製薬機械（装置）

Our plant assure sterilization in conformity with good manufacturing practices for LVPs, SVP etc. and in accordance with the cGMP issued by FDA. in short, excellent engineering coupled with efficient manufacturing.

Construction:

• Sterilization chamber in SUS 316, SUS 316L and SUS 316Ti stainless steel.
• Piping and valvels directly connected with chamber in stainless steel.
• Chamber piping all valves and fitting are sanitary class.
• Insulation by glass wool.
• Automatic temperature controller.
• Automatic temp. Recorder-6 points or 12 points.
• Sealed door packing: use heat-resistant silicon rubber material ring packing.
• Absolute air vent filter for prevention of sterilized product contamination.
• One door or pass through type double doors.
• Single wall (cylindrical chamber) or double walls (parallelepiped chamber) body.
• All control and safety components are adapted to the higher temperature and pressure.
• Option: RS 232 interface for connection to an external computer.

Process Control

The autoclave was a central control panel, which houses the programmable logic controller (PLC), signal conditioning units, safety circuits and emergency switch, the autoclave is controlled at all time by the PLC. Which contains the operation automatic screen, manual trend graph, parameter, dynamic and password etc, screen.

• The panel use LCD touch screen control.
• Program flow: use PLC control, for easy of operation and provide three sterilization programs or customer specifications.
• Simple & safe operation: the automatic programs provide with complete and safety control to ensure safe operating condition.
• Temperature recorder for continuous monitoring and recording of the stenilization process.
• Option RS232 can connect with computer direct to calculate.
• Following documentation is supplied with plants:
• Operating manuals
• Maintenance manuals
• Technological diagrams
• List of materials and components
• We supplies completed validation documentation as bellows

Installation qualification (IQ)
Operational qualification (OQ)
Performance qualification (PQ)

Ethylene Oxide Gas sterilization cycle

Plastic/ Membrane Container Sterilization Cycle

Solution Sterilization Cycle

Steam Sterilization Cycle for Dressing/ Instrument

Specifications: