INTERPHEX2007 Conference & Exhibition
April 24-26, 2007
New York, NY
Company Establishes Division Solely for Pharmaceutical Analysis
Located in Maryland Heights, MO, Cyanta Drug Development Services is the newly spun-off division of Chemir Analytical Services that specializes in pharmaceutical analysis. Cyanta was formed to help companies receive approval of their new drug application (NDA), abbreviated NDA (ANDA), and FDA 510(k) Food, Drug and Cosmetic Act submissions. Services include extractables and leachables studies, material/physical testing, failure analysis, analytical development, stability studies, method validation, formulation, and custom synthesis.
Appeared In Issue: March 2007
Cyanta
www.cyanta.com
Find the Proper Pressure Relief Devices with this Product Catalog
This company’s new full-color catalog offers information about its full line of pressure relief devices. Comprehensive descriptions and technical specifications are given for the firm’s rupture disks, rupture disk holders, sanitary products, rupture panels, single-use assemblies, alarms and sensors. Easy-to-read charts display burst pressure tolerance, panel-specification information, and temperature-limit data. New this year is information offered not only in psi, but also in barg.
Appeared In Issue: March 2007
Oseco
www.oseco.com
Simplify Cleanroom Cleanup Using These Wipers
Kimtech Pure CL4 critical task wipers are ideal for critical surface wiping in ISO Class 4 or higher cleanrooms. The wipers are made from 100% meltblown polypropylene. They are thermally bonded, and thus contain no glues or binders. Their straight, clean, knife-cut edges help to minimize lint, and they are delivered double-bagged in anti-static packaging. The wipers are resistant to acids, bases and solvents, and can be autoclaved and ETO-sterilized. In addition, they meet USDA requirements for food processing establishments. These wipers are available in 9-in. × 9-in. and 12-in. × 12-in. sizes. The line of Kimtech Pure CL4 wipers also includes a pre-saturated alcohol wipe, for one-step application of alcohol (70% isopropyl alcohol, 30% deionized water) to critical surfaces. The alcohol wipers are delivered in a re-sealable pouch and an anti-static liner bag, and they measure 9 in. × 11 in.
Appeared In Issue: March 2007
Kimberly-Clark Professional
www.kc-safety.com/gloves
Firm Now Offers GMP Pharmaceutical Analysis Services
This company’s Life Sciences group has added GMP pharmaceutical analyses to its service portfolio. The new services form a comprehensive addition to the company’s existing bioanalytical service offerings. New services for medical devices, containers and packaging include: leachables and extractables testing; medical device biocompatibility testing; trace silicone analysis; and trace ethylene diamine tetraacetic acid (EDTA) analysis. Services focusing on active pharmaceutical ingredients (API) and excipients include: metallo-drug analysis; heavy-metal analysis in over-the-counter (OTC) products; residual catalyst analysis; residual solvent analysis; raw material/impurity testing; and stability testing. In the area of biologics, batch-release testing (peptides) is available. For small molecules and metal-based therapeutics, services include: method development; method transfer; GLP/GMP validation; LC-MS/MS bioanalysis; and ICP-MS bioanalysis.
Appeared In Issue: March 2007
Cantest
www.cantest.com
Compact Syringe-Filling and -Closing Machine Offers High Output
The SV125 syringe-filling and -closing machine boasts a high output in a compact design. This fully automatic unit is designed for nested disposable syringes of all leading syringe manufacturers. Dosing volume is 0.1–50 mL with an output of 9,500 syringes/h.
Appeared In Issue: March 2007
Optima Group
www.optima-packaging-group.de
Weigh Boxes Provide a Physical Barrier Against Hazardous Airborne Particulates and Powders
The XPert weigh boxes have inlet and outlet HEPA filters and provide a physical barrier to protect the operator from hazardous airborne particulates and powders in a leakfree environment. These boxes are easy to use, are economically priced, and come with many accessories to enable customization for specific applications. They feature a static-pressure gage to monitor HEPA filter loading, an anti-static ionizer fan that is mounted on the interior box to reduce static charge, and a balance vibration isolator for delicate weighing operations. Other features include a seamless, one-piece, molded polyethylene shell that provides chemical resistance and is easily cleaned. The viewing window is made from 1/4-in.-thick laminated safety glass and is removable for loading equipment. The inner and outer transfer-chamber doors pivot upward and are counterbalanced and equipped with quick-latches. The main chamber boasts 13 ft3 of interior space and the transfer chamber has a 11-in.-nominal-dia. The XPert Weigh Box surpasses ASHRAE 110 standards, with average tracer gas levels at 0.05 ppm during perimeter scan testing. Airborne particulate cleanliness exceeds ISO Class 5 conditions and achieved ISO Class 3 conditions (equivalent to Class 1) at both minimum and maximum airflow volumes.
