NEW PRODUCTS
06/01/2005
Adjustable armrests
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Adjustable armrests and additional controls for seat and/or backrest adjustment are now available as options on BioFit Class 10 (ISO Class 4) cleanroom chairs. The selection increases opportunities for customizing basic Class 10 (ISO Class 4) models to meet the exact requirements of individual users and specific high-tech applications. The armrests are both height and width adjustable and have either upholstered or self-skinned urethane pads. Adjustability increases the armrests’ capability to provide proper arm support that can greatly reduce shoulder, back and neck strain from prolonged seated work. The adjustability also adds to a chair’s flexibility in providing comfort and support for multiple users. Depending on the chair model and control selected, a seated individual can adjust seat and backrest height and tilt as needed to support posture changes and work comfortably at desk, bench or high-bench work levels. Seat and backrest can be locked into place as required for the stability needed for close work.
BioFit Engineered Products
Bowling Green, Ohio
www.biofit.com
Hose identification
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These seven solutions for hose identification nearly double the number previously available. Imprinted, laser-etched, electronically tagged and color-coded products create traceability, allow for instant recognition, identify capabilities or limitations, improve safety and help achieve regulatory compliance. The hose identification methods are designed for tubing and hose manufactured of silicone and for rubber-covered or overbraided hoses of various materials. The solutions may be used separately or in combination with each other when complex applications call for multilevel identification. The selection of hose identification solutions already available includes AdvantaLabel, Color-Striped Silicone Tubing, Laser-Etched Hose Collars and Hose Track. The expanded options consist of Color Tracer Braid, Color Silicone Tubing and Laser-Etched Tags.
AdvantaPure
Southampton, Pa.
www.advantapure.com
Purification kit
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The Vivapure 8- to 96-well cobalt-chelate kit, a complete system for simultaneous purification of multiple His-tagged proteins, includes ready-to-use, membrane-based hardware for all steps of the purification process: lysate filtration, protein purification, eluate collection and storage. All kit components are compatible with multichannel devices and automated workstations, making the system suitable for high-throughput applications. The kit offers a unique modular format. Depending on the sample number, up to twelve individual 8-strips are inserted into frames with the footprint of standard 96-well plates. This feature results in proportionate savings when less than 96 samples are simultaneously processed.
Vivascience AG
Hannover, Germany
www.vivascience.com
Run-to-run application
The Run-to-Run (R2R) plug-in application for the Brooks Software’s Advanced Process Control (APC) platform provides a development environment that lowers the cost of ownership by reducing model management activities through a unified modeling structure and advanced technology particularly suited for high mix product environments. The R2R module includes a graphical development environment, enabling process engineers to quickly develop their own process controls without complex software code. Furthermore, users can deploy preconfigured controllers for common process areas such as lithography, etch, CMP and diffusion. The module provides a high level of interoperability to ensure that manufacturers can deploy the company’s best-of-breed application modules, as well as third-party control applications, or customer-developed proprietary applications. The platform provides a user interface and execution engine that allows users to configure APC strategies graphically without relying on costly software code or scripts.
Brooks Software
Chelmsford, Mass.
www.brooks.com
Thermal flow sensor
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The SS 20.60 FB enhanced air and gas flow sensors with integrated field bus interface deliver ready-prepared measuring values like Kg/hr or m3/min. The user has access to the sensor’s status information and is informed by the PLC of any defects. This compact sensor has several applications including combustion air control in gas, coal or oil burners as well as in fuel cells, volume flow measurements in nitrogen or other passivation gases, compressed-air consumption measurements and volume flow measurements in biological wastewater treatment.
SCHMIDT Technology GmbH
St. Georgen, Germany
www.schmidttechnology.de
POC analyzer
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This analyzer effectively and continuously monitors photochemical organic contamination (POC), such as nonmethane hydrocarbons and siloxanes, and provides real-time contamination results. POCs have the potential of absorbing laser throughput, forming contamination layers on optical surfaces or permanently degrading the optical system. With detection limits in the low ppb range and providing high accuracy, the POC analyzer can detect contamination before it causes irreversible damage. The POC analyzer can be combined with molecular contamination analyzers to monitor other compounds such as ammonia, total amines, total acids, or sulfur dioxide. Because of the monitor’s high stability, maintenance is infrequent and inexpensive.
