AccuRate, a unit of SCHENCK AccuRate

Achieve Precision Size Reduction with these Feeders
These volumetric and gravimetric feeders routinely meter dry pharmaceutical powders into jet mills used to do fine grinding. By accurately and consistently charging the jet mill, the milling process, and particle size uniformity are optimized. Feed rates for the various models range from 5 g/min up to 1,137 ft3/h. The feeders can also be used in pharmaceutical applications for tablet coating, tablet counter loading, and bulk ingredient batching and packaging.

AdvantaPure/New Age Industries Inc.

Molded Silicone Components Offer Utmost Purity
These molded silicone components consist of stoppers and sealing systems for carboys and vessels, bottles, laboratory equipment, and process and storage containers. Autoclavable, sterilizable and reusable, they are made from Class VI, platinum- cured silicone elastomer for the utmost in purity. The components also feature smooth, gap-free surfaces for a true seal, no taste or odor transfer, and excellent chemical resistance properties. They are biologically safe and work with receptacles of glass, metal or plastic. The components resist cracking and particle migration and provide a secure, sealed environment.

Arc Machines

Orbital Welding Power Supply
The.easy-to-use Model 307 orbitalwelding power supply is compatible with all new and existing AMI fusionweld heads, as well as some heads featuring wire feed. All new Windows-based software includes automatic weld and tack weld program development, programming by time or position, multiple weld schedule libraries and weld I.D. number recording with an available weld I.D. label printer. On-screen help, elaborate data acquisition and a graphical user interface further enhance the capability of this state-of-the-art power supply. It operates on single or 3-phase input power and is auto-switching from 100 to 240 VAC. Output power is rated at up to 200 A, and the duty cycle at 150 A is rated at 100%.

Aseptic Technologies

Filling System Cuts Costs and Improves Safety
The new closed vial and filling line from this firm are attractive alternatives to current aseptic filling technologies. The vial is gamma sterilized and provided ready-to-fill with the stopper secured in place. The filling is performed by a special needle piercing the stopper. The stopper is immediately heat-resealed by a laser. The benefits of the technology include improved sterility assurance to the patient, reduced investments and operating costs, and increased safety throughout the supply chain.

BEE International

DeBEE 2000 Pilot Plant High Pressure Homogenizer
The DeBEE 2000 Pilot Plant High Pressure Homogenizer provides unprecedented one-pass results with adjustable pressures up to 45,000 psi at flowrates to 1 L/min. Synchronized highpressure cylinders deliver a constant pressure for consistent processing to homogenize to the highest efficiencies. The heart of the machine is the patented modular homogenizing cell, which can be configured to deliver unmatched performance for diverse applications as nanometer size reduction, emulsions, viscous slurries, dispersions, suspensions, high-yield cell rupture, wet grinding and more.

Broadspire/NATLSCO

Assess Process Containment Efficiency
This firm offers consulting and lab services for the testing of containment efficiency in solids manufacturing, packaging and handling. Containment performance is an important factor in evaluating and understanding the risks of operator exposures and process contamination in pharmaceutical manufacturing. Testing can be performed on equipment, processes components or operations either in a controlled environment during the process design stage, or in a manufacturing environment for existing equipment or processes.

Budzar Industries, Inc.

Continuous Biowaste Inactivation (CEITM) System
The Continuous Biowaste Inactivation (CEITM) system consists of three zones — holding tank, waste deactivation and cooling. Options are available for sealless pumps, PLC control and monitoring, and pH control before discharging. Waste is stored in the holding tank, which is an ASME Type 316 stainless steel tank equipped with a filtered vent, inspection port and openings for clean-in-place media. The waste is deactivated by pumping it into steam or electric-traced heat exchangers that are maintained at 300°F. The deactivated waste is then pumped through a cooling exchanger. Upon obtaining the desired discharge temperature below 110°F, the waste is then diverted to the discharge port.

Central States Industrial Equipment & Service, Inc.

