interphex new

Interphex new

Peristaltic pumps
In biotechnological processes, peristaltic pumps are not only used for dosing additives, but also for sterile and deadleg-free media transport with minimal shear-stress during inoculation, harvest, or continuous processes. Depending on the application, Bioengineering’s “Peripex” pumpheads are equipped with 4–6 rollers to provide easy operation and essentially pulsation-free delivery. Peripex peristaltic pumps are available as on/off models or with variable speeds and an integrated, profibus-compliant controller and display. Bioengineering, Waltham, MA, www.bioengineering.ch, Tel. 781.672.2620


Drug manufacturing
Vetter Commercial Manufacturing can handle all stages of drug production from filling to packing. Vetter’s state-of-the-art, restricted-access barrier systems and patented dual-chamber injection systems guarantee sterile production, according to the company. All products and processes are monitored for quality and meet stringent international standards (e.g., FDA, EMEA). Vetter-Pharma-Turm, Yardley, PA, www.vetter-pharma.com, Tel.215.321.6930


In-stock tablet press delivery
Fette America has launched the “RediShip” program, which promises immediate delivery of in-stock tablet presses. According to the company, the program will keep an inventory of selected models “on hand” so that customers will not need to wait months for delivery. Fette America, Rockaway, NJ, www.fetteamerica.com, Tel. 973.586.8722


Laboratory fermentor–bioreactor
Sartorius BBI Systems has released the “Biostat B Plus” twin fermentor–bioreactor system. The compact system can accommodate two autoclavable culture vessels in either 1- or 10-L working volumes. The integrated system concept includes a stainless steel cabinet to house the control, a thermostat, aeration, stirrer controls, and integrated peristaltic pumps. The fermenter–bioreactor system is equipped with a graphical user interface and a touch screen operation for logical, action-oriented operation of the bioprocess. Sartorius BBI Systems, Bethlehem, PA, www.sartorius-bbi-systems.com, Tel. 800.258.9000


Filling–stoppering machine
inova pharma systems has introduced the “H3-5V” filling and stoppering machine for nested syringes. The unit has a maximum output capacity of 4500 syringes/h using five filling heads. All contact parts are made of 316L stainless steel to handle highly viscous products. The H3-5V machine is manufactured with Allen Bradley HMI and PLC components and is in compliance with CGMP regulations. inova pharma systems, Optima Machinery Corp., Green Bay, WI, www.optima-usa.com, Tel. 920.339.2222


Depth filter cartridge
The “DeltaMax” depth filter cartridge from Meissner Filtration Products is an absolute-rated, all-polypropylene filter available in 0.5–70-mm removal ratings. The filter’s spiral construction creates a gradient pore structure that is designed to maximize service life and flow rates. Cartridges are available in 10–40-in. lengths with an optional outer cage for applications requiring enhanced mechanical strength. The filters are not made with surfactants, lubricants, resin binders, adhesives, release agents, or other additives. Meissner Filtration Products, Camarillo, CA, www.meissner.com, Tel. 805.388.9911

Sterile wipers
Berkshire Corp. has launched the “Gamma Wipe” sterile wipers. The wipers are gamma irradiated and sterile validated to an SAL of 10–6 in accordance with American (ANSI, AAMI, ISO) and European standards (EN1174 and EN552). Berkshire’s sterile wipers are intended for aseptic processing zones where microbial and particle contamination causes expensive product loss. The validated, dry-sterile wipers are available in the Gamma Wipe 67, 120, and 300 styles. Berkshire Corp., Great Barrington, MA, www.berkshire.com, Tel. 800.242.7000


Total organic carbon analyzers
Ionics Instruments has introduced its “Sievers 900 Series” total organic carbon analyzers. The three-model series includes laboratory, on-line, and portable analyzers for improved analytical performance, ease of use, reliability, and productivity. Key enhancements include improved precision over an extended 0.03–50,000 parts/billion dynamic range; 4-min analysis time; automated protocols for calibration, verification, and instrument validation; a smaller instrument casing; a touch-screen display; and a USB port for data transfer. Ionics Instruments, Boulder, CO, www.ionicsinstruments.com, Tel. 303.444.2009


