HOME > Support > User Guide

Steam-In-Place Sterilization

2015-02-02

Because SIP sterilization is the most common source of damaging a filter, it is recommended to follow the procedure and instructions exactly.



Standard Operating Procedure(Making sure all valves are closed)
1. Check that the steam supply and compressed gas pressures are set up at the required values (steam pressure value: 1.5~2 bar).
2. Respectively open valve 1 and valve 2 to introduce steam to the system and to purge air from the system.
3. Completely open valve 4 and valve 5 to drain off condensates.
4. Slowly open valve 3 to increase flow of steam and to heat the cartridge (for 3~4 minutes).
5. Partially close valves 2, valve 4 and vent valve 5 for a continuous drainage of steam and water.
6. Respectively open valve 9 and valve 10 to establish a steady flow of steam and to allow for condensate drainage and air removal from the filter housing.
Notes:It’s of utmost importance to control the difference between pressure gauges P1 and P2 and keep the delta-P over the filter to a maximum of 350 mbar.
7. Ensure all air and condensate are effectively removed by keeping valve 2, valve 4, valve 5 and valve 10 cracked open so that a wisp of steam and a continuous drip of water can be seen exiting.
8. When the temperature throughout the system reaches over 121.1℃ (making sure the value of the temperature gauge 1 to a maximum of 128℃), as measured by the temperature gauge 2 (close enough to the exit of filter), the timer is started. Sterilization time should be at least 30 minutes or longer if validation has decreed so. During the sterilization phase both pressure and temperature should be recorded regularly.
9. When the required sterilization time has been achieved, close steam supply valve 1 and slowly open valve 6 to introduce sterile compressed gas into the system.
Caution:Make sure that the system remains under positive pressure (P1>P2>0) and control that the delta-P over the filter does not exceed 350 mbar.
10. Allow for steam purge from all vent valves and close valve 2 and valve 4 to increase the flow of sterile gas through the system. Maintain the gas flow to cool down the system until the temperature gauge 2 indicates approximately 30℃.
11. When it is not in use, respectively close valve 10, valve 9 and valve 5, and keep valve 6 and valve 3 open to keep a positive pressure into the sterile system (0<P1≤2bar).

Last Case: Integrity Test

Next Case: No information!

Need more information or get in touch with our team?
To serve you better, please fill the form. It’s quick and easy.

Name*:
Company*:
E-mail*:
Country:
Telephone:
Tell us your needs*:(as specific as possible)