The complete set of precautions for space fumigation (VHP hydrogen peroxide dry mist \/ ozone) in the pass box
\nIt consists of nine sections: pre-sterilization preparation, loading specifications, sealing safety, process control, exhaust and residue removal, material compatibility, GMP verification, personnel protection, and post-maintenance. It covers the general requirements for pharmaceutical enterprises, biological laboratories, and electronic clean workshops.
\n1. Pre-sterilization preparation inspection (core prerequisite, indispensable)
\nCavity thorough cleaning and drying
\nRemove oil stains, water stains, powders, and organic substances in advance; organic substances will consume the fumigating agent, creating sterilization dead zones; water accumulation on the inner wall will cause hydrogen peroxide condensation and ozone dissolution, significantly reducing the sterilization efficiency.
\nFull inspection of sealing performance to prevent gas leakage
\nFully close the inner and outer doors, check that the sealing strips are not cracked, hardened, or\u8131\u843d\uff1b any cracks or leaks in the door gap must be replaced or re-glued in advance.
\nThe interlock function must be intact\uff1b during fumigation\uff0c it is strictly prohibited to open both doors simultaneously\uff1b interlock failure prohibits fumigation and prevents fumigating gas from entering the clean area and contaminating the workshop or irritating personnel.
\nLayer-flow pass box\uff1a Turn off the circulating fan and block the exhaust channel to ensure cavity sealing.
\nTemperature and humidity are pre-adjusted (directly affects sterilization effect)
\nVHP hydrogen peroxide\uff1a cavity temperature 20-30\u2103\uff0c relative humidity 40%-70%\uff1b humidity <40% will cause rapid decomposition of the drug agent\uff0c >80% will produce a large amount of condensate water\uff0c corroding the box \/ materials.
\nOzone\uff1a humidity 50%-75%\uff0c in a dry environment\uff0c the sterilization power will significantly decrease.
\nRemove items not resistant to fumigation
\nPaper\uff0c cotton cloth\uff0c sponge\uff0c ordinary rubber\uff0c some plastics\uff0c lithium batteries\uff0c precision circuit boards\uff0c easily oxidized metals should be removed as much as possible\uff1b highly adsorptive materials will consume a large amount of fumigating gas\uff0c resulting in sterilization failure.
\nSelf-check of equipment
\nVHP model checks the liquid level of the agent\uff0c no crystallization or leakage in the pipeline\uff0c and the concentration sensor is calibrated effectively\uff1b ozone machine checks the generator and fan for no faults\uff1b the catalytic decomposition filter is in good condition.
\n2. Hard requirements for material loading (avoid sterilization dead zones)
\nLoading limit\uff1a the total volume of the items should be \u2264 75% of the cavity volume\uff1b reserve sufficient gas circulation space\uff1b do not fill the box completely.
\nSpacing\uff1a the distance between each item should be \u2265 5cm\uff1b do not stack\uff0c touch the cavity wall\uff0c or block the inlet \/ return air vents\uff1b the stacking tray must be placed on separate layers to ensure gas penetration and contact with the surface.
\nThe catalytic decomposition filter screen is in good condition.
\nBiological indicator BI should be placed in the coldest point\uff0c bottom of the items\uff0c door frame gaps\uff0c corners\uff0c etc.\uff0c which are the most difficult to reach the gas\uff0c for sterilization effect verification\uff0c GMP requires it.
\n3. Sealing and safety control (prevent gas leakage from injuring people and damaging the clean area)
\nDuring fumigation\uff0c all personnel must completely evacuate
\nAfter starting the fumigation\uff0c the operators should immediately leave the surrounding area\uff0c hang a warning sign “Fumigation sterilization\uff0c no entry allowed” at the door\uff0c and assign a person to stand guard\uff0c prohibiting anyone from opening the door.
\nIsolation of the clean area pressure difference
\nFor the high-clean area side\uff0c close the room door in advance\uff0c maintain normal positive pressure in the clean area to prevent fumigating gas from flowing back into the production area\uff1b during fumigation\uff0c close the personnel passage door of the connecting room.
\nProhibit open flames\uff0c static electricity\uff0c and electrical sparks
\nHydrogen peroxide and ozone both have the risk of oxidation and explosion\uff1b fumigation area prohibits alcohol wiping\uff0c electric welding\uff0c switching large-power electrical appliances\uff0c unplugging plugs.
\nHandling abnormal shutdown during fumigation
\nIf the fumigation is interrupted or the equipment fails during the process\uff0c do not force the door to open\uff1b wait for the exhaust and circulation to complete automatically or replace with clean air to a safe concentration before maintenance.
\n4. Parameter control during fumigation process (ensure sterilization compliance)
\n1. Vaporization of hydrogen peroxide VHP (mainstream aseptic workshops) Medicine: Specialized 35% food-grade hydrogen peroxide. Do not mix with other disinfectants such as alcohol or peracetic acid. Avoid chemical reactions and toxic gas generation.
\nThree-stage procedures cannot be reduced: vaporization and fogging \u2192 concentration maintenance for sterilization \u2192 catalytic exhaust decomposition; do not just perform fogging and open the door directly.
