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\nI. Basic Cleaning Specifications (General for All Cycles)
\n1. Cleaning Consumables Requirements
\nCleaning Tools: 300gsm or above dust-free ultra-fine fabric, no loose fibers
\nDisinfectant: 75% Ethanol \/ 70% Isopropyl Alcohol, rotate every half month to avoid microbial resistance
\nRinsing Medium: Purified Water, strictly prohibit tap water
\nProhibited Items: Chlorine-containing disinfectants, steel wool, sandpaper, strong acids and strong bases, abrasive cleaning agents (corroding 316L stainless steel, silicone sealing strips, sensor probes)
\n2. Cleaning after Each Use (Must Do)
\nRemove materials, clean debris in the chamber, debris, dust;
\nDust-free cloth dipped in 75% Ethanol wipe the inner walls, tabletop, door handles, observation glass, control panel;
\nFocus on wiping temperature and humidity sensors and probe, remove hydrogen peroxide crystallization (crystallization will cause monitoring data distortion);
\nWipe the groove of the sealing strip, the air outlet, the surface of the atomization nozzle;
\nDry all contact surfaces with dust-free cloth, no water accumulation or residual condensation in the chamber;
\nConfirm that the analysis stage is completed, VHP residue \u2264 1ppm before closing and waiting for standby.
\nII. Graded Preventive Maintenance Plan
\n(1) Daily Maintenance (Before and After Shift)
\nBefore Shift Inspection
\nElectrical System: Power supply, indicator lights, operation buttons, emergency stop, sound and light alarm functions normal, no garbled flashing;
\nInterlock Mechanism: No-load test of double door interlock, one side opening, the other side forced locking, response \u2264 0.5s;
\nSealing Inspection: Visual inspection of the door silicone sealing strip for cracking, hardening, or detachment, no obvious gap after closing;
\nCirculation Fan: Start empty load, no abnormal noise, severe vibration, abnormal temperature rise of the casing;
\nPipeline System: VHP hydrogen peroxide delivery hose, joints have no leakage, no aging and whitening;
\nConsumable Level: Check the liquid level of hydrogen peroxide medicine tank, replenish dedicated VHP disinfectant in time when below the lowest scale;
\nChamber Condition: Dry inside, no hydrogen peroxide crystallization accumulation.
\nAfter Shift Operation
\nComplete the full chamber cleaning and drying;
\nRun the complete VHP sterilization program once in an empty load to disinfect the chamber itself;
\nTurn off the main power supply of the equipment, fill in the “VHP Transfer Window Daily Inspection Record Form”, record the running time, parameters, and abnormal situations.
\n(2) Weekly Deep Maintenance
\nVHP Vaporization Generator Disassembly and Cleaning
\nRemove the quick-release atomization module, rinse the atomization chamber and nozzle with purified water, blow dry with compressed air, completely remove hydrogen peroxide crystallization to prevent nozzle blockage and atomization failure;
\nInitial Filter Net Cleaning
\nRemove the initial filter net, soak in 75% Ethanol for 30 minutes, gently wipe the filter net pores with dust-free cloth, dry completely in a cool place before reinstalling, prohibit high-temperature baking;
\nDeep Inspection of Sealing System: Use soft bristles to clean the dust in the groove of the sealing strip, thin-coat food-grade silicone grease on the surface of the sealing strip to delay aging;
\nAir duct, catalytic decomposition filter net blowing: Blow 0.3~0.5MPa clean compressed air on the white crystallization on the surface of the decomposition filter net, mark for replacement if severe;
\nNegative Pressure Sensor Surface Dust Cleaning, ensure stable negative pressure inside the chamber, no leakage of VHP gas;
\nRe-complete the full test of double door interlock, fan circulation, alarm system.
\n(3) Monthly Maintenance
\nFilter System: Record the pressure difference of the initial and HEPA high-efficiency filters; If the pressure difference is higher than the equipment calibration value by 250Pa, replace immediately; Clean the inlet and outlet of the HEPA filter, check for hydrogen peroxide soaking discoloration; Mechanical transmission: Add food-grade lubricating grease to hinges and tongue levers, adjust the tightness of door closure, keep the closing force at 20-30N, and ensure airtightness;
\nElectrical safety inspection: Open the electrical control box, check for no looseness, aging, or burn marks in the wiring, and ensure the equipment is independently grounded with a grounding resistance of \u2264 4\u03a9;
\nPipeline leak detection: Check the double hydrogen peroxide delivery hose section by section, replace the hose directly if it is aged, leaking, or cracked;
\nTemperature and humidity, pressure sensor basic calibration to eliminate data drift;
\nConfigure UV lamp model: Record the cumulative usage time of the UV lamp tube, replace the lamp tube after 5000 hours of cumulative use.
\n(4) Quarterly \/ Semi-annual maintenance (verification-level maintenance)
\nPrecise calibration of sensors
\nUse standard calibration equipment to calibrate VHP concentration, temperature humidity, and negative pressure sensors, with an allowable error of \u2264 \u00b15%, and issue calibration records;
\nCavity sealing integrity test: Pressure drop leak detection to confirm that the cavity has no gas leakage, avoiding insufficient sterilization concentration and VHP leakage contaminating the clean area;
\nPerformance test of catalytic decomposition module: Determine the decomposition efficiency of hydrogen peroxide, replace the catalytic filter if decomposition is incomplete or residues exceed the standard;
\nBiological indicator (BI) verification of sterilization effect
\nPlace Bacillus subtilis indicator in the cavity\u6b7b\u89d2\uff0c complete the standard sterilization procedure\uff0c and determine qualification if no colonies grow after cultivation\uff1b BI verification must be done after major equipment overhaul\uff0c cavity modification\uff0c or significant adjustment of sterilization parameters\uff1b
\nFan performance test\uff1a Measure the circulation air speed within the standard range of 0.36-0.54m\/s\uff0c repair or replace the fan or rotor if the wind speed is too low\uff1b
\nSort out the inspection\uff0c calibration\uff0c and consumable replacement records for the past 3 months\uff0c archive and retain for audit reference.
