Disposable, closed sterility test system
The Sterisart NF system is a new alternative for batch release that prevents secondary contamination. The disposable and closed sterility test system is based on the membrane filtration method as recommended by the international pharmacopeias for sterility testing. A special clamping technique and low adsorptive membrane known as Sartochem, specifically designed for sterility testing, allow for the elimination of inhibitors that could impede culture growth and generate false negatives.
No. 849 is a 500°F, electrically-heated, Class 100 (ISO Class 5) cleanroom oven used for drying various glass and stainless-steel parts at a customer’s facility. Workspace dimensions measure 36 inches wide x 36 inches long x 39 inches high. 20KW installed in Incoloy-sheathed tubular heating elements provide the heat, while a 1000 CFM, 1.5-HP recirculating blower furnishes horizontal airflow across the workloads. This cleanroom oven features 4-inch insulated walls, a Type 304, 2B finish stainless-steel interior with continuously back-welded seams, stainless-steel exterior with #4 brushed finish and an 8-inch x 10-inch double-pane Pyrex window. Cleanroom safety and control equipment on No. 849 include a 30-inch x 24-inch x 6-inch thick stainless-steel, high-temperature HEPA air filter, minihelic pressure gauge and DOP validation port across the filter, digital indicating temperature controller, manual-reset excess-temperature controller with separate contactors, recirculating blower airflow safety switch and digital shut-down timer to sound an alarm.
The Grieve Corporation
Round Lake, Ill.
FlexiPrene pharmaceutical-grade TPE outperforms other elastomers and plastics. Its versatile material can be extruded as tubing or injection-molded for fitting-free assemblies and manifolds. FlexiPrene meets USP Class VI standards and may be validated as well as sterilized, heat-sealed or welded. Its resistance to chemicals and absorption gives it an advantage over other process and pump tubing. A portable heat sealer quickly and cleanly seals tubing for sampling and other purposes.
Countertops with antimicrobial protection
Silestone has built-in Microban antimicrobial product protection and natural quartz surfacing, which provides a proven deterrent to the growth of bacteria that can cause stains, odors and product deterioration. Under certain conditions, microbes on an untreated surface can double every twenty minutes. These countertops penetrate the cell wall of organisms and inhibit their growth and reproduction. Unlike surface-applied coatings, the Microban protection incorporated into the molecular structure of the Silestone product during the manufacturing process will not wash off or wear away. These countertops inhibit the growth of common bacteria, yeasts, molds and fungi. Providing continuous microbe protection, the countertops are easier to clean and stay cleaner between cleanings for the lifetime of the product. Microban protection is not designed to protect users against foodborne illness or to replace the need for normal cleaning.
The Pelestat line of products is proven to permanently decrease static build-up in molded plastics. Pelestat is a permanent antistatic additive suitable for use in a range of thermoplastic base resins. Current applications include packaging materials and consumer parts for a variety of industries. The Pelestat product line keeps dust and dirt from collecting and lodging on surfaces or in crevices, protects electric circuits, and prevents malfunctions and electrical shock. Unlike conventional, low-weight molecular additives, Pelestat antistatic properties are embedded in the surface layer of the base resin. The antistatic property is permanent and does not diminish with surface cleaning or passage of time. Pelestat is dry-blended with the host resin and elongates from load shear. The elongated Pelestat forms a conductive matrix increasing and assisting static discharge. In contrast to clumping typically seen in conventional additives, the Pelestat matrix is uniform throughout the base thermoplastic resin. Available in pellet form, Pelestat can be mixed and compounded in standard twin-screw and single-screw extrusion equipment.
Tomen America, Inc.
New York, N.Y.
Softwall, hardwall modular cleanrooms
The series 556 vertical flow modular cleanrooms are available in Class 100 or Class 10 (ISO Class 5 or Class 4) softwall or hardwall models. The modular design of the series 556 combines functionality with flexibility. These units offer high energy efficiency and facilitate easy maintenance and wipe-down cleaning. They are ideal for areas with restricted overall height and that need full HEPA filter coverage. The series 556 features all-metal construction and is manufactured from heavy-duty, 16-gauge, cold-rolled steel with a white baked-enamel finish. The unit includes full-ceiling HEPA filter plenum sections that provide filtered laminar airflow uniformly to clean areas, with filtered air going to 100 percent of the available surface area. Blowers and optional cooling coils are contained in the unit’s vertical stainless-steel support member.
