The Pharmaceutical Solutions Update

Welcome to Pharmaceutical Online's Fall 2008 edition of The Pharmaceutical Solutions Update, bringing you up to speed on the latest product and service offerings for the pharmaceutical manufacturing industry.

This Comprehensive Product Guide is a collection of 40 different product and company listings arranged by product category and encompasses manufacturing and testing services, measuring devices, bioprocessing equipment, feeding and conveying solutions, components and instrumentation, and much more. Take a few minutes to peruse the listings by clicking on a product category in the Listing Index or visit one of our advertisers' storefronts through the Advertiser's Index — you just might find the perfect solution for your current design.

Once you've found the ideal solution for your needs in our Comprehensive Product Guide, check out the Exclusive Editorial Coverage, featured in The Pharmaceutical Solutions Update. These articles offer a range of perspectives from industry experts on how to implement new technologies and keep up to speed on emerging trends. Click here to read more.

Table Of Contents:
 • Advertiser's Index 
 • Listing Index 
 • Solution Listings 


Advertiser's Index:
 

 

Listing Index:

Bioprocessing Equipment
  Applikon Biotechnology, Inc.
  Sartorius Stedim North America Inc.

Blow/Fill/Seal
  Weiler Engineering, Inc.

CELL/TISSUE CULTURES
  MIDSCI

COMPONENTS AND INSTRUMENTATION
  MOCON, Inc.

CONTAINMENT
  
ChargePoint Technology

CONTRACT MANUFACTURING
  
Patheon

CONTRACT MANUFACTURING AND TESTING
  
Bionique Testing Laboratories, Inc.
  DSM Pharmaceutical Products
  Hospira Worldwide, Inc.
  Vetter Pharma-Fertigung GmbH & Co. KG

DATABASES
  International Centre for Diffraction Data

DISPOSABLE DOSING SYSTEMS
  Bosch Packaging Technology

DRYING
  
Applied Chemical Technology Inc.

ENGINEERING, COMMISSIONING, VALIDATION, AND CONSTRUCTION MANAGEMENT
  BE&K BioPharm
  CRB Engineers - Builders

EXCIPIENTS
  Allan Chemical

FEEDING AND CONVEYING SOLUTIONS
 
K-Tron America, Inc.

FILTRATION
  ZenPure Products Distributed by JALT Technologies

Inspection/Product Inspection
  Mettler-Toledo Safeline

LABORATORY EQUIPMENT
  Rees Scientific Corporation

LIMS
  
Thermo Scientific, Part of Thermo Fisher Scientific

LYOPHILIZATION
  Anteco

Measuring Devices
  Burns Engineering
  Microtrac Tinc

Melt Extrusion
  Foster Pharma

Microbiology Testing
  Lonza

PAT AND ANALYTICAL TECHNOLOGIES
  Thermo Scientific, Part of Thermo Fisher Scientific

Powder Processing
  Tote Systems

SINGLE USE COMPONENTS
  Gore PharmBIO Products

SINGLE USE TECHNOLOGY
  q/RT solutions LLC

SOFT GELS
  Banner Pharmacaps Inc.

TABLET PRINTING
  
R.W. Hartnett

TABLETS AND CAPSULES
  
Capsugel

TRADE SHOW/ASSOCIATION
  American Chemical Society
  INTERPHEX
  INTERPHEX Puerto Rico

VALVES
  Fisher Controls International LLC, Baumann Valves

WASTEWATER TREATMENT
  Aquafine Corporation
  Digital Analysis


Solution Listings:

BIOPROCESSING EQUIPMENT

BIOPROCESSING EQUIPMENT

Recent Finding In Growing Microbial And Mammalian Cells; There Is A Better Way!

In conjunction with celebrating their 25th anniversary, Applikon Biotechnology launches the μ-Flask.

Effectively replacing cumbersome shake flasks, μ-Flasks consist of a reusable, gas-permeable well-plate closure and a universal, shaker-mounting clamp device. Unlike other well-plate sealing options, such as tapes, μ-Flasks are free of crosscontamination risks, offer highly reproducible results, and eliminate well-plate related edge-effect phenomena. Utilizing a unique filter inlay and cover combination, μ-Flasks provide oxygen transfer rates (OTRs) equivalent to baffled Erlenmeyer flasks without the evaporative losses experienced with sealing tapes. Available in configurations for 24 and 96 low and deep volume, round, or square well plates, μ-Flasks offer flexible formats with working volumes ranging from 100uL to 4.0 mL per well.

μ-Flasks are suitable for both microbial and mammalian cell culture applications. Publications and a complete OTR table are available on Applikon's Web site at www.applikonbio.com.

Applikon Biotechnology, Inc.
1180 Chess Drive, Foster City, CA 94404
Contact Person: Howard C. Weber
PH: (650) 578-1396 FX: (650) 578-8836
E-mail: sales@applikonbio.com
Web site: www.applikonbio.com

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Sartopore® 2 XLG | XLI Sterilizing Grade Filters

We recently launched two new, premium-grade, sterilizing-grade filters: Sartopore 2 XLG and XLI. They offer significant performance benefits in many biopharmaceutical applications by combining more effective prefilter layers with a 30% increase in effective filtration area. These heterogeneous, double-layer, PES membrane filters have 0.8-μm (XLG) and 0.35-μm (XLI) prefilters with the same, reliable, 0.2-μm sterilizing-grade final membrane as our current Sartopore 2. Their total throughput performance exceeds most commercially available PES filter membranes by 80% to 100% in many applications including serum-free cell culture media and downstream intermediates filtration. This robust, application-specific approach represents a bright future for Sartorius Stedim Biotech Filtration Technologies.

