Summary: This sterilization method has a high sterilization grade, can kill spores, and achieves a sterile level, fully meeting the GMP sterile zone requirements. It is currently the most mainstream low-temperature gas sterilization method for clean rooms. The following will explain it in detail from core sterilization capabilities (actual effects), comparison, advantages and disadvantages, and compliance.
\n1. Core sterilization capability (actual effect)
\nExtremely wide sterilization spectrum
\nIt can inactivate bacteria, fungi, viruses, mycoplasma, and the most difficult-to-kill bacterial spores.
\nThe kill rate of Bacillus subtilis var. niger spores (ATCC9372, sterilization verification standard strain) is \u2265 6log, i.e., 99.9999%.
\nLow-temperature sterilization without high-temperature damage
\nThe sterilization temperature is generally 22\u201328\u2103, capable of sterilizing plastics, electronic components, paper packaging materials, culture media, and precision equipment, without deformation or aging.
\nGood gas permeability
\nThe vaporized H\u2082O\u2082 is gaseous and can penetrate gaps, threads, blind holes, and packaging interiors, more thorough than ultraviolet or alcohol wiping.
\nNo residual risk
\nThe decomposition products are water + oxygen, with no chemical residues after ventilation and residue removal, and no contamination of drugs or materials.
\n2. Comparison with other sterilization methods
\nCompared with ultraviolet transfer cabinets
\nUltraviolet can only reach the surface, and dead corners are ineffective, unable to kill spores;
\nVHP full-cavity without dead corners can kill spores and achieve sterility.
\nCompared with alcohol wiping
\nManual operation is uneven, dead corners are difficult to wipe, and it cannot sterilize items inside the packaging;
\nVHP is automated, uniform, and can batch sterilize.
\nCompared with ozone
\nOzone has poor penetration, causes corrosion to rubber, and residues are difficult to remove;
\nVHP is more stable and is more recognized by GMP.
\n3. Key indicators for GMP \/ verification (must be done in actual projects)
\nVHP transfer cabinet sterilization must perform microbial verification to be qualified:
\nBiological indicator: Bacillus subtilis var. niger spores, all negative after sterilization
\nChemical indicator: Color change meets standards
\nConcentration uniformity: The VHP concentration in the cavity fluctuates little, without dead corners
\nResidue removal: The H\u2082O\u2082 residue after sterilization is < 0.5 ppm, safe for entry and material handling
\n4. Key factors affecting sterilization effect (selection \/ usage focus)
\nCavity sealing: Poor sealing of the door leads to failure in sterilization
\nGenerator power: The larger the cavity, the higher the VHP power required
\nTemperature and humidity: The best effect is achieved at 40%\u201370% humidity; too dry or too humid will decrease the effect
\nLoading method: Items cannot be stacked to block the gas flow, ensuring gas circulation
\n5. Applicable grades
\nCan be used for A-class and B-class sterile zones for material transfer sterilization
\nVaccines, sterile preparations, cell rooms, biosafety laboratories are the first choice<\/p>","protected":false},"excerpt":{"rendered":"
Summary: This sterilization method has a high sterilization grade, can kill spores, and achieves a sterile level, fully meeting the GMP sterile zone requirements. It is currently the most mainstream low-temperature gas sterilization method for clean rooms. The following will explain it in detail from core sterilization capabilities (actual effects), comparison, advantages and disadvantages, and […]<\/p>","protected":false},"author":3,"featured_media":5437,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[92],"tags":[],"class_list":["post-5436","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-technology"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/posts\/5436","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/comments?post=5436"}],"version-history":[{"count":1,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/posts\/5436\/revisions"}],"predecessor-version":[{"id":5438,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/posts\/5436\/revisions\/5438"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/media\/5437"}],"wp:attachment":[{"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/media?parent=5436"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/categories?post=5436"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/tags?post=5436"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}