Clean Air Products
Stainless-steel locking pliers
Available now in five new sizes, the new “critical clean” series of stainless-steel locking pliers from Steritool are designed specifically for sterile processing applications where measures must be taken to reduce the risk of airborne particulate. Because stainless steel is a homogeneous material, there is no plating to peel, chip or flake. The chromium contained within the stainless alloy oxidizes to form a thin, protective chromium-oxide layer on the surface. This invisible layer is nonreactive, and therefore noncorrosive. With smooth, rounded edges, recessed rivets and flat, easy-to-clean surfaces, the “critical clean” locking pliers are ideal for use with a gloved hand in cleanroom environments. The smooth gliding release bar on the handle is easily reached with a finger, enabling easy, one-handed opening and closing. With a matte finish, all components of the pliers are manufactured from stainless steel and can be autoclaved repeatedly over years of use. Sizes include a 5-inch and 7-inch curved jaw, a 7-inch straight jaw and 6-inch and 11-inch long-nose models.
Spec-Master FN series multicompartment sinks offer optimum sanitation and efficiency in industrial workplace or lab settings. Available in 1-, 2-, 3- and 4-compartment models, these sinks feature 14-gauge, type 304 stainless-steel bowls, drainboard and backsplash, providing durable, rust- and corrosion-free surfaces for years of use. Each coved-corner sink bowl features a full 5/8-inch radius construction that handles water levels up to 14 inches. The “swirl-away” drain design facilitates swift drainage, minimizing the incidence of bacteria build-up. Each sink features type 304 stainless-steel left-to-right and front-to-back crossbracing, as well as stainless-steel gussets and legs. Sink legs are welded to type 304 stainless-steel reinforcing corner plates under the sink bowls for maximum weight support and stability. Adjustable stainless-steel bullet feet make it easy to position sinks securely on uneven surfaces. A 9.5-inch sink backsplash includes a 1-inch upturn and tile edge for easy installation and feathering to any wall-splash surface. The sinks are available with a variety of faucet and lever drain options.
iReticles 3.0, the latest version of the company’s system for managing the large number of reticles that exist in a typical semiconductor fab, gives semiconductor manufacturers real-time insight into the status of reticles across a single fab or across the enterprise and the supply chain, enabling better scheduling and use to improve manufacturing efficiency and productivity. The new version offers two options for reticle management: iRFab for managing reticles within a single fab and iREnterprise for reticle management across multiple fabs and the supply chain. The iREnterprise module offers waiver management for quick resolution of supply-chain issues and allows the electronic transfer of certificates of compliance between the supply chain and fab. iREnterprise also provides the security necessary for real-time supply-chain execution by offering a portal with XML certification and user authentication to ensure secure communication and transactions.
These sterile goggles have been sterilized via a validated irradiation process. The goggles ensure that every operator will comply with the most recent industry guidelines for proper operation of an aseptic cleanroom. The company’s gamma irradiated goggles are tested to ensure that their composition and properties remain intact after repeated sterilization. The company’s Validated Sterile Goggle Program delivers sterile goggles in accordance with industry cGMP guidelines.
Prudential Cleanroom Services
The Chemineer Clean Sweep mixer provides a hermetically sealed environment without a rotating shaft seal (mechanical seal). The mixer features an FDA/USP Class VI elastomeric seal. The mixer is ideal for low-shear, high-purity mixing applications and easily accommodates mixing at low-liquid levels. This mixer has a new impeller with specially shaped blades optimized to provide global mixing throughout the vessel, easily reaching the bottom of the tank. The impeller’s flow pattern was modeled using a commercial 3-D computational fluid dynamic code. The mixer eliminates particle shedding and product contamination, requires no baffles and has fewer cleanability issues.