Sartorius Stedim North America Inc.
131 Heartland Boulevard, Edgewood, NY 11717
Contact: Mandar Dixit, Product Manager — Sterilizing Grade Filters
PH: (631) 254-4249 ext. 8520 FX: (631) 253-5420
E-mail:
mandar.dixit@sartorius-stedim.com
Web site: www.sartorius-stedim.com

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BLOW/FILL/SEAL

CELL/TISSUE CULTURES

Colder Products Company advances steam-inplace technology with the introduction of Steam- Thru® Connections. The innovative design allows a quick and easy sterile connection to ease the transition from stainless to disposable.

The Steam-Thru Connections' three-port design allows steam to pass directly through the two lower ports. After the "steam on" SIP cycle is completed, the connector's valve is actuated, creating a sterile flow path. Media can now be safely transferred between a bioreactor and single- use system without the cleaning and validation concerns associated with reusable components.

Steam-Thru II offers the flexibility and reliability of "steam on" and "steam off" functionality. Following media transfer, the valve can be moved to the steam position. A second SIP cycle further minimizes contamination risks by allowing a sterile disconnection.

Steam-Thru Connections help today's biopharmaceutical manufacturers meet the challenges of increasing productivity, reducing costs, and decreasing time to market.

Weiler Engineering, Inc.
1395 Gateway Drive, Elgin, IL 60124
Contact: Chuck Reed
PH: (847) 697-4900
E-mail:
solutions@weilerengineering.com
Web site: www.weilerengineering.com

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MIDSCI-TPP Tissue Culture Plastics Providing the highest quality and most dependable products found anywhere in the world!

Serving all of your Tissue Cell Culture needs, TPP provides a wide range of Tissue Cell Culture Plastics designed to benefit the most demanding research scientists. Swiss-engineered quality, convenient yellow marking areas, and excellent optical clarity are just a few of the advantages you can expect with TPP.

Flasks: 25, 75, 150, 300 cm2 Peel-Off and Re- Closables Flasks 115 cm2 - 150 cm2; Dishes: 40, 60, 100, and 150 mm; 50 mL Bio-reactor Tubes; PCV Easy Read Cell Counting System; Flask/Tube: 10 cm2 Tissue Culture Treated; Serological Pipettes; New 25/40 mL and 50/70 mL Reservoir Serological Pipettes; FILTERMAX 0.2μm PES Vacuum Systems, 150, 250, and 500 mL; Bottle Top 0.2μm PES Filters; 0.2μm PES Syringe Filters; Cryo Tubes.

TPP-US Web site: http://tpp-us.com.

MIDSCI
280 Vance Road, St. Louis, MO 63088
Contact: Bill Gierasch
PH: (800) 227-9997 FX: (636) 225-9998
E-mail: tech@midsci.com
Web site: www.midsci.com

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COMPONENTS AND INSTRUMENTATION

CONTAINMENT

MOCON is the global market leader in high-quality permeation systems, leak detectors, and headspace analyzers. These analytical instruments can be used with a variety of structures and products to determine shelf life and permeation of oxygen, water vapor, and other molecules. Additionally, the company provides consulting and analytical services for those wishing to conduct off-site testing.

Typical users of MOCON's products and services are research laboratories, production facilities, quality control and safety departments in the pharmaceutical, packaging, medical, food, beverage, plastics, environmental, oil and gas, homeland security, and many other industries.

MOCON has the largest and most advanced permeation test laboratory in the world that offers a variety of analytical services for use in quality control, research, and product development applications. MOCON performs testing in compliance with a variety of standards such as cGMP, ISO, USP, ASTM, TAPPI, JIS, DIN, IPPO, UL, INDA, SAE-J-2659, as well as other testing methods and data gathering procedures.

MOCON, Inc.
7500 Boone Ave. N., Minneapolis, MN 55428
PH: (763) 493-6370 FX: (763) 493-6358
E-mail:
mocon@mocon.com
Web site: www.mocon.com

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ChargePoint Technology designs and manufactures containment valves for safe powder transfer across a wide range of pharmaceutical and biopharma manufacturing processes. The patented, ‘ChargePoint' Split Butterfly Valve technology provides high containment for a variety of solid dose and API handling applications: from reactor charging to milling, and from smallscale sampling to bulk IBC charging/discharging.

Further enhancements to the standard valve range enable OELs of <1μg/m³ to be achieved. The pressure rated ChargePoint enables product to be charged under pressure from full vacuum to 6BarG. A range of automated docking systems, clean in place solutions, and rigid and flexible containers are available to compliment the ChargePoint split valve range, giving the user maximum operability and containment performance.