Temperature and humidity data loggers
Dallas Semiconductor/MAXIM has released its new data logger brochure describing its complete line of digital data loggers. The “iButton” temperature–humidity loggers are small, rugged, and inexpensive. Measuring 16 mm in diameter and 5 mm thick, the data loggers integrate a unique global address, a thermometer and/or a hygrometer, a real-time clock, and enough memory to store as many as 8-K data points. An on-board lithium battery gives each logger 1-million measurement life span. Dallas Semiconductor/MAXIM, Dallas, TX, www.ibutton.com, Tel. 972.371.4000


Fabrications and assemblies
Swagelok offers high-quality special fabrications of biopharmaceutical products. Special fabrications-from basic to complicated configurations-can help meet critical construction deadlines, simplify system designs, reduce system footprints, and minimize installation times. Swagelok works with end-users to manufacture fabrications for unique requirements and offers third-party inspections in compliance with ASME-BPE standards. Swagelok Biopharm Services Co., North Tonawanda, NY, www.swagelok.com/industry/bio, Tel. 800.255.4111

PAT equipment
Aimed at meeting FDA’s process analytical technology (PAT) objectives, L.B. Bohle has combined its blending, fluid bed, granulating, and coating process technologies with task-specific analytical techniques. New turn-key systems provide improved processing and immediate and reliable data that can be remotely transferred to a personal computer. The combination of robust equipment design, reliable instrumentation, and easy-to-use software is designed to improve process control, shorten production times, reduce waste, and provide real-time checking with 100% accuracy. L.B. Bohle LLC, Warminster, PA, www.lbbohle.com, Tel. 215.957.1240

Silicone hoses
AdvantaPure has redesigned its reinforced silicone hoses. The “APSM” and “APSW” hoses are made from platinum-cured, Class VI silicone and offer multi-ply, mandrel-wrapped fabric for reinforcement. The APSW model has steel reinforced wire for added pressure, better vacuum capabilities, and kink and crush resistance. Both hoses contain a polyester fabric that makes them easier to bend without sacrificing their pressure-carrying capabilities. The APSM and APSW models are available in 0.5–4-in sizes. AdvantaPure, Southampton, PA, www.advantapure.com, Tel. 888.755.4370

Blow–fill–seal aseptic system
The blow–fill–seal (BFS) “Bottelpack” aseptic system by rommelag is designed for the aseptic filling of sterile solutions, creams, and ointments. Container production, filling, and hermetic sealing takes place in one cycle in one machine. The system is suitable for almost any application. Rommelag’s BFS technology provides complete compliance with applicable quality standards, high product and process safety, maximum economic efficiency, and low production costs. rommelag USA, Edison, NJ, www.rommelag.com, Tel. 732.738.7950

Aseptic-filling machine bags
Advanced Scientifics (ASI) offers custom-designed bags for use with aseptic-filling machines that can fill 100-mL to 20-L bags with ,1-min change-over volumes. ASI’s bags can be designed with components such as exit ports, tubing, and connections. Filling machines can be configured to eliminate CIP and SIP processes by using disposable bags and fluid-transfer sets for reduced cross contamination and a truly aseptic process, according to the company. Advanced Scientifics, Millersburg, PA, www.advancedscientifics.com, Tel. 717.692.2104

Parenteral contract manufacturing services
HollisterStier Contract Manufacturing specializes in the manufacture of parenteral products. The company’s capabilities include aseptic processing of lyophilized and liquid dosage forms at commercial and clinical scales. HollisterStier Laboratories LLC, Spokane, WA, www.fill.hollisterstier.com,
Tel. 888.THINK.HS

Disposable syringe inspection
Brevetti offers its model “K6,” an automatic particulate and cosmetic inspection machine for large-volume parenteral containers. The K6, which offers five inspection stations, can inspect for fill level, glass defects, heavy particles, aluminum cap crimping, and stopper presence, and has three stations for particle inspection. The machine can be controlled through a Siemens PLC S7 or Windows 2000. Change parts for 50-mL vials are included. Victor International/Brevetti CEA, Morristown, NJ, www.brevettiusa.com, Tel. 973.267.8900

