{"id":375633,"date":"2025-01-20T11:16:16","date_gmt":"2025-01-20T16:16:16","guid":{"rendered":"https:\/\/caiready.com\/life-sciences\/?post_type=case-study&p=375633"},"modified":"2025-06-22T15:49:05","modified_gmt":"2025-06-22T19:49:05","slug":"environmental-monitoringperformance-qualification-empqand-validation-support-services","status":"publish","type":"case-study","link":"https:\/\/caiready.com\/life-sciences\/case-study\/environmental-monitoringperformance-qualification-empqand-validation-support-services\/","title":{"rendered":"Environmental Monitoring Performance Qualification (EMPQ) and Validation Support Services"},"content":{"rendered":"\n
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Environmental Monitoring Performance Qualification (EMPQ) and Validation Support Services
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Download the PDF<\/a><\/div>\n<\/div>\n<\/div><\/div><\/div><\/div>\n\n\n\n
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PROJECT OVERVIEW<\/h2>\n\n\n\n

CAI provided comprehensive EMPQ and validation support services for a rapidly growing pharmaceutical\/biotech company in Fargo, North Dakota. The project, which began in early 2022 and spanned over two years, involved qualifying a new series of aseptic processing rooms and supporting various aspects of quality control and validation. CAI’s team generated protocols, executed sampling and provided documentation for room qualifications and air handler qualifications. As the client’s needs expanded, CAI offered flexible support, including laboratory technician staffing, training and mentorship. The project resulted in a 50% increase in available aseptic manufacturing space and successful completion of multiple validation and qualification projects.<\/p>\n\n\n\n

Topics covered<\/h2>\n\n\n\n
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  • Aseptic processing room qualification<\/li>\n\n\n\n
  • Environmental monitoring performance qualification (EMPQ)<\/li>\n\n\n\n
  • Air handling unit qualification<\/li>\n\n\n\n
  • Quality control laboratory support<\/li>\n\n\n\n
  • Validation and qualification activities in pharmaceutical manufacturing<\/li>\n\n\n\n
  • Cleanroom classification and monitoring<\/li>\n\n\n\n
  • Training and mentorship for new industry professionals<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
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    CATEGORY:<\/h3>\n\n\n\n

    Compliance & Regulatory Issues<\/p>\n\n\n\n

    CLIENT:<\/h3>\n\n\n\n

    Confidential<\/p>\n\n\n\n

    LOCATION:<\/h3>\n\n\n\n

    Fargo, North Dakota<\/p>\n\n\n\n

    Contract Size:<\/h3>\n\n\n\n

    N\/A<\/p>\n<\/div><\/div><\/div>\n<\/div><\/div>\n<\/div><\/div>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

    In early 2022, CAI was approached by a rapidly growing pharmaceutical\/biotech company to qualify a new series of aseptic processing rooms.<\/p>\n","protected":false},"featured_media":375640,"template":"","meta":{"_acf_changed":true},"categories":[820],"resource-category":[271],"resource-featured-status":[],"resource-type":[268],"class_list":["post-375633","case-study","type-case-study","status-publish","has-post-thumbnail","hentry","category-compliance-regulatory-issues","resource-category-compliance-regulatory-issues","resource-type-case-studies"],"acf":[],"_links":{"self":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/case-study\/375633","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/case-study"}],"about":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/types\/case-study"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media\/375640"}],"wp:attachment":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media?parent=375633"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/categories?post=375633"},{"taxonomy":"resource-category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-category?post=375633"},{"taxonomy":"resource-featured-status","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-featured-status?post=375633"},{"taxonomy":"resource-type","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-type?post=375633"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}