ChargePoint Technology
8 Estuary Banks, Estuary Business Park, Liverpool, L24 8RG, UK
PH: +44 (0)151 448 7700 FX: +44 (0)151 448 7703
E-mail:
sales@thechargepoint.com
Web site: www.thechargepoint.com

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CONTRACT MANUFACTURING

CONTRACT MANUFACTURING AND TESTING

Quality products, close relationships, and reliable service — these are the principles on which Patheon was founded. Today we're renewing our commitment to these principles. And we are taking it a step further. Our vision is to be the industry's best provider of development and commercial manufacturing services to the pharmaceutical industry. We call it the Patheon Customer Experience. With over 3 million square feet of capacity, 4,700 employees at 11 locations across the globe, and 30 years of industry-leading experience, we are determined to turn vision into reality. Of course we can only be the best when our customers tell us we are — over and over again. For this reason we will always be...

100% committed to the Patheon Customer Experience — that's our guarantee.

Patheon
7070 Mississauga Road, Suite 203, Mississauga,
Ontario L5N 7J8 Canada
PH: (905) 821-4001 FX: (905) 812-2121

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Bionique® Testing Laboratories, Inc. is a leading global organization specializing in the testing of cell cultures and biologicals for mycoplasmal contamination. The company has been providing mycoplasmal testing services, diagnostic kits, and consultation to pharmaceutical companies, biotechnological companies, research institutions, and media/sera manufacturers since 1983. Bionique plays a critical role in the success of its clients by assuring the integrity of their cell lines and the biosafety of their final product.

Our core services include direct culture, indicator cell lines, DNA-fluorochrome assays, antibiotic sensitivity profiles, validation studies, mycoplasmal elimination, and contractual research and development services. Kits include the exclusive CELLshipper® and Control Slides. Bionique Testing Laboratories has the capabilities and expertise to provide timely and reliable results at an affordable price.

Bionique® Testing Laboratories, Inc.
156 Fay Brook Drive, Saranac Lake, NY 12983
PH: (518) 891-2356 FX: (518) 891-5753
Web site: www.bionique.com

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CONTRACT MANUFACTURING AND TESTING

CONTRACT MANUFACTURING AND TESTING

DSM Pharmaceuticals, Inc., a business unit of DSM Pharmaceutical Products, is an established custom manufacturer providing clinical trial custom manufacturing services to the biopharmaceutical and pharmaceutical industries worldwide.

CTM services from DSM include:

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Hospira is a global, specialty pharmaceutical and medication delivery company. The company's One 2 One business is a world leader in the custom development and manufacture of parenteral products packaged in vials, prefilled syringes, cartridges, flexible containers, and ampules.

One 2 One offers development and manufacturing services at its worldwide facilities located in North America, Europe, and Australia. With more than 70 years of parenteral manufacturing experience, One 2 One is known for its customer service orientation.

Hospira Worldwide, Inc.
275 North Field Drive, D-0988, Bldg. H-1, Lake Forest, IL 60045
PH: (224) 212-2267 FX: (224) 212-3210
E-mail:
one2one@hospira.com
Web site: www.one2one.hospira.com

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CONTRACT MANUFACTURING AND TESTING

DATABASES

Vetter is an independent, international specialist in the production of aseptically prefilled injection systems, cartridges, and vials. For more than 25 years, the name of Vetter has stood for quality, innovation, and strategic partnerships. Our customized products and processes have been approved by the FDA, the EMEA, and other authorities, which ensures a maximum of quality and safety. Our customers from the biotech industry can count on highly efficient collaboration and strict adherence to international standards. This particularly means best support for perfect adaptation of administration of the active ingredient. Our production processes are both as effective and as cautious as possible with the active ingredients. Combined with our innovative application systems they come up to the high expectations of these types of sensitive substances. From the development phase through to global market supply, Vetter thus helps its partners' products to advance in their markets.

Vetter Pharma-Fertigung GmbH & Co. KG
Schuetzenstrasse 87, 88212 Ravensburg, Germany
PH: +49 751 3700-0 FX: +49 751 3700-4000
E-mail:
info@vetter-pharma.com
Web site: www.vetter-pharma.com

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   Organic Materials Analysis

PDF-4/Organics 2009 is designed for rapid materials analysis of organics and organometallic materials and their common formulations. While PDF-4/Organics contains predominantly organic and organometallic materials, it also contains thousands of reference data for polymeric and inorganic excipients, common inorganic salts, and starting materials. We have added all the types of materials typically found as reaction products and formulation ingredients.

Applications

PDF-4/Organics Content

Visit ICDD's Web site for publications related to the technology and applications of the Powder Diffraction File. http://www.icdd.com/support/references/default.htm

International Centre for Diffraction Data
12 Campus Boulevard, Newtown Square, PA 19073
PH: (610) 325-9814 FX: (610) 325-9823
E-mail: marketing@icdd.com
Web site: www.icdd.com

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DISPOSABLE DOSING SYSTEMS

DRYING

The Prevas™ Disposable Dosing System is the latest technology from Bosch Packaging Technology's Pharma business unit. Prevas is the industry's first prevalidated, preassembled, and presterilized liquid dosing system for clinical and production applications. Prevas is available in a number of standard or custom configurations. Disposable dosing systems eliminate costly cleaning and validation procedures, making them an economical and easy-touse solution.

