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9.0 Connection to Bioreactor (ATF-to-Bioreactor)
Two types of connections between Filtration Assembly and bioreactor are commonly available.
• Hard connection that can be sterilized by SIP
• Soft connection that use single use connectors such as the Kleenpak, AseptiQuik, Opta,
Readymate DAC, Pure-Fit, or other connectors now available from various vendors.
9.1 Hard Connection
The user should verify the following procedure:
• Typically used with stainless steel bioreactor systems where steam is readily available.
• This connection consists of at least two isolation bivalves (Figure 1). One bivalve
attached to the vessel and the second bivalve attached to the Filtration Assembly.
• A flexible hose between the main branches of the two valves.
• Steam inlet- The side valve on one of the bivalves may be used for steam inlet.
• Condensate-The side valve on the other bivalve is used for drain condensate. This valve
should be the low point valve to assure complete condensate drainage. Attach a steam
trap to this valve and connect to a drain
• Close both Steam inlet and Condensate valves.
• Securely connect a regulated steam source to the steam inlet valve.
• Open steam service.
• Slowly open steam inlet valve.
• Slowly open steam condensate valve.
• Sterilize connection for about 20min. at 121
0
C and ~16psi
• Cool-down.
• Close the Condensate valve.
• Rapidly close the Steam inlet valve and immediately open the main valve into the
Filtration Assembly to minimize a pressure drop in the connection.
Note that following SIP of the connection, the cool-down of the connection post SIP will
generate a vacuum within the connection, which must be minimized.
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