All Fedegari steam autoclaves are designed and built to the highest standards, meeting all relevant cGMP regulatory requirements.

As standard, the chambers are AISI316Ti, polished to <0.5µRa and built to PED pressure vessel code (other codes available). Robot welding, numerically controlled milling and advanced laser-cutting techniques all ensure consistent, close-tolerance quality standards.

All pipework and valves are AISI316L, to ASME BPE sanitary standards where appropriate.  Fedegari use process valves which minimise interconnecting welded pipework, adhere closely to cGMP standards as they evolve, maintain quality standards and guarantee supply over the full life of the autoclave.

The Thema 4 controller is fully GAMP compliant, with built-in audit trails, data logging and 21CFR11 compliant control systems.

• The hardware platform is Proface, Siemens or Allen Bradley with Windrivers VXWorks real-time operating system.
• The application software uses a library of specialised control functions, continuously developed and refined over the last 30 years.
• All software code is pre-validated. As a GAMP Category 5 system, project-specific customisation is achieved by configuration only, with no new software code needed. This minimises the risks of software errors.
• Open systems architecture ensures full SCADA connectivity.

Documentation is in English, fully supporting the validation demands of the FDA and other regulatory authorities.