The MicroPleat EC is a programmable fan/filter with an electronically commutated DC motor that runs on AC. MicroPleat EC units allow substantial energy savings due to the electronics package that consumes just 110 W of power at 90 fmp airflow. Standard AC-powered units consume up to 400 W at the same flow rate. The fan/filter features low energy use, low noise and low heat generation. The installation can be monitored and controlled from a central station; computerized controls allow the speed of units to be controlled individually, in groups, or simultaneously. Units can also be turned on or off individually or in groups. The system is provided with all components required for installation, including the computer, computer interface, repeater boxes, AC/DC power adaptor and wiring. Software to monitor and control the units is preloaded and verified as operational before it is shipped to the job site.
Ion exchange membrane
The new Mustang XT5000 capsule provides greater throughput, superior binding capacity and fast processing in a capsule format for use in a wider range of process chromatography applications. The next-generation ion exchange membrane capsule extends Mustang’s chromatography uses beyond removal of contaminants such as DNA, viruses, endotoxins and host cell proteins. It enables super-efficient capture of large molecules, especially important for the development of new drugs and therapies that use recombinant proteins, plasmids and other viral vectors and blood plasma fractions. With the ability to process large fluid volumes 30 times faster than traditional chromatography resins during capture and polishing steps, the new capsule brings the benefits of Mustang technology to both ends of the process chromatography spectrum. The 5-liter Mustang XT5000 offers time and cost savings as a function of its single-use format, high volumetric throughput and the ability to efficiently process large molecules. As a single-use capsule, the Mustang XT5000 does not require media packing, cleaning or cleaning validation and precludes the need for cleaning buffers and costly resin. It also prevents cross-contamination risks. The capsule uses the company’s ion exchange membrane technology to offer exceptional flow rates and high dynamic binding capacity.
East Hills, N.Y.
The Pod platform, an innovative filter system for normal flow clarification and prefiltration applications, is designed for greater process flexibility and productivity. The patent-pending disposable technology improves process speed, safety and economics in the manufacturing of biopharmaceuticals. The platform consists of an expandable holder and modular filters that overcome many operational limitations of traditional stainless-steel housings. Developed as a self-contained device, each Pod is a single-use filter that reduces the need for clean-in-place procedures. This minimizes costs associated with water usage, cleaning and validation. The design not only protects operators from exposure to process fluids, but also allows the units to be drained before change-out for lighter devices that are easier to move. In addition, the design and construction of the Pods can reduce hold-up volume from 40 percent to 73 percent over typical configurations of lenticular discs, providing an increase in product yield. The modular Pod platform delivers process scalability and flexibility. Without changing hardware, customers can run their system in serial or parallel configurations to meet specific process and batch size requirements of 20 to 12,000 liters. The small footprint saves valuable floor space and the lightweight design eliminates the need for hoists or high ceiling heights. In addition, the holder is on casters for easy assembly and movement.
Particle counter software
PortAll Version 2 software expands the capabilities of handheld and portable particle counters to simply and easily organize, archive and retrieve particle count data. The enhanced features in this release make PortAll an effective tool for pharmaceutical, aerospace, indoor air quality and electronics industries with critical areas requiring particle monitoring. Operators use PortAll to track particle count data, identify trends and eliminate particle contamination sources. Identifying trends before exceeding a limit potentially prevents crises, saving a bad process batch or preventing wasted production. PortAll saves time and simplifies a number of particle counting and data management processes. A scheduler feature permits PortAll’s automated collection of particle-counts data. Operators can reduce the frequency of gowning up by getting counts from outside the cleanroom. PortAll’s Windows-based software interface, including a report wizard, enables easy calculation and presentation. PortAll simplifies validation by verifying adherence to standards and regulations, including ISO 14644-1, FS209E and BS 5295, and 21CFR Part 11. The software also conducts rapid pass/fail reporting.
Hach Ultra Analytics
Grants Pass, Oreg.
