First delivered at the beginning of 2004, Thema4 is today the most reliable and fastest-developing process controller in the industry.
Thema4 is defined as a completely configurable standard product (classified by GAMP5 as Category 4 – Configured Products) and is managing all industrial machines manufactured by Fedegari, guaranteeing a total integration among them.
This achievement is the logical consequence of almost three decades of painstaking work on process controller combined with infrastructure investments, close collaboration with strategic partners and un compromised values because there is no easy shortcut to durable success.
Thema4, in fact, is the natural evolution of the previous generation of controllers (like Thema3 and SuperSpectra before that), that were based on custom-made hardware. While Thema4 has inherited the process management principles of its predecessor, it is absolutely different in terms of hardware components (COTS), software architecture, HMI and general and integration functions.
With Thema4, Fedegari assures the commercial availability of standards components, the integration levels required in modern pharmaceutical plants together with functions and performances to meet quality and safety standards of those production processes for which the application is intended.
Aiming to guarantee the highest system reliability, Fedegari has chosen Wind River VxWorks real time operating system (RTOS). Wind River is a world leader in embedded and mobile software. It has been pioneering computing inside embedded devices since 1981 and its technology is found in more than 1 billion products. The VxWorks Edition with a set of functional modules allows Fedegari’s customers to choose the combination of functions that best fits their specific needs. Fedegari adopted VxWorks because this commercial RTOS has the ability to manage a wide range of hardware devices and ensure robustness, reliability and versatility meeting the company’s critical business requirements.
In order to meet the most demanding pharmaceutical requirements, great care has been taken in designing Thema4 life cycle management: from the conception phase to components selection and definition of system architecture and project management, through the project phase and the definition of product management procedures (change control, configuration management, support, repair, maintenance, etc.) according to the GAMP guidelines.
Now, after continuous improvements of software and hardware components, functions and processes, Thema4 finds itself in the maturity of the operation phase and the reference guideline for its management is the GAMP5.
Several new software versions are released every year that include those developments requested or suggested by our end-users. That’s why investing in a sterilizer with a Thema4 process controller allows the buyer to capitalize on decades of cumulative experience in managing pharmaceutical manufacturing processes developed for the most demanding companies worldwide.
An extensive team of experts assures that the controller is constantly innovated and manages all new developments in accordance with the end users needs and the adopted GMP standards.