Particle Measuring Systems
Boulder, Colo.
www.pmeasuring.com
Spill sensor
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The new OS 250 detects spills and leaks before they cause a problem. As little as three drops of liquid will cause the OS 250 to react. The system consists of a moisture-sensing mat made of a material specially developed for detecting liquid spills. A simple connection between the mat and the OS 250 controller will sound an audible alarm, flash an LED and will turn off the power of any device plugged into the single-outlet, solid-state power controller. The switched power outlet can control up to 8 amps. The spill sensor is supplied with the controller and four reusable 30 cm x 30 cm mats that can be cut to any size with a knife or sharp scissors. It also includes the connector cable between the mat and the controller. The overall dimensions of the controller are 4.6 cm x 8.2 cm x 18 cm. Applications for the OS 250 include pharmaceutical, chemical, petrochemical, biotechnology, semiconductor, plastics, industrial, government and scientific research and development markets.
KD Scientific Inc.
Holliston, Mass.
www.kdscientific.com
Handheld airborne particle counters
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The APC and APC Plus stainless-steel handheld airborne particle counters are easier to decontaminate for entry into your critical environments and can simultaneously measure up to four particle size ranges. Additional features include a user-friendly control panel, programmable count and hold times and two concentration modes. The particle counters are a part of the company’s HYCON system, which is a complete line of products used for environmental monitoring. This system includes the RCS microbial air samplers and contact slides for surface sampling. All HYCON products are designed to be used in a wide range of contamination-control applications.
Biotest Diagnostics Corporation, USA
Denville, N.J.
www.BiotestUSA.com
Dust collector cartridge filters
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A new HemiPleat filter offers greatly extended service life and lower pressure drop compared to standard dust collector cartridge filters. The HemiPleat line includes filter elements to fit virtually all types of new and existing cartridge dust collectors, providing high-efficiency capture of dry dusts in a full range of applications. The key to the filter’s performance is a patent-pending pleating technology that has never before been used in the manufacture of a cylindrical dust collection filter. A media pack design holds the pleats of the cartridge open, making virtually all the media surface available for filtration. The wide, uniform spacing results in lower pressure drop for more efficient performance. This design also causes dust to release more readily from the cartridge during pulse cleaning and uses less compressed air for many applications. Extensive testing shows that the HemiPleat cartridge also holds more dust than conventional filters, allowing a longer time period between cleaning cycles.
Farr Air Pollution Control
Jonesboro, Ark.
www.farrapc.com
Microbial identification system
The MicroSeq microbial identification system supports customers in meeting U.S. FDA requirements for aseptic processing for the manufacture of sterile drug and biological products under current Good Manufacturing Practice (cGMP) regulations (21 CFR Parts 210 and 211). The MicroSeq system is the first DNA sequence-based system to provide advanced identification of sterility isolates to the species level. The MicroSeq system can help manufacturers positively identify and classify even new and previously uncharacterized bacteria and fungi because the system uses PCR-based sequencing methods to amplify and rapidly identify organisms. The sequences are compared to a validated library for positive identification and taxonomic classifications. The MicroSeq system provides microbial identification capacities for quality control to some of the world’s largest clinical laboratories, environmental monitoring agencies and pharmaceutical and vaccine manufacturers. The system allows users to develop properly documented manufacturing quality controls that can help them rapidly identify and solve sterility failures.
Applied Biosystems
Foster City, Calif.
