AUGUST 2007 ISSUE
Pall Fluorodyne® EX High-Flow Filters
Pall Fluorodyne EX hybrid filters combine high flow rates with high capacity.
Sterilizing grade filters are used throughout the drug processing cycle from initial
purification steps to final formulation and filling to remove bacteria and other
contaminants. Pall introduces the new Fluorodyne® EX hybrid sterilizing-grade filter
to address current production bottlenecks arising from advances in high-titer protein
manufacturing capabilities.
Pall Fluorodyne® EX filter cartridges are a high flow, high capacity sterilizing
grade filter that can be steamed under wet or dry conditions. The new Fluorodyne
EX filter is constructed with Pall’s proprietary Ultipleat® high-efficiency membrane
packing technology with a new small-core design enabling a 50% increase in filter
membrane area in the same size filter element. The filters have been optimized for
performance with a built-in proprietary polyether sulfone (PES) pre-filter over
a polyvinylidene fluoride (PVDF) membrane. This dual membrane combination also delivers
high dirt-holding capacities and high flow rates.
The Fluorodyne EX filter technology can be used to sterilize a wide range of fluids
including buffers, biological fluids, tissue culture media, and ophthalmic products.
The asymmetric built-in prefilter membrane layer enables the Fluorodyne EX filter
to process the heightened levels of contaminants often found in high protein biotech
solutions, with low protein and preservative binding, and low extractables.
Call 1.925.443.9800 for additional information or to schedule a visit with a local
RHFS Life Science representative. Please note that RHFS does not represent Pall
Corporation in all United States geographies.
Real-Time Measurement of Total Organic Carbon (TOC)
Accurate measurement of water quality is critical to the pharmaceutical production
process. Regulations mandate monitoring of Total Organic Carbon (TOC) levels for
Purified Water, Water for Injection (WFI) and Highly Purified Water. Testing requirements
are defined in the United States Pharmacopeia (USP) Chapter <643> and European Pharmacopeia
(EP) 2.2.44 guidelines.
TOC measurements respond to a broad range of organic compounds. Most TOC sensors
used in monitoring water quality oxidize organics to CO2 in order to detect them
by conductivity. The difference in conductivity before and after oxidation is used
to determine the TOC concentration. In a process environment, response time is critical.
Using Thornton’s 5000 TOC USP <643> compliant Sensor with continuous measurement
technology, organic compounds are measured in real-time, so that excursions in water
systems can be immediately evaluated.
Combine Thornton 5000 TOC Sensor(s) with a 770MAX Multi-parameter Instrument for
an ideal analytical package. The 770MAX accepts one or two sensors and provides
two additional smart channels for conductivity, pH, DO or Ozone measurement. Two
pulsed flow channels are also available.
Call 1.925.443.9800 for more information.
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RHFS is pleased to offer high quality Parker seals and o-rings for biopharmaceutical
applications.
Call 925.443.9800 for more information.
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