The process is divided into four stages: pre-humidification \u2192 drug addition and sterilization \u2192 maintaining exposure \u2192 residue removal. The industry standard duration is provided directly, and it is differentiated between small and large transfer windows.
\n1. General standard time (Pharmaceutical GMP standard)
\na) Small VHP transfer window (cavity size around 600\u00d7600\u00d7600)
\nPre-humidification: 5\u201310 minutes
\nDrug addition + maintaining sterilization exposure: 20\u201330 minutes (core sterilization time)
\nResidue removal (ventilation and decomposition): 20\u201340 minutes
\nTotal cycle: 45\u201380 minutes
\nb) Large VHP transfer window (cavity > 800mm, or double-door interlocked large volume)
\nSterilization exposure time: 30\u201345 minutes
\nResidue removal longer: 30\u201360 minutes
\nTotal cycle: 70\u2013115 minutes
\nKey point: The exposure maintenance time is the actual sterilization time. Generally, maintaining for \u2265 30 minutes can stably achieve 6log spore kill and meet the aseptic level.
\n2. What determines the sterilization time?
\nCavity volume: The larger the volume, the longer the time
\nVHP generator power: Higher power, faster drug addition, can shorten the time
\nHumidity: 50%\u201365% humidity has the best effect, and meeting the standard can shorten the sterilization time
\nVerification requirements: GMP projects must verify the final time using biological indicators (BI), not a fixed value
\nAll negative results of Bacillus subtilis var. niger ATCC 9372: The time is qualified
\n3. Industry commonly used experience parameters (directly applicable)
\nDaily routine sterilization: Exposure 30 minutes
\nHigh-risk aseptic areas (Class A\/B, vaccines, cell rooms): Exposure 40\u201345 minutes
\nResidue removal must be achieved: Hydrogen peroxide residue < 0.5 ppm before opening the door
\n4. Quick memory
\nSmall standard: Sterilization 30 minutes, total duration approximately 1 hour
\nHigh-risk large: Sterilization 40\u201345 minutes, total duration about 1.5 hours<\/p>","protected":false},"excerpt":{"rendered":"
The process is divided into four stages: pre-humidification \u2192 drug addition and sterilization \u2192 maintaining exposure \u2192 residue removal. The industry standard duration is provided directly, and it is differentiated between small and large transfer windows. 1. General standard time (Pharmaceutical GMP standard) a) Small VHP transfer window (cavity size around 600\u00d7600\u00d7600) Pre-humidification: 5\u201310 minutes […]<\/p>","protected":false},"author":3,"featured_media":5440,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[92],"tags":[],"class_list":["post-5439","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\/5439","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/comments?post=5439"}],"version-history":[{"count":1,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/posts\/5439\/revisions"}],"predecessor-version":[{"id":5441,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/posts\/5439\/revisions\/5441"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/media\/5440"}],"wp:attachment":[{"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/media?parent=5439"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/categories?post=5439"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/tags?post=5439"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}