INTRODUCTION

Sterilization-in-place (SIP) can be defined as the sterilization of a system or piece of process equipment in situ. The purpose of SIP is to eliminate, or greatly reduce, the need for post-sterilization handling, including that necessary to make aseptic connections. Mobile process equipment (e.g., portable tanks, storage vessels, and other equipment), once sterilized in this manner, may be relocated. The SIP process can be carried out by using any of the following physical methods: moist heat, dry heat, gas, liquid, or vapor (described below) according to the approaches described in Sterilization of Compendial Articles 〈1229〉, as adapted for use with the specific equipment or system.