Bank sorbent panel
The Camsorb CF4A built-up bank sorbent panel assemblies provide high-capacity control of odors, gases and particulate contaminants. Applications include commercial and industrial properties, medical facilities and other buildings where the control of gaseous contaminants or odors may be a concern. The modular assemblies may also be used to reduce outside air requirements by increasing recirculated air. Each CF4A adsorber module assembles into a built-up bank of gaseous and particulate filtration with 85 pounds of adsorbent per 2000 cfm, a prefilter of any depth and a final filter of any depth. Adsorber sections feature corrosion-resistant, 16-gauge galvanized steel with integral tracks and an easy-to-access design that facilitates installation and servicing of adsorber panels. Each full-size unit uses twelve Camsorb CF one-inch panels, which come filled with loose-fill sorbent media or a choice of application-specific sorbents. The sorbent section is sandwiched between two particulate filter holding frames that allow installation of various combinations of prefilters and ASHRAE-grade final filters. The assemblies may be stacked up to six units high without modifications. Resistance to airflow is also minimal at 0.35 inch w.g. at 500 fpm (2000 cfm per full-size module) for energy-efficient performance.
TFF system software
Chromatography and tangential flow filtration (TFF) are critical purification steps widely used to process biotech drugs, including monoclonal antibody-based therapeutics. The latest version of the company’s operating software package simplifies operation of these complex systems. By allowing engineers to make process changes to TFF systems themselves, this software package helps engineers avoid time-consuming and costly steps associated with reprogramming and revalidation. Its modular design, user-friendly touch screen and pull-down menu further simplify control of critical biopharmaceutical processes. The software simplifies scale-up of process control by providing a standard platform for chromatography and TFF applications from pilot to full-scale production. The software’s ability to operate on multiple control platforms also enables process systems to be even more tailored to specific customer needs. An intuitive interface and modular design enables process interaction and optimization in simplified steps, thereby reducing training and labor. As a 21CFR Part 11-enabling solution, the new process control software ensures the authenticity and integrity of electronic records and associated electronic signatures. It is designed and developed following ISPE GAMP 4 guidelines to provide high quality and well-documented information, simplifying end-user validation.
East Hills, N.Y.
Barrier laminate locks
CorrLam LD keeps corrosion out and provides continuous protection around parts. Designed to meet the toughest industrial conditions, CorrLam LD provides a barrier to water vapor, corrosive gases and ultraviolet light. With flexible material properties, it allows easy heat sealing and vacuum sealing to provide protective packaging for large format equipment as well as small parts. CorrLam LD is a useful product for extreme long-term storage applications, in some cases up to twenty years. The product’s multilayer construction provides exceptional protection for moisture-sensitive and oxygen-sensitive products. The unique multilayer construction consists of an outer layer of high-strength, cross-laminated PET film and a middle layer of foil, which are both laminated to Cortec VpCI 126 polyethylene film. This special construction sets up a high barrier block with a very low water vapor and oxygen transmission rate of less than 0.003 g/100 in2 (0.003 g/6.45 m2) per day. The patented VpCI technology provides continuous corrosion protection for both ferrous and nonferrous metals. Its vapor action reaches all areas of exposed metal including recesses, voids and cavities. Because of its barrier capabilities, CorrLam LD can be fitted with a one-way vacuum valve to remove moisture vapor and other gases from the interior of the package for difficult-to-protect products.
White Bear Lake, Minn.
Helium leak detector
The SmartTest helium leak detector is setting new standards in vacuum leak detection. Because of the one-button operation of this product, there is now a simple and secure way to look for leaks. The SmartTest is a powerful, rugged tool for leak detection, characterized by: fast, reliable results at a maximum inlet pressure of 25 mbar; lowest detectable leak rates of 5 x 10-12 mbar l/s; and a short recovery time. A broad selection of interfaces affords simple integration. The modular concept of the SmartTest enables it to be combined with a wide variety of backing pumps. These different configurations enable it to be optimally adapted to every application. The SmartTest features an award-winning modern design, having won the 2005 “Reddot Design Award” in the product design category.