{"id":22,"date":"2016-01-06T19:56:44","date_gmt":"2016-01-06T18:56:44","guid":{"rendered":"http:\/\/www.gkh-walldorf.de\/en\/?page_id=22"},"modified":"2018-02-28T11:46:30","modified_gmt":"2018-02-28T10:46:30","slug":"operating-room","status":"publish","type":"page","link":"https:\/\/www.gkh-walldorf.de\/en\/operating-room\/","title":{"rendered":"Cleanrooms"},"content":{"rendered":"

Qualification \/ requalification of cleanrooms and clean zones<\/h3>\n
\n

in accordance with DIN EN ISO14644 1-4<\/strong> und GMP-Annex 1<\/strong><\/p>\n

Procedure and documentation<\/h4>\n

For conducting a qualification or a requalification, we have defined the following procedure:<\/p>\n\n\n\n\n\n
1.) Preliminary discussion:\u00a0<\/strong>
\nRecording of all target parameters from the planning phase (resulting in the drawing- up of the qualification, (work) schedule and work instruction plans – SOP)<\/td>\n		<\/td>\n2.) Presentation of drawn-up documentation:<\/strong>
\nApproval to conduct the qualification in accordance with generated documentation by the client\u2019s QMS<\/td>\n<\/tr>\n
3.) Qualification, requalification:<\/strong>
\nPerforming qualification \/ requalification according to the schedule and SOP<\/td>\n		<\/td>\n4.) Handover of the draft qualification documents:<\/strong>
\nRelease of draft documentation by the QMS of the client<\/td>\n<\/tr>\n
5.) Final meeting and hand over of documentation<\/strong><\/td>\n<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Air technical measurements (technical and physical examination)<\/h4>\n
    \n
  • room air temperature and room humidity<\/li>\n
  • air velocity \/ volume flow for calculating the air exchange rate<\/li>\n
  • differential pressures at the terminal particulate air filters in order to determine the degree of contamination for subsequent measurements<\/li>\n
  • pressure level verification (proof of flow direction by means of a smoke test)<\/li>\n
  • pressure cascades (detection of positive or negative pressure into the respective adjoining cleanroom areas; measurement with subsequent adjustment of the pressure monitoring system)<\/li>\n
  • pressure sound level measurement<\/li>\n
  • flow visualization<\/li>\n<\/ul>\n

    Particulate and microbiological examination<\/h4>\n
      \n
    • filter integrity test according to DIN EN ISO 14644 Part 3 or filter scan test according to 1946-4 (in older systems, in case a filter integrity test is not possible structurally)<\/li>\n
    • microbiological examination (in older systems until 2008, the terminal particulate air filters are subject to a measurement of the number of airborne microbes) room class determination by means of an examination of the number of particles and microbes in the air<\/li>\n
    • recovery test according to DIN EN ISO 14644-3<\/li>\n<\/ul>\n

      The test report contains a detailed listing of all measured values and their evaluation in accordance with mandatory legal requirements and regulations.<\/p>\n","protected":false},"excerpt":{"rendered":"

      Qualification \/ requalification of cleanrooms and clean zones in accordance with DIN EN ISO14644 1-4 und GMP-Annex 1 Procedure and documentation For conducting a qualification or a requalification, we have defined the following procedure: 1.) Preliminary discussion:\u00a0 Recording of all target parameters from the planning phase (resulting in the drawing- up of the qualification, (work) […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"_links":{"self":[{"href":"https:\/\/www.gkh-walldorf.de\/en\/wp-json\/wp\/v2\/pages\/22"}],"collection":[{"href":"https:\/\/www.gkh-walldorf.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.gkh-walldorf.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.gkh-walldorf.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.gkh-walldorf.de\/en\/wp-json\/wp\/v2\/comments?post=22"}],"version-history":[{"count":8,"href":"https:\/\/www.gkh-walldorf.de\/en\/wp-json\/wp\/v2\/pages\/22\/revisions"}],"predecessor-version":[{"id":92,"href":"https:\/\/www.gkh-walldorf.de\/en\/wp-json\/wp\/v2\/pages\/22\/revisions\/92"}],"wp:attachment":[{"href":"https:\/\/www.gkh-walldorf.de\/en\/wp-json\/wp\/v2\/media?parent=22"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}