Single-use/disposable process systems are becoming ever more popular in the face of industry demands for improved productivity and reduced costs associated with laboratory, pilot and process activities. Sean Ottewell reports.
Demands for quick batch changes, easier maintenance and reduced costs continue to drive interest in single use process systems. The latest advances were on show at the Interphex 2009 exhibition in March in New York.
One leading supplier, Pall Life Sciences, added to its growing single-use portfolio with the launch of a flexible depth filter capsule system for demanding pre-filtration and clarification processes.
The company's new Pall Stax single-use depth filter platform helps reduce costly labour time and eliminates equipment cleaning expenses and cleaning validation requirements incurred by manufacturers with traditional plate and frame depth filtration systems (Fig.1). The platform can be anchored to the floor or placed on casters for easy mobility. Its compact vertical design - up to two metres high - reduces floor space requirements.
The Stax system is comprised of interchangeable single-use depth filter capsules housed in a stainless steel chassis that can be managed easily by a single operator. Scalable in size and for performance to meet lab, pilot and process requirements, the capsule sizes (small-medium-large) permit mix-and-match incremental increases in filter area (0.25m2 to 2.0m2 effective filtration area) throughout the modular design. The system offers two manifold configurations - bottom in/top out and bottom in/bottom out.
With three chassis sizes and a wide selection of depth filter media, the platform offers flexibility to operate the capsule stack in a serial flow mode. Two grades of filter media capsules can operate in series within one chassis. Multiple chassis can operate in a parallel configuration.
The new platform uses Pall's cellulose-based Seitz high performance depth filter media and its second generation Supradisc II dual drainage plate modular design to encapsulate the media, assuring high performance filtration and overall process stability.
The novel cage-like structures of SupradiscII modules are fitted within the Stax capsules. Interlocking inside and outside separators support the depth filter media and eliminate the possibility of media ruptures from pressurisation. These same separators serve as drainage plates that enable full access of feed solutions to the available filter area, and they also account for accurate and reliable utilisation of the entire filter capacity.
Pall also used Interphex as a vehicle to launch its Pall Q and S HyperCel ion exchange sorbents. The company says these are the most advanced chromatography sorbents for processing large amounts of protein during the capture and intermediate steps of purification and contribute significantly to cost/time savings for laboratory to production scale applications.
In order to further spread the message about single-use systems, Pall has introduced a year-long advertising and marketing campaign that explains the many benefits of single-use systems.
"Single-use disposable technology is a proven alternative solution. By reducing cross contamination, it provides a greater assurance of sterility. It also reduces capital investment costs for facilities and equipment, lowers costs associated with cleaning and associated cleaning validation, and reduces lead times to help get products to market faster. In applications that process hazardous materials, such as cytotoxic drugs and potent biological materials, closed disposable systems isolate operators from dangers," explained Zoch Zamaniyan, vice president, biopharmaceuticals, Pall Life Sciences. "The marketing and communications initiative will convey how Pall Allegro single-use systems save money and time, and how Pall's expertise in filtration systems provide support through the development, process engineering and implementation stages, and help bring new products to market," he added.
Millipore was also busy at Interphex, with the launch of its Mobius FlexReady solutions which help users to readily convert to single-use technologies.
"We have worked very closely with our customers to develop these innovative, best in class single-use manufacturing solutions," said Jean-Paul Mangeolle, president of Millipore's bioprocess division. "The biomanufacturing industry is changing rapidly and our customers are asking for operational flexibility that will save them time and money while giving them the quality and peace of mind that Millipore has always provided."
With Mobius FlexReady solutions, users can configure their hardware and Flexware assemblies and validate their processes quickly and easily, which significantly shortens development and manufacturing time. Mobius FlexReady solutions are designed to accommodate clarification, media and buffer preparation, tangential flow filtration (TFF) and virus filtration unit operations.
"A significant amount of engineering and process development expertise went into the Mobius FlexReady solutions," said Paul Chapman, Millipore's vice president of downstream processing. "The result is a whole new standard in operational flexibility and efficiency for our customers, while also using Millipore's years of applications expertise and existing high performing products and technologies."
The pre-assembled, pre-tested Mobius FlexReady solutions features leading Millipore technologies, including: Millistak+ pod filters; Pellicon3 TFF cassettes, Viresolve Pro Parvovirus removal filters, Millipore Express sterilising-grade filters; Lynx sterile connectors; and Mobius mixing and storage systems.
The Mobius FlexReady solutions hardware is ergonomically designed to hold integrated disposable flowpaths for faster set-up, maximum adaptability to changing process needs and reduced risk of operator error.
Meanwhile, Colder is able to provide process engineers seeking a secure and cost-effective aseptic disconnect from equipment with a reliable, easy-to-use solution: HFC39 Series couplings. Extensively tested for biocompatibility and performance, the HFC39 Series couplings are designed to prevent external organisms from entering through the connector and into the flow path during disconnection.
When integrated into pre-sterilised single-use systems, the HFC39's automatic shut-off valves allow an aseptic disconnection by closing off the flow path prior to fully disconnecting. For the first time operators can complete an aseptic break between silicone tubing assemblies. The valve design also eliminates the need for pinch clamps or tubing welders.
"Biopharmaceutical manufacturers have been using HFC39 connections for years, proving the product's reliability," said John Boehm, business unit manager, bioprocessing, Colder Products. "Now we have validated its aseptic disconnect capability, giving bioprocessors the confidence to use the HFC39 in their most critical applications."
A slightly different approach has been taken by Metrics, with its custom-engineered system of isolators that eliminate the need for the use of powered air purifying respirators (PAPRs) in its new potent facility. Equipment and change parts are dedicated exclusively to potent and cytotoxic use, and containment is achieved at levels approximately 30nanograms per cubic metre of room air.
Metrics' new potent facility features two processing rooms that come complete with independent entry double airlocks, independent decontamination showers and exit airlocks, independent equipment airlocks, and access to a dedicated washroom. It is designed for one-way flow of material, personnel and equipment. Each processing room contains a series of multi-use hard-wall isolators that can accommodate up to three pieces of equipment. Processing equipment may be installed at any location through the rear wall of each isolator.
The installation of processing equipment through the isolator is achieved by a novel docking system. Several pieces of processing equipment have been integrated through a standardised metal baffle. These baffles form the rear wall of the isolator and separate the product contact surfaces of the equipment from the mechanical and control areas. This allows processing under containment while mitigating contamination of non-product contact surfaces. Once all the equipment is in place, the isolator is sealed and pressurised. Negative pressure at 0.3inches of water imparts additional protection.