抄録
ISO 13408 Part 4 and Part 5 include requirements and guidance that are to be observed during cleaning in place (CIP) and sterilization in place (SIP). The purpose of this standard is standardization in the field of validation and routine control of CIP and SIP processes that are used for cleaning and sterilization of the systems that is used in the manufacture of health care products. The most important issue to consider in establishing CIP and SIP technologies is to ensure the design of the systems that are able to successfully clean and sterilize manufacturing systems to the desired sterility assurance level (SAL). The term “Steam-in-place” is used in ISO 13408 Part 1, and this term is sometimes abbreviated as SIP. However, in this part of ISO 13408 Part 5, “SIP” is used with a wider meaning and includes not only steam-in-place, but all kinds of sterilization used for the sterilization in-place. In this section, I introduce the important items mentioned about CIP, SIP and steam SIP from the system design point of view, according to the latest working draft of ISO 13408 Part 4 and Part 5.