Appeared In Issue: March 2007
Labconco
www.labconco.com
Keep the Environment Sterile with these All-Stainless Maintenance Hand Tools
Stainless-steel hand tools are an efficient and cost-effective solution for maintaining sterility in the servicing of process equipment in a sterile environment. Stainless steel requires no plating, which can generate dangerous particulate, to maintain its corrosion resistance. In the event the surface is scratched or damaged, stainless steel forms a pure chromium oxide (a passive, non reactive) layer, protecting it against further corrosion without exposing ferrous surfaces that can contaminate a cleanroom environment. Stainless-steel handles are currently available from stock on the firm’s nut drivers, ball hex drivers, and hex bit drivers (available with eight sizes of stainless steel bits).
Appeared In Issue: March 2007
Steritool
www.steritool.com
Get Expert Help from Professionals Dedicated to the Pharmaceutical and Biotechnology Industries
This firm’s team of more than 1,000 professionals, provides technical and regulatory solutions for the pharmaceutical and biotechnology industries. Backed by 75 years of project experience in solid dosage, parenterals, biologics, and R&D, the company offers technical expertise and experience in all facets of project delivery, including fully integrated engineering, procurement, construction and validation. It also provides concurrent commissioning and qualification implementation and effective use of modular design. With delivery centers in key global tax-advantaged areas, the firm offers local service throughout the world.
Appeared In Issue: March 2007
CH2M HILL Lockwood Greene
www.lg.com
Pump Features a Closed Fluid Path that Preserves the Integrity of Fragile, Shear-Sensitive Products
The closed fluid path that characterizes the peristaltic process of this pump assures that sterile product never comes in direct contact with any moving parts before being dispensed. Product passes from the bulk tank directly into sterile medical-grade silicone tubing that is placed onto the circular track of a filling head. A very gentle massaging motion lightly compresses the tubing against a proprietary dual-roller rotor to achieve a smooth, non-pulsing flow. This gentle pumping operation moves and dispenses even the most delicate liquids. A simple change of the sterile tubing and filling needle is all that is required during product changeover.
Appeared In Issue: March 2007
Flexicon America, Inc.
www.flexiconamerica.com
Scalable Mixer/Dryer Can Handle Applications from Bench-Top Development to Plant Production
The FM-75 laboratory mixer/dryer is constructed from stainless-steel, allowing for easy disassembly and cleaning. The unit provides the process industries with a scalable solution to go from bench-top development to plant production. The jacket is designed for heating and cooling and is rated at 90 psig at 330°F. With a 5-, 7-1/2- or 10-hp single-speed motor, the mixer has enough power for even the most demanding lab applications. Charging is accomplished through a charging door. A high-speed 5-hp chopper is available. A contoured door is provided as the standard discharge, with a semi-spherical valve or ball valve available as an option. The entire unit is self-contained on a rugged, mild steel or stainless steel base, which measures 24 in. high from floor to discharge door.
Appeared In Issue: March 2007
Littleford Day, Inc.
www.littleford.com
Modular Explosion Detection and Control System is Easy to Install and Use
EPACO is a sophisticated explosion detection and control system made up of five basic modules: explosion protection controller (EPC); power-supply unit (PSU); relay card (RC8); annunciator module (AM); and the Cerex detector. The system is pre-configured to recognize danger signs and make important decisions about when to activate Fike explosion-isolation and explosion-suppression systems to prevent an explosion from damaging equipment. EPACO can also alert users of what the problem was and when it happened.
