{"id":3286,"date":"2023-04-11T15:14:43","date_gmt":"2023-04-11T13:14:43","guid":{"rendered":"https:\/\/wp.delphin.de\/?post_type=loesung&p=3286"},"modified":"2025-07-10T12:55:55","modified_gmt":"2025-07-10T10:55:55","slug":"clean-room-monitoring","status":"publish","type":"loesung","link":"https:\/\/www.delphin.de\/en\/loesungen\/prozessmonitoring-stoerungsanalyse\/reinraummonitoring\/","title":{"rendered":"Clean room monitoring"},"content":{"rendered":"
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Cleanroom monitoring - ensure air quality, protect processes<\/h2>\n\n\n\n

In cleanrooms, such as those used in pharmaceutical production, storage and research, consistently high air quality is crucial for process reliability and product quality. Our measurement technology for cleanroom monitoring makes it possible to monitor relevant parameters such as temperature, humidity, pressure and particle count precisely and tamper-proof, detect deviations at an early stage and react immediately. An integrated audit trail ensures that all user actions are fully logged and tracked, allowing you to reliably meet the requirements of FDA Part 11 and GMP\/GAMP guidelines.<\/p>\n\n<\/div>\n\n

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What advantages does cleanroom monitoring with Delphin offer you?<\/h2>\n\n\n\n
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  • Reliably ensure air quality:<\/strong> keep particles and impurities below limit values.<\/li>\n\n\n\n
  • Recognize deviations early:<\/strong> Identify faults immediately and initiate countermeasures.<\/li>\n\n\n\n
  • Protect process and product quality:<\/strong> Ensure the stability and security of sensitive processes.<\/li>\n\n\n\n
  • Tamper-proof data capture:<\/strong> Fully comply with regulatory requirements.<\/li>\n\n\n\n
  • Audit trail included:<\/strong> Log all user actions in a traceable manner.<\/li>\n<\/ul>\n<\/div>\n\n\n\n
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    • Self-sufficient data storage:<\/strong> Secure and independent storage parallel to the PC.<\/li>\n\n\n\n
    • Flexible alerting:<\/strong> E-mail, SMS or switching outputs for a quick response.<\/li>\n\n\n\n
    • Individual visualization:<\/strong> Clearly display and evaluate reports and trends.<\/li>\n\n\n\n
    • Scalable system:<\/strong> Flexible use for small cleanrooms and large pharmaceutical plants.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n<\/div>\n\n
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      By using measurement technology, cleanroom monitoring can make an important contribution to ensuring process reliability and product quality. Typical areas of application are<\/strong><\/p>\n\n\n\n

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      • Part 11 compliant pharmacy monitoring<\/li>\n\n\n\n
      • Clean room monitoring <\/li>\n\n\n\n
      • Distributed systems for pharma monitoring tasks <\/li>\n\n\n\n
      • Monitoring of production facilities according to FDA<\/li>\n<\/ul>\n<\/div>\n\n\n\n
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        • Integrated total monitoring solutions in pharmaceutical production <\/li>\n\n\n\n
        • Integrated alarm systems<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n<\/div><\/div><\/div>\n<\/div>\n<\/div>\n\n
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          Practical example of cleanroom monitoring<\/p>\n\n\n\n

          Monitoring the long-term stability of active pharmaceutical ingredients in a hospital pharmacy<\/h2>\n\n\n\n

          A large German hospital pharmacy regularly tests the long-term stability of its manufactured cytostatics and sensitive medicines in order to prove their efficacy and safety over the entire storage period. For this purpose, samples are stored in climate chambers and freezers under precisely defined temperature and humidity conditions, sometimes for periods of up to two years. To monitor these storage conditions and ensure compliance with GMP requirements, a Delphin cleanroom monitoring system was installed, which continuously records and stores the temperature, humidity and door contacts of the storage areas. It is crucial that all measured values are recorded in a tamper-proof manner and that changes to operating parameters such as target temperatures or limit values are fully documented. The integrated user and alarm management system logs every user action and records every access in a traceable manner in order to meet the requirements of FDA Part 11 and hospital certifications.<\/p>\n\n\n\n

          If a deviation such as an exceeded temperature occurs, it is automatically detected, documented and immediately forwarded by email to the responsible employees so that they can react immediately to avoid endangering the stock. Weekly logs of all alarms are automatically created and stored, while changes to parameters are saved monthly with user comments. All data is archived redundantly so that it is available at any time for internal audits or official verification. By using the Delphin system, the hospital pharmacy was not only able to increase its process reliability, but also considerably simplify documentation for external and internal audits. At the same time, the risk of loss of active ingredients due to unnoticed temperature deviations has been minimized, which contributes to cost savings and compliance with the high quality requirements.<\/p>\n\n<\/div>","protected":false},"excerpt":{"rendered":"

          Manipulation-proof recording of all measured values according to FDA Part 11<\/p>","protected":false},"author":6,"featured_media":5514,"parent":1084,"menu_order":40,"template":"","format":"standard","categories":[],"tags":[],"class_list":["post-3286","loesung","type-loesung","status-publish","format-standard","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/loesung\/3286","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/loesung"}],"about":[{"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/types\/loesung"}],"author":[{"embeddable":true,"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/users\/6"}],"version-history":[{"count":8,"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/loesung\/3286\/revisions"}],"predecessor-version":[{"id":16388,"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/loesung\/3286\/revisions\/16388"}],"up":[{"embeddable":true,"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/loesung\/1084"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/media\/5514"}],"wp:attachment":[{"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/media?parent=3286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/categories?post=3286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/tags?post=3286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}