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Tamper-proof documentation for sterile and hygienic processes

The requirements for GMP-compliant production mean that manufacturers and OEMs (have to) comprehensively document numerous work steps. This includes keeping check lists, maintenance books, plant plans and inventory lists, as well as taking various approaches to ensure the captive identification of every component.

Requirements are constantly increasing for hygienic processes as well, which is why more and more resources are restricted by the documentation. Thanks to GEMÜ CONEXO, commissioning, operation and servicing are not only paperless, but greatly simplified.

Digital identification and installation qualification

At any time, individual valve, measurement and control components can be identified in the system directly by the inserted or attached RFID chip, which makes installation qualification more simple, for example. Information about declarations of conformity, reports and certificates is stored per component/per identification via a mobile software solution. The delivery note number, order confirmation number, date of manufacture and article number are clearly assigned to the device. This information can be entered and saved accordingly for products from third-party suppliers. Both processes are paperless and only take seconds.

Further job-specific documents such as datasheets and operating instructions are seen or can be seen and added per component/per identification.

Product conformity and process reliability

The conformity of all GEMÜ products in accordance with USP Class VI, FDA and EU regulation 1935/2004 still applies with the RFID chip, if it applied previously. Various manufacturing steps and cleaning processes can still be implemented. This includes electropolishing, pickling/passivating, electrochemical machining and autoclaving (at 123 °C–135 °C). Even the CONEXO app and portal have been programmed in accordance with GMP guidelines, and all components communicate exclusively using security standards and with encrypted data.

Paperless maintenance and expanded service applications

Using the mobile software solution on the tablet, the maintenance technician is actively guided through the maintenance schedule which can be individually structured and edited, and has all the assigned information, such as instructions, test reports and testing documentation directly available. This package is further supplemented by the maintenance log book and photo documentation options. The photo documentation option in particular is used to optimize maintenance cycles for each plant section as all data can be compared one-to-one on a single screen over a prolonged time period.

Retrofitting and cloud solution

Thanks to CONEXO Retrofit, it is possible to retrofit GEMÜ valves, devices and products from third-party suppliers in existing systems. In addition, products from third-party suppliers are integrated in the software with this module. The individual components are additionally supplemented by a cloud solution. This type of connection facilitates network-independent access to data stored in the cloud from anywhere in the world. As with the portal solution which can be installed on site, GEMÜ cannot connect with the customer system or call up data with this package either.