I. Cleanliness Grade Standard
ISO 14644 classifies the air cleanliness of clean rooms (areas) and related controlled environments according to the only index of suspended particle concentration, and only considers the particle swarms with cumulative distribution in the range of 0.1um to 5.0um in the particle size limit (low limit).
According to particle diameter, it can be divided into conventional particles (0.1um-5.0um), ultrafine particles (<0.1um) and macroparticles (>5.0um).
Air Cleanliness classification standard: ISO14644-1 (international standard)

Classification standard of air cleanliness: GB/T16292-1996 (Chinese standard)

II. Layout Requirements for Dust-free Workshop Construction
According to YYO033-2000 "Standards for the Production and Management of Aseptic Medical Devices" Appendix B of the Cleanliness Level Setting Guidelines for the Production Environment of Aseptic Medical Devices to set the cleanliness difference. The following aspects should be paid attention to in setting up dust-free workshop:
1. The per capita area of clean rooms should be no less than 4m (except corridors and other items), so as to ensure safe operation areas.
2. Layout according to production process. The trend of people flow and logistics is reasonable. Personnel cleaning rooms (clothes room, bathroom, clothes room and buffer room), material cleaning rooms (outsourcing room, buffer room and double-deck transfer window) must be equipped. In addition to the rooms required for product process, they should also be equipped with sanitary ware rooms, laundry rooms, temporary storage rooms, workstation equipment cleaning rooms, etc. Each room is mutually exclusive. Independent, the area of clean workshop should be in line with the production scale on the premise of guaranteeing the basic requirements.
3. There is no pollution in the same clean room (area) or between adjacent clean rooms (area).
4. According to the level of air cleanliness, it can be written in the direction of flow of people, from low to high: the workshop is from inside to outside, from high to low.

3. Requirements of temperature and humidity in dust-free workshop:
1. Adapt to the requirements of production technology
2. When there is no special requirement for production process, the temperature of clean room (zone) with 100,000-grade air cleanliness should be 20 ~24 C, the relative humidity should be 45%~65%, the temperature of clean room (zone) with 100,000-grade air cleanliness and 300,000-grade air cleanliness should be 18 ~26 C, and the relative humidity should be 45%~65% when there is special requirement. Requirements are determined.
3. The temperature of personnel purification room should be 16 ~20 ~C in winter and 26 ~30 ~C in summer.
IV. Requirements for aseptic testing rooms
Dust-free workshop must be equipped with a sterile testing room (separate from the production area) of an independent purification air-conditioning system, requiring a local 100-level under 10,000-level conditions. Aseptic testing room should include: personnel purification room (clothing room, toilet, clean clothes room and buffer room), material purification room (buffer room or double transfer window), aseptic testing room, positive control room.
Shandong Aide Purification Engineering Co., Ltd. focuses on laboratory system engineering, medical purification engineering and clean workshop system engineering. With the relevant business qualification of the industry, from engineering consulting design, construction management, equipment and consumables supply, technical services, to laboratory certification, maintenance management, etc., to provide a comprehensive and complete solution for the medical purification engineering, laboratory system engineering, clean workshop system engineering industry. To learn more about the medical purification industry, please pay attention to the Wechat Public No. Aide-188 (Ed Purification and Oxygen Supply)