Air shower self-cleaning transfer window with complete installation + standard operating procedures The air shower self-cleaning transfer window (air shower transfer window) is equipped with a fan, high-efficiency filter, blowing nozzle, ultraviolet disinfection, electronic/mechanical double-door interlock. It is used for the transfer of small items between clean areas and non-clean areas, or between different clean levels. It uses high-pressure clean air flow to blow off dust on the surface of the materials and prevent cross-contamination of air flow. It complies with the GB50591 construction specifications for clean rooms. Scene of the installation of the air shower transfer window I. Installation Construction Process (including pre-installation preparation, fixation, wiring, and acceptance) (1) Pre-installation Preparation Positioning and wall hole opening Select an independent logistics partition wall, away from the air shower door, with a wall thickness matching the equipment depth; Hole size: 10-20mm larger than the equipment outer frame to facilitate leveling and sealant application; Wall surface leveling: vertical deviation ≤ 2mm/m, horizontal deviation ≤ 1mm/m. Hollow walls / color steel plate partitions need to be reinforced around to prevent equipment deformation and air leakage. Box opening inspection Check the completeness of the box body, fan, primary / high-efficiency filters, interlock door, sealing

Comparison of Filter Lifespan Differences for Explosion-proof FFU Based on three dimensions: pre-filtering (initial / intermediate efficiency), end-stage high-efficiency HEPA/ULPA (glass fiber, PTFE-coated), and structural style (flat / without partition / V-shaped), combined with lithium battery, chemical, and pharmaceutical explosion-proof conditions, the lifespan differences are explained. I. Classified by level: pre-filter vs end-stage high-efficiency (the largest lifespan gap) 1. Top-of-FFU initial efficiency / pre-filtering net (G3/G4) Material: non-woven fabric, nylon net, metal net Characteristics: Intercepts hair, flocculent substances, large-particle dust, protecting the rear-end high-efficiency Explosion-proof scenarios lifespan: Low-dust pharmaceutical / laboratory: 1-3 months, washable 2-3 times before replacement Lithium battery, solvent workshop: 15-30 days, oil and dust are highly prone to clogging the net Feature: The shortest lifespan, but the lowest cost, is the core consumable for extending the lifespan of the high-efficiency 2. Intermediate-efficiency filter (F5-F9, for new air systems, rarely built-in in FFU) Lifespan: 3-6 months in clean explosion-proof area; 1.5-3 months in high-dust explosion-proof workshop 3. End-stage high-efficiency filter (determines cleanliness, the most expensive) All core consumables of explosion-proof FFU, the lifespan is much longer than the pre-filter, but the difference in filter materials is extremely large. II. Comparison of high-efficiency filter material (the most core lifespan

Audit Control Plan for Accuracy and Completeness of Negative Pressure Weighing Room Inspection Records (Applicable to GMP Audit) This plan is implemented from six dimensions: personnel management, filling norms, on-site control, rechecking and verification, traceability closure, and training assessment, to completely eliminate the problems of omitted filling, false filling, data distortion, and missing records. I. Pre-control: Ensure the authenticity and completeness of records from the source 1. Define job responsibilities and assign them to individuals Operator’s primary responsibility: Pre-checking before startup, observing parameters during operation, confirming cleaning at the end of the shift, filling in immediately during the shift, prohibiting filling after the shift or making up entries the next day. Team leader’s review responsibility: Before each shift ends, check each record item one by one, verify abnormalities and blank items on the spot. QA inspection supervision: Conduct on-site random checks daily, compare real-time equipment parameters with paper records. Equipment administrator’s archiving review: Recycle ledgers weekly, uniformly check for completeness, and hold accountable for missing records. 2. Standardize record forms to prevent omissions Fixed mandatory items in the template: Negative pressure and wind speed must have a numerical filling column, not just a checkmark for normal/abnormal; Each inspection item is

Sealant liquid (jelly-like gel) replacement cycle standard It is divided into two parts: fixed cycle and immediate replacement judgment conditions, which are suitable for different working conditions in pharmaceutical GMP and electronic dust-free workshops: 1. Regular complete replacement cycle (empty the entire tank and replace with new gel) Frequent VHP hydrogen peroxide fumigation of A/B grade sterile areas, operating rooms, P2/P3 laboratories Replace once every 6 months The fumigation of oxidants will accelerate the aging, stratification, and blackening and precipitation of the gel, easily causing leakage of the seal. GMP verification pays special attention to this. General pharmaceutical clean areas, thousand-level/electronic clean workshops, and less fumigation environments Replace the entire tank once every 12 months (1 year) Cleanrooms with low dust, stable temperature, and almost no space sterilization The highest quality silicone-based sealant can be extended to once every 2 years for replacement, but it is not recommended to exceed 2 years Note: Only replenish and do not add (no replacement) Monthly inspection only replenishes the liquid: when the liquid level is below the standard scale, there is a small amount of evaporation loss, directly add the same type of new gel; Do not mix large amounts of new and

