Risk Assessment Document For Steam Heat Sterilizer (Autoclave)

This risk analysis is conducted for a HPHV Steam heat Sterilizer (Autoclave)for production consisting of the following main components:

• Sterilization chamber
• Connections for clean media piping
• Vacuum system
• Heating and cooling system
• Control System
• Instrumentation/equipment for process control, monitoring and recording

The unit shall be used for sterilization of Equipments, Garments and other components used in aseptic area.

The sterilization processes would be facilitated by use of pure Steam.

Most of the possible risk concerning the handling/operation of the Steam heat sterilizer  has been considered in this RAD.