Pharmaceutical Sterilizers

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