I. General Standards (Pharmaceutical Factory \/ GMP mainstream)
\nNormal operating conditions (ordinary raw materials and excipients, low dust): HEPA high-efficiency filter: 12-24 months
\nHigh dust \/ high activity \/ toxic powders (anti-cancer drugs, hormones, sterile powders, fine powders of traditional Chinese medicine): HEPA high-efficiency filter: 6-12 months. Forced shortening
\nII. Not based on time, but on pressure difference (most accurate, GMP recognizes this)
\nBased on the initial pressure difference of the equipment:
\nWhen the final pressure difference reaches twice the initial pressure difference \/ the upper limit of the manufacturer’s calibration \u2192 immediately replace, don’t wait for the cycle
\nDaily pressure difference increase is fast: indicates a large dust load, replace in advance
\nIII. Reference period for matching filters (companion notes)
\nPrimary efficiency: 1-3 months of cleaning, 3-6 months of replacement
\nIntermediate efficiency: 6-12 months of replacement (protecting the high-efficiency filter, frequent replacement of intermediate efficiency = prolonging the life of HEPA)
\nIV. Key mandatory requirements (must be inspected by inspection agencies)
\nAfter each replacement of the high-efficiency filter: must conduct PAO leak detection + wind speed balance test + re-calibration of pressure difference, and retain the verification report.<\/p>","protected":false},"excerpt":{"rendered":"
I. General Standards (Pharmaceutical Factory \/ GMP mainstream) Normal operating conditions (ordinary raw materials and excipients, low dust): HEPA high-efficiency filter: 12-24 months High dust \/ high activity \/ toxic powders (anti-cancer drugs, hormones, sterile powders, fine powders of traditional Chinese medicine): HEPA high-efficiency filter: 6-12 months. Forced shortening II. Not based on time, but […]<\/p>","protected":false},"author":3,"featured_media":5244,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[92],"tags":[],"class_list":["post-5252","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\/5252","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=5252"}],"version-history":[{"count":1,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/posts\/5252\/revisions"}],"predecessor-version":[{"id":5253,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/posts\/5252\/revisions\/5253"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/media\/5244"}],"wp:attachment":[{"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/media?parent=5252"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/categories?post=5252"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bacintl.com\/es\/wp-json\/wp\/v2\/tags?post=5252"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}