Here is a set of methods for inspecting the leak of ultra-clean workbench high-efficiency filters that are applicable to both pharmaceutical factories and laboratories, and can be directly incorporated into the SOP. The focus is on the most commonly used and compliant PAO method for leak detection, which is simple and easy to understand and can be performed on-site.
\nI. Applicable Standards
\nCommonly used in the pharmaceutical \/ GMP field: ISO 14644-3, GB\/T 25915
\nCore: Check whether the high-efficiency filter, the filter paper itself, and the frame seal are leaking
\nII. Most Common Method: PAO Aerosol Leak Detection Method
\n1. Required Tools
\nPAO aerosol generator
\nAerosol photometer (leak detector)
\nClean gloves, alcohol
\n2. Basic Principle
\nUpstream dust generation: Introduce PAO aerosol to the inlet side of the high-efficiency filter
\nDownstream scanning: Use the photometer to scan the outlet side
\nExceeding the standard \u2192 Leakage is determined
\n3. Operating Steps (Special for Ultra-clean Workstations)
\nStart the ultra-clean fan and let it run for \u2265 10 minutes. The airflow should be stable.
\nUpstream dust generation: Place the nozzle of the PAO generator on the inlet side of the high-efficiency filter (generally on the top \/ rear), allowing the aerosol to evenly enter the duct. Control the upstream concentration: around 10-20 \u03bcg\/L is sufficient.
\nDownstream scanning for leak detection: Use the photometer probe to slowly scan the outlet side of the high-efficiency filter:
\nThe entire filter paper surface
\nThe four corners of the frame seal
\nThe compression strips, joint positions
\nThe probe should be 2-3 cm away from the surface and move at a speed of 3-5 cm\/s
\nJudgment Criteria
\nThe photometer reading exceeds the upstream concentration by 0.01% \u2192 Leakage is determined
\nContinuous leakage of the frame, filter paper with pinholes \/ damage \u2192 Replacement is necessary
\nIII. Without professional instruments, simple leak detection (for reference only, cannot be used in GMP)
\n1. Smoke Method
\nUse a smoke pen \/ smoke generator to emit smoke on the back (inlet side) of the high-efficiency filter
\nObservation on the front:
\nSmoke directly blows out \u2192 Clear leakage
\nSmoke from the frame \u2192 Loose seal
\n2. Wind Speed Comparison Method
\nLocal wind speed fluctuates greatly, with obvious vortex \u2192 Possible leakage
\nThis method can only be used as an auxiliary judgment, not as a replacement for PAO leak detection
\nIV. Leak Detection Result Handling
\nMinor leakage (frame) re-pressurize, apply sealant, replace the sealing strip, and re-check for leakage.
\nFilter paper leakage, damage, or pinholes that cannot be repaired must be replaced immediately.
\nAfter replacement, re-check for leakage before it can be put into use.
\nV. Common GMP \/ Pharmaceutical Factory One-Sentence Specification
\nAfter installation, high-efficiency filters should be inspected for leaks using the PAO aerosol method, scanning the surface and frame of the filter. The leakage rate should not exceed 0.01%. If\u4e0d\u5408\u683c\uff0c replacement or re-sealing and re-checking are necessary.<\/p>","protected":false},"excerpt":{"rendered":"
Here is a set of methods for inspecting the leak of ultra-clean workbench high-efficiency filters that are applicable to both pharmaceutical factories and laboratories, and can be directly incorporated into the SOP. The focus is on the most commonly used and compliant PAO method for leak detection, which is simple and easy to understand and […]<\/p>","protected":false},"author":3,"featured_media":5109,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[92],"tags":[],"class_list":["post-5302","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\/5302","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=5302"}],"version-history":[{"count":1,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/posts\/5302\/revisions"}],"predecessor-version":[{"id":5303,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/posts\/5302\/revisions\/5303"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/media\/5109"}],"wp:attachment":[{"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/media?parent=5302"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/categories?post=5302"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bacintl.com\/fr\/wp-json\/wp\/v2\/tags?post=5302"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}