I will provide you with a set of practical and directly applicable methods for the cleanroom site, fully GMP-compliant, with the sole aim of significantly extending the lifespan of the high-efficiency filters without compromising the cleanliness level, and saving costs and reducing risks. 1. Core concept (in one sentence) Make the high-efficiency filters do less work: The previous filters block all the dust, and the high-efficiency filters only perform the final check. 2. 6 most effective and immediately actionable methods 1. Replace the primary and intermediate filters on time (most crucial!): The primary and intermediate filters should be replaced every 1 to 3 months. As long as the first two stages are replaced in time, the lifespan of the high-efficiency filters can be directly extended by 1 to 2 times. 2. Control the indoor dust sources (reduce the load at the source) Reduce open operations of powders, particles, and dust materials Use lint-free cloths for cleaning, and prohibit ordinary mops and rags Have personnel change clothes according to regulations, reducing hair and skin flakes Avoid opening boxes, unpacking, and sanding under the high-efficiency air intake 3. Control humidity to prevent the high-efficiency filters from getting moldy and collapsing Control the

I will provide you with a detailed, accurate, and complete cost breakdown for the replacement of high-efficiency filters in the cleanroom industry, which can be directly used for budgeting, procurement, and cost analysis. This breakdown excludes any fictitious items and is clear and easy to understand. Cost of high-efficiency filter replacement = Explicit cost + Implicit cost I. Explicit cost (money spent directly) Purchase cost of high-efficiency filters Unit price of HEPA/ULPA filters Prices vary depending on size, air volume, and grade Replacement cost of pre-filter Initial efficiency G4 Intermediate efficiency F8/F9 (Generally, it is recommended to replace the intermediate efficiency filters simultaneously) Labor cost Air conditioning maintenance workers / Cleanroom engineers On-site quality control / QA supervision Cost of testing instruments and consumables PAO/DOP leak detection consumables Use and calibration of spectrophotometer Verification / testing costs Leak detection test Re-measurement of cleanliness (particle counting) Re-adjustment of pressure difference and air volume II. Implicit cost (easily overlooked but actually exists) Loss due to downtime / production halt The need to shut down / adjust the air conditioning system during replacement Production interruption, batch waiting, and capacity decline Cleanroom cleaning and disinfection costs Dust from the removed air intakes, requiring re-cleaning,

I’ll provide you with a direct and practical on-site solution for extending the lifespan of the clean room, without any unnecessary details. Here are the key points: 1. Control the environment (root cause approach for longevity) Maintain stable temperature and humidity, avoid high humidity and condensation, prevent rusting of the frame and aging of the rubber strips. Reduce direct exposure to acids, organic solvents, and disinfection gases to prevent material corrosion. Control the source of dust: change shoes, change clothes, wind shower, reduce dust-laden operations. 2. Replace filters at regular intervals (the most cost-effective method for longevity) Primary: Check and clean / replace every 1-3 months Intermediate: Replace every 3-6 months High-efficiency: Replace every 1-3 years (depending on resistance and cleanliness) If the filter is not clogged, the fan does not get tired, and the room body does not leak air, the lifespan is directly extended. 3. Protect the structure and seals Do not collide, squeeze, or forcibly pull the soft curtains, glass, or frame. Fix any gaps, leaks, or cracked rubber strips in time with sealant / replacement. Regularly check if the FFU, lamps, and strips are loose. 4. Correct usage and operation habits Start and stop the fan

The main structure of the clean room consists of three main materials. The most commonly used and stable ones in the industry are as follows. I will explain clearly without any circumvention: 1. Frame material (load-bearing skeleton) Aluminum alloy profiles (most commonly used, highest cost-effectiveness) Lightweight, non-corrosive, quick to install Preferred for electronics factories, clean rooms, and general dust-free workshops Life expectancy: 8 to 12 years 304 stainless steel frame (for medicine, food, and high-humidity environments) Corrosion-resistant, easy to clean, high strength Used in pharmaceuticals, medical devices, and food factories Life expectancy: 10 to 15 years Square steel with powder coating / galvanized iron (cheap, temporary, low requirements) Low cost, but prone to moisture, easy to rust The lifespan in humid environments will be significantly shortened Life expectancy: 5 to 8 years 2. Enclosure panels / partitions (the enclosed part) Clean color steel plates (EPS / rock wool / magnesium) Most standard and universal Sound insulation, heat insulation, flat and easy to clean Tempered glass / acrylic plates Transparent, beautiful, easy to observe Suitable for display areas, laboratory clean rooms PVC soft curtains (simple, low cost) Quick to dismantle and install, cheap But prone to aging, poor sealing Industry’s simplest

