SIP
Steam-in-Place (also Sterilise-in-Place)
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Sterilisation or sanitisation of assembled process equipment and pipework in situ using clean steam held at temperature for a defined time, without dismantling the system. Usually performed after CIP and immediately before aseptic use.
The two expansions are used interchangeably in practice but are not identical in intent: steam-in-place names the method, sterilise-in-place names the outcome. Where a document must be precise about whether sterility is being claimed, the distinction is worth making explicitly rather than relying on the abbreviation.
As with moist-heat sterilisation generally, the evidence is lethality delivered to the coldest point of the assembly, not time at setpoint at the steam header.
EU GMP Annex 1 (2022) for sterilisation processes; ISO 17665 for moist-heat sterilisation of health care products; EU GMP Annex 15 (2015).
Frequently asked questions
What does SIP stand for?
SIP stands for Steam-in-Place (also Sterilise-in-Place).
What is SIP?
Sterilisation or sanitisation of assembled process equipment and pipework in situ using clean steam held at temperature for a defined time, without dismantling the system. Usually performed after CIP and immediately before aseptic use.
Which regulations cover SIP?
EU GMP Annex 1 (2022) for sterilisation processes; ISO 17665 for moist-heat sterilisation of health care products; EU GMP Annex 15 (2015).