  • USP/NF Class IV Materials
  • Gamma Irradiated
  • Preassembled, Ready to Use
  • ISO 11137 Sterilization
  • No Cleaning or Validation
  • Economical
  • Reduced Operator Exposure

Bosch Packaging Technology
8700 Wyoming Ave. N., Minneapolis, MN 55444
PH: (763) 424-4700 FX: (763) 493-6776
E-mail:
sales@boschpackaging.com
Web site: www.boschpackaging.com

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Applied Chemical Technology works with the Pharmaceutical Industry to provide standard and custom-designed fluid bed systems. The 100N Fluid Bed System offers a perfect solution for process testing or development. The 100N is easy to set up and use.

With the ACT 100N you can easily experiment with fluidization velocities, operating temperatures, coating methods, drying and cooling curves, and other process variables. The 100N is also ideal for batch production runs and product development/evaluation. In addition, all data is directly applicable for scale up to the ACT commercial scale fluid bed systems.

Please visit ACT in Booth # 2060, at the AAPS meeting, for a demonstration of the 100N Fluid Bed System.

Applied Chemical Technology Inc.
4350 Helton Drive, Florence, AL 35630
Contact: Alan Nix
PH: (800) 228-3217 FX: (256) 760-9638
alannix@appliedchemical.com
Web site: www.appliedchemical.com

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ENGINEERING, COMMISSIONING, VALIDATION, AND CONSTRUCTION MANAGEMENT

ENGINEERING, COMMISSIONING, VALIDATION, AND CONSTRUCTION MANAGEMENT

Global Service — Local Support

E&K continues to expand its biotechnology, pharmaceutical, and medical device service business with our centers of excellence in Newark, DE; Raleigh, NC; Guaynabo, Puerto Rico; Leatherhead, United Kingdom; and Singapore.

Our philosophy in all project delivery, from a large-scale, EPCMV capital project to a small feasibility study, is "to think like an owner." This focus assures our clients that our solution is not delivered until the scope of work is executed and the regulatory compliance is complete. Our services to the pharmaceutical, medical device, and biotechnology business include:

Our team of experts is dedicated to providing all of our clients the most current compliance guidance, design, and professional service at reasonable costs.

BE&K BioPharm
242 Chapman Road, Newark, DE 19702
Contact: Tom Madden
PH: (302) 452-9054 FX: (302) 452-9010
E-mail:
maddent@bek.com
Web site: www.bek.com

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CRB is dedicated to offering specialized services to the pharmaceutical, biotech, and medical device industry. We can take total responsibility for your project, or we can help with any individual step along the way. Services include:

  • Consulting
  • Design
  • Construction
  • Commissioning
  • Qualification

We have completed over 7,500 projects for hundreds of clients, most of whom have been repeat clients. This track record strengthens our belief that in order to earn a client's confidence as an A/E/C partner, we must first serve them effectively as a business partner.

With more than 400 employees, in 10 offices nationwide, CRB is the perfect partner to deliver your complex projects on time and on budget.

CRB Engineers — Builders
7410 NW Tiffany Springs Parkway, Suite 100
Kansas City, MO 64151
Contact: Sue Dreckman
PH: (816) 880-9800 FX: (816) 880-9898
E-mail:
crb@crbusa.com
Web site: www.crbusa.com

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EXCIPIENTS

FEEDING AND CONVEYING SOLUTIONS

Allan Chemical offers a wide variety of high-quality excipients for the pharmaceutical industry, manufactured in ISO certified, cGMP facilities; among them:

  • Calcium Stearate
  • Magnesium Stearate
  • Sodium Stearate
  • Zinc Stearate
  • Diethyl Phthalate
  • Triacetin
  • Triethyl Citrate

Kosher and Halal certified products are available. We can also customize our products to meet your particular specifications. Stocks are on hand for prompt shipment in Harrison, NJ, and Kennesaw, GA.

Allan Chemical Corporation
PO Box 1837, Fort Lee, NJ 07024
Contact: Allan or Rulú
PH: (201) 592-8122 FX: (201) 592-9298
E-mail: allanchem@allanchem.com
Web site: www.allanchem.com

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K-Tron Process Group manufactures solids and liquid feeders, pneumatic conveying equipment, and systems specific to the pharmaceutical industry.

The K-Tron Micro-Ingredient (MT12) feeder and other pharmaceutical feeders are available in twin-screw, volumetric, and loss-in-weight versions. Applications include jet milling, extrusion, dispensing, continuous blending, granulation, coating, and lubricant feeding. Premier Pneumatics conveying equipment meets demanding requirements of powder transfer for dilute and dense phase applications. K-Tron has engineered process automation systems including:

  • Extrusion — both wet granulation and hot melt types
  • Lubrication of tablet press tooling
  • Continuous direct compression, blending, and coating systems
  • Feeding for milling and micronization of powders
  • Dispensing applications

K-Tron's designs are engineered to meet rigid requirements of cGMP standards and the use of FDA approved/certified materials of construction. All units are designed for cleaning requirements, ease of disassembly and maintenance, and required containment levels.

Options include systems integration for batch or continuous processing, containment designs, and CIP rinse in place designs.