Validation and regulatory services
VTS Consultants offers commissioning, validation, and regulatory services such as developing general operating procedures and turn-key validation activities for new facilities in the pharmaceutical, biotechnology, and medical devices industries. VTS Consultants’ regulatory consulting and quality groups provide the expertise needed to perform vendor and quality system audits to assist with government submissions. The company provides on-site training for current regulatory topics. VTS Consultants, Westborough, MA, www.vtsconsultants.com, Tel. 508.870.0007

Walk-on ceilings
MSS Pharma walk-on ceilings are designed to provide cost and schedule savings for manufacturers. The ceilings function as platforms so that work can be done above and below the cleanroom simultaneously, thus reducing requirements for catwalks. It also is not necessary to shut down operations to access space above ceiling equipment during maintenance. The walk-on ceiling is a component of the modular MSS Pharma “Cleanroom System,” manufactured by AES Clean Technology. AES Clean Technology, Montgomeryville, PA, www.aesclean.com, Tel. 215.393.6810

Particle-size analyzer
Horiba Instruments has introduced its “Partica LA-950” laser diffraction particle-size analyzer. The instrument offers a wide measurement range (0.01–3000 mm), fast analysis time (1 min sample-to-sample), and powerful wet and dry sample dispersion systems. The optical system is designed to combine high accuracy, precision, and resolution with ease of use. Horiba Instruments, Irvine, CA, www.horibalab.com, Tel. 800.446.7411, ext. 168

Doors and hardware
Tippet specializes in doors and hardware for pharmaceutical applications such as providing completely seamless stainless steel doors and frames for cleanroom environments. Tippet also can handle all clients’ hardware needs from door closers and locks to complete interlocking systems. Tippet, Waukegan, IL, www.tippetinc.com, Tel. 847.623.5130

Pressure regulator
Tescom Corp. has added the “DH-16” pressure reducing regulator to its line of industrial regulators, valves, and electronic controllers. The DH-16 regulator features a high flow capacity (5.0 Cv) and can operate at temperatures ranging from –20 to 165 8F. The device provides high accuracy throughout the control range and features low droop (e.g., 15 psig droop at 300 SCFM). The regulator incorporates a “Gylon” PTFE diaphragm for less contamination than elastomer-based diaphragms. Tescom Corp., Elk River, MN, www.tescom.com, Tel. 800.447.9635

Peristaltic pumps
Watson-Marlow Bredel offers its “400 series” of compact single, dual, and multichannel pumps. Designed for applications in which sizes can range from micro-liters to hundreds of milliliters per min, the pumps are well-suited for biopharmaceutical applications. The pumps offer zero contamination, sterility, easy cleaning, accurate metering, low shear, smooth flow, and reliability. The pumps also offer manual and auto-analog speed control as well as remote switching options. All pumpheads have precision-machined aluminum rotors and low-friction rollers. Watson-Marlow Bredel, Wilmington, MA, www.wmbpumps.com, Tel. 800.282.8823

Dry-heat sterilization
Central Research Laboratories (CRL) has developed a patented dry-heat technology for use with its sterilizing transfer ports. The technique is a reliable and effective sterilization method for material transfers in aseptic barrier systems or isolators, according to the company. Testing has shown that CRL’s sterilizable ports achieve a 6-log spore reduction. This technology is part of an FDA-approved process and is used by several North American pharmaceutical manufacturers. Central Research Laboratories, Red Wing, MN, www.centres.com, Tel. 651.388.3565

Hardness testers
SOTAX has presented its line of manual, semiautomated, and fully automated hardness testers. The semiautomated “HT 10” tablet testing system measures the thickness, diameter or length, and hardness of as many as 20 products. Because the instruments are equipped with the “Auto Alignment” device, uncommon tablet shapes are automatically aligned correctly. SOTAX Corp., Horsham, PA, www.sotax.com, Tel. 215.422.1500