\n(5) Annual comprehensive overhaul and consumable replacement
\nList of mandatory consumables replacement
\nCatalytic decomposition filter (oxidation failure\uff0c significant decline in decomposition capacity)\uff1b
\nAged silicone sealing strip (suggested to be replaced every half year for high-frequency use models\uff0c annual replacement for regular models)\uff1b
\nAged hydrogen peroxide delivery hose\uff1b
\nHeated HEPA high-efficiency filter with excessive pressure difference or damage\uff1b
\nWhole machine disassembly inspection\uff1a Comprehensive maintenance of heating tube of vaporizer\uff0c atomization core\uff0c fan bearing\uff0c electromagnetic valve\uff0c and magnetic control door sensor\uff1b
\nFull-item electrical system inspection\uff1a Voltage\uff0c current\uff0c and insulation of the wiring\uff0c UPS backup power function test\uff1b
\nAnnual full re-verification\uff1a Complete all sets of sealing\uff0c airflow\uff0c sensor accuracy\uff0c and BI biological challenge tests\uff0c issue the annual equipment verification report\uff1b
\nStainless steel cavity maintenance\uff1a Wipe with neutral cleaner\uff0c remove long-term oxidation spots\uff0c avoid hard objects scratching the inner wall and forming microbial breeding corners.
\nIII. Key Maintenance Points for Core Components
\n1. VHP vaporizer (core sterilization unit)
\nCauses of blockage\uff1a Accumulation of hydrogen peroxide crystals in the nozzle and heating chamber\uff1b
\nMaintenance cycle\uff1a Disassemble and clean weekly\uff1b
\nProhibition\uff1a Do not dryly burn the vaporizer\uff0c do not start the atomization program if the drug box is lacking liquid.
\n2. Silicone door sealing strip (key for airtightness)
\nDamage risk\uff1a Long-term oxidation of VHP\uff0c dust abrasion\uff0c drying hardening\uff1b
\nMaintenance\uff1a Clean weekly + thin coating of silicone grease\uff1b Replace immediately if there are cracks\uff0c leakage\uff0c or hardening\uff1b
\nRisk\uff1a Failure of sealing will lead to leakage of VHP gas\uff0c contaminating adjacent clean areas\uff0c and also causing insufficient sterilization concentration.
\n3. Catalytic decomposition filter (VHP decomposition filtration)
\nFunction\uff1a Decompose residual hydrogen peroxide in the cavity after sterilization\uff1b
\nMaintenance\uff1a Weekly compressed air blowing\uff1b Replace directly if the surface crystallization is heavy and the decomposition time is significantly prolonged.
\n4. Various sensors (concentration \/ temperature humidity \/ negative pressure)
\nFault manifestations\uff1a Jumping of monitoring values\uff0c low\/high concentration\uff0c negative pressure alarm\uff1b
\nMaintenance\uff1a Daily wipe the probe of the sensor to remove crystals\uff0c professional quarterly calibration\uff0c and annual detection of sensor sensitivity.
\n5. Double door interlock mechanism
\nFault risk\uff1a Dust blocking the door magnetic switch\uff0c lock tongue jamming\uff1b Maintenance: Conduct weekly functional tests and monthly lubrication of the latch; prohibit use if interlock fails, to prevent cross-contamination between different cleanliness zones and air flow pollution.
\nIV. Safety Maintenance Operating Procedures
\nBefore cleaning and disassembling the equipment, cut off the main power supply, empty the residual VHP in the chamber, and ventilate and analyze until the concentration is \u2264 1 ppm;
\nWhen contacting high-concentration hydrogen peroxide or disassembling the generator, wear corrosion-resistant gloves and goggles, and rinse the skin with a large amount of flowing clean water for 10 minutes;
\nThe filters and rags contaminated with hydrogen peroxide generated during maintenance should be handled in accordance with chemical hazardous waste regulations;
\nDo not directly rinse the electronic control panel, sensors, and electrical box with water to prevent short circuits and component burnout;
\nThe chamber wiping should adopt the S-shaped one-way wiping method to avoid cross-contamination.
\nV. Records and GMP Audit Requirements
\nEstablish three ledgers to completely retain for at least 3 years:
\n“Daily Inspection Record Sheet”: Operating duration, program parameters, equipment abnormalities;
\n“Component Replacement Ledger”: Filter, sealing strip, lamp tube, pipeline replacement time, model;
\n“Calibration and Verification Report”: Sensor calibration, chamber leak detection, BI biological indicator verification;
\nAfter major equipment repair or replacement of core components, re-perform sterilization effect verification and record archiving;
\nAll maintenance, cleaning, and calibration operations should be marked with the operator and date, allowing for complete traceability.
\nVI. Simple Troubleshooting for Common Faults (Maintenance Support)
\nEquipment cannot start: Check the power supply, liquid level of the reagent, whether the door body is fully closed, and interlock signals;<\/p>","protected":false},"excerpt":{"rendered":"