Appeared In Issue: March 2007
Fike Corp.
www.fike.com
No External Steam Supply? No Problem for this SIP Fermentor
The BioFlo 415 benchtop fermentor provides the convenience of automatic sterilization-in-place with no need for an external steam supply. Using only laboratory water and the unit’s built-in heater, it provides rapid heat up and cool down, to speed research through production processes. This cGMP-compliant, validatable system is capable of controlling up to 32 process loops, including multiple thermal mass-flow controllers, as well as signals from up to 10 external scales, analyzers, sensors or other devices, for optimized process yields. A large, easy-to-use 15-in. touchscreen integrates it all for simple setup, calibration and operation.
Appeared In Issue: March 2007
New Brunswick Scientific
www.nbsc.com/cepb.htm
Powder Tester Rapidly Identifies Critical Performance Properties
The FT4 state-of-the-art universal powder tester offers automated bulk, shear and dynamic property measurement. The data generated correlate directly with various aspects of processing behavior making the instrument ideal for formulation and process optimization, as well as effective quality control. With this unit, powders are tested in a consolidated, conditioned and aerated state to fully characterize behavior and the factors influencing it. This facilitates the rapid identification of properties with a critical impact on performance. The FT4’s patented dynamic methodology and unique conditioning step, coupled with automated test programs that eliminate operator-to-operator variability, deliver precise, repeatable and reproducible results. Testing is quick; a test program is typically completed in around 5 min, while the latest software delivers rapid data analysis, remote from the laboratory where necessary.
Appeared In Issue: March 2007
Freeman Technology
www.freemantech.co.uk
Peristaltic Pumps Accurately Meter, Dose and Transfer Sensitive Fluids
The 520/620/720 peristaltic pumps are designed for the accurate metering, dosing and transferring of sensitive fluids in sanitary environments, making them ideal for accurate filtration, fermentation, dispensing, coating and seamless integration into reusable or disposable bioprocess applications. The 720 Series peristaltic pump allows for production speed and flow control for high-capacity throughput, allowing the user to scale up from laboratory operations to production using the same pump interface familiar to the 520 and 620 user. The 720 Series offers flowrates up to 33 L/min and peak pressures up to 30 psi. The 520/620 peristaltic pumps combine power and control in a compact and rugged package. The 520 combines the ability to perform in-process applications, with dispensing and dosing programming built in to handle delicate laboratory environments and the accuracy demands of filling lines. The 620 Series is ideal for a wide range of biotech and pharmaceutical applications, including the scale transfer of pharmaceutical products, live cell cultures, nutrients and bioreactor constituents.
Appeared In Issue: March 2007
Watson-Marlow Bredel
http://www.watson-marlow.com
Platinum-Cured Silicone Hose Now Comes with an Anti-Wick Seal Option
The APSH flexible braid-reinforced, platinum-cured silicone hose is now available with anti-wick seals to prevent liquid absorption within the hose walls. The anti-wick seal is created by molding silicone material to the cut end of a length of hose, which seals in the polyester yarn braid and prevents liquid absorption. It is especially helpful in applications where the hose is used as dip tubing, as it prevents fluids from becoming trapped within the hose walls. The APSH hose has undergone extensive physical, chemical and biological testing. It meets USP Class VI, FDA CFR 177.2600, ISO 10993, European Pharmacopoeia 3.1.9, and 3-A standards, and is certified to be free of animal-derived ingredients. Its core material is NSF 51 listed. The APSH hose is suitable for fluid or air transfer in temperatures ranging from –100°F to 400°F.
Appeared In Issue: March 2007
AdvantaPure/New Age Industries Inc.
http://www.advantapure.com
Maximize Interchangeability and Efficiency with this Modular Vessel Seal
With a modular cartridge design, the heavy-duty gas-lubricated Universal Seal (7800 Series) is ideal for use in a wide variety of mixing and agitating equipment, as well as other top-entry mixer applications. The Type 7800 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 seals use 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.