Tablet-coating system
The “ACCELA-COTA Spectrum” tablet-coating system from Thomas Engineering is designed to safely and efficiently apply high-potency, active coatings and hazardous compounds; functional aqueous coatings; high-uniformity coatings; conventional aqueous coatings; and sugar coatings. The system uses “containment-at-the-source” technology and rapid-transfer ports to meet exposure level requirements. Thomas Engineering, Hoffman Estates, IL, www.thomaseng.com, Tel. 847.358.5800

Water-washable tablet press
Kikusui has introduced its “Aquarius III” full-containment tablet press. The unit can conduct tabletting in a vacuum, thus completely isolating it from the compression area. In addition, the Aquarius tablet press has wash-in-place and clean-in-place functions. The unit includes removable die tables and vacuum drying for quick changeover speeds. Kikusui USA, Toms River, NJ, Tel. 732.349.3131

Isolator
EnGuard Systems offers contained vial- or syringe-filling isolators for automated parenteral-filling machines. Capabilities include the ergonomic integration of any EnGuard filler platform; validation support; aseptic loading; off-loading; and material supply. This portable and flexible isolator meets CGMP regulations and has the capacity for clinical trials and short runs.
EnGuard Systems, Indianapolis, IN, www.enguardsystems.com, Tel. 317.753.5312

Contract services
Micron Technologies offers contract particle-size reduction and analytical services exclusively for the pharmaceutical industry. Primary capabilities include micronization (gram, kilo, and ton quantities) in addition to other particle-reduction techniques. Analytical services include particle-size analysis, materials characterization testing, and stability studies as well as methods development and validation. Facilities are FDA-registered and operate under CGMP requirements. Micron Technologies, Exton, PA, www.microntechnologies.com, Tel. 610.425.5100

Drug development and production
DPT, a DFB Pharmaceuticals company, offers full-service, turnkey, or stand-alone development, production, packaging, and distribution for a variety of semisolid and liquid, prescription, biopharmaceutical, and consumer products. The company specializes in aerosol and intranasal delivery methods. DPT Laboratories, San Antonio, TX, www.dptlabs.com, Tel. 210.476.8150


Packaging performance management
SYSTECH International has introduced its packaging performance management solution. The solution facilitates packaging line data collection and aggregation, visibility, analysis, reporting, and integration with enterprise business systems to ensure global supply chain integrity. SYSTECH has expertise in machine vision inspection, packaging line automation, and enterprise packaging performance management solutions that help manufacturers adhere to regulatory requirements and increase productivity. SYSTECH International, Cranbury, NJ, www.systech-tips.com, Tel. 800.847.7123

Microbial identification
Boston Analytical offers a rapid genetics–based approach to microbial identification. Through comparative DNA sequencing technology, the company provides clients an accurate and rapid genomics-based approach to microbial identification. In less than 24 h, Boston Analytical can help clients track down the source of a contamination problem. The company also provides USP microbiological testing and environmental monitoring services. Boston Analytical, Salem, NH, www.bostonanalytical.com, Tel. 603.893.3758


Interchangeable turret tablet press
The “Hata CVX” tablet press from The Elizabeth Companies features removable turret technology and an “easy-clean” design for quick parts removal and changeover between product runs. The press also has an easy-access press interior and fewer parts with less weight on heavier press components. The tablet press is mechanically designed to operate turret speeds as fast as 100 rpm on single-sided models. Other features include an optimized take-off area and special press doors that provide clear visibility into the compression zone. The Elizabeth Companies, McKeesport, PA, www.eliz.com, Tel. 412.751.3000


Multimode ion source
Agilent’s “Multimode Source” is the first simultaneous multimode ion source for mass spectrometry, according to the company. The instrument operates at typical HPLC flow rates (as fast as 2 mL/min in all modes), which is needed for high-throughput screening. Although the multimode ion source provides high sensitivity in all modes, it can operate in electrospray ionization and atmospheric pressure chemical ionization simultaneously or alone. By operating the device at high flow rates without switching modes, researchers can generate more data from each chromatographic peak. Agilent Technologies, Palo Alto, CA, www.agilent.com, Tel. 877.424.4536


