chemical equipment update
11
The company says these are the most advanced connectors; and Mobius mixing and storage systems.
chromatography sorbents for processing large amounts The Mobius FlexReady solutions hardware is
of protein during the capture and intermediate steps ergonomically designed to hold integrated disposable
of purification and contribute significantly to cost/time flowpaths for faster set-up, maximum adaptability to
savings for laboratory to production scale applications. changing process needs and reduced risk of operator
In order to further spread the message about error.
single-use systems, Pall has introduced a year-long Meanwhile, Colder is able to provide process
advertising and marketing campaign that explains the engineers seeking a secure and cost-effective aseptic
many benefits of single-use systems. disconnect from equipment with a reliable, easy-to-use
“Single-use disposable technology is a proven solution: HFC39 Series couplings. Extensively tested for
alternative solution. By reducing cross contamination, it biocompatibility and performance, the HFC39 Series
provides a greater assurance of sterility. It also reduces couplings are designed to prevent external organisms
capital investment costs for facilities and equipment, from entering through the connector and into the flow
lowers costs associated with cleaning and associated path during disconnection.
cleaning validation, and reduces lead times to help get When integrated into pre-sterilised single-use
products to market faster. In applications that process systems, the HFC39’s automatic shut-off valves allow
hazardous materials, such as cytotoxic drugs and potent an aseptic disconnection by closing off the flow path
biological materials, closed disposable systems isolate prior to fully disconnecting. For the first time operators
operators from dangers,” explained Zoch Zamaniyan, can complete an aseptic break between silicone tubing
vice president, biopharmaceuticals, Pall Life Sciences. assemblies. The valve design also eliminates the need
“The marketing and communications initiative will for pinch clamps or tubing welders.
convey how Pall Allegro single-use systems save money “Biopharmaceutical manufacturers have been using
and time, and how Pall’s expertise in filtration systems HFC39 connections for years, proving the product’s
provide support through the development, process reliability,” said John Boehm, business unit manager,
engineering and implementation stages, and help bring bioprocessing, Colder Products. “Now we have validated
new products to market,” he added. its aseptic disconnect capability, giving bioprocessors
Millipore was also busy at Interphex, with the the confidence to use the HFC39 in their most critical
launch of its Mobius FlexReady solutions which help applications.”
users to readily convert to single-use technologies. A slightly different approach has been taken by
“We have worked very closely with our customers Metrics, with its custom-engineered system of isolators
to develop these innovative, best in class single-use that eliminate the need for the use of powered air
manufacturing solutions,” said Jean-Paul Mangeolle, purifying respirators (PAPRs) in its new potent facility.
president of Millipore’s bioprocess division. “The Equipment and change parts are dedicated exclusively
biomanufacturing industry is changing rapidly and our to potent and cytotoxic use, and containment is
customers are asking for operational flexibility that will achieved at levels approximately 30 nanograms per
save them time and money while giving them the quality cubic metre of room air.
and peace of mind that Millipore has always provided.” Metrics’ new potent facility features two processing
With Mobius FlexReady solutions, users can rooms that come complete with independent entry
configure their hardware and Flexware assemblies double airlocks, independent decontamination showers
and validate their processes quickly and easily, which and exit airlocks, independent equipment airlocks, and
significantly shortens development and manufacturing access to a dedicated washroom. It is designed for one-
time. Mobius FlexReady solutions are designed way flow of material, personnel and equipment. Each
to accommodate clarification, media and buffer processing room contains a series of multi-use hard-
preparation, tangential flow filtration (TFF) and virus wall isolators that can accommodate up to three pieces
filtration unit operations. of equipment. Processing equipment may be installed at
“A significant amount of engineering and process any location through the rear wall of each isolator.
development expertise went into the Mobius FlexReady The installation of processing equipment through
solutions,” said Paul Chapman, Millipore’s vice the isolator is achieved by a novel docking system.
president of downstream processing. “The result is Several pieces of processing equipment have been
a whole new standard in operational flexibility and integrated through a standardised metal baffle. These
efficiency for our customers, while also using Millipore’s baffles form the rear wall of the isolator and separate
years of applications expertise and existing high the product contact surfaces of the equipment from the
performing products and technologies.” mechanical and control areas. This allows processing
The pre-assembled, pre-tested Mobius FlexReady under containment while mitigating contamination of
solutions features leading Millipore technologies, non-product contact surfaces. Once all the equipment
including: Millistak+ pod filters; Pellicon3 TFF is in place, the isolator is sealed and pressurised.
cassettes, Viresolve Pro Parvovirus removal filters, Negative pressure at 0.3 inches of water imparts
Millipore Express sterilising-grade filters; Lynx sterile additional protection. v
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