable design is to ensure the stable operation of clean room premise, but if not pay attention to operation maintenance or unscientific operation, will make clean room air cleanliness gradually decreased, resulting in a number of indicators in the actual production environment deviate from the requirements, so that the quality of products decline, even unqualified situation.Therefore, correct and scientific maintenance of clean rooms is very important.So, what do you need to pay attention to when maintaining a clean room?
First, human pollution is the main source of pollution. The activities of workers in the clean environment will obviously increase the pollution degree of the clean environment.Therefore, enterprises should formulate the responsibility of full-time managers, access system for clean room personnel, personnel training and education regulations, and management of "clean room personnel net procedures".
Secondly, the facilities in the clean room, such as floor, wall and ceiling, are diffusing particles.Therefore, when materials enter, all kinds of equipment enter, and the maintenance and management of related equipment and pipelines, it should be done not to bring particles and microorganisms into the room.At the same time, enterprises should make clear regulations on cleaning and sterilization methods, cycle and inspection of all kinds of equipment and facilities in dust-free rooms to prevent and eliminate the generation, retention and reproduction of dust particles and microorganisms in dust-free rooms.
Thirdly, the staff need to wear clean clothes when entering the clean room. The materials, use and cleaning of the clothes should be paid attention to.Enterprises should do a good job in the management of clean clothing, including the procurement and production of clean clothing, the use of clean clothing management, clean clothing cleaning regulations and other aspects.
Fourthly, the safe operation of various types of equipment is the prerequisite to ensure the safety of clean room shall formulate the corresponding operational procedures, ensure all kinds of equipment, the facility functioning as required, including purifying air conditioning system, all kinds of hydropower systems, production techniques, equipment and instruments, etc, to ensure that the product production process requirement and air cleanliness level.
In addition, the enterprise shall conduct regular maintenance and inspection of the clean room.For example, a particle counter is used to measure the number of particles of controlled size at a specified time and place.Determine the number of settled colonies or planktonic bacteria at the specified time and place;In terms of temperature and humidity, measure and check continuous measurement records at specified time and place.
For example, measure the differential pressure of the filter that purifies the air conditioning system, check whether the air filter is blocked, whether the installed gaskets are in good condition or the leakage caused by the damaged filter, and use the anemometer to check the air volume of the local exhaust device.Use noise meter to measure noise value at specified time and place.
To sum up, pharmaceutical enterprises need to strictly control the cleanliness of the clean room from the aspects of personnel, equipment, facilities, reasonable management, regular maintenance and inspection.Ensure pharmaceutical enterprise of pharmaceutical production environment clean is a key factors to ensure drug safety production, enterprise in addition to select reasonable design of clean room and clean system, also need to clean room for the correct and reasonable maintenance and management, always put the safety and quality production to hang in the heart, perfecting dust-free workshop clean room facilities and equipment of the isolation system to avoid a cross contamination with the device itself, for the improvement of drug quality lay a solid foundation.