The Process
The Sterilize-In-Place (SIP) process, normally used in BioPharma and Bio-Safety sanitary plumbing applications, allows chamber steam to sterilize the air filter.
The following provides a functional description of the SIP process for the current PSS9 control platform. The valve designations noted below may be different from currently installed PRIMUS sterilizers depending on the age of the sterilizer and the type of control platform used:
- Steam pressure from the chamber causes steam to flow through the 0.2 Micron Air Filter (HVY 01), through Check Valve (CV 609), through the Filter Drain Trap Bypass Valve (HV 03) and through the Filter Steam Trap (LCV 02) to the drain. The Filter Drain Trap Bypass Valve (HV 03) allows for constant flow through the filter when the trap is closed.
Note
Since the Sterilize phase provides the greatest steam pressure, the time of
sterilization of the air filter should be based on the sterilization exposure time.
- This process occurs during all phases except the Air-In phase at which time the Chamber Air Valve (AV 515) opens, equalizing the chamber to atmospheric pressure.
Validation
Filter sterilization validation should be performed using standard techniques such as the use of bacteriological indicators (BI), or testing of the air filter itself after SIP.
Other Information
This SIP feature comes standard with all sanitary piping systems (normally, these are BioPharma and Bio-Safety applications).
Normally the 0.2um filter elements, due to their critical nature and frequent steam exposure, should be replaced after 100 to 150 hours of steam exposure or as required from integrity test results or per the respective facility’s Standard Operating Procedure (SOP).
Contact the PRIMUS parts store for answers to all of your PRIMUS parts questions at
Spire Integrated Solutions PRIMUS parts store
(877) 679.7800 extension 1010 or email us!
How to purchase a filter
PRIMUS carries the 0.2um disposable filter elements in stock in Spire’s Great Bend facility for shipment.
See our entire stock of filters on the PRIMUS parts store.
These filter elements are normally supplied in a stainless steel filter housing in a single open-ended (SOE) double “O ring design” to fit into both sanitary and threaded plumbing systems (P/N 400934).
P/N 400063 is used as a pre-filter before the filter housing in most applications.
This filter style can be provided as both Air In and Air Out applications to protect not only the sterilized load, but also the facility itself from potential biological contamination.
PRIMUS P/N 400063 – FILTER, AIR, 0.2, 10″ Double open-ended air-in filter on the dog bone on top of the sterilizer
PRIMUS P/N 400934 – FILTER, AIR, 0.2, 10″ Single open-ended air filter used in the filter housing on top of the sterilizer
Filters can be purchased on the PRIMUS parts website. Contact our parts department at 877.679.7800 x1010 or parts@spire-is.com.
More Information
Have a question or having difficulties? Talk to Dave Schall, our PRIMUS sterilizer expert who is here to assist you anytime at 877.679.7800 extension 1212 or email at dschall@spire-is.com.
Visit us at spire-is.com