The main structure of the clean shelter typically has a service life of 5 to 15 years. The core components (filters, fans) need to be replaced regularly. The overall lifespan is greatly influenced by the material, environment, and maintenance. 1. Service life of the main structure (based on material) Frame / Enclosure Material Applicable scenarios Normal service life Influencing factors Stainless steel frame (304/316) Medicine, food, high humidity / corrosive environments 10th – 15th year Resistant to acid and alkali, with high strength and the longest lifespan Aluminum alloy frame Electronics, laboratory, conventional cleanliness 8th – 12th year Lightweight, corrosion-resistant, and with high cost-effectiveness. Galvanized steel / powder-coated iron frame Temporary, low-cost, dry environment 5-8 years Prone to rusting, lifespan is significantly shortened in humid environments. Hard protective enclosure (tempered glass / stainless steel plate) High cleanliness, long-term use More than ten years Durable, easy to clean, and resistant to aging Soft drapes (PVC / polyester) Temporary, infrequent, non-critical areas 3-5 years Prone to aging and deterioration, requiring frequent replacement II. Replacement Cycle of Core Components (Determining Cleanliness and Operating Life) High-efficiency Filters (HEPA/ULPA): 2-3 years (in normal environment); 1 year or even shorter in dusty/high-humidity environments. Primary / Intermediate

The environmental factors that affect the lifespan of the clean room mainly include the following categories, which directly determine the speed of aging of the frame, panels, filters, and seals: 1. Temperature and humidity (the most crucial factor) High humidity environment: This is the most damaging to the clean room, accelerating: Metal frames rusting, spray-painted layers peeling off Sealant strips, sealing strips getting moldy, hardening, and cracking High-efficiency filters getting damp, getting moldy, having increased resistance, and being prematurely scrapped Severe temperature fluctuations: Materials expand and contract, leading to sealing failure, gaps widening, and air leakage. 2. Corrosive gases / chemicals Acidic and alkaline gases, organic solvents, disinfectants (such as frequent use of ozone, peracetic acid) Will directly: Corrode aluminum alloys, stainless steel, galvanized layers Aging plastics, PVC curtains, sealants Damage fan motors, electrical components 3. Dust concentration High dust and particle content: Initial / mid / high-efficiency filters quickly clog up, resistance surges Fans operating under high load for a long time, motors prematurely damaged Cleanliness rapidly decreases, maintenance costs increase sharply 4. Vibration and external forces High ground vibration, frequent collisions, pushing, pulling, and squeezing: Frame loosening, deformation Wall panels, ceiling panels cracking, air leakage FFU, lamps, filters

Service life of high-efficiency filters (HEPA) Normal use: 1 to 2 years Harsh environment / High dust: 6 to 12 months Critical clean areas (sterile, high requirements): recommended not to exceed 1 year 1. The actual lifespan is determined not by time, but by these 4 indicators Satisfy any one of them, it must be replaced; it cannot be used any longer: Final resistance reaches twice the initial resistance (The most critical indicator, mandatory for GMP) DOP/PAO leak test fails (leakage rate > 0.01%) Filter paper is damaged, blackened, damp, moldy, or yellowed Use time exceeds 2 years (regardless of pressure difference, it is recommended to force replacement) 2. Tips for extending lifespan (very practical on-site) Primary and secondary filters should be replaced on time (generally 1–3 months) Avoid high humidity, water leakage, and direct spray from water jets towards the air outlet Daily cleaning only wipe the diffusers, do not wipe the high-efficiency filter paper Regularly record the pressure difference and observe the upward trend 3. Summary (can be memorized directly) The theoretical lifespan of high-efficiency filters is 1 to 2 years, In practice, it is replaced when the pressure difference ≥ 2 times the initial resistance, DOP leak

DOP HEPA box Daily Maintenance I. Daily Maintenance Objectives To ensure the integrity of the high-efficiency filter, no air leakage, normal airflow, and meeting the cleanliness standards, in accordance with GMP/ISO requirements. II. Daily Maintenance Contents (Divided into three levels: per shift / per week / per month) 1. Daily Maintenance (Operation Inspection) Visual inspection The supply air panel and diffuser plates are free of dust, stains and deformation. There is no condensation water or mold spots. Operating status The air supply is normal, without whistling or abnormal vibration. The airflow is uniform, without obvious vortex or wind short-circuiting. Pressure difference check (when a pressure difference meter is available) The pressure difference before and after the filter is within the normal range. There is no sudden increase or decrease. Cleaning Use a lint-free cloth and 75% ethanol to gently wipe the surface of the panel and diffuser plate. Do not rinse with water directly, and do not impact the high-efficiency filter. 2. Weekly maintenance (deep cleaning + inspection) Remove the diffuser plate / diffuser panel (operate gently) Clean the diffuser panel and the inner wall of the air outlet Check: Seal strips have no aging, no detachment, no fracture Compression