www.microseq.com
Reverse osmosis
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The Osmotron Inject is a plant for the production of highly purified water (HPW) by means of two reverse osmosis stages and electrodeionization. The compact unit is entirely hot water-sanitizable and constitutes a safe, closed system. In the first process step, after having passed the security filter, softened water reaches the reverse osmosis at a high pressure. The water passes through the membrane with a residual salt content of approximately two percent, leaving most of the dissolved and any suspended matter behind. In the next step, the permeate passes to the patented, temperature-stable electrodeionization module Septrosan, where it is fully demineralized. This treatment also reduces pyrogens and microbial contamination to a great extent due to the very high pH gradients (pH 2 to pH 12). The last process step is reverse osmosis or, when an integrity test is required, ultrafiltration (UF). The hollow-fiber UF module is also sanitizable and can be completely drained. The Osmotron Inject produces a water quality considerably better than the limit values of USP 27 and EP 5, with conductivity reaching a value of approximately 0.1 μS/cm and the TOC value is typically less than 20 ppb. The relevant microbial values are typically less than 5 CFU/100 ml and endotoxin levels are less than 0.06 EU/ml. The standard product range provides 500 to 10,000 liters per hour and customized configurations are available for higher flow rates. The Osmotron Inject is manufactured using 316 L, orbitally welded sanitary pipework with a surface roughness Ra of less than 0.8 μm.
Christ Water Technology Group
Aesch, Switzerland
www.christwater.com
Stainless-steel cable containment system
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HYCON is a modular, hygienic stainless-steel cable containment system. It is fully sealed and waterproof to European standard IP66 (power hose-proof). HYCON, constructed of 316 grade steel, uses new and patented technology. It is suitable for full-wash, is neutral to contamination, and has hygienic installation qualities. It is useful in pharmaceutical plants, cleanroom environments, chemical plants and food-processing plants. The company also offers a semisealed variant, HYCON-S.
Dunreidy Engineering Ltd.
Kilkenny, Ireland
www.hycon-irl.com
Leak detection instrument
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Sensistor Technologies has introduced the H2000TM, which uses a safe, nonhazardous mixture of 5 percent hydrogen in 95 percent nitrogen to detect leaks. This method allows for nondestructive testing with short cycle times and reliable results, regardless of temperature variations or the test object’s shape. This leak-detection solution is suitable for a variety of medical applications including medical implants, medical consumables, medical instrumentation and medical packaging-including the ability to locate leaks in collection bags, blood bags, IV bags, and nourishment bags. It is a compact and robust system that is extremely sensitive to hydrogen gas and can be used to detect leaks that are smaller than a bacterium. This product is easily transportable, making it easy to move around when searching for leaks on a large objects. It is entirely electronic, requiring no pumps, valves, or vacuums and, thus, needs minimal maintenance. The instrument features a standard probe with no sample suction, so dust contamination is prevented. The probe can also be equipped with a protective cover that allows leak detection on wet objects, and is easy to replace if damaged. The H2000’s user-friendly display makes changing menu settings fast and easy.
Sensistor Technologies, Inc.
Boston, Mass.
www.sensistor.com
Clean bench
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The Series 204 horizontal laminar flow clean benches include an internal motorized filter unit for full filter coverage and three-side access for easy cleaning. They come in several sizes ranging from 2 x 2 feet to 2 x 6 feet. They are designed for installation on top of an existing tabletop, with the filter in the rear of the unit and the hood on the front of the unit. The prefilter may be serviced from behind the unit. This product also features a decorative, white-painted steel housing. Options include a stainless-steel housing, stainless-steel hood and integrated light.
Clean Air Products
Minneapolis, Minn.
www.cleanairproducts.com
Aerosol monitor
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The AES-1000 aerosol monitor has an easy-to-read LED display that indicates the current air cleanliness level (equivalent to Class 100-Class 100,000/ISO Class 5-Class 8) by using a scale of one to ten. The monitor is extremely portable and can be set up almost anywhere particulate levels (0.3 μm and larger) must be monitored. The AES-1000 can be linked to an Ethernet system or connected to an existing LAN cable.
Shinyei Corporation of America
San Diego, Calif.
www.shinyei.com
Dispensing system
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The Acerta DS1 dispensing system is a single-head liquid-filling unit that uses a pre-assembled, sterile, disposable filling module. The system is designed for final sterile injectables and diagnostics in biotechnology and classical pharmaceutical manufacturing across a range of fill weights and applications. This includes process development, new drug development testing, clinical trial filling and small scale production. To provide complete product containment for enhanced sterility assurance and operator safety, all contact parts in the filling assembly are pre-assembled and disposable. This makes the Acerta DS1 system useful for cytotoxic and gene therapy products. In addition, the single-use module eliminates autoclaving, steam-in-place and clean-in-place procedures, and reduces validation efforts. The equipment can easily be configured for manual filling, as well as integrated into existing or new filling lines. The system can perform up to 40 fills per minute, and dispenses from 0.2 to 10 mL consistently within +/- 0.5 percent, even at small volumes. Easy to set up and use, the system improves flexibility and productivity for filling operations.