Pharmaceutical Expertise Available
This company provides: onsite CIP testing, vessel evaluation, leak repair, heat transfer surface repair, spot electropolish, refinish vessel interior, and in-house modifications. With more than 20 years of experience in pharmaceutical vessels, the firm meets ASME repair requirements, and provides any additional documentation that may be requested.

Chemineer, Inc

Clean Sweep Mixers
The Clean Sweep mixer’s new design revolutionizes mixing technology by utilizing a swinging motion instead of the customary rotating motion. The mixer features a FDA/USP Class VI elastomeric seal. The Clean Sweep mixer is ideal for low-shear, high-purity mixing applications and easily accommodates mixing at low-liquid levels. This unique type of mixer has a new impeller with specially shaped blades optimized to provide global mixing throughout the vessel. Equipped with a center-mounted agitator, the Clean Sweep mixer eliminates particle shedding from mechanical seals or magnetic drive in-tank bearings.

CIMCON Software, Inc.

Process Analytical Technology (PAT) Tool
Implemented at leading FDA-regulated manufacturing sites, eProcessinfo is a powerful Process Analytical Technology (PAT) tool that transforms process data into knowledge to gain process understanding. eProcessinfo helps determine the sources of process variability and understand the relationships among critical process factors.

Comecer

Compact Isolator Manipulates Toxic Products
This compact isolator has been designed to manipulate toxic products ensuring top security levels for the operator and for the environment. It provides high-tech solutions in a compact unit suitable for any chemical, pharmaceutical or biotechnological laboratory, such as bag-in/bag-out for the HEPA filters, automatic pressure control and adjustment, liquid atomizing system, ULPA filtering system for technical gases and a sophisticated software that via PLC controls all the system components. This compact isolator is compatible with EU-GMP (Class A & B), ISO14644 (ISO 5) and FED-STD 209E (Class 100) validation process.

Elfab Ltd.

Hygienic Opti-Gard
The hygienic Opti-Gard is equipped with a non-fragmenting, reverse-acting rupture disk with a smooth, uninterrupted surface finish to reduce contamination and maximize stream SIP and CIP procedures. To facilitate installation, the system is designed to fit directly between ISO2852 standard food industry couplings and clamp fittings. Opti-Gard features a performance tolerance of only 5% across a wide range of burst pressures and a 95% operating ratio.

Entegris

Major Study on Materials Just Commissioned
Bringing 50 years of experience to the biopharmaceutical industry with its advanced research and capabilities applied through a range of CIP technology and engineering services, this firm will announce the commissioning of a leading research university to conduct a major new study of the impact various materials and surface finishes have on the cleanability of biofilms and other soils.

ErtelAlsop

Model 4T Laboratory Filter
Designed for use in laboratories to perform filtration trials and scalability studies, the Model 4T laboratory filter is constructed from Type 316 stainless steel with protected Pyrex glass cylinder for filtration up to 30 psig. Stainless steel cylinders are available for pressures up to 50 psig. Small constant flow pumps, compressed air or inert gas can be used to flow liquid through the filter media. The 4T Laboratory Filter has a media diameter of 47 mm with EPDM gasket material. The filtration area is 13.8 cm2 with a pressure limit of 80 psi. Any flat media type may be used with the 4T Laboratory Filter, which has a 250-ml volume and a 0–2.5 bar pressure gauge.

FAMAT

125TC Sampling System
The 125TC sampling system is used to take samples of powder as well as pasty media from reactors, dryers, filters, nutsches and pipes under vacuum or pressure. Its functional principle is based on a self-sealing piston which expands when closed. Since neither O-rings nor a packing are used for sealing, absolute tightness with zero dead space is guaranteed. It is now possible, due to quick-coupling connections, to easily dismantle the valve in order to completely clean all the parts. The system can be flexibly adapted to any vessel or pipe. A choice of materials and seals is available, depending on the product.

