( fermentor, fermenter, cell culture, cellculture,bioreactor, bioreacter, solid state fermentation, liquid state fermentation, sterile equipment ) | |||
Sterile Technical Interpretation | Micro-giant BioEngineering 2009.06.19 |
To create and maintain sterile environment during the basic preprocess of microorganism (purebred) culture fermentation of sterile equipment is the most important. To avoid bacteria interfere and affect the harvest rate, furthermore cause failure or variation (especially the secondary products of metabolism). To make a provision of sterile technical interpretation for sterile equipment concern as follows:
Ⅰ. No Blind Angle Design:
Arc-shaped design no angle of all the wetted part inside the fermentor, all the ports from the nearest stop valve or blind cover (neck) must be <2d (inner diameter). All the pipes with secondary SIP of sterile equipment are required concept of sterilization buffer room, ex. sampling valve(tube), feeding tube, transfer tube, seal…etc. All wetted parts adopt diaphragm valve or least food or pharmaceutical sanitary valve (Note: still need to take care of the sterilization method.)
Ⅱ. Complete Sterilization:
Sterilization basically using SIP. It’s using enthalpy inside the superheated steam to achieve the sterilization. If that’s CIP; must take care of sterilize concepts.Weather sterilze throughtly or not related to these four elements below:
Ⅲ. Maintain Positive Pressure
To ensure that the sterilization can be maintained, it is the key to keep positive pressure for the system from sterilization to harvest. Generally sterile equipment use filtered 0.2μm sterile air to maintain. Therefore in case the power outage, the sterile equipment system can still keep positive pressure for 12 hours or more, so all the auto valves (N.C. type)need to consider if the power outage happens.
First enter cooling section during sterilization, relief pressure too fast will easily cause sudden boiling and thus should adopt segmented relief cooling.
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