Workshop Class iso 5 clean room

GMP cleanliness level standard：

• Grade A corresponds to ISO5

• Grade B corresponds to ISO6

• Grade C corresponds to ISO7

• Grade D corresponds to ISO8

Clean room principle：

FFU cooperates with the fan to inhale external air, pass through the filter, and finally send out from the channel with a uniform wind speed. Due to the continuous supply of clean air, an air flow layer will be generated in the clean room, and the air will flow upward, eventually forming a cycle, thus ensuring the cleanliness of the clean room.

• Ventilation system: Cleanrooms are usually equipped with efficient ventilation systems to keep the air moving and reduce particulates and other pollutants in the air. The ventilation system also exhausts unclean air and introduces filtered fresh air.

• Filters: The ventilation system of the cleanroom includes high-efficiency air filters, usually HEPA (high-efficiency particulate air filter) or ULPA (ultra-high-efficiency particulate air filter). These filters can capture and remove tiny particles, ensuring that particulate matter in the air remains at an acceptable level.

• Air quality control: Cleanrooms usually use negative or positive pressure systems to prevent outside air from entering or internal air from escaping. This helps maintain a clean environment.

Workshop Clean room features：

• Air purification: High-efficiency filters are used to effectively remove dust particles in the air and ensure that the cleanliness reaches Class 100.

• Independent air conditioning system: Equipped with separate air conditioning and return air systems, it can reduce the degree of pollution and further improve the purification effect.

• Anti-static treatment: Anti-static curtains or tempered glass are used to effectively suppress the generation of static electricity and ensure a clean environment.

• Flexible combination: Class 100 clean sheds can be used individually or multiple connections can be connected to form a clean area to meet the needs of different scenarios.

• Easy to move: Equipped with universal wheels, it is convenient to adjust the position of the clean shed to meet the changes in the clean area during the production process.

Clean room material：

• Frame: 40*40 plastic-sprayed steel square tube (stable, beautiful, rust-free, dust-free)

• Static curtain: 0.5mm mesh (good anti-static effect, high transparency, clear mesh, good flexibility, no deformation, not easy to age; dust-proof and anti-static)

• Acrylic sheet: Only fully transparent acrylic sheet has the light transmittance comparable to laminated glass, but the hardness is only half of tempered glass. In addition, it is not as easy to break as laminated glass, and even if it is damaged, it will not produce sharp fragments like tempered glass. Filter unit FFU: AC EBM355 centrifugal fan, size 1175*1175*350mm, high-efficiency two-stage filtration system, filtration efficiency 99.99% (0.3um), adjustable wind speed, maximum air volume: 2200m3/min), (with long life, low noise, maintenance-free, low vibration, stepless speed change and other characteristics, reliable fan quality, long working life and unique air duct design, greatly improve the efficiency of the fan and reduce noise) Top: acrylic board or mesh soft curtain enclosure, FFU fan filter unit, to achieve 10,000-level purification level

Clean room installation：

• Installation location: The clean shed should be installed in a dry, ventilated, well-lit environment, avoiding direct sunlight. The installation location must also meet the special requirements of related industries, such as anti-static and anti-corrosion.

• Foundation construction: The foundation construction of the clean shed should meet the design requirements to ensure that the foundation is flat, solid and horizontal. After the foundation construction, it should be inspected and accepted, and the clean shed can be installed only after it is qualified.

• Frame installation: The clean shed frame is made of steel, and the verticality and horizontality of the frame should be ensured during installation. After the frame is installed, anti-corrosion and anti-rust treatment should be carried out.

• Ceiling and wall panel installation: The ceiling and wall panels should be made of purification panels or other materials that meet the clean requirements. During installation, the flatness and joints of the ceiling and wall panels should be ensured to avoid loopholes.

• Air purification system installation: The clean shed should be equipped with an air purification system, including high-efficiency filters, air showers, ultraviolet disinfection lamps, etc. During installation, the connections between the components should be ensured to avoid air leakage.

• Lighting system installation: The clean shed should be equipped with a lighting system, including LED lamps, etc. During installation, the waterproof and dustproof performance of the lamps and the uniformity of illumination should be ensured.

• Electrical system installation: The electrical system of the clean room should comply with relevant national standards and industry requirements. During installation, the power supply should be stable and safe, and the normal operation of each electrical equipment should be ensured.

• Grounding treatment: The grounding treatment of the clean room should meet the design requirements to ensure the safe operation of the equipment inside the clean room.

• Acceptance and commissioning: After the installation of the clean room is completed, acceptance should be carried out. After the acceptance is qualified, the clean room should be debugged to ensure the normal operation of each system and achieve the expected clean effect.

Clean room inspection:

• Clean room inspection fee

  The number of sampling points is determined according to the size of the clean room, and the inspection fee is determined according to the sampling points and test items. Secondly, the sampling fee for personnel needs to be added.

• Clean room inspection items

  Temperature, relative humidity, air volume, static pressure difference, illumination, noise, dust count, settling bacteria, floating bacteria, high-efficiency filtration leak detection, etc.

• Clean room inspection standards

  Pharmaceutical industry clean room design standard GB50457-2019

Test method for clean room (area) of pharmaceutical packaging material production plant YBB00412004-2015:

• Food industry building technical specifications GB50687-2011

• Clean room construction and acceptance specifications GB50591-2010

• Experimental animal environment and facilities GB14925-2010

• Electronic industry clean room design specifications GB50472-2008

• Health food good manufacturing practice GB17405-1998, etc.

Clean room inspection cycle: 3-5 working days