Millipore Corporation
Billerica, Mass.
www.millipore.com
Oxygen analyzers
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The Rapidox 2100 and 3100 oxygen analyzers allow for fast and accurate analysis of oxygen gas from under 1 ppm all the way up to 100 percent volume. These units were designed for a variety of applications from gas purity to vacuum leak detection. Each unit comes complete with software for data logging and offers comprehensive facilities normally found on much more expensive models. The units are easy to use and simple to calibrate using any two oxygen concentrations in the range of the analyzer. The display and outputs are all user programmable. The Rapidox 2100 is a transportable version with remote sensor head. The sensor head is a zirconia ceramic tube heated to 650°C. The analyzer supplies this through the provided two-meter cable. An optional air pump can be used to provide a smooth flow of gas drawn from flexible tubing. The Rapidox 3100 is a fixed version with built-in air pump and internal sensor. This unit is available bench-mounted or panel-mounted.
CEA Instruments, Inc.
Emerson, N.J.
www.ceainstr.com
Mass spectrometers
These two new mass spectrometers, the 3200 Q TRAP and the API 3200 LC/MS/MS systems with Turbo V source for added sensitivity, throughput, and cost-effectiveness in mass spectrometry-based workflows, are designed for food and beverage, environmental, forensic, clinical research and pharmaceutical analysis markets. By incorporating the Applied Biosystems/MDS SCIEX proven Turbo V source and API 4000 LC/MS/MS system series interface and ionization sources into a smaller platform, these new systems provide increased sensitivity, greater flexibility, and improved ease-of-use when compared to similarly priced instruments. The ceramic interface of these two systems reduces chemical background and improves sensitivity under LC conditions, yielding better efficiency relative to older source technologies, especially at higher flow rates. The API 3200 LC/MS/MS system with Turbo V source provides improved performance, especially at high flow rates, allowing for easy method transfer from LC/UV to LC/MS/MS workflows, which offers the advantages of improved sensitivity, speed and simplified sample preparation in the pharmaceutical analysis, environmental and forensic markets. Additionally, because the Turbo V source family is now compatible with five Applied Biosystems/MDS SCIEX LC/MS/MS systems, method development can be carried out on these new instruments with simple transfer to the higher sensitivity systems.
Applied Biosystems Group
Foster City, Calif.
www.appliedbiosystems.com
Absolute humidity transmitter
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A new transmitter design, Model AHT-200, uses thermal conductivity sensors to measure moisture content at elevated temperatures up to +200°C. The unit outperforms conventional capacitive
esistance humidity sensors in harsh environments and it recovers from deposits and condensation. Washable and easy to clean, it is useable with most gases. The range is 0 to 130 grams/m3; accuracy is ±3 grams/m3 (±2.3 percent RH at 35 grams/m3) at 60°C; output is 0-5V, 0-10V, or 4-20mA.
OHMIC Instruments
Easton, Md.
www.ohmicinstruments.com
Validation report
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The Steam-Thru Connection (STC) validation report includes independent testing from NAMSA, Northview Laboratories and the University of Minnesota’s Biotechnology Resource Center. The STC can be used in a range of applications, including media manufacturing, cell harvesting, bioreactor feedings and pharmaceutical production. By creating a one-step, steam-in-place process, the STC speeds the connection process and reduces the contamination risks associated with reusable steam-in-place components. The disposable STC also reduces the need for time-consuming cleaning and cleaning validation steps. The Bacterial challenge verified that a 30-minute steam-in-place process killed bacterial contaminants introduced into the STC. The Microbial Ingress test verified the seal integrity of the STC in steam and flow positions after gamma irradiation at doses to 50 kilograys. The seal integrity of the STC in steam and flow positions was also tested by Northview Laboratories after two cycles of autoclave sterilization at 128°C (265°F). In Class VI tests, conducted by NAMSA, polysulfone and silicone materials found in the STC were tested to meet the requirements of USP Class VI, MEM elusion, hemolysis in vitro, and physicochemical tests. The STC works with existing systems without retrofit, enabling a seamless transition to this steam-in-place process. The device features industry-standard terminations of 3/4” Mini and 1.5” Tri-clamp, and its 3/8” and 1/2” hose barbs connect to popular tubing sizes. The report is available for download on the company’s Web site.