Fenwal Protection Systems

Fenwal PistonFire Suppressor
The innovative Fenwal PistonFire suppressor is designed to discharge an explosion suppressant into a process vessel in milliseconds without the use of explosive actuators. It’s safer to transport and store than conventional explosive actuators and features a supervisory switch to meet OSHA lockout/tagout requirements. The Fenwal PistonFire suppressor has a longer (five years) actuator service life to reduce maintenance costs. Its field-rechargeable design minimizes production downtime in the event of a suppressed explosion and saves on recharge costs.

Horiba Instruments Inc.

Partica LA-950 laser diffraction particle size analyzer
The Partica LA-950 laser diffraction particle size analyzer has a wide measurement range (0.01–3000μm), fast analysis time (one minute sample-to-sample), and powerful wet- and drysample dispersion systems. The easy-to-use optical system provides extreme accuracy, precision and resolution.

Informetric

InfoBatch Web Server
The InfoBatch Web Server enables authorized users to generate comprehensive batch and production reports from standard desktop Internet browsers. The server enforces the InfoBatch security model, ensuring compliance with FDA 21 CFR Part 11. InfoBatch enables manufacturers to maximize quality and productivity by demonstrating that GMP is maintained through all phases of batch production. Users can quickly create comprehensive exception and production reports without programming. InfoBatch supports the leading batch and process historians, and can easily connect to existing process control and information systems.

JETPHARMA USA, Inc.

Safely Load and Charge APIs
The Charge Tube is a special system designed for the safe loading and charging of APIs supplied in various drum sizes into a process vessel IBC or other charging application, while providing extreme levels of containment and control over the environmental conditions within the isolation system. The Charge Tube consists of single vessel charging glove box, which is connected directly to a process vessel, charge port, or process hopper via a discharge valve in the base of isolator. A drum transfer chamber is mounted onto the rear wall of the main isolator chamber and separated by an internal transfer door. The whole system operates under negative pressure to the outside environment and has been designed for a zoned environment with all controls functionality being implemented using pneumatic relay logic.

John Crane

7800 Series Universal Seal
The heavy-duty gas-lubricated 7800 Series universal seal is ideal for use in a wide variety of mixing and agitating equipment, as well as other top entry mixer applications. The seal uses modular hardware, allowing for maximum interchangeability and efficiency. This convertible format will support contacting dry, contacting wet, non-contacting or a combination of non-contacting and dry contacting seal technology without the need to change any adaptive hardware. The patented grooved rotor allows equal lift in the presence of up to 0.125- in. radial run-out, while the primary ring shape responds under pressure, further enhancing very low speed face separation. Lift-off and the double cartridge uses common springs, allowing for seal-adjustment to axial motion, and the optimized drive minimizes seal face to seal cartridge hardware interaction, eliminating low speed hang-up.

Koch Membrane Systems

SelRO Nanofiltration Membranes
The SelRO nanofiltration membranes provide outstanding chemical and thermal stability to satisfy the demanding requirements of pharmaceutical processes involving high and low pH, high temperature and organic solvents media. Most nanofiltration membranes previously available were limited to aqueous applications within the pH range from 2 to 11. The SelRO membranes can be operated within a pH range of 0–14. They enable the concentration of pharmaceutical intermediates in aqueous solutions, which may also contain organic solvents such as methanol, ethanol, acetone, acetonitrile and others. The membrane modules are available in tubular and spiral configurations in a wide variety of pilot and commercial sizes.

M.O. Industries, Inc.

Vispro System
Developed to transfer viscous products from the manufacturing site to other locations, the Vispro system uses an air pressure to raise a plunger located inside the smooth walled 200-L stainless steel drum. The product is discharged through an outlet in the unit’s lid. The system has various safety features and is designed to minimize loss with transferring products.