K-Tron America, Inc.
Routes 55 and 553, Pitman, NJ 08071
PH: (856) 589-0500 FX: (856) 582-3937
Contact: Sharon Nowak
E-mail:
info@ktron.com
Web site: www.ktron.com/pharma

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FILTRATION

INSPECTION/PRODUCT INSPECTION

Custom Filtration

ZenPure provides one-stop full service for custom solutions of your filtration needs from concept, to engineering design, to finished product.

ZenPure provides validated capsules with standard and gamma stable materials for critical processes. Both the inlet and outlet fittings can be selected or designed separately from multiple fittings to meet your exact plumbing requirements. Our newest capsule fittings, the male and female quick connect couplings, allow for rapid filter replacement. This facilitates quick start up and minimizes the risk of contamination.

ZenPure has over ten thousand different possible combinations of capsules that can be ordered. Utilizing a variety of filtration membranes, as well as several different capsule sizes, ZenPure can provide high-performance filtration from laboratory scale up to production.

ZenPure Products Distributed by JALT Technologies
PO Box 597, Manassas, VA 20108
PH: (703) 335-9910 FX: (703) 310-6232
Contact: Ken Adrian
E-mail:
Info@jalttech.com
Web site: www.jalttech.com, www.zenpure.com

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Boost profits and protect your brand with the METTLER-TOLEDO HI-SPEED and METTLERTOLEDO SAFELINE line of checkweighers, metal detectors, and x-ray inspection equipment for the pharmaceutical industry.

Mettler-Toledo Hi-Speed delivers productivity and profits with its comprehensive line of high precision checkweighers. The XSSeries combines the patented METTLER-TOLEDO EMFR weighing technology with user advanced touch screen controls for unmatched accuracy, simple operation, convenient integration, and maximum uptime. Starweigh checkweighers are an ideal solution for applications where laboratory accuracies and high production rates are essential for profitability and compliance.

Mettler-Toledo Safeline metal detectors and x-ray inspection systems lead the product inspection industry in sensitivity, durability and ease-of-use. Both technologies automatically detect and reject pharmaceutical products containing ferrous, non-ferrous and stainless steel contaminants. Our x-ray inspection systems can also detect and reject products containing glass, stone, bone or high-density plastic contaminants and also inspect for portion control and package integrity.

Mettler-Toledo Hi-Speed
5 Barr Road, Ithaca, NY 14850
Contact: Terry Eldred
PH: (607) 257-6000
E-mail:
hispeed@mt.com
Web site: www.mt.com/hispeed

Mettler-Toledo Safeline
6005 Benjamin Road, Tampa, FL 33634
Contact: Sarrina Crowley
PH: (813) 889-9500
E-mail:
Safeline.marketing@mt.com
Web site: www.mt.com/safelineus

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LABORATORY EQUIPMENT

LIMS

Wireless Monitoring Has Evolved!

V.2 — The next generation of Rees Scientific's Wireless Environmental Monitoring provides data reliability, robust security, wireless flexibility, and the expertise and support of the industry's premier provider of environmental monitoring solutions. Key features include 2.4 GHz True DSSS transmissions, data buffering at the transmitter level, low battery alarm, and reliable two-way communication with self-healing mesh networks. V.2 Wireless is compatible with existing sensors and Rees Hardware.

Coupled with CentronSQL, our most powerful environmental monitoring system to date, Rees Scientific offers centralized alarm notification and data collection, Joint Commission, GxP, FDA 21CFR11, and USP <797> compliance. Meet today's toughest regulatory standards with advanced and custom reports utilizing crystal reports, independent logging rates, graphical input status reports, and scalable maps. Alarm notification via local sonic, relay, text messaging, telephone, and E-mail notification, combined with Web access, ensures that the right people are notified and will respond quickly, wherever they are.

Rees Scientific Corporation
1007 Whitehead Road Extension, Trenton, NJ 08638
PH: (609) 530-1055 FX: (609) 530-1854
E-mail: sales@reesscientific.com
Web site: www.reesscientific.com

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Thermo Scientific Darwin LIMS™ is specifically designed to address the unique needs of pharmaceutical manufacturing and research and development QA/QC labs. Darwin's unique batch and product-oriented design aligns directly with pharmaceutical manufacturing processes, allowing research and development and production data to be logically organized, summarized, and reported. The substantial costs and risks associated with customizing a generic laboratory information management system (LIMS) to serve the needs of pharmaceutical manufacturing have given rise to the trend toward out-of-the-box, or purpose-built, software solutions like Darwin.

The benefits of application-specific LIMS are obvious: less customization means dramatically reduced implementation, training, validation, and maintenance costs — for a lower total cost of ownership and higher end-user acceptance.

Thermo Scientific, Part of Thermo Fisher Scientific
1601 Cherry St., Suite 1200, Philadelphia, PA 19102
PH: (215) 964-6020 FX: (215) 964-6021
E-mail:
marketing.informatics@thermo.com
Web site: www.thermo.com/informatics

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LYOPHILIZATION

MEASURING DEVICES

Anteco Pharma offers formulation, lyophilization, and packaging services to the pharmaceutical, medical device, and food industries. We specialize in innovation, flexibility, and quick response with a new GMP compliant facility, state-of-the-art equipment, and an experienced staff with track records of success.

