Pharmaceutical Sterilizers tuttnauer

Providing a Safe Environment is our Priority
In recent years, Tuttnauer has developed close partnerships with leading companies in the pharmaceutical industry. Complementing its products with a range of services, the company has become the first choice for sterilization and infection control products specially suited to the needs of this industry.

We design, build and validate highest quality Autoclave system for reliable sterilization of the most complicated products and loads. Our Autoclave complies with the International standards to FDA, EMEA, GAMP 4 and CFR 21 Part 11.
Our Pharmaceutical Autoclave package includes the following:
Fabrication
High internal chamber polish with extra electropolishing
Clean piping on all clean utilities (pure steam/compressed air)
Sterile diaphragm valves on clean utilities piping
Sanitary connections and fittings
Documentation
Full weld mapping with CD record of weld inspection
Heat # of all piping and accessories
Full weld log and welding parameters
Isometric drawings fully scaled
Full ASME stamp and documentation on chamber
Control system
Control system based on commercial PLC (Allen Bradley, Siemens etc.) with HMI touch screen panel
Optional: SCADA with PC HMI
Control system consists of synoptic, operation and alarm screens
Full CFR 21 Part 11 compliance
Full GAMP 4 compliance
Simulation & operational protocols
Validation
DQ protocols for on site execution
IQ protocols for on site execution
OQ protocols for on site execution
Optional: typical PQ protocols for validation