Principles of Steam In Place PharmTech

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Figure 1 Left In line vent filter housing where downstream condensate is drained by. gravity to the vessel Middle T type gas filter housing in which a slope must assist. condensate drainage to the tank Right Incorrect set up. fore be designed and in,stalled for correct drainage. of condensate with the inlet,sterile side of the cartridge. fitted on the sterile vessel,This setup is preferred since. the housing closure as well,as the connections to vent. and drain valves may pres,ent risks of leakage on the.
upstream side of the filter A,reverse mounting would re. Figure 2 Reverse steam sterilization of vent filters. sult in the filter bypass and,along with the associated vessels. would compromise the,equipment s sterility, Figure 1 shows the correct instal be installed on the top of the filter to. lation of a vent filter The in line de evacuate noncondensable gases dur. sign of the housing allows the ing the sterilization cycle This en. drainage of downstream condensate sures the penetration of steam to all. from the vertical connection to the filter assembly extremities. vessel The T type housing needs a In most cases vent filters are. fall on pipework to ensure conden steam sterilized along with their as. sate drainage to the vessel In both sociated vessels see Figure 2 Be. cases the upstream condensate is cause large amounts of steam are re. eliminated through a steam trap fit quired to start the SIP cycle heat the. ted on the drain port of the housing system and remove non condensa. A thermostatic steam trap also must ble gases it is better to introduce. Pharmaceutical Technology FILTRATION 2004 s41,Filtration. steam into the vessel first and then,sterilize the vent filter with a reverse.
steam flow This procedure is pre,ferred to a forward steam injection. from the filter to the tank because it,limits the steam flow rate It also. avoids high differential pressure,over the filter and prevents contact. with superheated steam The reverse,steam flow through the filter is re. duced significantly because it only,compensates for condensate elimi.
nated by the steam traps opening, upstream of the filter assembly Re Figure 3 Separate filter and vessel. verse steaming is safe if using a sterilization This configuration allows. locked filter three different SIP procedures separate. As shown in Figure 3 some in filter sterilization in the case of. stallations such as water for injec replacement vessel sterilization only and. tion WFI tanks or fermenters may simultaneous filter and vessel. require separate vent filter steriliza sterilization. tion to allow their replacement with, out re sterilizing the vessel All con test is conducted at 2 barg pressure. figurations require the installation of Superheated steam will be present. a pressure relief safety valve as well at the beginning of the sterilization. as pressure gauges upstream and cycle because of high velocity and. downstream of the filter This en sudden steam expansion into the. sures that the reverse differential tank Therefore it is better first to. pressure does not exceed specifica admit regulated saturated steam. tions throughout the SIP procedure into the tank and then maintain the. Temperature probes are located in isolated filter All the bleed valves on. the coldest points of the filter as the vessel must be open to ensure. sembly and the vessel i e the drain removal of condensate and noncon. points to monitor the SIP process densable gases The duration of this. Adding steam traps downstream of operation depends on the size of the. the bleed valves allows condensate equipment and is established during. removal reduces the steam flow the validation of the SIP cycle When. rate and minimizes the pressure the drain temperature reaches 110. differential across the filter 8C or the tank pressure is approxi. Flushing noncondensable gases and mately 0 5 barg the valve is open to. heating the system Before starting the filter and the steam quickly rises. the SIP cycle it is important to and heats the filter housing. check the leak tightness of the sys Eliminating all noncondensable. tem A five minute pressure hold gases normally requires flushing the. s42 Pharmaceutical Technology FILTRATION 2004 www phar mtech com. system with 10 volumes of saturated pressure should be in the range of. steam which might take between 5 6 2 8C from the actual temperature. and 20 min The maximum amount as accepted by the European stan. of condensate is generated at the SIP dard EN 285 A current industry. start because of the high tempera practice checks for both pressure. ture difference between steam and and temperature during the valida. the heat transfer equipment Steam tion and uses tighter acceptance cri. traps shut automatically once the teria for the deviation 6 1 8C. steam exits the drain and vent valves Provided that routine SIP opera. and indicates that air and conden tions are implemented using the. sate have been removed This limits same validated SOP only the tem. the steam flow and allows the sys perature is monitored This is ac. tem to be increased and maintained ceptable because equipment SIP. at the desired sterilization tempera processes generally involve numer. ture Steam traps will open intermit ous sterilization conditions. tently to evacuate condensate and Automatic SIP can be regulated. allow replacement with fresh satu directly or indirectly via a steam. rated steam For manual SIP systems inlet control valve Another possible. that may not include steam traps regulation simply involves accurate. the bleed valves must open progres pressure regulators for the inlet. sively to avoid excessive pressure dif steam and steam traps at the drain. ferential when steam flows through ing points During SIP condensa. the filter The bleed valves remain tion spontaneously draws fresh sat. cracked open during the SIP cycle to urated steam and energy at the. eliminate condensate and adjust the points where it occurs and the ster. flow rate across the filter ilization temperature is maintained. Sterilization cycle Once the moni at the set value For manual proce. toring temperature probes located dures the steam flow and pressure. in the slowest heating points of the differential are regulated via the. system generally the vessel and fil manual steam supply valve and the. ter drains indicate the set steriliza bleed valves which remain cracked. tion temperature the SIP plateau open Air and condensate are elimi. begins and continues for the re nated continuously through the. quired time period defined by the open bleed valves during the SIP. validation study The pressure dif cycle, ferential over the filter must not ex Venting steam drying and cooling. ceed 70 mbar during the entire ster Upon SIP completion it is necessary. ilization cycle to maintain the filter to release the steam pressure and re. integrity Both pressure and temper move residual condensate from the. ature should be monitored to ensure lowest drain points of the system. that saturated steam conditions are This step is critical because steam. met The theoretical saturation tem condensation can create vacuum. perature calculated from the actual and compromise integrity A mole of. Pharmaceutical Technology FILTRATION 2004 s43,Filtration. saturated steam at 1218C occu,pies a volume of 15 L whereas.