The maintenance cost of the air supply ceiling is generally higher and much higher than that of ordinary air conditioning vents. 1. Why is the maintenance cost higher (four major cost components)? 1. Consumables replacement cost (the largest expense) The air supply ceiling is equipped with primary + intermediate + HEPA/ULPA three-level filters as standard. The cost of consumables continues to increase: Primary filter: 3-6 months for cleaning / replacement; Intermediate filter: 6-12 months for replacement; H14 high-efficiency filter: 1-2 years for replacement, with unit prices ranging from several hundred to several thousand yuan, and the larger the size, the more expensive; Silicone rubber sealing strips: 2-3 years for replacement; Equalizing membranes aging and damage require the entire set to be replaced. Ordinary vents only have a single coarse filter layer, which can be washed and reused, with almost no large-scale consumable expenses. 2. Higher labor maintenance cost and more frequent maintenance High operational threshold Replacing high-efficiency filters, PAO/DOP leak detection, wind speed uniformity testing, and internal cleaning of the static pressure box must be carried out by certified purification engineers, with labor costs much higher than those of ordinary HVAC maintenance workers. Complex procedures and long time consumption Old

General Daily Maintenance for Transfer Windows (including common / UV / VHP models, with GMP compliance checks) I. General Basic Maintenance (applicable to all types of transfer windows) 1. Daily Cleaning (must be done before and after shifts) Inside and outside chambers, tabletop, door frames, observation windows Cleanroom standard: use purified water and 75% ethanol for wiping, clean stubborn oil stains with neutral non-phosphorus cleaner, strictly avoid strong acids and strong alkalis. All rounded corners, sealing strip grooves, door hinge dead corners wiped, no material residue, water stains, mold spots. Observation glass / acrylic: wipe with dust-free cloth, do not use steel wool to scratch, to prevent scratches and bacterial accumulation. Around the floor: clean the bottom and surrounding floor of the transfer window simultaneously, to avoid dust from accumulating into the chamber. Prohibited cleaning: do not spray a large amount of water for rinsing, to prevent water ingress in the electrical box and short circuit. 2. Daily Function Inspection Double door interlock: test whether the inner and outer doors can be opened simultaneously, if the interlock fails, immediately stop and report for repair. Sealing strip: check if the silicone seal is cracked, hard, fallen off, or has gaps for

Standard for Determining the Replacement of Explosion-proof FFU Filters (Enforced in explosion-proof workshops, divided into 4 levels, with differential pressure as the primary basis) 1. Core determination: Differential pressure standard (the most authoritative and priority execution) 1.1 Resistance value threshold New HEPA initial differential pressure: 130～180 Pa General explosion-proof workshop alarm value: 280 Pa (warning, arrange for planned replacement) Mandatory replacement differential pressure: 300～350 Pa Lithium battery, electrolyte, high solvent explosion-proof workshop: Replace directly if the pressure exceeds 280 Pa, do not wait until 350 Pa Explosion-proof key: Excessive differential pressure causes the fan load to soar, motor temperature to rise beyond the limit, easily forming an ignition source, and there is an explosion hazard. 1.2 Special situations of differential pressure abnormality Short-term rapid increase in differential pressure (increase by more than 80 Pa within one week), indicating a sudden increase in dust/oil mist concentration in the workshop, even if it is not yet 300 Pa, it is necessary to replace immediately. 2. Operating condition determination (differential pressure not exceeding the standard, but the following situations must be replaced) Same speed fan significantly smaller, laminar flow effect in the clean area deteriorates, particle concentration continues to exceed the standard; FFU

Standard Set for Judging the Material of the Observation Window Glass of Ultra-clean Workbench (On-site Self-inspection + Professional Acceptance) Compliance Standards: 5mm or thicker tempered float glass. All 3C, non-tempered, thin ordinary glass are all unqualified. The judgment is divided into four parts: visual inspection, practical operation, certificates, and usage compatibility. I. First step: Check the 3C mandatory marking (the most basic determination basis) Qualified glass requirements On the lower right corner / corner of the glass, there should be a permanent etched 3C mark + factory code, which cannot be erased or scraped off; Complete marking example: CCC + E0XXXX (glass factory code). Unqualified situation Only a sticker 3C, which falls off when torn: laterally pasted fake marking, not tempered glass; Complete absence of 3C etching: ordinary flat glass, prone to cracking, does not comply with laboratory safety regulations; Printed ink 3C, which can be scraped off with fingernails: counterfeit marking. II. Second step: Thickness measurement (industry hard standards) The minimum thickness of the observation window of the ultra-clean bench is 5mm tempered glass. GMP / pharmaceutical factory priority 6mm: Tools: ruler, vernier caliper, measure the exposed thickness of the glass on the side; Avoidance points: 4mm or less

