Class 100,000 clean workshop standards for cosmetics and Class 100,000 clean workshop standards for pharmaceutical companies1

We have seen class 100,000 clean workshops in many places, and the requirements of many clean workshops are basically in this range. In a popular sense, class 100,000 clean workshops refer to the control of particles per cubic meter in the workshop. Within 10W, then what are the standards of the 100,000-level for cosmetics and the standard of the 100,000-level for pharmaceutical companies? 1. The standard of cosmetic 100,000-level Cosmetics GMP is based on 'Good Manufacturing Practice for Cosmetics Products----Customers' 'Health Protection' (referred to as GMPC) as the standard, based on the third-party certification based on the health protection of customers. For cosmetics sold in the US and EU markets, whether they are produced domestically or imported from abroad, they must comply with the US Federal Cosmetics Regulations or the EU Cosmetics Directive (this is a hard requirement), that is, implement GMP certification and comply with relevant product standards (EN76/ 768/EEC Directive) to ensure the health of consumers after normal use. Why does the cosmetics industry have to do dust-free workshops? 1. The raw materials and ingredients used in cosmetics are easily deteriorated. 2. In the production process of cosmetics, the cleanliness of production pharma machinery is required. 3. Products that generate dust or use harmful, flammable and explosive raw materials during the production of cosmetics must use a dust-free purification room. 4. Modern cosmetics are closely related to people's daily life. Most people use cosmetics. Therefore, the quality of cosmetics should be safe, stable, usable, and useful. Therefore, it is determined that cosmetics need to be in a good environmental space. Production, manufacturing, that is, dust-free pharmaceutical cleanroom. 5. Bacterial air can easily cause secondary pollution to products in the manufacturing, standing, filling, packaging and other links of cosmetics. According to the requirements of the new version of 'Hygienic Standards for Cosmetics Manufacturing Enterprises', the total number of bacteria in the air of the production workshop shall not exceed 1000 / At the same time, the semi-finished product storage room, filling room, clean container storage room, dressing room and its buffer zone must have air purification or air disinfection facilities. Therefore, when choosing cosmetics processing, you must choose a GMPC 100,000-level dust-free workshop. In summary, when cosmetics are processed, the storage room adopts the 10,000-level air purification standard, and the pharma machinery, raw material room, filling room, inner packaging material disinfection storage room and dressing room all adopt the 100,000-level air purification standard. Other areas adopt the 300,000-level air purification standard. In this way, 99.97% of bacteria and dust in the air can be effectively removed, and all products can be manufactured and packed in a safe and pollution-free environment. 2. Standard of Class 100,000 Clean in Pharmaceutical Factory The design of in the pharmaceutical industry has an important impact on the requirements of high-efficiency air filters. According to different production process requirements, pharmaceutical industrial plants can be divided into two categories: general production areas and clean areas. Among them, the 'Design Specifications for Clean Plants in the Pharmaceutical Industry GB/T14294-1993' stipulates that the air cleanliness in the clean area of ​​the clean room is 100 and 10000, and the temperature is generally controlled at 20 to 24 ℃, and the relative humidity is 45 to 60% flat; 100000 The area is generally controlled to have a temperature of 18 to 28 °C and a relative humidity of 50 to 65%; 10 to 30% of the total air supply for non-unidirectional flow clean rooms, and 2 to 4% of the total air supply for one-way flow clean rooms; guarantee The amount of fresh air per person per hour in the room is not less than 40m3; the clean room must maintain a certain positive pressure. In addition, the static pressure difference between the clean areas of the clean room of the pharmaceutical industry and between the clean area and the non-clean area should not be less than 5Pa, and the static pressure difference between the clean area and the outdoor should not be less than 10Pa. Industry experts said that the pharmaceutical industry clean room is different from other industrial clean rooms in that it is necessary to control not only the sol particles in the general suspended state in the air, but also the number of live microorganisms in the aseptic production of preparations and raw materials. The corresponding air cleanliness environment (sterile room) necessary for the production of sterile medicines. Therefore, the air-conditioning system in the pharmaceutical industrial plant should also control the microorganisms within the specified standards through sterilization, sterilization, disinfection and other methods. Relevant sterilization and disinfection pharma machinery is also particularly important. Among them, the air filter is a device that captures dust from the gas-solid two-phase flow through the action of porous filter materials and purifies the gas. The air filter is to purify the air with low dust content and send it into the room to ensure the process requirements of the clean room and the air cleanliness in the general air-conditioned room. For some dust-free pharmaceutical workshops with higher requirements, high-efficiency air filters are required for filtration. The high-efficiency air filter is mainly used to capture particulate dust and various suspended solids below 0.5um. The high-efficiency air purifier is mainly composed of a filter element and a shell. The basic requirements are high filtration efficiency, low flow resistance, and continuous use for a long time to reduce the cost of later consumables. With the improvement of GMP standards in recent years, as well as the improvement of energy saving and emission reduction requirements. High-efficiency air filters are increasingly valued by the pharmaceutical industry,The pharma machinery on the market is also becoming more and more abundant, making the competition among manufacturers increasingly fierce.

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