What are the requirements and standards for purification equipment and installation materials used in purification workshop project?
The purification equipment and installation materials of purification workshop Project must strictly follow the three core standards of industry norms, cleanliness grade requirements and usage scene characteristics. Different types of equipment and materials have clear technical indicators, and the specific requirements are as follows:
I. Requirements and standards for purification equipment
Purification equipment is the core of maintaining the cleanliness of the workshop, which needs to meet the requirements of filtration efficiency, operation stability and compliance. The standards of key equipment are as follows:
Air filtration equipment
Primary filter: It mainly filters dust particles ≥5μm, and the material is non-woven fabric and wire mesh, which must meet the standard of Air Filter (GB/T 14295), with a filtering efficiency ≥35% (by weight method) and a resistance ≤50Pa, and is easy to disassemble and clean, and the replacement cycle is generally 1-3 months.
Medium-effect filter: Filter particles ≥1μm, made of glass fiber or non-woven fabric, which must meet the GB/T 14295 standard, with a filtration efficiency ≥60% (counting method) and a resistance ≤100Pa, to protect the back-end high-efficiency filter and reduce its load.
High Efficiency Filter (HEPA)/ Ultra-high Efficiency Filter (ULPA): the core filtering component of purification workshop. HEPA should meet the standard of High Efficiency Air Filter (GB/T 13554), and the filtering efficiency for 0.3μm particles should be ≥ 99.97%; The filtration efficiency of ULPA is more than or equal to 99.999%, which is suitable for clean workshops of class 100 and above.
Installation requirements: the filter frame should be made of galvanized steel plate or stainless steel, and the gasket should be made of aging-resistant silicone or polyurethane, and the sealing leakage rate with the installation frame should be ≤0.01%.
Air shower room/cargo shower room
It shall conform to the Standard for Construction and Acceptance of Clean Rooms (GB 50591), the outlet wind speed of the nozzle shall be ≥25m/s, and the air shower time shall be adjustable (10-30s); Equipped with electronic interlocking device, the front and rear doors cannot be opened at the same time; The box body is made of 304 stainless steel, with smooth inner wall and no dead angle, which is convenient for cleaning and disinfection; The running noise of the fan is ≤65dB, which meets the requirements of noise reduction in the workshop.
Clean air conditioning unit
It must have the function of accurate temperature and humidity control, with the temperature control accuracy of 1℃ and the humidity control accuracy of 5%; The fan adopts frequency conversion speed regulation design, which can automatically adjust the air volume according to the workshop pressure difference and reduce energy consumption.
The shell of the unit needs to be treated with heat preservation and anti-corrosion to prevent condensation; Internal heat exchanger, humidifier and other components need to be made of food-grade or pharmaceutical-grade materials to avoid the precipitation of harmful substances; It conforms to the standard of Combined Air Conditioning Unit (GB/T 14294).
Transfer window
It is divided into mechanical interlock and electronic interlock. The inner wall is made of 304 stainless steel, and the double door interlock is reliable. The transmission window with embedded ultraviolet disinfection lamp should have an ultraviolet wavelength of 253.7nm and a disinfection time of ≥30min to meet the requirements of microbial killing; Meet the design specification of cross-pollution prevention and control in clean workshop.
Pressure difference and environmental monitoring equipment
The accuracy of the differential pressure sensor should reach 1 Pa, and it can display the differential pressure between clean area and unclean area in real time (maintaining 10-20Pa positive pressure); The temperature and humidity recorder shall conform to the standard of Temperature Measuring Instrument (GB/T 13823), and the data can be stored and exported to facilitate compliance traceability. The particle counter must meet JJG 547 Verification Regulation of Dust Particle Counter, and can accurately detect the number of particles with particle sizes of 0.3μm and 0.5 μ m..
Second, the requirements of the installation materials standard
The installation materials directly affect the sealing, corrosion resistance and cleanliness maintenance ability of the workshop, and should follow the principles of no dust, easy cleaning and no pollution. The specific requirements are as follows:
Envelope material
Color steel plate: priority is given to machine-made rock wool color steel plate or polyurethane color steel plate, the core material is flame retardant (combustion performance reaches Grade A), the thickness of steel plate is ≥0.5mm, and the surface is coated with antibacterial electrostatic coating to avoid dust adsorption; For tongue-and-groove splicing design, neutral silicone sealants shall be applied at the joints of plates, which conforms to the standard of GB 50591, so as to ensure that the enclosure structure is seamless and leakproof.
Clean doors and windows: the door frame and door leaf are made of 304 stainless steel, and the observation window is made of double-layer hollow tempered glass with light transmittance ≥ 85%; The sealing strip is made of food-grade silica gel, which is aging-resistant and odorless; The door body is equipped with a door closer, and the gap between the door body and the door frame after closing is ≤0.1mm, which meets the sealing requirements.
Ground material
Self-leveling epoxy floor: It shall conform to the Technical Specification for Self-leveling Epoxy Floor Engineering (GB/T 50589), with a smooth surface, no cracks, no hollowing, wear resistance and acid and alkali corrosion resistance; Thickness ≥2mm, surface resistance of antistatic epoxy resin floor should reach 10-10Ω, which is suitable for clean workshop in electronic industry.
PVC antistatic floor: made of food-grade PVC, without plasticizer precipitation; The antistatic performance is stable, and the joints are treated by hot welding, without gaps; It is resistant to cleaning, high-pressure water gun washing and disinfectant wiping, and is suitable for medicine and food workshops.
Duct and pipe materials
Ventilation duct: galvanized steel plate (thickness ≥0.75mm) or 304 stainless steel plate is preferred, with smooth inner wall and no burr to reduce wind resistance and dust accumulation; The air duct connection adopts flange connection, and the flange gasket is high-temperature resistant silicone gasket, which is sealed tightly; The manufacture of air duct shall conform to Code for Acceptance of Construction Quality of Ventilation and Air Conditioning Engineering (GB 50243), and the air leakage rate shall be ≤3%.
Water supply and drainage pipes: 304 stainless steel pipes or PPR food-grade pipes should be selected for water pipes in clean areas to avoid rust and secondary pollution; The drain pipe shall be equipped with a water-sealed floor drain, and the water-sealed height shall be ≥50mm, so as to prevent sewer odor and bacterial backflow, and meet the requirements of GB 14881 General Hygienic Standard for Food Production.
Sealing and auxiliary materials
Sealant: Neutral silicone sealants or polyurethane sealant must be selected, which is solvent-free and odor-free, and does not produce volatile organic compounds (VOC) after curing, which conforms to the standard of Silicone Structural Sealant for Building (GB 16776) to avoid polluting the clean environment.
Thermal insulation material: centrifugal glass wool or rubber-plastic insulation board is selected as the thermal insulation layer of air-conditioning duct and water pipe, and the combustion performance is Grade A. The surface is covered with aluminum foil protective layer to prevent the debris of thermal insulation material from entering the air and causing secondary pollution.
III. General compliance requirements
Industry specific standard
Pharmaceutical industry: It shall comply with good manufacturing practice (GMP) and Design Standard for Clean Workshop in Pharmaceutical Industry (GB 50457).
Food industry: It must comply with GB 14881 and Technical Code for Building Clean Houses in Food Industry (GB 50687).
Electronic industry: It shall comply with the Code for Design of Clean Workshop in Electronic Industry (GB 50472).
Environmental protection and safety requirements of materials
All materials need to provide test reports to prove that no harmful substances such as formaldehyde and heavy metals are precipitated; The flame retardant performance should meet the building fire protection code to avoid fire hazards.