Various daily physical disinfection methods for transfer windows and their corresponding applicable scenarios I. UV-C ultraviolet radiation (most common, suitable for all scenarios) Applicable scenarios Electronic dust-free workshops (class 10,000, 100,000 clean rooms) Daily material transfer in chip, lithium battery, optical, food packaging workshops, semi-finished product transportation of plastic, metal, paper box, daily disinfection standard. General medical device clean workshops (non-sterile) Transportation of components, packaging consumables, testing tools, daily sterilization, reducing surface microbial load. General hospital clean operating rooms, laboratories, pharmacies Transfer of equipment, consumables, test samples, rapid short-time disinfection. Daily transfer pre-treatment in sterile workshops As a basic disinfection, combined with wiping, and then regularly do VHP deep fumigation. General sample transfer in biological laboratories (non-positive bacteria / high pathogenic areas) Regular disinfection of samples, consumables. Inapplicable scenarios Severe material stacking obstruction, multi-pore materials cannot be completely sterilized by UV alone; High-level sterile areas cannot be solely sterilized by UV. II. laminar flow FFU self-cleaning blow (exclusive physical disinfection for laminar transfer windows) Applicable scenarios High-level electronic clean workshops (class 10,000, 100,000) Extremely strict dust particle control, not only sterilization, but also removal of floating dust and floating bacteria to prevent external particles from entering the clean area. Precision

1. Ultraviolet UV-C irradiation (General basic physical disinfection) Applicable scenarios Various electronic dust-free workshops (100,000-level, 10,000-level): daily transfer and disinfection of plastic, hardware, packaging materials, and tooling equipment; General food clean workshops, packaging workshops: transfer of raw materials packages, consumables, and finished products; Hospital laboratory, pharmacy, general clean operating rooms: transfer of test samples, medical consumables, and small instruments; Non-sterile clean areas of medical devices: daily transfer of spare parts and testing tools; General physical and chemical laboratories, physical and chemical inspection rooms: transfer of glassware and routine samples; Daily pre-treatment of sterile pharmaceuticals / sterile instrument workshops: as a basic disinfection measure, combined with chemical wiping, and regular VHP deep sterilization. Not suitable Materials with many pores, folds, and severe stacking; areas with high-risk spore contamination cannot achieve sterility requirements solely by ultraviolet light. II. laminar flow FFU self-cleaning blow-off (special for laminar flow transfer windows) Applicable scenarios High-grade clean workshops (thousand-level, hundred-level): for semiconductors, optical lenses, and precision lithium batteries, strict control of dust particles; Sterile raw drug products, implantable medical devices clean area: control dust and suspended bacteria simultaneously to prevent aerosol contamination; Cell rooms, ordinary biological laboratories: reduce floating microorganisms and reduce cross-contamination; Precise testing laboratories

The comprehensive impacts brought about by the shortened lifespan of filter elements due to high humidity environments I. Significant increase in production and operation costs Increased cost of consumables In a dry environment, filter elements need to be replaced every 8-12 months, while in a high-humidity environment, the replacement period is only 2-6 months. The frequency of filter element purchases has doubled, and the unit price of high-efficiency filter elements is high, resulting in a significant increase in long-term consumables expenditure. Increased labor costs for filter element replacement Frequent shutdowns for filter element replacement require specialized personnel to operate, occupying the workforce in the workshop; as the frequency of replacement increases, the labor hours also increase. Increased wear and tear of supporting materials The sealing strips and sealants of filter elements age along with the filter elements. Each time a filter element is replaced, the sealing components need to be replaced synchronously; the frame of the boat rack gets damp and rusts, and the cost of rust removal, painting, and maintenance increases. II. Production downtime losses and reduced production capacity Filter element replacement requires partial or full system shutdowns, and self-cleaning in the purification area. Frequent replacements will disrupt the

A Complete Solution for Extending the Service Life of the Boat Frame High-efficiency Filter with High Humidity Environment It is divided into five sections: front-end humidity control pre-treatment, optimization of filtration levels, daily operation and maintenance management, optimization of selection and installation, and disinfection and shutdown regulations. These can be directly written into the SOP maintenance documents. 1. Source Control of Humidity: Reduce the humidity of the air entering the high-efficiency section (the core and fundamental measure) Install a deep dehumidification unit for central air conditioning Stabilize the relative humidity of the supply air at RH 45% – 60%, preventing the air from carrying high-humidity water vapor directly to the high-efficiency filter; add independent pipeline dehumidification systems in cold storage and cooking workshops to prevent the convergence of cold and hot air and condensation. Prevent local condensation in the workshop Control the temperature difference between the clean area and the supply air temperature ≤ 3℃ to prevent water droplets from condensing on the cold pipe walls, static pressure boxes, and the outer walls of the boat frame units; Install local negative pressure exhaust at steam production positions (mixing, cooking, cleaning) to discharge the water vapor locally and prevent it from