Technical Brief

Data Sheet

Design of a Single-Use
Powder Delivery Solution for the
Mobius® MIX Single-Use Mixing System
Introduction
One of the most common daily process tasks in the
biopharmaceutical industry is the mixing of media
and buffer solutions for use in both upstream and
downstream unit operations. This unit operation
increasingly utilizes single-use mixing systems to
increase operational flexibility, decrease process and
validation time, and decrease risk of contamination. The
Mobius family of single-use mixing systems is designed
to efficiently mix a variety of media and buffer solutions,
as well as high-value product processing, including
bulk drug substances and vaccines. Mobius mixers are
available in a wide range of sizes (100 L, 200 L, 500 L, and
1,000 L) and include a single-use process container with
an integral, magnetically-driven levitating impeller and
electronic drive unit.

Mixing a powder into solution using a single-use mixer

requires adding the powder to liquid in the process
container. Ideally, this addition is done in a controlled
manner that permits gradual dispensation at a controlled
rate, using a container that is easily washed to remove
residual powder. Currently available technologies are
limited due to uncontrolled rate of delivery, and potential
issues removing residual powder from the delivery
container. To this end, EMD Millipore has designed a
new single-use powder delivery container for addition
of powders to the Mobius MIX single-use mixing system
in a controlled manner. The powder delivery container
is easily washed to remove residual powder, providing
an ideal solution for mixing applications. This paper
describes the design considerations to achieve optimal
powder delivery, specifically powder container geometry,
wash-down capabilities, and valve design.

EMD Millipore is a division of Merck KGaA, Darmstadt, Germany.

 NO FLOW Powder Container Geometry
Powder container geometry significantly impacts the
Erratic solids flow rate for bulk solids. There are at least three
Flow possible flow issues due to container geometry design.
The first is ratholing, which occurs when powder only
flows through a channel above the opening (Figure 1).
This is more likely in containers with shallow angles and
when using powders with strong cohesive forces, as
material would be more likely to remain stagnant outside
the channel. Other potential issues include arching,
which occurs when powder bridges across the outlet
(Figure 1), which is also the result of particle bonding
Ratholing Arching when the particle size is relatively large compared to the
Effect Effect outlet diameter. Finally, a potential issue is erratic flow,
which is alternating behavior between ratholing and
Figure 1. Potential issues with powder flow from
containers due to improper design. The design of arching.
the Mobius Powder Delivery Container minimizes the
potential of ratholing, arching and erratic flow.
Studies on powder properties were performed that
led to a novel asymmetric geometry to optimize flow
performance of solids, eliminating potential arching at
the discharge outlet and minimizing ratholing (Figure
2). Powder properties were initially studied in order
to determine optimal angles and outlet dimensions to
induce mass flow. Permeability testing was performed
to reduce arching by defining the rate of discharge
limitations and erratic feed rates. Based on the results,
the container opening was enlarged to an ideal diameter
of 4 inches to minimize the potential of arching. These
studies also indicated that an asymmetric design, one
side of the container having a 110° angle, as shown in
Figure 2, would eliminate uniform symmetry of forces
that create arching, and encourage mass flow behavior of
both coarse and fine powders.

Figure 2. Final Mobius

Powder Delivery Container
design
Wash-Down Capabilities A.
Figure 3.

An optimal powder delivery container design prevents A) The wash-down handle

design improves recovery
residual powder from accumulating at any point in the of residual powder over
container. Containers with a single side port do not the single-port design.
provide complete cleaning through wash-down, due to B) Bladder design angle
streams against container
incomplete coverage of the interior of the container. To B.
sidewalls and within
improve product recovery, a novel wash-down design the support ribs of the
was created, whereby the wash-down handle supports molded handle.

the container and evenly distributes a stream of water to

scavenge powder from sidewalls (Figure 3A). The spray
pattern of the film bladder is angled to permit rinsing of
the upper and lower surfaces (Figure 3B).

To verify the wash-down capability of the container

design, a cleaning study was performed using riboflavin
powder. The interior of a clean, dry 25 kg powder
delivery container was coated with riboflavin such that
all contact surfaces, including the bag interior, wash-
down bladder, and ribs of the handle were covered Figure 4.
A. B.
(Figure 4A). Rinsing the bag with 25 psi of water for one A) Powder delivery container
coated with riboflavin.
minute (using approximately 8.27 L of RO water) revealed
B) Same container after
high coverage along seals and upper and side surfaces wash-down.
with minimal dead spots in rinsing coverage (Figure 4B).
A similar experiment using a single side port container
verified the superior wash-down from the improved
design (data not shown). Further, similar wash-down
experiments using a variety of media, including
powdered sugar, sodium chloride and phosphate
buffered saline, yielded similar results (data not shown).

Figure 5.
Valve Design A. B.
A) Contact surface of valve.
The third area of design improvement over currently B) Exterior of valve in closed
available powder delivery containers was the design of position.

a molded valve featuring an actuating flap, allowing

metered flow of product from the container. This is a
significant improvement over the currently available
design which requires the end user to clamp or tie the
end of the container, disallowing control of discharge
rate. For the new valve, a butterfly valve was designed
into a 4 inch port which easily connects to MIX
containers. The valve contains a swing-out handle,
permitting compact storage, and a novel screw cap to
fit over the entire valve. This cap protects the outlet and
handle during transportation and long-term storage.
Summary
The unique design of the Mobius Powder Delivery
Container was developed to provide the efficient
transfer of powder for mixing applications. Studies of
container geometry led to a novel asymmetric geometry
to optimize flow performance of solids, eliminate
potential arching at the discharge outlet, and minimize
ratholing. Further design innovations were included in
the molded valve featuring a novel actuation method
and cover design to protect the valve and product
during handling and storage. The new design permits
the end user to dispense powder in a controlled manner,
a significant improvement over currently available
technologies.

To Place an Order or Receive

Technical Assistance
In the U.S. and Canada, call toll-free 1-800-645-5476
For other countries across Europe and the world,
please visit www.millipore.com/offices
For Technical Service, please visit
www.millipore.com/techservice

www.emdmillipore.com
EMD Millipore and the M logo are trademarks of Merck KGaA, Darmstadt, Germany.
Mobius is a registered trademark of Millipore Corporation.
Lit. No. TB1200EN00 DP-SBU-11-04220 06/11
© 2011 Millipore Corporation, Billerica MA, 01821 USA. All rights reserved.