{"id":16926,"date":"2025-10-29T12:13:27","date_gmt":"2025-10-29T11:13:27","guid":{"rendered":"https:\/\/www.delphin.de\/?post_type=loesung&p=16926"},"modified":"2025-10-29T15:49:54","modified_gmt":"2025-10-29T14:49:54","slug":"cleanroom-monitoring-and-production-monitoring-pharma","status":"publish","type":"loesung","link":"https:\/\/www.delphin.de\/en\/loesungen\/reinraumuberwachung-und-produktionsmonitoring-pharma\/","title":{"rendered":"Clean room monitoring and production monitoring"},"content":{"rendered":"
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Efficient environmental monitoring in the GMP environment: more safety and less effort<\/h2>\n\n\n\n

Seamless monitoring in regulated areas<\/h3>\n\n\n\n

In regulated environments such as clean rooms, laboratories or pharmaceutical storage areas, seamless monitoring of environmental conditions is essential. Temperature, humidity or particle contamination must not only be precisely recorded, but also documented in a tamper-proof manner and evaluated in accordance with applicable guidelines. Automated monitoring solutions not only provide proof of process safety, but also reduce the time and effort required for audits and official verifications - a decisive factor for quality, compliance and cost-effectiveness. <\/p>\n\n\n\n

A current project that we have implemented for a well-known customer in the GMP environment shows how successfully this works in practice.<\/p>\n\n\n\n

GMP monitoring in a hospital pharmacy<\/h2>\n\n\n\n

A large German hospital pharmacy regularly carries out stability tests on its manufactured cytostatics and other temperature-sensitive medicines in order to prove their efficacy and safety over the entire storage period. For this purpose, samples are stored for months to two years in climate chambers and freezers under precisely specified temperature and humidity conditions.<\/p>\n\n\n\n

Implementation of a Delphin cleanroom monitoring system<\/h3>\n\n\n\n

A Delphin cleanroom monitoring system was installed to monitor these conditions seamlessly in accordance with GMP guidelines. It continuously records the temperature, humidity and door contacts of all storage areas and stores all measured values in a tamper-proof manner. Changes to target values or limit parameters are also logged automatically - including user ID and time stamp - so that the requirements of FDA 21 CFR Part 11 and relevant hospital certifications are met.<\/p>\n\n\n\n

Automated alerting and audit-proof documentation<\/h3>\n\n\n\n

If a deviation such as an excess temperature occurs, the system recognizes it immediately, documents it and automatically informs the responsible employees by email. This enables an immediate response before stored medicines are at risk. In addition, the system creates weekly alarm logs and saves monthly parameter changes including user comments. All data is archived redundantly and is available at any time for internal audits or official verification.<\/p>\n\n\n\n

The result: More process reliability and less audit effort<\/h3>\n\n\n\n

With the Delphin system, the hospital pharmacy was not only able to significantly increase process reliability, but also noticeably reduce the amount of documentation required for audits. At the same time, the risk of loss of active ingredients due to undetected temperature deviations has been reduced - a significant contribution to economic efficiency and compliance with the highest quality standards.<\/p>\n\n<\/div>","protected":false},"excerpt":{"rendered":"

Seamless GMP monitoring for cleanrooms and pharmaceutical storage areas - tamper-proof data acquisition, alarming and audit documentation in one system.<\/p>","protected":false},"author":6,"featured_media":0,"parent":0,"menu_order":0,"template":"","format":"standard","categories":[],"tags":[],"class_list":["post-16926","loesung","type-loesung","status-publish","format-standard","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/loesung\/16926","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":14,"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/loesung\/16926\/revisions"}],"predecessor-version":[{"id":16971,"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/loesung\/16926\/revisions\/16971"}],"wp:attachment":[{"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/media?parent=16926"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/categories?post=16926"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delphin.de\/en\/wp-json\/wp\/v2\/tags?post=16926"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}