{"id":1000,"date":"2020-11-10T11:53:08","date_gmt":"2020-11-10T11:53:08","guid":{"rendered":"http:\/\/www.aroundlab.org\/news\/?p=1000"},"modified":"2020-11-10T15:31:29","modified_gmt":"2020-11-10T15:31:29","slug":"application-note-cleanroom-n-01-out-of-specification-oos-in-cleanroom","status":"publish","type":"post","link":"https:\/\/www.aroundlab.org\/news\/application-note-cleanroom-n-01-out-of-specification-oos-in-cleanroom\/","title":{"rendered":"Application Note \u2013 Cleanroom N.01 \u2013 Out of Specification (OOS) in Cleanroom"},"content":{"rendered":"

Application Note \u2013 Cleanroom N.01<\/span><\/h1>\n

Out of Specification <\/span>(OOS) in Cleanroom<\/span><\/h1>\n
\n

\u201cInvestigation for \u201cOOS\u201d results<\/span><\/strong><\/p>\n

If there are significative variation in the trend, the following investigations are necessary:<\/span><\/p>\n

    \n
  • (a) Identification of isolated environmental micro-organisms<\/span><\/li>\n
  • (b) Revision of the trend during the last 6-12 months in the specific area<\/span><\/li>\n
  • (c) Particle monitoring<\/span><\/li>\n
  • (d) Monitoring and Servicing of the air conditioning or HVAC System<\/span><\/li>\n
  • (e) Sampling improvement<\/span><\/li>\n
  • (f) Revision of the sterilization processes<\/span><\/li>\n
  • (g) Revision of the cleaning and disinfection processes<\/span><\/li>\n
  • (h) Revision of staff training about cleaning, disinfection, sterilisation<\/span><\/li>\n<\/ul>\n

    Corrective actions in case of \u201cOOS\u201d<\/span><\/strong><\/p>\n

      \n
    • (i) Environmental Sampling procedure revision<\/span><\/li>\n
    • (l) Re-environmental monitoring of the considered area<\/span><\/li>\n
    • (m) Use of other specific microbiological media<\/span><\/li>\n
    • (n) Revision of production procedures<\/span><\/li>\n
    • (o) Revision of cleaning and disinfection procedures<\/span><\/li>\n
    • (p) Challenge of isolates vs products<\/span><\/li>\n
    • (q) Challenge of isolates vs disinfectants<\/span><\/li>\n
    • (r) More appropriate staff training<\/span><\/li>\n
    • (s) Further controls on products<\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

      Application Note \u2013 Cleanroom N.01 Out of Specification (OOS) in Cleanroom \u201cInvestigation for \u201cOOS\u201d results If there are significative variation in the trend, the following investigations are necessary: (a) Identification […]<\/p>\n","protected":false},"author":1,"featured_media":1025,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"footnotes":""},"categories":[20,21,15],"tags":[22],"class_list":["post-1000","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-application-note","category-application-note-cleanroom","category-en","tag-application-note-cleanroom"],"yoast_head":"\nApplication 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