Appeared In Issue: March 2007
John Crane
www.johncrane.com
Microfluidizer Processor Can Integrate Machine Controls and Data Recording onto a Single Platform
Designed for use in the biopharmaceutical industry, the Aseptic M-7250CP constant-pressure system is a premium Microfluidizer processor that incorporates new system architecture and is able to integrate machine controls, functions and data recording onto a single common platform. Standard features include a Yokogawa data acquisition station (DAQ) that continuously monitors temperature, pressure and flow, enabling users to easily and cost-effectively record and print digital testing data. Additionally, the system offers steam-in-place (SIP) for aseptic processing of drugs in a cGMP environment, and ultra-clean-in-place (UCIP) that eliminates the need for disassembly for cleaning between batches or before storage. A programmable logic controller (PLC) manages on-board sensor signals and coordinates audio-visual alarms, operator acknowledgment and motor control interlocks. In the event that an operating parameter is out of tolerance, the embedded controller will manage the signal processing. In addition, the PLC coordinates these signals in conjunction with the data recorder to provide the customer with an event log detailing testing data. This enhances the batch record keeping function and aligns with the requirements of GAMP4 guidelines.
Appeared In Issue: March 2007
Microfluidics
http://www.microfluidicscorp.com
Tablet Press Lubricant Feeder Can Reduce Lubricant Use by as much as 97%
Adapted from the firm’s sanitary pharmaceutical twin-screw feeder, this tablet press lubricant feeder features the addition of a specialized gas venturi for aspiration of the lubricant (magnesium stearate) directly to the tablet press. The unit is available on a portable cart, in both volumetric and loss-in-weight models. It offers an automated, nearly constant feed rate, for uniform coating of the tablet tools, thereby avoiding sticking problems. The benefits of its use include reducing the consumption of stearate (sometimes by as much as 97%), lowering material and operating costs, and improving product quality. Use of the loss-in-weight model enables validation of product mass flow and ensures higher accuracy.
Appeared In Issue: March 2007
K-Tron Process Group
www.ktron.com
Continuous Thin-Film Dryer Minimizes Residence Times
The Contivac NDP processor can provide a reduction in residence time by up to 500 times for many pharmaceutical/food applications in which batch dryers have conventionally been applied. Residence time, even with moderate process temperatures, can produce unwanted side reactions and color changes. In addition to better product quality, the quick response time of the Contivac thin-film dryer reduces manpower and reduces or eliminates product storage. Individually adjustable heating and cooling zones in the thin-film dryer allow its use in complex processes, eliminating transport problems and product contamination. Mixing, reacting, flashing and drying can be carried out in the same unit, with several different substance streams being fed into the processor simultaneously. The Contivac’s design allows for CIP cleaning and complies with GMP requirements. Systems are generally smaller than batch-operated dryers and require lower investment.
Appeared In Issue: March 2007
LCI Corp.
www.lcicorp.com
Ball Valve Delivers Consistent Flow and Reduces Pressure Drops
CleanFLOW ball valves are engineered to be a piping component to specifically meet the demanding processes found in the pharmaceutical, biotech, semiconductor, cosmetics, food and other industries, where particle generation and contamination can threaten the outcome of the product. The port opening of the valve’s flow path is dimensionally identical to the adjacent tubing. This “Tube-ID” feature provides predictable flowrates and pressure drops and ensures thorough cleaning and full drainability as mandated by ASME/BPE. As a BPE-compliant product, CleanFLOW valves may be specified and installed plant-wide, making the process of design, construction, startup and maintenance easier to manage, while helping to minimize overall project costs.
Appeared In Issue: March 2007
SVF Flow Controls, Inc., CleanFLOW Div.
www.cleanflow.net
Manage Corporate-wide Training Policies and Requirements with this Software System
TrackWise is an enterprise process-management software system that enables companies to strategically ensure compliance, improve control, reduce risk, and lower costs by consolidating management of issues and actions, automating workflow, and facilitating trending and reporting. TrackWise is offered with pre-packaged, industry-specific solutions and is also fully configurable to meet specific business needs. TrackWise quality management software and its Training Manager functionality enables organizations to manage corporate-wide training policies and requirements using a centralized, fully automated, business-rules-driven electronic training system. It features a common user interface that provides a distinct advantage over other software solutions that provide a module-based approach. TrackWise training management features include: curriculum management; automated scheduling; integrated training workflow and tracking; escalation; integrated corrective and preventive action (CAPA) and change control; and reporting.
Appeared In Issue: March 2007
Sparta Systems
www.sparta-systems.com