Maintenance and Management of Dust-free Workshop Project in Grade 100 Pharmaceutical Factory
Release time:2019-09-07 source:
Class 100 clean room dust-free workshop engineering refers to the dust number of more than 5 UG in 1 cubic meter of air does not exceed 100, and the average number of colonies can not exceed 5. In recent years, Class 100 clean room dust-free workshop has been widely used in various fields (pharmaceutical engineering, operating room, etc.). Therefore, it is necessary to strengthen the maintenance and management of Class 100 clean room project in order to ensure its good environment and function.
Clean room engineering (commonly known as dust-free workshop engineering), in FED-STD-2, is defined as a room with air filtration, distribution, optimization, construction materials and devices, which is controlled by the concentration of air suspended particles. The design director of Cowatt Electrical and Mechanical Engineering told Xiaobian that the construction and use of clean room engineering should reduce indoor induction and production. The temperature, humidity and pressure of raw and retained particles and other indoor parameters are controlled according to the requirements. The cleanliness of a clean room is distinguished by the number of particles of a certain size per unit volume of air. Class 100 clean room dust-free workshop engineering refers to the dust number of more than 5 UG in 1 cubic meter of air does not exceed 100, and the average number of colonies can not exceed 5.
In recent years, it has been widely used in various fields (pharmaceutical engineering, operating room, etc.). Therefore, it is necessary to strengthen the maintenance and management of Class 100 clean room project in order to ensure its environment and function to run well. How to manage maintenance?
Management of Environmental Monitoring
The "sterile" environment of Class 100 clean room is maintained mainly by air filtration, laminar flow and indoor maintaining a "positive pressure" state. The control and management of environmental laboratory is very important, mainly from the following aspects.
(1) Controlling the temperature and humidity of clean room air, indoor temperature at 22 ~25 ~C and humidity at 50%~60% is suitable, which not only satisfies human comfort, but also is not conducive to the survival of indoor microorganisms.
(2) Microbial testing is carried out regularly, once a week. Determine maintenance procedures for test results.
II. Operation Management
(1) Correct use of clean rooms
The items in the clean laboratory engineering room are placed reasonably, which is conducive to operation, and the materials of the articles are reduced as much as possible, and the times of entry and exit of the articles are controlled.
(2) Setting up strict workflow
Set up strict workflow, clearly distinguish the clean area. Develop a strict workflow.
(3) Control of cleaning quality
The first use of clean laminar flow air conditioning system must run continuously for 24 hours, and the air bacteria can be used only after two qualified cultures. Open the laminar flow air conditioning and ventilation system 30 minutes before each entry, so that the ventilation and air conditioning system can run continuously, exhaust the polluted dust as far as possible, and ensure the air quality. Regularly check the operation of the air conditioning system, and do a good job of maintenance. Before and after daily operation, 84 disinfectant solution of 1:100 was used to remove dust from doors, windows and floors. Every week should be swept up once, including the ceiling, walls and floors, especially ventilation, return air outlet is easy to hide dust, Tibetan bacteria should be removed and cleaned regularly to check and replace, in order to prevent its own pollution. Initial and intermediate effect filters are replaced once every 6 months, and filters are replaced once every 1-2 years. The return air outlet, like the return air outlet in the central air conditioning project, needs to be cleaned once a week to ensure the dust filtering effect.
III. Personnel Management
(1) Strictly control the entry and exit of personnel. Reduce the number of people entering and leaving as much as possible.
(2) Strict dress management requirements. Change aseptic clothes, wear shoes and hats, and strictly wash and disinfect hands.
(3) Strengthen personnel training, actively carry out theoretical study, clarify the working principle and environmental requirements of laminar 100 class clean room, and familiarize themselves with basic knowledge and operation requirements. Strictly standardize personnel behavior and various operating rules and regulations.
Ed Purification is a purification engineering company specializing in the design, construction, commissioning and installation of food aseptic workshop, GMP purification workshop, electronic dust-free workshop, food and pharmaceutical packaging workshop, medical equipment workshop, laboratory purification and other projects.
To learn more about the medical purification industry, please pay attention to Wechat Public No. Aide-188 (Ed Purification and Oxygen Supply)