APRIL 2006

N E W T E C H N O L O G Y F O R T H E P H A R M A C E U T I C A L I N D U S T RY

Disposable Technology Improves

Fluid Handling In Depth Filtration
By Charles Lambalot and Craig Jackson, Millipore Corporation

Conventional lenticular disc filters have long

been the standard in clarification and prefiltration process steps. The effectiveness of the
charged depth filtration media make these filters ideal for use in mammalian cell culture
applications. However, inherent in the format
are issues and challenges, including scalability
limitations, considerable cleaning requirements and operator safety concerns.
Traditional lenticular disc filters used in depth
filtration involve the use of heavy stainless steel
housings with internal components that can be
hard to clean, and cumbersome filter pads that
are difficult to handle. The stainless steel housings are massive, requiring hoists as well as extra floor space for assembly or disassembly and
do not offer flexibility in terms of scale up. In addition, the large filter pads housed inside the
stainless steel housings are extremely heavy and
awkward to handle when they become saturated
with process fluids. Operators can be exposed to
biohazardous materials as they lift the used filters over the centerpost and out of the housings.
The housings and components of the lenticular
disc system require time-consuming and costly
CIP steps, cleaning validation steps, and can
pose safety issues.
Disposable technologies are successfully
addressing many of these same issues in
other process steps, however, the large volumes in clarification applications have for the
most part prevented disposable technology
from migrating successfully to this step.
Disposable filter formats typical in sterile filtration for instance, consisting of a cartridge
filter contained in a disposable capsule, are
not a practical format for larger scale clarification applications. Manufacturing a disposable
depth filtration capsule with the robustness
required for the demanding process conditions would be a significant challenge. While
it could be handled more safely when wet
with fluid, assembling a system would require
manifolding many capsules together, render-

Lenticular disc technology can be heavy and awkward to handle.

ing them still difficult to employ in a clarification process. For these reasons, a disposable
capsule would have some inherent size limitations, making it nearly impossible to scale
efficiently to the high volumes in clarification
applications.
In the past few years, some process compression has been possible through combining
clarification and prefiltration steps by incorporating multiple media grades in a single filter.
Millipores Millistak+ HC media combines
charged depth media and membrane technologies to enhance filter capacity and retention.
The filters compress multiple stages of clarification and prefiltration into one efficient step.
While this kind of process compression
does result in reductions in time, resource
and cleaning requirements, the inherent issues of the stacked disc format are still present. If these issues could be solved, it would
bring better fluid handling capabilities and
additional operating efficiencies to the manufacturing process. Engineers at Millipore
Corporation believed that disposable technology could bring significant benefits in these
areas, but that a new approach to disposables was required. The result: the Pod platform, which uses a disposable filter format

The Millipore Pod system brings the advantages of disposable technology to the clarification and prefiltration steps. (2-rack processscale holder shown)

Flexible, modular Pods offer easy scalability from pilot to process

scale. (Pilot-scale holder shown)

designed to deliver security and flexibility in

clarification and prefiltration applications.

Summary
The ability to adopt disposable technologies
has been a challenge for clarification and prefiltration processes because of the large volumes at that stage of the process. While traditional lenticular disc technology has been
employed in these processes for decades, the
inherent limitations of the format do have an
effect on the process productivity.

Posted from Pharmaceutical Processing, April 2006. Copyright Reed Business Information, a division of Reed Elsevier, Inc. All rights reserved.
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