Population assay kit
SGM has released a population assay kit that provides users with the same supplies and culture medium used by SGM for the recovery of spores in its QC release test. According to SGM, the kit will provide a more accurate assessment by users than current methodology and was developed so that users could purchase the same medium that SGM uses for its spore population verification of biological indicators (BIs). For convenience, end users can purchase a population assay kit with each new lot of BIs. SGM Biotech, Bozeman, MT, www.sgmbiotech.com, Tel. 406.585.9535

Validation services
Validation Masters is a full-service validation company serving the pharmaceutical, biotech, and
clinical research industries. Validation Masters’ expertise includes extensive knowledge of manufacturing and laboratory equipment, computer systems, master plan development, protocol development and execution, SOPs, software vendor auditing, and more. Validation Masters also can provide resources to support your needs. Validation Masters, Mount Laurel, NJ, www.validationmasters.com, Tel. 856.234.7733

Anticounterfeiting solutions
Cardinal Health Packaging Services has released a brochure describing its anticounterfeiting solutions. Overt devices that are visible to the end users include optical variable devices, security papers, microtext, bar coding, and tamper-proof/evident techniques. The company also offers covert devices that are invisible to the naked eye such as UV/IR light-visible elements, microscopic nanotext, hidden images, and RFID technology. The anticounterfeiting team will suggest a strategy to address the client’s specific needs. Cardinal Health, Philadelphia, PA, www.cardinal.com/pkg, Tel. 215.613.3001


Record retention management policies
A new white paper from AssurX addresses why FDA places the responsibility for smart record retention squarely on companies’ shoulders. The authors explain that sensible policies and plans should be in place, yet still are not practiced by many of the Fortune 500 companies. The pharmaceutical industry still lacks distinction between disaster recovery and business archiving, but the paper helps companies understand the difference. AssurX, Morgan Hill, CA, www.assurx.com, Tel. 408.778.1376, ext. 705

Manufacturing software
The “PAS-X” manufacturing execution system from Werum America is a software package that interfaces with enterprise software and complies with the requirements of 21 CFR Part 11. The PAS-X has an audit trail function that provides documentation for all user actions and a security function that only grants access to authorized users. Werum America, Towaco, NJ, www.werum-america.com, Tel. 973.257.0808

Contract chemistry services
Chemic Laboratories is an FDA-registered, DEA-licensed contract chemistry organization that provides full-service CGMP and GLP solutions for pharmaceutical development, contract analytical testing, and small-scale manufacturing. The company offers a range of services including CMC analytical development and validation; ICH development and validation; extractables/leachables analysis and container closure validation; bioanalytical methods development; validation and sample analysis; CGMP organic synthesis and formulation; QC analytical testing; and ICH stability programs. Chemic Laboratories, Canton, MA, www.chemiclabs.com, Tel. 781.821.5600

Dry fog system
Minntech offers its “Minncare” dry-fog system, a complete solution for cleanroom aerosol-based disinfection. Features include an autoclavable design, less cleanroom downtime, ultrafine droplets, and optimized biocidal efficacy. The system is adaptable to differing room dimensions, can be adjusted to suit any room height, and can disinfect rooms as large as 35,000 ft3. Minntech Filtration Technologies Group, Minneapolis, MN, www.minntech.com, Tel. 800.328.3340

Exipients
Dow Water Soluble Polymers has released a brochure describing its “Ethylcellulose,” “Hypromellose,” and “Poly ethylene oxide” pharmaceutical excipients and their use in controlled-release systems, tablet coatings, and granulation. The brochure also highlights their properties for facilitating extrusion, liquid preparations, and mucosal bioadhesives. Dow Pharmaceutical Excipients, Midland, MI, www.dow.com, Tel. 800.447.4369

