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

Ensure that the daily maintenance records of the air supply ceiling are accurate. The key points are: accurate instruments, true data collection, strict filling, thorough verification, and clear standards. This will prevent “estimated, fabricated, modified, or incorrect” data from being generated at the source. Here is a set of actionable measures you can follow: 1. First, ensure that the measurement data is accurate. The instruments must be calibrated regularly. Pressure gauges, anemometers, temperature and humidity meters, etc., should be sent for calibration at regular intervals, and the calibration certificates should be attached. Any expired or non-compliant instruments must not be used. Before use, conduct a self-check. Before measuring the pressure difference, check if the zero point is normal; Before measuring the wind speed, confirm that the probe is clean and in the correct position. Use a unified measurement method. Fix the measurement point position, height, and reading time to avoid data deviation due to different individuals. 2. Second, ensure that the record process is true and not falsified. Numbers must be written: pressure difference XX Pa, wind speed XX m/s, resistance XX Pa. Fill in immediately after maintenance， without relying on memory or centralized re-filling. Only write the measured values，

The accuracy of the maintenance records for the air supply ceiling directly determines whether the cleanroom can operate stably, comply with standards, control risks, and reduce costs. Once the data is inaccurate, it will have a chain effect on the overall operation of the cleanroom in five aspects: environment, quality, compliance, equipment, and cost. 1. It directly determines whether the cleanliness of the cleanroom truly meets the standards. Accurate records: They can truly reflect the resistance of the filter, pressure difference, air velocity, and sealing status, and promptly detect efficient blockage, air leakage, and uneven airflow, ensuring that suspended particles and settled bacteria meet the standards. Inaccurate records: False data / incorrect data will cover up filter failure, static pressure box leakage, and diffuser plate contamination, making it seem normal but the cleanliness has exceeded the standard, and the cleanroom becomes meaningless. 2. It determines whether equipment failures can be predicted in advance and avoid sudden production line shutdowns. Accurate records: Through resistance trends, pressure difference fluctuations, and wind speed changes, it can predict the lifespan of the filter and component aging, achieving preventive maintenance. Inaccurate records: It cannot identify abnormal trends, resulting in sudden filter leakage, sudden drop in

Ensure that the maintenance records of the air supply ceiling ( laminar flow ceiling / efficient air supply outlets ) are complete, compliant, and traceable. The key is to achieve full coverage of content, standardized filling, closed-loop process, and secure storage, while also meeting the compliance requirements of clean rooms (GMP/ISO14644). Here are the practical methods that can be directly implemented: 1. First, clarify: All dimensions that must be recorded (no omissions) The maintenance records of the air supply ceiling cannot simply state “normal”; they must cover all aspects including structure, filtration, airflow, components, environment, and personnel: Basic Information Room number / Cleanliness level, supply air ceiling number, installation location, record date / time, operator / reviewer. Daily inspection items (must be noted) Appearance: No damage, dust accumulation, deformation, loosening of the diffuser plate / uniform flow membrane; Sealing of the frame is intact Pressure difference: Inlet/outlet pressure difference of the high-efficiency filter, pressure difference reading, comparison with the reference value Wind speed / airflow: Uniformity of the outlet wind speed, presence of vortex, dead corners Sealing: No air leakage, condensation, abnormal noise in the static pressure box, flange, soft connection Cleaning and disinfection record Cleaning method (wiping / vacuuming),

The retention period for the daily maintenance records of the air supply ceiling is mainly determined in accordance with industry regulations/standards, taking into account both the need for product traceability and the management of the equipment’s entire life cycle. Daily records and key verification/replace records can be set at different levels to ensure compliance and traceability. The following are clear, actionable standards and practical suggestions. 1. Core regulations and general benchmarks The maintenance records of the air supply ceiling, as a core component of the HVAC system in a cleanroom, must first follow the mandatory industry norms. ISO14644 mainly emphasizes traceability and does not mandate a uniform retention period; the core constraints come from various industry-specific regulations: Pharmaceutical GMP (2010 edition): Equipment maintenance records should be kept until one year after the expiration date of the drug; for drugs without an expiration date, at least five years should be kept; verification records (including PAO leak detection) are recommended to be kept until one year after the equipment is scrapped, with a minimum of five years. Medical device GMP: General records should be kept for at least two years from the date of product release or the product’s lifespan (whichever is

The leak detection determination for DOP high-efficiency liquid filter is based on the core standard of **≤0.01% penetration rate (leakage rate)**. It is accompanied by repair and re-test rules, which need to cover the filter material, seal, and frame, and meet the specifications such as ISO 14644-3 and GB/T 6165-2008. Here are the determination criteria and practical key points: Core determination indicators Penetration rate threshold: The continuous and stable penetration rate of all scanable points of the filter ≤ 0.01% (that is, one ten-thousandth of the upstream concentration), any point exceeding this threshold is judged as不合格， and it needs to be marked for repair or replacement. Scan coverage range： Filter material surface， filter material – frame bonding area， frame – liquid tank sealing surface， liquid tank – static pressure box / enclosure joint， frame joint seam， etc. Detection parameters： Scan speed ≤ 5cm/s， probe distance from the filter surface is approximately 25mm， line overlap ≥ 10mm； the upstream aerosol concentration is stable at 10–20μg/mL (or meets the instrument linear range). Repair and re-test rules Project Qualified upper limit Re-test requirements Single repair length ≤38mm After repair, a re-measurement of the entire area was conducted, and the penetration rate remained ≤

