How to control pollution in medical purification engineering

In recent years, due to the rapid development of my country's food processing, chemical production, medical and health, electronic information and other industries, the field of medical purification engineering has also ushered in a new period of development, and its market size is constantly expanding. Especially since the release of the new version of GMP-2010 and the implementation of the medical structure reform, it has greatly promoted the demand of the purification engineering industry in the food industry and the pharmaceutical field, making the purification engineering industry more promising. GMP requires pharmaceutical, food and other production enterprises to have good production equipment, reasonable production process, perfect quality management and strict testing system to ensure that the quality of final products (including food safety and hygiene) meets regulatory requirements. One of its core requirements is Prevent errors, contamination and cross-contamination. Dongguan dust-free workshop is at the core of pharmaceutical production, and its cleaning effect directly affects the quality of medicines. If the environment of the clean room is polluted, it is difficult to guarantee the quality of medicines. Such medicines will delay or aggravate the patient's condition, and bring huge physical harm and adverse social effects. So how should the pharmaceutical field control the pollution of the dust-free workshop to make it meet the requirements of GMP. 1. Reasonable layout of space and area Reasonable space and area are conducive to reasonable zoning, as well as operation and maintenance. The larger the clean room is, the better. The size of the area and space is related to the energy consumption of the air conditioner and the investment of the project. Reasonable production space is conducive to management, reducing environmental cleaning and disinfection work, and saving energy. At the same time, there should be an intermediate station for materials inside the workshop to facilitate clear partitions to minimize errors and cross-contamination. Various pipes, vents, lighting facilities and other public facilities should avoid parts that are not easy to clean. The layout should be reasonably arranged according to product characteristics, room pressure difference, and equipment conditions. 2. Strengthen personnel management In dust-free workshops, people are the biggest source of pollution, and people are an important factor in determining the generation of particulate pollutants. The proportion of particle sources in the dust-free workshop is: 7% infiltration in the air, 8% in the raw materials, 25% in the transfer of equipment, 25% in the production process, and 35% due to human factors. Therefore, the dress code must be followed before entering the Dongguan clean room. Put on a clean suit and AClean nitrile gloves that meet the appropriate cleanliness class. At the same time, the staff in the clean room must be repeatedly trained to improve the cleanliness awareness of the workers in the clean room. 3. Strictly control the flow of people and logistics The dust-free workshop should set up special flow of people and logistics channels. Personnel should enter according to the prescribed purification procedures, and the number of people should be strictly controlled. In addition to the standardized management of personnel entering and leaving the clean room, the entry and exit of raw materials and equipment must also go through the cleaning process, so as not to affect the cleanliness of the clean room. Fourth, improve the equipment level The material, processing accuracy, airtightness and management system of the dust-free workshop equipment are all related to cross-contamination. Therefore, improving the automation level of the equipment to reduce the number of operators is a necessary measure to prevent cross-contamination. The new version of GMP requires aseptic isolation operation technology. Sterile isolator systems are completely sealed to control and process pharmaceuticals and biological products to a sterile state. The use of isolation operation technology can prevent product contamination to the greatest extent, protect the safety of operators, and avoid injury from toxic substances. 5. The air-conditioning purification system of the dust-free pharmaceutical cleanroom with the air-conditioning purification system should be divided according to different cleanliness levels. For dust-free workshops such as hormones, highly toxic microorganisms, anti-tumor drugs, and radiopharmaceuticals, high-efficiency filters should be installed at their exhaust outlets. equipment to minimize contamination of these drugs. For dust-free workshops that generate dust and harmful gases, a separate local exhaust system should be set up. The opening and closing of supply air, return air and exhaust air should have interlocking devices. Pollution control runs through the entire pharmaceutical production activities, and pollution control in Dongguan dust-free workshops must also be implemented in all aspects. Control the pollution of the clean room from the aspects of rationally arranging the space area, improving the equipment level, setting up the air-conditioning purification system, strictly controlling the flow of people and logistics, and strengthening the personnel management.

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