Services include:

  • Lyophilization capacity from 1 liter to 2000 liters
  • Class 10,000 manufacturing suites
  • Temperature-controlled processing and storage
  • Formulation
  • Packaging
  • Process development, scale-up, and process transfer
  • Project management and compliance support

Our quality system is compliant with drug, medical device, and food GMPs. Customer and third-party audits are encouraged and supported.

Let us show you how we can use these resources to provide cost-effective solutions to your toughest manufacturing challenges.

Anteco Pharma
925 Development Drive, PO Box 100, Lodi, WI 53555
PH: (608) 592-6925 FX: (608) 592-7925
E-mail:
info@antecopharma.com
Web site:
www.antecopharma.com

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BE confident

We drive value with our knowledge of how temperature plays a role in the Life Sciences manufacturing process:

Join our community of temperature-measurement experts: visit burnsengineering.com today!

Burns Engineering
10201 Bren Rd. E., Minnetonka, MN 55343
PH: (800) 328-3871
E-mail:
info@burnsengineering.com
Web site:
burnsengineering.com

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MEASURING DEVICES

MELT EXTRUSION

Particle Size Analyzers

At Microtrac Inc. we specialize in particle size instrumentation, offering a complete line of products that will enable you to control your product or process. The Nanotrac and Nanotrac Ultra series, with DLS technology, operate with a particle size analyzing range of .8 to 6500nm. The S3500 series Tri-Laser diffraction analyzer, with a particle size range from .01 to 2816 microns, allows wet/dry operation. Microtrac Inc. has proven itself again with the releases of the all new Bluewave (True Blue Lasers) and the all new Zetatrac (Zeta potential with Nano particle size capability) series instrumentation.

Visit our Web site at: www.microtrac.com

Contact Domestic Sales:
Jay Schild
jay_s@microtrac.com

Contact International Sales:
John Foley
john_f@microtrac.com

Europe:
Paul Cloake
paul_c@microtrac.com

Microtrac Inc.
12501A 62nd Street North, Largo, FL 33773
PH: (727) 507-9770 ext. 13 FX: (727) 507-9774
Web site: www.microtrac.com

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Foster Pharma is a polymeric materials and process specialist on a mission to provide innovative solutions to current and future drug delivery challenges. These polymeric materials are modified to include a functional active or pharmaceutical ingredient to increase solubility and bioavailability, achieving greater therapeutic results.

Foster's melt technology increases the safety and security of innovative therapies and improves the overall performance of the drug. Foster's technology can be applied to applications such as controlled release of drugs, bioresorbable coatings for medical devices, taste-masking, targeted delivery, patient-specific solutions, adulteration-proofing, ingestible substrates, drug capsules, antimicrobial products, anti-counterfeiting measures, and other technologies. With a focus on cost-effectiveness, the melt extrusion process is well-suited for generics, low-volume, and orphan drug formulations. Activities include engineering planning, design, experimenting, development, formulation development support, process trials, scale-up, manufacture of supplies for bioavailability and clinical trials, validation, technology transfer, and production.

Foster Pharma
Contact: Dan Lazas, President
PH: (860) 481-9232
E-mail: dlazas@fostercomp.com
Web site: www.fostercomp.com

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MICROBIOLOGY TESTING

PAT AND ANALYTICAL TECHNOLOGIES

Lonza has rapid solutions for your testing needs. The microCompass™ system is a genetic-based microbiology testing system that gives you accurate results in as little as four hours. Complex samples are not a problem for microCompass™. It is ideal for applications where time to results is critical. Examples include raw material testing, bioburden monitoring, and cell culture. Its streamlined, more accurate testing procedures mean your company could profit with labor and cost savings.

The PyroSense® automated on-line endotoxin detection system was developed to monitor the quality of water systems directly from the water loop. The innovative robotics and recombinant reagents in the system reduce the variability inherent in current testing methods leading to quality by design. The PyroSense® system offers a cost-effective solution for early identification of potential contamination in your water system, reducing overall testing costs and reducing risk.

Lonza
8830 Biggs Ford Road, Walkersville, MD 21793
PH: (301) 898-7025 FX: (301) 845-4024
Web site: www.lonza.com/RTS

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Thermo Scientific

The Thermo Scientific brand represents superior analytical instruments, laboratory equipment, software, services, consumables, and reagents. Find better workflow solutions spanning sample preparation, sample analysis, and data interpretation. Explore new capabilities from top names now sold as Thermo Scientific.

Visit  www.thermo.com to explore:

  • Analytical instruments
  • Reagents and consumables
  • Essential lab equipment
  • LIMS and analytical software
  • Services and support

Thermo Scientific, Part of Thermo Fisher Scientific
81 Wyman St., Waltham, MA 02451
PH: (781) 622-1000
Web site:
www.thermo.com

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POWDER PROCESSING

SINGLE USE COMPONENTS

TOTE SYSTEMS® invented the Intermediate Bulk Container (IBC) in 1946…we have been an innovator and quality manufacturer ever since.

Today TOTE® is your DOMESTIC provider of all components associated with industrial, food, healthcare, and pharmaceutical materials handling.