Filter plates
Millipore has released its 384-well “MultiScreenHTS” filter plates that are optimized for high-throughput bioassays. The filter plates are available with glass fiber or phosphocellulose paper, and the automation compatibility increases throughput on a range of robots without loss of sensitivity, robustness, or precision.The plates provide a direct scale-up solution from 96-well filter-based assays incubation filter plates. Designed for coincidence scintillation counting, the units allow quantitative data to be collected at very low activity-specific levels and for challenging tritiated (3H) ligands. Millipore Corp., Billerica, MA, www.millipore.com/HTS, Tel. 800.MILLIPORE

Trace-level detection
GE Infrastructure Sensing offers its “Kaye Validator‚ ITMS” at-line instrument for trace-level detection of pharmaceutical compounds. The instrument uses dual-mode ion mobility spectrometry to quickly analyze a swab sample for small-molecular API residues or cleaning agents. Equipment usage and production capacity benefit directly by cutting process downtime attributed to the cleaning validation, according to the company. GE Infrastructure Sensing, Billerica, MA, www.gesensing.com, Tel. 978.437.1000

Moisture-protective coating
Röhm America offers a brochure describing a moisture-protective coating from degussa. Röhm Pharma Polymers. The “Eudragit EPO” solid oral dosage form coating ensures product stability by incorporating a micronized amino methacrylic copolymer that prevents sedimentation during storage and spraying. The coating also can reduce dispersing time to 1 h when the liquid is heated to 50 8C. degussa.Röhm Pharma Polymers, Piscataway, NJ, www.rohmamerica.com, Tel. 877.764. 6872 ext. 5383

Automatic tablet tester
An automatic tablet tester that is designed to test tablet weight, thickness, diameter, and hardness is available from Dr. Schleuniger Pharmatron. The 21 CFR Part 11–compliant “Autotest” 4 tester can maintain alignment of various tablet shapes and sizes and is controlled by Microsoft Windows–based software. Options include a 12-magazine feeder for QC environments and an in-line testing deduster–diverter with optional tablet air transport. Dr. Schleuniger Pharmatron, Manchester, NH, www.pharmatron.com, Tel. 603.645.6766

Contract manufacturing
DSM Pharmaceuticals offers contract manufacturing and development services. Capabilities include the manufacture and development of sterile liquids and lyophilized products to solid, semisolid, and liquid dosage forms. The company provides assistance with formulation and development, production scale-up, regulatory consultation, secondary manufacturing, and primary and secondary packaging. DSM Pharmaceuticals, Greenville, NC, www.dsmpharmaceuticals.com, Tel. 252.707.2307

Particle-sizing instruments
Microtrac has introduced a line of particle-sizing instruments. The “Nanotrac 150” and “Nanotrac 250” analyzers use dynamic light scattering technology for high-concentration particle sizing (0.008–6.5 mm). The line also includes the “S3500” laser diffraction-based analyzers with advanced “Turbotrac” dry-induction feeder, which uses three solid-state lasers for accurate particle-size analysis (0.02–3000 mm). The instrument determines particle sizes within seconds and makes quick wet–dry conversions. Microtrac, Largo, FL, www.microtrac.
com, Tel. 888.643.5880

Software
EtQ offers its compliance management system, which is the only intranet/Internet-based enterprise quality and compliance (CGxP, ISO 9000:2000, ISO 13485/14000/18000) software that can be configured by a Web browser without programming, according to the company. Key modules include: CAPA, audits, customer complaints, training, nonconforming materials, and document control. All modules comply with 21 CFR 11 requirements. EtQ, Farmingdale, NY, www.etq.net, Tel. 516.293.0784

Filter press
The “EA Series” filter presses from ErtelAlsop provide an efficient means of liquid and solid separation through pressure filtration, either for solution filtration or sludge volume reduction. Presses provide a method for high compaction pressure to compress and dewater solids into cakes of 25–60% total concentration. This method provides clearer filtrate solutions than systems that only remove free water. Every press is available with a rugged, double-side driven plate shifter and a uniform-fill manifold with the appropriate valves. ErtelAlsop, Kingston, NY, www.ertelalsop.com, Tel. 845.331.4552

