Sterile In Place (SIP)

Dear All,

Can anyone provide reference document or guideline for performing Sterile in Place (SIP)?

What are the pre-liminary requirements for performing the Sterile in Place (SIP)?

Looking forward for reply.

Thanking you,


No such specific guidline,
Be careful that the equipment to sterilie achives the temoperature and time as per requirment.

Hi, Here is a guideline.

Aseptic Guideline (1987)
“Where equipment, such as large tanks and immobile piping is sterilized in place by the passage of pressurized steam it is important that validation considers temperature and pressure at various locations in order to identify potential “cold spots” where there may be insufficient heat to attain sterility”

guide to GXP (1992)
The position of the temperature probes used for controlling the sterilisation cycle should have been determined during the validation

• Adequate system design
(piping, bleeds, traps, valves, filters, monitoring instruments…)
• Displacement and elimination of air in the system
• Assurance that the steam used in the SIP is saturated
• Maintain sterility after the SIP process


Can you please share the guideling,