TOTE® has extensive experience in all facets of bulk materials handling including CONTAINERS, FILLING, DISCHARGING, VALVING, BLENDING, LIFTING, and WASHING.

From a single TOTE® to a fully automated, integrated TOTE SYSTEM®, we are ready to assist you and demonstrate our commitment to every facet of the order process.

If it doesn't say TOTE®, it is not a genuine TOTE SYSTEM®.

TOTE®…the name that started an industry.

Tote Systems
651 N. Burleson Blvd, Burleson, TX 76028
Contact: Sharon Flowers
PH: (888) 838-4178 FX: (817) 447-7801
E-mail:
sales@totesystems.com
Web site: www.totesystems.com

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The Gore product portfolio includes single-use components that enable the safe transfer, containment, and sampling of sterile liquids as well as high-purity solutions for SIP and CIP applications in long-life, highly durable form and packaging solutions. Gore tubing, hoses, connectors, manifolds, sampling and collection systems, and custom-molded components are manufactured in a cleanroom operation. GORE™ STA-PURE™ High-Resilience Tubing effectively resists the mechanical stress of peristaltic pumps.

The GORE™ STA-PURESM Bioprocess Configurator for Custom Assembly Design enables customers to minimize fluid assembly system design time while providing fully customizable design options specific to various process needs.

GORE™ LYOGUARD® Freeze-Drying Products improve lyophilization processes while reducing product and freeze-dryer contamination risk.

GORE® Filtration Products help to optimize product collection of pharmaceutical dry powders as well as dust emissions.

GORE™ Microfiltration Media enables pharmaceutical filter manufacturers to engineer high-performing, reliable filters.

GORE™ Packaging Vents facilitate closed, pressure-equalized systems for multi-dose drug packaging applications.

Gore PharmBIO Products
100 Airport Road, Elkton, MD 21922
PH: (800) 294-4673
E-mail:
pharmbio@wlgore.com
Web site: www.gore.com/pharmbio

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SINGLE USE TECHNOLOGY

SOFT GELS

Specializing in injection molding services and manufacturing, q/RT solutions LLC has designed a disposable depth housing (DDH) utilizing multiple filter manufacturers' 12" multicell depth modules with a possible filtration area up to 4.0 m². Our unique design can accommodate both flat gasket and double o-ring connections. Materials of construction meet all USP VI requirements and can maintain an operating pressure of 40 psi. With standard, 1.5" sanitary connections, and a stand-alone design, the DDH does NOT require any additional support or racking system for use. Simple-to-use, disposable, large-volume depth filtration is finally here.

With years of injection molding experience and innovative design engineering, look for q/RT to be your single-use systems innovator. In 2009, check out our new and exciting products to improve single-use technologies and systems.

q/RT solutions LLC
2620 Christian Court, Chaska, MN 55318
Contact: Scott Pritchard
PH: (952) 361-3394
Web site:
www.qrtsolutions.com

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At Banner, talented scientists from all over the world have been brought together to develop the drug delivery technologies of the future — and to create new products and line extensions that will set you and your compounds apart. Our global research and development group includes more than 80 professionals working in labs in our United States headquarters, as well as Europe and Mexico.

We actively develop new technologies to fulfill needs in oral drug delivery and consumer health care that address improved compliance, safety, and cost. With experience in biochemistry, cellular biology, pharmaceutics, industrial pharmacy, and analytical chemistry, our focus is on combining technologies to enhance bioavailability through our innovative softgel technologies.

Banner works closely with pharmaceutical companies to develop new products and product line extensions that incorporate the proven, consumer-preference advantage that softgels offer — maximizing the value of intellectual property, and offering healthcare options that are more effective and preferred by consumers.

See our advertisement on page 31.

Banner Pharmacaps Inc.
4125 Premier Drive, High Point, NC 27265
Contact: Pam Smith
PH: (336) 812-7404 FX: (336) 812-3719
E-mail:
pesmith@banpharm.com
Web site: www.banpharm.com

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TABLET PRINTING

TABLETS AND CAPSULES

R.W. HARTNETT COMPANY
Women Owned #7098058GC

Founded in 1880, R.W. Hartnett Co. is the original designer and first manufacturer of tablet, hard gelatin capsule, and soft gelatin printing machines. Both large pharmaceutical and small entrepreneurial companies continue to rely upon our pioneering approach for their technological and mechanical solutions. R.W. Hartnett Co. is recognized around the world for producing a superior, dependable product. R.W. Hartnett Co. currenty has machines in more than 33 countries. All our machines are customized specifically for your product. Ink printing and laser printing (non-contact) are just two of the operations of our machines. Custom inspection/rejection systems can be added to any of our machines to ensure a perfect print — each and every unit printed. No matter the size, shape, or texture of your product, we can print it. We proudly mark this, our 128th year in business.

R.W. Hartnett Company
2055 Bennett Road, Philadelphia, PA 19116
PH: (215) 969-9190 FX: (215) 969-9030
Contact: Keith Boyce
E-mail:
sales@rwhartnett.net
Web site: www.rwhartnett.com

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CFS 1200 Capsule Filling And Sealing Machine

Designed to allow formulation scientists the ability to better exploit the potential of lipid-based formulations for poorly soluble compounds, the CFS 1200 helps accelerate the development timeframe and achieve faster time to first in man.

