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The clean room (commonly known as the purification room) is a room where the concentration of airborne particles is controlled, and its construction and use should reduce the indoor induction, generation and retention of particles, and other relevant indoor parameters such as temperature, humidity and pressure are controlled according to requirements. The clean room distinguishes the degree of cleanliness by the number of particles of a certain size per unit volume of air. The class 100 clean room means that the number of dust above 5μg in 1 cubic meter of air does not exceed 100, and the average number of colonies cannot exceed 5.
In recent years, it has been widely used in various fields (pharmaceutical engineering, organ transplantation, operating room, etc.), so it is necessary to strengthen the maintenance and management of the class 100 clean room to ensure the good operation of its environment and function. We mainly control management from the three aspects of environmental monitoring management, operation management and personnel management, so that the use of medical device microbial testing in the clean room is more reasonable and standardized, to ensure the quality of testing.
I. Management of Environmental Monitoring
The "sterile" environment of the class 100 clean room is mainly maintained through the "filtration" of the air, "laminar flow" and the indoor maintenance of "positive pressure" state. Environmental control management is crucial, mainly from the following aspects.
(1) To control the temperature and humidity of the air in the clean room, the indoor temperature is controlled at 22 ° C ~ 25 ° C, and the humidity is controlled at 50% ~ 60%, which not only meets the comfort of the human body but also is not conducive to the survival of indoor microorganisms.
(2) Strengthen hygiene and cleaning management The surface and floor of the wall cabinet in the clean room should be wiped once a day with disinfectant. Clean thoroughly once a week, and then clean once a month. The cleaning tools used should not be made of fabric materials with fiber. The number of air dust particles, noise, temperature and humidity were detected once. If necessary, increase the number of cleaning and disinfection according to the frequency of use. Sterilize with ultraviolet radiation for 30 minutes after each operation.
(3) Regular microbial testing, once a week. Determine maintenance procedures for test results.
II. Operation Management
(1) Correct use of clean rooms
The items in the clean room are placed reasonably, which is conducive to operation, and the materials of the items are reduced as much as possible, and the number of items in and out is controlled.
(2) Set a strict workflow
Set up strict work procedures and clearly distinguish decontamination areas. Develop a rigorous workflow.
(3) Control the cleaning quality
The clean laminar flow air conditioning system must run continuously for 24 hours for the first time, and the air bacteria can be used after being cultured twice. Turn on the laminar flow air conditioning system 30min before each entry to make the air conditioning system run continuously, exhaust the polluted dust particles as far as possible, and ensure the air quality. Regular special personnel to check the operation of the air conditioning system, do a good job of maintenance. Remove door, window, floor and other dust with 1:100 84 disinfectant before and after daily operation. It should be cleaned once a week, including the ceiling, walls and floors, especially ventilation, and the return air outlet is easy to store dust and bacteria. It should be removed, cleaned and regularly checked and replaced to prevent itself from being contaminated. The primary and middle effect filters are replaced once every 6 months, and the high efficiency filters are replaced once every 1 to 2 years. The return air outlet is cleaned once a week to ensure the dust filtering effect.
(4) Equipment maintenance
In order to ensure the constant temperature and humidity of the room, the air conditioner is turned on 30min in advance according to the actual situation. The special person is responsible for checking the air conditioning display on the control board regularly, and is responsible for the maintenance of the air conditioning system. Clean the initial effect filter once a week, and the outlet once to prevent itself from being polluted. The replacement of medium and high efficiency filters is generally replaced once every 2 years according to the results of air culture.
III. Personnel Management
(1) Strictly control personnel access. Minimize the number of people in and out.
(2) Strict dress management requirements. Enter the purification room to change sterile clothing, wear shoes and hats, and strictly wash hands and disinfect.
(3) Strengthen personnel training, actively carry out theoretical learning, clarify the working principle and environmental requirements of laminar flow class 100 clean room, and be familiar with the basic knowledge and operational requirements of training. Strictly regulate the behavior of personnel and various operating rules and regulations.
The air purification measures used in the class 100 clean room are to filter and disinfect the dust ions in the air, so that bacteria can spread without carrier. Although air purification is the main contradiction, more importantly, it depends on the whole process and comprehensive control and management. Strengthening the use and management of the purification room, making it maintain a good environment and function, strengthening the concept of asepsis and standardized management is the fundamental guarantee and requirement.
