Steam-In-Place

One of the most common methods for creating a sterile bioprocessing environment uses heat in the form of steam to eliminate unwanted organisms. Colder Products manufactures connections using high temperature medical-grade plastics that may be steam sterilized. These include polycarbonate and polysulfone MPC/MPX as well as polysulfone HFC and Steam-Thru Connections.

Steam sterilization is dependent on three variables: temperature, pressure and time. For example, Colder's Steam-Thru Connection is rated for autoclave sterilization at 265°F for 30 minutes for Steam-In-Place (SIP) sterilization up to 30 psi and 266°F.

Autoclaves are heated/pressurized chambers. Small to medium size items including small bioreactors are steam sterilize in autoclaves. Autoclaves may be automated to maintain several pre-programmed cycles of temperature/pressure/duration and exhaust method for uses with a variety of materials including liquids.

Autoclaving is impractical for large bioprocess equipment. Steam-In-Place (SIP) processes are used to sterilized stainless steel bioreactors and support vessels in bioprocess facilities. These processes require a clean-steam source supply, separate steam piping and valves, and removal of excess condensate created during sterilization. SIP equipment requires thorough validation to ensure reliable and repeatable sterilization.