Double-Door Pass-Through Autoclaves for Terminal Sterilisation & SIP
A production Steam Sterilizer — commonly a double-door, pass-through (bio-sealed) autoclave — is used for terminal sterilisation of vials, ampoules, garments, filling-line components, and other loads in cGMP-classified manufacturing environments. Installed through a cleanroom wall with interlocked doors, it transfers sterilised loads from a lower-grade preparation area directly into a higher-grade aseptic core without cross-contamination. Multiple cycle types — saturated steam, steam-air mixture, air overpressure, and superheated water spray — allow the same unit to safely sterilise both rigid and flexible/liquid-filled loads.
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Key Features
• Double-door, bio-sealed, wall-mounted construction with mechanically/electrically interlocked doors
• Rectangular chamber for efficient trolley loading, jacketed for rapid, uniform heat-up
• Multiple validated cycles: saturated steam, steam-air mixture (SAM), air overpressure, superheated water spray
• Pre- and post-sterilisation vacuum pulses for effective air removal and rapid drying
• Automatic loading/unloading trolley and transfer-car system for high-throughput operation
• HEPA-filtered air admission and biological/chemical indicator (BI/CI) ports for validation
• PLC/SCADA control with F0 value calculation, batch recording, and 21 CFR Part 11 support -
Typical Applications
• Terminal sterilisation of vials, ampoules, and pre-filled syringes (liquid cycle)
• Sterilisation of garments, wipes, and other soft/porous loads entering aseptic core areas
• Sterilise-in-place (SIP) support and sterilisation of filling-line change parts and tooling -
Technical Specifications