Colder Products Company
St. Paul, Minn.
www.colder.com
Flange-mounted impellers
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New ECOFIT®-brand flange-mounted backward curved impellers provide optimal airflow and substantially lower installed cost for OEM customers. These new impellers are ideal for cleanrooms (fan filter units), fume hoods for factories, ventilation hoods for commercial kitchens and in HVAC systems. The impellers are attached to a unique flange with a built-in air inlet. The flange allows the fan to be installed quickly and securely with just four screws, cutting installation time from minutes to seconds and eliminating unnecessary parts and materials. The built-in inlet is perfectly sized to the impeller and factory-installed to prevent airflow loss, ensuring the best possible airflow in any application. At 60 Hz, airflows range from 255 up to 942 CFM and the maximum static pressures from 1.20” up to 3.2” of water, in temperatures ranging from -4 to +158 °F. Available in nine UL-listed models, standard features include IP44 protection, UL94 V-O polyamide or galvanized steel impellers, G2.5 balancing, Class F winding and thermal protection. Finger-guards are built in as an option.
Rosenberg
Charlotte, N.C.
www.rosenbergusa.com
Particle size analyzer
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Malvern Instruments has introduced the Insitec Voyager, a mobile, on-line particle size analyzer that can be attached to fixed sampling ports at a variety of points in a production line. It can also be used to sample from different production lines within the same manufacturing plant. Insitec Voyager for the pharmaceutical industry is based on the standard Insitec Voyager platform, but will offer a fully validatable, pharmaceutical industry compliant package. Mobile, modular and cleanable, the Insitec Pharma Voyager features a touchscreen monitor for clean and easy operation. It meets current GAMP requirements, with a simple-to-clean cell and flowpath, and the system features triclamping and 316 stainless-steel parts for easy cleaning. Its software enables full compliance with the FDA’s 21 CFR Part 11 requirements. The Insitec Voyager is the first standard mobile unit for real-time on-line particle sizing. It can be used on-line and at-line. The system is ideal for pharmaceutical sites where there are many manufacturing lines requiring optimization, or for first-time buyers who would like to evaluate the use of on-line particle sizing for their application. The Voyager unit houses all the instrumentation and software needed for on-line particle size analysis and can be moved easily around a plant. Voyager is suitable for use even in highly regulated environments.
Malvern Instruments
Southborough, Mass.
www.malps.com
Disposable filter assembly
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Meissner Filtration Products, Inc. announces the addition of an inline UltraCap® filter assembly to its existing line of T-style assemblies for disposable filtration in biomanufacturing. The UltraCap assembly is an integrally sealed filter and housing system. This completely disposable system saves cleaning and cleaning validation costs and provides faster, more convenient filter change-outs than traditional cartridge and filter housing systems. The UltraCap disposable filter assembly is available with absolute removal ratings from 0.04 μm 70 μm to meet a range of filtration applications, including sterile filtration of serum, tissue culture media, microbiological growth media, and other viscous biological liquids; sterile tank venting, and filling line applications with disposable plastic biocontainers. For critical applications, the UltraCap is available with membrane filters in PVDF (SteriLUX®), polyethersulfone (STyLUX®), polypropylene (Chemdyne ®), and PTFE (Ultradyne®). Meissner also offers the UltraCap with pleated microfiber filters in polypropylene (ALpHA ®) and borosilicate glass (ProtecTM), and polypropylene depth filters (DeltaMaxTM). A gamma-irradiated version is also available for aseptic applications. Product scale-up is simplified with the new UltraCap. The sanitary, T-style connections or inline versions are available in 10”, 20”, and 30” lengths.
Meissner Filtration Products, Inc.
Camarillo, Calif.
www.meissner.com