Business applications
Stratus Technologies offers continuous-availability solutions, with more than 24 years of experience focused on business-critical applications in industries that require reliable environments. The company’s solutions provide high levels of reliability for Windows-based environments, delivering 99.999% uptime or better-an average of less than 5 minutes of downtime per year. Stratus Technologies, Maynard, MA, www.ebrs.stratus.com, Tel. 978.461.7499

Preventive maintenance program
Allegheny Bradford’s “AST Preventive Maintenance Program” is designed to keep stainless steel process equipment at peak condition while reducing the risk of emergency shut-downs. The program provides scheduled, fully documented, on-site, visual Level 2 inspections, and fully documented or certified on-site equipment refurbishments. Clients also receive preferred treatment from the “AST Rapid Response” refurbishment team in case of emergency. Allegheny Bradford Corp., Bradford, PA, www.alleghenybradford.com, Tel. 866.266.9293

Coating technology
Emerson Resources offers “Marcoat” and “Plasacryl” ingredient technologies to help solve formulation problems related to coating flexibility and efficiency. Marcoat is a 25% aqueous-based shellac coating system. The film is deposited out of water and offers reduced moisture–vapor transmission. Release characteristics are consistent throughout the dosage form’s shelf life. Plasacryl (formerly “Plas II”) is an additive used in acrylic coating systems to eliminate the need for talc. Emerson Resources, Norristown, PA, www.emersonresources.com, Tel. 610. 279.7450

Pressure transmitter
Anderson Instrument Company offers its HA-Series autoclaveable miniature pressure transmitter. The transmitter, when ordered with the autoclave option, can withstand autoclave temperatures ,124 8C (255 8F) for ,1 h. The transmitter includes the quick-disconnect connector, and is available with both 1.5-in. triclamp and Anderson CPM fittings. The device is designed for CIP/SIP conditions. Anderson Instrument Co., Fultonville, NY, www.andinst.com, Tel. 800.833.0081

Contract services
Exygen Research offers a brochure describing its contract testing and R&D services. Capabilities include drug discovery method development and analysis, GLP-compliant bioanalytical support for preclinical development, CGMP-compliant method development and validation, and stability and release testing. Exygen Research, State College, PA, www.exygen.com, Fax 814.272.1019

Surface analyzers
Micromeritics’ “Gemini V Series” analyzers have been designed for measuring the surface area and porosity of pharmaceutical materials. The “Gemini 2365” determines singlepoint and multipoint BET and Langmuir surface areas, total pore volume, and micropore analysis by the t-method. The “Gemini 2380” can provide BJH pore volume distributions. Optional software addresses requirements specified by 21 CFR Part 11 regulations. Micromeritics Instrument Corp., Norcross, GA, www.micromeritics.com, Tel. 770. 662.3688

Data historian software
GE Fanuc’s “iHistorian” software is designed to collect, retain, and distribute large amounts of plant floor data at high speeds. The software is scalable to 100,000 data points per server and can store and retrieve more than 20,000 events/s. iHistorian can be connected to most HMI/SCADA applications. GE Fanuc Automation, Charlottesville, VA, www.gefanucautomation.com/global, Tel. 800.526.3486

Esters
Morflex offers a series of esters that perform as excipient plasticizers in pharmaceutical coatings. The esters include four citrates and one sebacate. The plasticizers are compatible with resins for the controlled release of drug actives in solvent and aqueous formulations. The release profile may be customized by selecting a plasticizer with desired solubility characteristics. The plasticizers offer enteric coating protection in acidic media with improved toughness and strength. Morflex, Greensboro, NC, www.morflex.com, Tel. 336.292. 1781

Development services
Quintiles offers a range of development services, including the formulation and process development of oral solids and liquids, semisolids, aerosols, and parenterals. Additional services include analytical chemistry, stability testing, ADME, bioanalysis, DMPK, clinical PK–PD, and pharmacology and toxicology. Quintiles has the resources to expand small-scale processing for clinical batches into full-scale commercial production. Quintiles Preclinical and Pharmaceutical Sciences, Kansas City, MO, www.quintiles.com, Tel. 816.767.3900