The leak detection of the DOP (now mostly using PAO) high-efficiency liquid tank filter is based on the principle of upstream dust generation and downstream scanning. It involves detecting the transmittance using a photometer to determine whether the filter material, the liquid tank seal, and the frame are leaking, strictly following ISO 14644-3, GB/T 6165-2008, and GMP standards. The operation process is divided into 6 core stages, covering the entire process and being feasible for implementation: 1. Preparations before leak detection (key points: calibration + system confirmation) Instrument calibration and inspection Aerosol photometer: Start the machine for 30 minutes of preheating, complete zero calibration and 100% concentration calibration (using upstream standard aerosol), confirm the range and response time are normal, and the probe is not clogged. Dusting device: Check the oil level of DOP/PAO, heating temperature, and nozzle status to ensure stable dusting; Connect the air compressor to confirm the pressure and flow meet the standards. Auxiliary tools: Prepare scanning probes, extension rods, marker pens, record sheets, sealant / patches (for compliant repair), and differential pressure gauges. System and filter status confirmation Air conditioning system: Turn on the fan corresponding to the target high-efficiency filter, run stably for ≥ 30

Standardized Use and Maintenance Methods for Horizontal Flow Class-100 Clean Workstations The core value of horizontal flow clean workstations is to provide a dust-free and clean environment of 100-level (ISO 5 class) through stable horizontal laminar flow. The core principles for its use and maintenance are: reducing air turbulence, strictly controlling the cleanliness of the operation area, regularly ensuring the filtration efficiency, and maintaining the stability of the laminar flow. All operations should be carried out in accordance with these principles. At the same time, considering its characteristic of “air flow blowing directly from the back to the front without personnel protection capability”, standardized usage and maintenance procedures should be formulated. The following are practical operation guidelines that can be directly implemented, including the entire operation process (before startup / during operation / after shutdown), daily and regular maintenance, common fault troubleshooting, and core prohibitions. They also take into account operability and compliance. I. Standardized Use Procedure (in stages, directly executable) The laminar flow field of horizontal flow clean workstations is prone to be disturbed by external forces. The standardization of operation directly determines whether the cleanliness is met. It is necessary to strictly follow the “preparation before startup →

Specification for Filter Replacement of Horizontal Flow Cleanroom Workstations (Primary Efficiency + High Efficiency) The filters of horizontal flow cleanroom workstations are divided into primary efficiency filters (preliminary protection, washable / replaceable) and high-efficiency filters (HEPA/ULPA) (core filters, not washable, as the core item for replacement). The replacement procedures, timing, and operation requirements for the two types are significantly different. The core principle of replacement is: power-off operation, clean protection, model matching, strict sealing, and verification after replacement. The entire process should avoid introducing dust pollution into the duct, ensuring that the operation area reaches 100-level (ISO 5 grade) cleanliness after replacement. The following are the direct and applicable replacement steps for each type, including replacement timing, preparation, practical operation, and verification throughout the process. Core prerequisite: Determine the replacement timing (avoid blind replacement / overuse) 1. Replacement timing for primary efficiency filters (priority cleaning, replace if not recoverable) The primary efficiency filter is a washable consumable. First, clean it according to maintenance requirements with water / compressed air. Replace it if any of the following situations occur: After 2-3 cleanings, the filter screen is deformed or damaged, or the surface dust cannot be completely removed, and the airflow speed

The core feature of the horizontal flow ultra-clean workstation is that the airflow is sent forward horizontally from the rear of the operation area, forming a uniform horizontal laminar flow, providing a 100-level (ISO 5 grade) dust-free and clean environment for samples. It is mainly designed to offer a sterile environment of 100-level protection for samples, without providing personnel biological protection capabilities. It is only suitable for operations without biological hazards, toxicity, or harmful aerosols. All applicable scenarios are centered around the core principle of “only needing to isolate external dust and particles to ensure sample cleanliness, and the operation process poses no direct safety risk to personnel”. The specific sub-scenarios are as follows: 1. Core applicable prerequisites Before use, the following basic conditions must be met; otherwise, this equipment is strictly prohibited from being selected: The operation objects, reagents, and samples have no pathogenicity, no infectivity, no microbial proliferation risk, and do not contain pathogenic bacteria, viruses, fungi, etc. of biological hazards. The operation process does not produce toxic, harmful, corrosive, or volatile gases, and does not form harmful aerosols to the human body. The core requirement is only to prevent the contamination of samples by dust, hair, fibers,

First, clarify the core concepts: A clean bench is a general term for a type of purification equipment that provides a local high-cleanliness environment. Horizontal flow workbenches and vertical flow workbenches are the two main types of clean benches classified by the direction of air circulation. These two are not separate devices from the clean bench but are two branches of the clean bench. The core differences lie in the direction of air flow, protection, and application scenarios. I. Core Definitions 1. Clean Bench It uses three-stage filtration (initial filter, intermediate filter, and high-efficiency air filter (HEPA/ULPA)) to purify the air, and then delivers it in a laminar flow to the operation area, creating a local ISO 5-level (hundred-level) ultra-high cleanliness environment. It prevents external pollutants from entering the operation area and avoids the diffusion of pollutants within the operation area. It is widely used in research and production scenarios with extremely high cleanliness requirements. 2. Vertical Flow Clean Bench The mainstream type of clean bench. The air flows vertically downward from the top of the clean bench and uniformly passes through the operation surface. Some of the air flows are purified through the return air inlet at the bottom