The classification type of clean workshop and the precautions and points of clean workshop

The clean pharmaceutical cleanroom is mainly to remove particles, harmful air, bacteria and other pollutants in the air within a certain space, and control the indoor temperature, cleanliness, indoor pressure, airflow speed and airflow distribution, noise, vibration, lighting, and static electricity. Within a certain demand range, to ensure that the product can be produced and manufactured in a stable and good environment. So how do clean workshops differentiate their grades? What are the precautions and key points of clean workshops? 1. Classification and types of clean workshops Cleanliness and continuous stability of pollution control are the core standards for inspecting the quality of clean workshops. The standard is based on Regional environment, cleanliness and other factors are divided into several levels, commonly used international standards and domestic regional industry standards. The dust-free workshop can be divided into several levels according to the different factors such as the regional environment and the degree of purification. The following is a list of the corresponding applicable industry categories according to the different cleanliness levels of the dust-free pharmaceutical cleanroom, hoping to help you. Level 100: Many people think that this level of clean room is the most commonly used and therefore the most important clean room, which can be used for aseptic manufacturing processes in the pharmaceutical industry. This clean room is widely used, such as the manufacture of internal objects. , surgical procedures, including transplants, the manufacture of integrators, and the isolation of patients who are particularly susceptible to bacterial infections, such as after bone marrow transplants. Class 1000: This class of clean room is mainly used for the production of high-quality optical products, as well as for testing, assembling aircraft gyroscopes, and assembling high-quality miniature bearings. Class 10000: Class 10,000 clean room is used for the assembly of hydraulic pharma machinery or pneumatic pharma machinery, and in some cases, it is also used in the food and beverage industry. In addition, class 10,000 clean room is also commonly used in the pharmaceutical industry. Class 100,000: Class 100,000 dust-free workshops are used in many industrial sectors, such as the manufacture of optical products, the manufacture of small components and large electronic systems, the manufacture of hydraulic or pneumatic systems, the production of food and beverages, and the pharmaceutical industry. This level of clean room is often used. The mode of class definition is as follows: Class X (at Y μm ) where X is the class of the clean room, such as 100 or 10000, etc., Y is the particle size such as 0.2 μm,

0.5μm, etc., can be checked. This means that the user specifies that the clean room particle content, at these particle sizes, must meet the limits of the class. This can reduce disputes. Here are a few examples: Class1 (0.1μm, 0.2μm , 0.5μm) Class 100 (0.2μm , 0.5μm ) Class 100 (0.1μm, 0.2μm , 0.5μm ) In Classes 100 (M3.5 ) and Greater (Class

100, 1000, 10000....), generally just look at one particle size. In Classes Less than 100 (M3.5) (Class 10, 1....

), generally depends on several particle sizes. The second trick is to specify the state of the clean room, for example: Class X (at Y μm), At-rest The supplier knows very well that the clean room is to be accepted in the At-rest state. The third trick is to customize the upper limit of particle concentration. Generally, the clean room is very clean when As-built, and it is not easy to test the particle control ability. At this time, you can simply lower the upper limit of acceptance, for example: Class 10000 (0.3 μm<= 10000), As-built Class 10000 (0.5 μm<= 1000), As-built The purpose of this is to ensure that the clean room still has sufficient particle control capability when it is in the Operational state. 2. Precautions and key points in clean workshop 1. Each purification operation room is centrally set up with an independent front room as an airlock, and the airlock room is connected with each operation room at the same time to ensure that the air in the low clean area does not penetrate into the high clean area. 2. The flow of people in the pharma machinery passes through the locker room to change clothes and shoes → wash hands in the washing room → buffer room → air shower room → each operating room. 3. The logistics of food/clean workshop is sterilized from the outer corridor through the mechanical chain self-disinfection transfer window, and then enters the buffer corridor and then enters each operating room through the transfer window. 4. High-efficiency and medium-efficiency air purification equipment should be selected according to the needs of the clean workshop. 5. The walls and ceilings of the clean pharmaceutical cleanroom are constructed with materials that do not produce dust and that do not accumulate dust and have a smooth surface, and there should be no dead corners in the workshop. 6. The ground is made of solvent-based epoxy resin, the strength is above C20, the surface is dense, and there is no sand, hollow, and cracks. Bright colors, long-lasting anti-static properties, can withstand moderate loads and high temperature resistance. 7. Ceiling purification lamps should be used in clean areas, and ordinary fluorescent lamps should be used in non-clean areas. 8. The food industry has clear regulations on the movement of personnel and materials, and cross-flow is not allowed. The material flow needs to set up a special material transfer port or transfer door; the personnel flow needs to go through a special personnel channel. 9. According to the production process, hygiene and quality requirements, scientifically divide the cleanliness level and make it meet the corresponding requirements of the specific level. 10. For the liquid processing workshop, special attention should be paid to the stains caused by flushing remaining in the installed aluminum profiles, and the musty smell in summer requires special treatment. 11. The hand-washing faucet for personnel must be non-manual (induction, foot pedal or hand-lined), and a work boot disinfection pool shall be installed when necessary at the entrance of the production workshop.

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