the same mole of condensate only,occupies 18 mL Condensation. must be compensated by sterile,gas such as air or nitrogen Sterile. compressed gas pressurizes the,system and completely purges the. condensate through the bleed,valves The maintenance of steril. ity is ensured as long as the pres,sure gauges indicate a positive.
reading in all parts This opera Figure 4 System designed for SIP and. tion also allows the cooling of the integrity testing of vent filter. equipment and filter which is,critical when post SIP integrity. testing has to be performed to wet hydrophilic filters makes. Integrity testing the vent filter Post their sterilization easier because. SIP integrity testing of the vent filter condensate can pass through the. increases the level of sterility assur membrane along with the steam. ance Integrity testing must be per and reduce the occurrence of blind. formed without compromising the filters Conversely the hydrophilic. sterility of the downstream equip nature of product filters makes pre. ment This is achieved easily by the and post SIP drying difficult Water. water based testing method see wet filters do not allow air passage. Figure 4 Because water flow when the pressure is below the bub. through an integral filter is mini ble point pressure typically 3 6 4. mal it can be used in place after SIP barg, In line integrity testing of the filter Polymer materials used for fabri. before the process avoids potential cating hydrophilic filters do not ex. time loss and rejected product hibit high thermal conductivity and. caused by a damaged filter The ster are good insulators for heat transfer. ilizing vent filter then is used for Furthermore the air entrapped in. aseptic compensation of liquid the polypropylene support layers. movements in the tank or for prod the microporous membrane and the. uct transfer Post use testing also is pleated structure of the filter acts as. required to ensure that the filter was a barrier to the heat transfer. not damaged during the manufac process,turing process The filter system must be equipped. with appropriate vent and drain, Liquid filter engineering valves as well as designed and placed. System design installation and stan in the upright position to properly re. dard operating procedure The ability move air and condensate These. s44 Pharmaceutical Technology FILTRATION 2004 www phar mtech com. Figure 5 Left In line filter housing Middle T type filter housing Right T type filter. housing equipped with a steam trap on top for air evacuation. valves permit a continuous steam trol the differential pressure Temper. flow during SIP and eliminate poten ature probes are located in the drain. tial dead flow areas point downstream of the filter assem. Figure 5 depicts possible filter bly to monitor the set temperature. configurations The in line housing The addition of steam traps and. design allows the downward evacua downstream bleed valves allow con. tion of air and condensate through densate removal and reduce both the. the vertical connection to the down steam flow rate and the pressure dif. stream thermostatic steam trap The ferential across the filter. T type housing needs a fall on Sterilization cycle If the filter was. pipework for condensate drainage integrity tested before sterilization it. If the steam is supplied from the must be dried with pressurized air or. product line a thermostatic steam nitrogen to provide a path for subse. trap must be installed on the top of quent steam flow through It cannot. the filter to evacuate air and ensure exceed the maximum pressure drop. that steam penetrates all filter as of 0 35 barg across the filter. sembly extremities In all cases the Water present in the steam line at. upstream condensate is eliminated the beginning of the sterilization. via a steam trap fitted on the drain cycle first must be purged upstream. port of the housing of the filter to avoid wetting and. Liquid filters should be sterilized in subsequent blocking The bleed. the forward direction separately valves on the filter are open to en. from their associated downstream sure condensate and air removal. equipment to reduce the steam ex Once the temperature probe indi. pansion volume at the beginning of cates the set sterilization tempera. the SIP cycle Such a procedure will ture the SIP cycle begins and con. limit superheat effects and reduce the tinues for the required time defined. steam flow rate over the filter Pres during validation The pressure dif. sure gauges are required upstream ferential over the filter must not ex. and downstream of the filter to con ceed 350 mbar to maintain the filter. Pharmaceutical Technology FILTRATION 2004 s45,Filtration.
integrity Both pressure,and temperature are,recorded to ensure that. saturated steam is pres,ent in the system,Automatic SIP is reg. ulated via the steam inlet,pressure reducing valve. and steam traps Manual,procedures are regulated,via the manual steam. supply valve and down, Figure 6 SIP and post SIP integrity testing of liquid.
stream bleed valves The,bleed valves must be,opened progressively to. avoid excessive pressure differential has remained integral during the. as well as eliminate air and conden entire manufacturing process. Drying cooling and integrity testing Conclusion, the filter After SIP the steam supply Steaming in place SIP is the pre. valve is closed and compressed air ferred method for sterilizing pro. or nitrogen is admitted to the sys cessing equipment including vessels. tem for cooling and drying the filter valves process lines filter assem. Quick drying is obtained with both blies manifolds and filling nozzles. the gas flow and the high tempera The confirmation of a well designed. ture of the system As required by and engineered filtration system is. the European Commission s Good the ability to validate the SIP cycles. Manufacturing Practices Guide fil using thermocouples and biological. ter integrity testing must be per indicators Following the design and. dequate configuration of steam in place SIP systems is vital and must be considered at the early conception stage of the plant The critical requirements associated with SIP include proper steam dis tribution noncondensable gases re moval and continuous condensate elimination Good engineering practices adequate piping design steam traps valves and monitoring instrumentation are

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