Tuttnauer pharmaceutical autoclaves are designed and manufactured in a state of the art facility in compliance with cGMP regulations to meet the technical challenges of pharma and biotech industries. With over 350,000 installations, Tuttanauer provides customized autoclave solutions to various areas such as Post-production Terminal Sterilization, Pre-production sterilization, laboratory and R&D, quality control , bio-hazard waste sterilization etc.
To ensure uniform manufacturing results and precision-made sterilization equipment Tuttnauer uses high-tech industrial processes including laser cutting, robotic bending, robotic polishing, and automated welding. The autoclaves are equipped with robust ASME and PED compliant chambers as large as 17,000 liters. The advanced user-friendly Allen-Bradley control system gives the operator precise and realible control of all autoclave operations. The PLC features sophisticated custom cycles, cycle simulation, detailed cycle data recording, file transfer ability, and connections to SCADA and WiFi devices. The PLC is 21 CFR part 11 validated. Tuttanauer implements a strict documentation and qualification process according to cGMP regulations. The documentation package includes URS & compliance, Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification(OQ), Full set of manuals, SAT Validation etc