\nMaintain concentration and duration: The chamber should be stably maintained at hundreds of ppm, with an effect of \u2265 30-45 minutes, ensuring a 6-log spore-killing effect.
\nReal-time monitor the concentration. If the concentration fluctuates too much, terminate the procedure and investigate sealing, loading, temperature and humidity issues.
\n2. Ozone fumigation (simple workshop, not recommended for long-term use in sterile areas)
\nMaintain concentration \u2265 20mg\/m\u00b3, act for 60-90 minutes; insufficient concentration cannot kill spores.
\nDo not use for long-term high-frequency use. Strong oxidation of ozone will accelerate the aging of rubber sealing strips and discoloration of stainless steel.
\nVII. Exhaust and removal of residues after sterilization (mandatory step before opening the door)
\nThe complete exhaust and decomposition cycle must be completed; do not open the door prematurely.
\nVHP: The built-in catalytic decomposer continuously replaces until the residual hydrogen peroxide in the chamber is \u2264 1ppm. The door body can be opened only after the system automatically unlocks.
\nOzone: Forced ventilation for at least 30 minutes. The space ozone must be \u2264 0.16mg\/m\u00b3 (safety occupational limit) before operation.
\nDoor opening sequence: Open the non-clean area side door first, let it be replaced for a few minutes before opening the clean area side door to prevent residual gas from entering the clean room.
\nIf there is a large amount of hydrogen peroxide condensation on the inner wall, wipe it dry with a dust-free cloth to avoid corrosion of materials and sealing strips by residual substances.
\nVIII. Material compatibility prohibitions (to prevent equipment damage)
\nVHP fumigation tolerance: 304\/316 stainless steel, glass, PP\/PC plastic;
\nNot tolerant: Ordinary natural rubber, silicone, long-term high-frequency fumigation is prone to aging, paper, wood, copper parts, carbon steel.
\nOzone fumigation: Almost all rubber sealing strips will accelerate cracking. Use only for short-term emergency use. After fumigation, thorough ventilation is required.
\nCheck the sealing strips and sealant for any whitening, cracking, or hardening after each fumigation and replace immediately if damaged.
\nIX. Personal protection for personnel (diluting medicine, maintenance, emergency handling)
\nWhen configuring medicine and cleaning equipment crystallization, it is necessary to wear: corrosion-resistant nitrile gloves, goggles, protective half-face mask, anti-static clean clothing.
\nIf skin accidentally comes into contact with high-concentration hydrogen peroxide, rinse with a large amount of flowing water for 10 minutes immediately; if coughing or eye irritation occurs due to fumigation gas inhalation, immediately transfer to a ventilated area for medical treatment.
\nDo not look directly at ozone or fogging nozzle without protection.
\nX. GMP verification and record requirements
\nRecord the complete fumigation process: date, chamber temperature and humidity, medicine concentration, loading method, fumigation duration, exhaust time, final residual concentration, BI culture results.
\nIf there is a significant change in loading method, major equipment overhaul, or chamber modification, a biological indicator challenge verification must be conducted to confirm the effectiveness of the sterilization procedure before it can be put into use.
\nConduct quarterly calibration of concentration sensors and temperature and humidity meters, and retain calibration certificates.
\nXI. Post-fumigation maintenance
\nAfter each fumigation, use a dust-free cloth to wipe the corners of the chamber, sealing strips, and glass windows, removing the crystallization of medicine and condensation water.
\nVHP model: Regularly clean the vaporization pipeline and catalytic decomposition filter screen to prevent blockage and incomplete exhaust.
\nCheck the sealing glue for any oxidation cracking due to fumigation every week. Remove the gap in time and reapply sealant.
\nFor high-frequency fumigation (more than once a day), shorten the replacement cycle of the sealing strip to 6 months.
\nXII. General prohibitions (red line)
\nOpen the door before fumigation is completed and the residual concentration exceeds the limit;
\nStart fumigation when both doors are open simultaneously;
\nFumigate with a box that is not dry and has water stains;
\nFill the box with materials once and stack to block the airflow;
\nStay in the equipment area during fumigation;
\nMix multiple fumigation chemical agents;
\nOmit the exhaust step and take materials directly;
\nReplace the routine surface wiping disinfection with fumigation.<\/p>","protected":false},"excerpt":{"rendered":"
The complete set of precautions for space fumigation (VHP hydrogen peroxide dry mist \/ ozone) in the pass box It consists of nine sections: pre-sterilization preparation, loading specifications, sealing safety, process control, exhaust and residue removal, material compatibility, GMP verification, personnel protection, and post-maintenance. It covers the general requirements for pharmaceutical enterprises, biological laboratories, and […]<\/p>","protected":false},"author":12,"featured_media":5053,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[92],"tags":[],"class_list":["post-5534","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-technology"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/posts\/5534","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/comments?post=5534"}],"version-history":[{"count":1,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/posts\/5534\/revisions"}],"predecessor-version":[{"id":5535,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/posts\/5534\/revisions\/5535"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/media\/5053"}],"wp:attachment":[{"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/media?parent=5534"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/categories?post=5534"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/tags?post=5534"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}