Sterilization-in-place

Sterilization, in fermentation, 11 35-36 Sterilization-in-place (SIP), 11 40 Stern-Langmuir equation, 24 139 Stern-Langmuir isotherm, 24 138 Stern plane, 7 285-286 Steroidal ketones, dehydrogenation of,... 

Liquid product is fed to the BFS machine from a holding tank or vessel. The pathway is sterilized in place prior to receiving product, and product is sterilized by means of in-line sterilizing-grade filters. There is usually more than one stage of sterile filtration required on the product pathway. 

Pipework systems, valves and vent filters should be properly designed to facilitate cleaning and sterilization. The use of clean in place and sterilize in place systems should be encouraged. Valves on fermentation vessels should be completely steam sterilizable. Air vent filters should be hydrophobic and validated for their scheduled lifespan. 

Figure 4.11. a so liter bench fermenter that can be scaled for production of recombinant proteins. The bench-top scale configuration contains all the control valves and ports necessary to monitor and control cell cultivation while maintaining sterility of the culture. The stainless steal reaction vessel allows easy cleaning and permits heat and pressure sterilization in place by connecting the vessel to a steam supply. (New Brunswick Bioflo-4500, adapted from the manufacturer s literature with permission)... 

A suitable holding tank is sterilized in place by steam. The following sterilized parts are aseptically connected to the tank a blender valve, a safety relief valve, and a vent filter assembly containing a 0.2 im filter. Prepare the media according to manufacturer instruction. Adjust pH. 

Mobile bulk vessel the sterilization in place (SIP) cycle is specified... 

Agalloco, J. Sterilization in place technology and validation. In Agalloco, J., Carleton, F.J. (eds.). Validation of Pharmaceutical Processes Sterile Products. New York Marcel Dekker, 1998. 

This type of centrifuge is well suited to CIP and some models can also be sterilized in place as part of a hygienic or contained bioseparation process. 

Fixed equipment in the compounding area (nonaseptic or aseptic) is cleaned in place. This eliminates traces of prior products, particles, and pyrogens. Sterilization in place is required for the aseptic fixed equipment and is sometimes employed for the nonaseptic equipment as well as a bioburden control measure. Fixed transfer lines must be cleaned and sterilized as well, and this is accomplished independently or in conjunction with the vessels. The reuse of hoses and tubing is discouraged as cleaning and extractables cannot be confirmed beyond a single use. 

Technical Procedures for Operation of Cleaning-in-Place and Sterilization-in-Place Process for Production Freeze-Drying Equipment... 

Systems that are sterilized in-place are often immensely complex. The initial challenges to their sterilization are the removal of air and the elevation of the temperature of the pipework to prevent heat losses and condensation. As such, most work in the development of sterilization specifications for SIP systems is concerned with the heat-up phase. Appropriate questions are Is the sterilization temperature achieved throughout the system Where is the slowest location to achieve... 

BFS machinery and associated equipment for aseptic manufacture should be constructed in such a way that the product pathways are of hygienic design with hygienic valves and minimal joints to facilitate cleaning and sterilizing in place. 

A liquid fill operation is delivered to a pump throu lines that have been sterilized in place or sterilized and assembled aseptically. 

The prevention of bacterial or fungal infections in cell culture and recovery systems can be assured, to a high degree of confidence, by the use of a piping and vessel system which maintains absolute containment of the sterile medium fluids. The equipment used must be of a nature to allow cleaning and sterilizing by Clean in place (CIP) and Sterilize in place (SIP) procedures (usually high-quality stainless steel). Most cell culture processes require... 

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