1.3 BPC characteristics
1.3.1 S.U.M. BPC features
Two standard BPC configurations are available for the S.U.M.:
a closed-top configuration, and a linear with a separate impeller
sleeve for open-top mixing. The BPC (or open-top liner) contains the
mixing process. The BPC chamber is manufactured from CX 5-14
film and the open-top liner from CX 3-9 film. Both are co-extruded
film structures specifically designed for biopharmaceutical process
usage. All materials are qualified for a range of physical, mechanical,
biological, and chemical compatibility requirements. The BPC is
validated using gamma irradiated processes.
1.3.2 Open-top mixing configurations
The open-top mixing configuration (Figure 1.9) includes an open-top
liner that also utilizes a separate, single-use sleeve that covers the
drive shaft once it is inserted into the mixing assembly. A reusable
bearing hub is used for all open-top mixing applications. A quick
connect fitting is used to connect the drive shaft sleeve to the bearing
hub.
Figure 1.8. Mixing motor
assembly
Motor
Latch pin
for safety
cover
Cap
Safety
cover
Drive shaft
head
Drive
shaft
Figure 1.9. Open‑top liner
Thermo Scientific
Chapter 1
|
DS 300 S.U.M. overview
HyPerforma DS 300 Single‑Use Mixer User's Guide
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13