{"id":5939,"date":"2026-08-28T14:05:17","date_gmt":"2026-08-28T06:05:17","guid":{"rendered":"https:\/\/www.bacintl.com\/?p=5939"},"modified":"2026-08-28T08:38:40","modified_gmt":"2026-08-28T00:38:40","slug":"gmp%e2%80%91compliant-core-parameters-and-acceptance-criteria-for-negative%e2%80%91pressure-weighing-booths-in-pharmaceutical-powder-processes","status":"publish","type":"post","link":"https:\/\/www.bacintl.com\/ar\/gmp\u2011compliant-core-parameters-and-acceptance-criteria-for-negative\u2011pressure-weighing-booths-in-pharmaceutical-powder-processes\/","title":{"rendered":"GMP\u2011Compliant Core Parameters and Acceptance Criteria for Negative\u2011Pressure Weighing Booths in Pharmaceutical Powder Processes"},"content":{"rendered":"

\"\"<\/p>\n

I. Core Compliance Performance Parameters<\/h3>\n
    \n
  1. Cleanliness Class: Both static and dynamic conditions of the operating area shall reach ISO Class 5 (Class 100) to prevent contamination of sterile powders and active pharmaceutical ingredients.<\/li>\n
  2. Negative\u2011Pressure Differential: Stable negative pressure of 5\u201110\u202fPa inside the equipment relative to the surrounding workshop environment, free of positive\u2011negative pressure fluctuations, to eliminate powder leakage.<\/li>\n
  3. Filtration Efficiency: Supply\u2011air H14 high\u2011efficiency particulate air (HEPA) filters shall achieve \u226599.995\u202f% filtration efficiency for 0.3\u202f\u03bcm particles; exhaust filters shall precisely intercept ultrafine powders.<\/li>\n
  4. Air Velocity Parameters: Laminar supply\u2011air velocity ranges from 0.36\u202fm\/s to 0.45\u202fm\/s with uniform airflow and no dead zones.<\/li>\n
  5. Operating Noise: Overall unit noise \u226475\u202fdB(A), suitable for long\u2011duration operations.<\/li>\n
  6. Material Standard: The complete unit adopts 304 stainless steel with seamless welding; no dust\u2011accumulating dead corners, corrosion\u2011resistant and easy\u2011to\u2011clean &\u2011disinfect.<\/li>\n<\/ol>\n

    II. Core On\u2011Site GMP Acceptance Criteria<\/h3>\n

    \"\"<\/p>\n

      \n
    1. Dust Tightness Acceptance: No powder spills at chamber openings during equipment operation; no powder residues in surrounding workshop areas; stable negative\u2011pressure gradient.<\/li>\n
    2. Cleanliness Acceptance: Under dynamic production conditions, airborne particles, airborne viable particles and settleable particles in the operating area shall meet ISO Class 5 requirements.<\/li>\n
    3. Airflow Acceptance: Stable unidirectional airflow without eddy currents or backflow; no dead corners for powder retention.<\/li>\n
    4. Function Acceptance: Differential\u2011pressure indication, air\u2011velocity monitoring, fault alarm and variable\u2011frequency control functions work properly with accurate data display.<\/li>\n
    5. Structural Acceptance: No weld dead corners; intact seals, smooth opening\u2011closing actions and no blind spots for cleaning.<\/li>\n<\/ol>\n

      III. Documentation for Inspection Reference<\/h3>\n

      \"\"<\/p>\n

      Equipment factory test reports, on\u2011site acceptance records, filter leak\u2011test reports, air\u2011velocity & negative\u2011pressure calibration records, daily cleaning & maintenance logs, and filter\u2011element replacement records. All data shall be complete and traceable to satisfy routine regulatory inspections.<\/p>","protected":false},"excerpt":{"rendered":"

      The parameter compliance and performance stability of negative\u2011pressure weighing booths are key focuses during GMP inspections for pharmaceutical enterprises. Unstable negative pressure, non\u2011compliant cleanliness levels and powder leakage may result in inspection non\u2011conformances. Targeting powder weighing and batching processes in the pharmaceutical industry, this article specifies core compliance parameters, on\u2011site acceptance criteria and inspection checkpoints for equipment, providing references for equipment acceptance and daily compliance management.<\/p>","protected":false},"author":3,"featured_media":5941,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[92],"tags":[],"class_list":["post-5939","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-technology"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.bacintl.com\/ar\/wp-json\/wp\/v2\/posts\/5939","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bacintl.com\/ar\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bacintl.com\/ar\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/ar\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/ar\/wp-json\/wp\/v2\/comments?post=5939"}],"version-history":[{"count":1,"href":"https:\/\/www.bacintl.com\/ar\/wp-json\/wp\/v2\/posts\/5939\/revisions"}],"predecessor-version":[{"id":5946,"href":"https:\/\/www.bacintl.com\/ar\/wp-json\/wp\/v2\/posts\/5939\/revisions\/5946"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bacintl.com\/ar\/wp-json\/wp\/v2\/media\/5941"}],"wp:attachment":[{"href":"https:\/\/www.bacintl.com\/ar\/wp-json\/wp\/v2\/media?parent=5939"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bacintl.com\/ar\/wp-json\/wp\/v2\/categories?post=5939"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bacintl.com\/ar\/wp-json\/wp\/v2\/tags?post=5939"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}