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7.0 XCell™ ATF Hollow Fiber Module and Diaphragm Replacement
The following is a guideline for replacing a Hollow Fiber Module (HFM) or the diaphragm within the
Diaphragm Pump. Since the procedures for replacing these parts are similar, a generalized description is
provided. Where necessary, more specific references and descriptions will be provided.
Example 2
Replacing a HFM in Filtration Assembly connected to a pressure rated vessel:
Prerequisites: Steam is available and the HFM has to be replaced in mid run in a sterile manner. Refer to
Figure 1.
7.1 Separating the Filtration Assembly from the bioreactor
7.1.1 STOP the C410v4B controller.
7.1.2 Stop the filtrate / harvest pump.
7.1.3 Disconnect Diaphragm Pump pneumatic line from the pump air inlet filter.
7.1.4 Close or disconnect compressed air and vacuum services from the P-BOX.
7.1.5 Disconnect any sensors from the Filtration Assembly to P-BOX
7.1.6 If necessary, remove the P-BOX from the proximity of the Filtration Assembly.
7.1.7 Close and disconnect the filtrate line.
7.1.8 Disconnect the Filtration Assembly from the vessel as follows:
a1. Securely close both bivalves connecting the Filtration Assembly to the vessel.
a2. Drain liquid from the connection. Optionally, purge the connection with water, steam or
some other medium.
a3. Disconnect the Filtration Assembly from vessel between the two bivalves.
a4. Remove the Filtration Assembly to an appropriate work area, i.e., a sink.
7.2 HFM removal
7.2.1 Drain the system into an appropriately sized drain or waste vessel.
7.2.2 Remove all sensors from the Filter Housing
7.2.3 Remove air inlet filter connected to the Diaphragm Pump and any other connections
to the XCell™ ATF System
7.2.4 Open the clamp connecting the Filter Housing to the Diaphragm Pump and separate
7.2.5 Open the clamp connecting the Reducer to the Filter Housing and separate
7.2.6 The HFM may then be removed from the Filter Housing by firmly pressing it from one
end
7.2.7 Remove the exposed “O” ring at the exposed end of the HFM
7.2.8 Press the HFM in the opposite direction to remove the HFM
1.2.9 Prepare Filter Housing for cleaning and reuse or for cleaning and setting aside
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