Millipore Viresolve Pro VPMCPDKNB9 User Manual

Notice
The information in this document is subject to change without notice
and should not be construed as a commitment by Millipore Corporation.
Millipore Corporation assumes no responsibility for any errors that may
appear in this document. This manual is believed to be complete and
accurate at the time of publication. In no event shall Millipore Corporation
be liable for incidental or consequential damages in connection with or
arising from the use of this manual.
Introduction
Viresolve Pro Micro Devices are typically used for process optimization,
viral clearance validation and filtration of small batch volumes of proteins.
This manual applies to the following devices:
Process Development
Kit
Catalogue No. VPMCPDKNB9
Solid Teal
Color
Integrity
Not Binary Gas Tested
Testing
Process Development
Primary
Optimization, scale-up,
Intended Use
etc.
Validation Kit
VPMCVALNB9
Teal and White
Binary Gas Tested
Virus Validation
Installing the Device
Testing should be conducted with a user supplied pump at a constant
flow rate or a constant pressure. A low volume constant pressure holder
(Millipore Catalog number VIRUSVMAX or equivalent) is recommended
for constant pressure testing of Viresolve Pro devices. This user guide
provides instructions for conducting testing at a constant pressure. Contact
Millipore for instructions on testing at a constant flow rate.
1. Remove caps from all devices. Attach a two-way luer valve to both the
feed port (V1) and vent port (V2) of the device. Connect the feed vessel
to the luer valve on the feed port. Close both luer valves.
2. Position a filtrate
collection vessel and
a weighing balance
(to record filtrate
mass) beneath the
device. Fill the feed
vessel with at least
125 mL of
Prefilter
Milli-Q water,
®
(optional)
water for injection
(WFI) or equivalent.
3. Record the
Collection
temperature of the
Vessel
fl uid.
4. Purge the system by
following the device
purging sequence.
Purging the Device
Purging is recommended to remove air from the device before use.
1. Open V2. Open V1 until fluid begins to drain from V2 (approximately
five seconds).
2. Close V2. Close V1.
Feed
Reservoir
Feed Port
Vent Port
V1
V2
Outlet Port
Balance/Weigh
Scale
Figure 1. Typical setup