I. Scope of Application Cleanroom / Transfer Window / Air Shower / Clean Workbench HEPA/ULPA High-Efficiency Filters Method: Aerosol Scanning Leak Detection Method (Upstream Dust Generation + Downstream Scanning) II. Preparations Before Testing 1. Instruments and Consumables Aerosol Photometer (with dual channels for upstream/downstream) Aerosol Generator (heated / cooled PAO/DOP) Isokinetic Sampling Gun, Hose Calibration Certificate within Validity Period Clean Rags, 75% Ethanol 2. System Status Air Conditioner / Fan Running for ≥ 10 minutes continuously Cleanliness Filters Surface Cleaned Free of Dust Clean Area Free of Dust, No Operations, Minimum Personnel All Doors, Windows, Inspection Holes Closed 3. Instrument Preparation Photometer Turned On and Preheated for ≥ 15 minutes Zero Point Calibration, Range Calibration Connect Upstream Sampling Tube to Filter Upstream Static Pressure Box III. Formal Leak Detection Operating Steps (Full Version) Step 1: Establish Upstream Challenge Concentration Connect the aerosol generator to the upstream air duct of the high-efficiency filter Turn on the generator, let the dust generation stabilize for 3-5 minutes Read the upstream concentration with the photometer: Controlled within 10-30 μg/L Photometer Settings: Display Mode: Leakage Rate (% Penetration Rate) Alarm Threshold: ≤ 0.01% Step 2: Zeroing of the Photometer (Baseline Calibration) Confirm the stability of

DOP/PAO High-Efficiency Filter Leak Detection Principle (Full Version) I. Core Sentence Inject aerosol towards the upstream, measure the leakage concentration at the downstream, and determine the integrity of the filter and seal by the “penetration rate”. II. Detailed Principle (GMP/ISO Standard Explanation) 1. What is DOP/PAO DOP: Di-Isopropyl Phthalate, an early used aerosol PAO: Poly α-Ether, the current mainstream, safe, and recommended Both are oily aerosols, capable of generating challenge particles of about 0.3μm — This is precisely the particle size that is most difficult for HEPA filters to filter and most prone to leakage. 2. Leak Detection Physical Principle: Challenge upstream + Scan downstream 1) In the upstream, create a stable concentration of aerosol to heat or cool it and send it into the filter intake side (upstream). Form a uniform and stable challenge concentration C₀. 2) The normal filtration principle of HEPA: HEPA filters have a filtration efficiency of ≥ 99.97% for 0.3μm particles. Under normal circumstances: Upstream: There is aerosol Downstream: Almost undetectable 3) Leakage = Aerosol “circles around” the filter. If any of the following occurs: Filter paper damage Pinholes Border seal not tight Installation gap Rubber strip aging The aerosol will directly leak to the

Daily inspection of the DOP (PAO) laminar transfer window focuses on the integrity scanning and leak detection of the high-efficiency filters to ensure no leakage and that the filtration efficiency meets the standards. This is a key daily inspection for controlling contamination in the clean area. I. Inspection Objectives Verify that the HEPA/ULPA filters are undamaged and leak-free Confirm the integrity of the sealing structure (frame, joint, installation surface) Meet the compliance requirements of GMP, ISO 14644, GB 50591, etc. for clean rooms II. Inspection Cycle (Daily / Routine) Daily inspection: per shift / daily (visual + simple functional check) Regular DOP scanning: once every quarter (key areas can be monthly) Annual full performance: including DOP, air velocity, cleanliness, pressure difference, interlock III. Preparations Before Inspection 1. Equipment and Consumables Aerosol generator (heated DOP / cold PAO) Aerosol photometer (with upstream/downstream dual channels, accuracy 0.01%) Wind speed meter, pressure gauge, dust particle counter Clean cloths, alcohol, sealant (for backup) 2. Environment and Status The transfer window is operating normally (fan, UV, interlock, self-cleaning) There is no cross-operation in the clean area, adjacent doors/windows are closed The instrument is preheated for ≥ 15 minutes, calibrated / reset Clean the surface of

I. First, clarify: Daily inspection = two parts Functional daily check (per shift / daily) DOP/PAO high-efficiency filter leak detection (performed regularly, not measured every day during daily inspection) I will provide you with the most standard, detailed, and writeable SOP process. II. Daily functional check for DOP/PAO laminar transfer window (per shift must be done) 1. Appearance and cleanliness Check the inner and outer surfaces of the transfer window, glass, door frame for no stains, no damage, no rust Seal strip flat, no deformation, no detachment No debris, no water accumulation, no odor inside 2. Interlock function When one side door is opened → the other side must be unable to open After closing, the interlock automatically resets, with normal sound and light indication 3. Fan / laminar operation After starting, the fan operates smoothly, without abnormal noise, without vibration The airflow at the outlet is uniform, without obvious turbulence The operation indicator light is normal 4. Ultraviolet germicidal lamp The lamp lights up normally, without flickering, without blackening The timing is accurate, the cumulative usage time has not exceeded the lifespan (generally 9000 hours) 5. Pressure difference (if any) The pressure on the clean side is higher than