A fully automatic, cGMP compliant machine, it fills and seals up to 1,200 capsules per hour with liquid or semisolid formulations without banding.

  • Designed for ease-of-use and high reliability, with the ability to quickly clean and change capsule sizes with available change parts.
  • Product integrity ensured with gentle handling of capsules before sealing and during the drying cycle.
  • A robust filling pump with highly accurate temperature control.
  • Improved capsule manipulation before sealing and during drying using new ‘Cap-edge' handling system.
  • Improved design of filling and sealing process ensuring better control and cleanability.

Capsugel
535 North Emerald Road, Greenwood, SC 29646
PH: (888) 783-6361 FX: (888) 783-6360
E-mail: glenda.oliver-smith@pfizer.com
Web site:
www.capsugel.com

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TRADE SHOW/ASSOCIATION

TRADE SHOW/ASSOCIATION

Join the Largest Scientific Society for Professionals in the Chemical Sciences

ACS Membership includes:

Joining ACS may be the best professional decision you'll ever make. Why wait? Join today.

American Chemical Society
1155 Sixteenth St. NW, Washington, DC 20036
PH: [US] (800) 227-5558 or [Worldwide] (202) 872-4600
E-mail: NewMember@acs.org
Web site: www.acs.org/join

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INTERPHEX is the world's most trusted source for leading-edge technology, education, and sourcing of the products and services that drive scientific innovation for Life Sciences manufacturing from drug development to market — accelerating regulated products for patient care globally.

INTERPHEX is the only Life Sciences event that represents a true cross-section of the pharmaceutical and biopharmaceutical industries. Industry-leading professionals worldwide make INTERPHEX the industry's annual focal point for driving change and efficiencies for the global pharmaceutical and biopharmaceutical market.

Visit www.INTERPHEX.com for more information.

INTERPHEX
383 Main Ave, Norwalk, CT 06851
Web site:
www.INTERPHEX.com

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TRADE SHOW/ASSOCIATION

VALVES

INTERPHEX Puerto Rico, co-located with MEDICAL DEVICE Puerto Rico and featuring Supply Chain & Logistics Puerto Rico, is the pharmaceutical industry's respected source of innovation, education, and professional advancement for a globally important center of drug manufacturing, from process development through delivery to market. Networking essential to business success is as important here as the exploration of new products and services that enhance human life and health.

Sponsored by ISPE, Pharmaceutical Processing, Pharmaceutical Engineering, Pharmaceutical Technology, PRMA, and INDUNIV, this event includes in-depth educational workshops, plus a showcase of products and services to help you work more productively and efficiently in today's competitive industry.

Visit www.interphexpuertorico.com for more information.

INTERPHEX Puerto Rico
383 Main Ave, Norwalk, CT 06851
Web site:
www.interphexpuertorico.com

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Whatever The Flow Control Challenge, Rely On Baumann™ Valve Solutions

Baumann digital control valves minimize process variability, increase system uptime, and are designed to meet stringent Life Science requirements.

A Division of Emerson Process Management, Baumann is a world leader in the manufacture of technologically innovative valves. Together with our Local Business Partner Network, we are well positioned to provide global expertise to our customers. Offerings:



Fisher Controls International LLC
Baumann Valves
130 International Drive, Portsmouth, NH 03801
E-mail:
Info.Baumann@emerson.com
Web site:
www.Baumann.com

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WASTEWATER TREATMENT

WASTEWATER TREATMENT

Established in 1949, Aquafine Corporation is a Southern California-based company recognized as one of the largest ultraviolet equipment manufacturers in the world. Operating as a strategic business unit of Trojan Technologies, Aquafine now brings over 80 years of combined experience to the global industry, becoming the "center of excellence" for the collective industrial/commercial base.

Located in Valencia, CA, Aquafine's state-of-the-art facility and UV technology allows the Aquafine advanced UV water treatment systems to meet the changing requirements and needs of a diverse customer base around the world. Aquafine provides UV solutions worldwide for TOC reduction, chlorine and chloramine destruction, ozone destruction, and disinfection.

Aquafine Corporation
29010 Avenue Paine, Valencia, CA 91355
PH: (661) 257-4770 FX: (661) 257-2489
Toll Free: (800) 423-3015 [outside CA, within US and Canada]
E-mail:
sales@aquafineuv.com
Web site: www.aquafineuv.com

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Packaged Wastewater Treatment Systems, pH Adjustment, And Biowaste Inactivation

Digital Analysis manufactures packaged, skid-mounted pH adjustment and bio-inactivation systems ranging in size from 1 GPM to more than 1,000 GPM. Our unique optimization technology allows for higher throughput in a smaller footprint while providing guaranteed performance.

Systems are completely automated, requiring little or no operator intervention. All systems are completely fabricated and tested in our facility before shipping.

Bio-Inactivation Options Include:

System Features:

Digital Analysis Corp.
PO Box 95, Skaneateles, NY 13152
PH: (877) 685-0760
E-mail:
info@digital-analysis.com
Web site:
www.phadjustment.com

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