NARA Machinery

Laser Ablation
Laser ablation (LA) is a popular preparation methods for thin films and fine particles in the nanometer regime. By controlling the laser wavelength and fluence, this technology can be applied not only to inorganic materials, but also to organic compounds like drugs or proteins. One of the most attractive applications is to prepare nanoparticles of sparingly soluble drugs, in order to increase its dissolution rate, thus increasing the bioavailability. This firm’s LA system enables deposition of these nanoparticles on a substrate, as well as on particulate systems. It has also developed a specialized kit for LA in liquid environment, used for preparation of nanosuspensions.

New Brunswick Scientific

BioFlo Pro Fermentors and Bioreactors
This company recently expanded its line of pilot and production-scale bioprocessing systems to include fermentors sized 75–3,000 L and cell culture bioreactors to 500 L. The BioFlo Pro fermentors and bioreactors are modular in design, offering ready customization, quick delivery and the ability to expand system capabilities as needs change. All utilize robust, industry-standard components for dependable operation, and a validatable, GaMP-compliant, programmable-logic controller (PLC) for easy integration into any production facility. These systems feature a compact frame, with open piping for easy access to filters and valves. Flush-mounted vessel connections in hardto- clean places minimize contamination risk.

Optek-Danulat, Inc.

Optek AF46 Dual Wavelength UV Absorption Sensor
The optek AF46 dual wavelength UV absorption sensor features two discrete measurement channels, each with separate wavelengths. This allows a differential measurement that provides superior baseline stability and background noise rejection. Ideally suited for biotechnology and pharmaceutical applications, such as chromatographic separation, the AF46 can measure extremely high protein concentrations in ranges up to 30 OD. The AF46 is suited for CIP/SIP and Ultra-sanitary applications, and is available with NIST-traceable validation accessories.

Optima Machinery Corp.

Flexofill Monoblock Machine
The Flexofill monoblock machine is a combination filling and closing innovation for products from liquid to paste consistencies. Ideal for the pharmaceutical and cosmetic industries, the Flexofill has the capability to handle press-in, screw and crimp closures, spray pumps with dip tubes, roll-on, pipette closures, measuring cups, veterinary syringes to name a few. Manufactured GMP-compliant, the Flexofill is modular in construction, offering a small footprint.

PINK GmbH

Isolator System Protects Against Highly Potent Products
Designed to protect operators against toxic vapors and materials, this isolator system is equipped with an integrated vacuum drying oven and a pressure nutsch. It is inerted with nitrogen, and the oxygen levels are less than 1%. The product can be loaded through RTP ports on the side of the isolator or direct through a feed tube into the pressure nutsch. Filtration of the product can be done in the pressure nutsch, after which it is scooped onto trays. that are placed in a vacuum drying oven. After drying is complete, the trays are emptied into a container that is connected with an RTP port on the surface in front of the oven. Easy to clean, the complete system can be located in an explosion-proof area (Div. 1).

Sweco

PH12 PharmASep is a 12-in. Filter Dryer
All the machinery and controls necessary to operate this aseptic self-contained laboratory filter dryer are mounted on an easy-touse mobile cart. Only 4-ft high × 4-ft wide × 22-in. deep, the PH12 PharmASep is a 12-in. filter dryer for batch processing of up to 1 kg. It will fit under a standard 60- in. exhaust hood, yet includes motor control pneumatics for discharge cylinder actuation, vacuum and nitrogen flow instrumentation, quick disconnects and storage space for screens. The PH12 PharmASep uses the firm’s patentpending Vibro-Dry technology to accelerate drying time by mechanically fluidizing product on the screen surface during filtration and vacuum drying. It also has validatable CIP/SIP capability.Larger models for processing batches up to 100 L are also available.

Sympatec

QICPIC Unit
The QICPIC unit offers size and shape with image processing of the highest order from 1 μm to 10,000 μm. Using a pulsed light source with sub-nanosecond illumination, QICPIC provides up to 500 frames/sec of 1024 × 1024 pixels, 3:1 thru 1:10 ranges, providing parameters of size and shape including area-equivalent circle, boundary rectangle, chord length, sphericity, Feret & Martins diameters.