How to achieve dust-proof and anti-static in the clean workshop of pharmaceutical factory
The clean workshop is at the core of the production of the pharmaceutical factory, and its cleaning effect directly affects the quality of the medicine. The environment of the clean workshop is affected by fine dust and static electricity, and the quality of medicines is difficult to guarantee. Such medicines will delay or aggravate the patient's condition.
It brings huge physical harm and adverse social effects. Therefore, dust control in clean workshops must be taken seriously and strictly implemented for pharmaceutical factories. So, how can the clean workshop of the pharmaceutical factory be dust-proof and anti-static? 1. The anti-static floor in the clean workshop of the pharmaceutical factory should meet the following requirements: a. The surface layer of the clean pharmaceutical cleanroom should have Conductive properties, and should maintain stable performance for a long time. b. The surface layer of the clean workshop floor should be made of static dissipative materials, and its surface resistivity should be 1.0×105 ~ 1.0×1012Ω or volume resistivity should be 1.0×104 ~
1.0×1011Ω·cm. c. The ground of the clean workshop should be equipped with conductive discharge measures and grounding structures, and the discharge resistance value to the ground should be 1.0×105~1.0×109Ω. How to prevent static electricity from being generated in the clean workshop of a pharmaceutical factory sz-pharma will explain to you: what are the specific measures to prevent static electricity from generating in the clean workshop 1. Keep the clean pharmaceutical cleanroom to a certain humidity, we all know that the northern region or in the dry winter, so the fault caused by static electricity much larger than in the southeast coastal areas or other seasons, so in some important places such as
Computer rooms, semiconductor purification workshops, and assembly workshops of electronic instruments should consider the issue of maintaining a certain humidity, especially for those closed air-conditioned rooms, there should be certain humidity control pharma machinery. 2. Semiconductor devices should be placed in anti-static plastic containers or anti-static plastic bags. This anti-static container has good electrical conductivity and can effectively prevent the generation of static electricity. Of course, if possible, it should be placed in a metal container or packaged with metal foil. 3. Use ion air gun, ion head, ion rod and other facilities to prevent static electricity within a certain range. 4. Lay anti-static floors or carpets. At present, there are plastic floors or carpets with certain electrical conductivity, which can effectively inhibit the generation of static electricity due to people's walking. 5. For clean workshop operators, they should wear anti-static wrist straps on their wrists. This type of wrist strap should have good grounding performance, which is the most effective measure. 2. Dustproof in the clean workshop of the pharmaceutical factory 1. Air conditioning clean system The whole process of controlling the clean workshop is essentially the overall control of fine dust around the two links of controlling dust production and effective dust removal. The environment of the clean workshop includes the structure of the clean workshop, wall materials, water system, air conditioning clean system, etc. Proven air conditioning cleaning system,
It can meet the requirements of cleanliness under normal working conditions. The fine dust formed by the air conditioning cleaning system is divided into two types: one is the fine dust caused by the operation of the system objectively, and the other is that the control factor does not meet the standard. 2. People are an important source of dust in clean workshops The metabolism of the human body will produce dust, and the human body will carry dust, and people will generate and disperse dust in large quantities when they move in the clean workshop. The source of fine dust in the clean workshop, after analysis of the test results,
Workers account for about 80%, and the dust increases significantly when people enter and leave the clean room. When someone moves, the cleanliness is significantly deteriorated.
Validators are the main cause of dust in clean workshops. As the largest source of dust and the most important transmission medium in drug production, human beings are always in direct or indirect contact with drugs, which affects the quality of drugs. This influence comes from two aspects,
One is the original physical condition of the personnel. The second is personal hygiene. Therefore, the health management and supervision of people should start from the following aspects. 3. Production material dust control The production facilities in the clean workshop will also generate dust,
Design and installation must consider the impact of the facility work on the environment and the regular cleaning work in the future. The following mainly describes the precautions for dust control of production materials in the clean workshop. 3.1 Material cleaning measures Before the material enters the clean workshop, the particles and microorganisms contaminated by the outer surface must be effectively eliminated. to this end,
The material cleaning room should include cleaning room, air lock room or transfer window. The material is removed from the outer packaging in the outer packaging cleaning room and placed in a clean container for use. In addition, the clean room should be entered through the airlock room or transfer window.
The materials sent to the sterilization room should be sterilized. When the transfer window room is used to transfer items indoors and outdoors or between clean rooms of different cleanliness levels,
In order to prevent damage to cleanliness, it is a device that temporarily blocks airflow through. The transfer belt for transferring materials shall not be transported from a low clean level to a high clean level area. Generally, it can only be conveyed in sections on both sides of the transfer window. 3.2 Material channel The clean path of materials and the clean path of people are set separately and independently. The entrance and flow direction of materials must also be separated from the flow of people, so as not to cross back and forth as much as possible.
Avoid logistics through the area of operation. For large-scale integrated production plants, multiple material inlets can be considered, but they must not affect each other. The production operation area shall not be used as a channel for material transfer,
The space of the production site should minimize the opening of the door to ensure the airtightness and cleanliness of the operating room.
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