Pharmaceutical Technology EPR Monthly Issue:
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Pharm Tech
April 15/2015
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SPECIAL EDITION

With less than one week until INTERPHEX 2015 (April 21–23, Javits Center, NYC), it is time to start planning to get the most out of your visit. This special edition is designed to keep you up to date with industry trends, best practices, and new products.

PRODUCTION TRENDS

What's Old is New Again: Wresting Value from Second-Hand Equipment

Experts discuss some of the latest trends in buying and selling used pharmaceutical equipment assets.
/ read more /

Coming to INTERPHEX—PharmTech Educational Programming

Educational programs from PharmTech on the show floor will include expert presentations on serialization, continuous solid-dosage manufacturing, advances in tableting, the contract services market, and cell-therapy commercialization.
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Now Online

Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk Assessment.
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TROUBLESHOOTING

Trouble-Free Lyophilization

Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.
/ read more /

PACKAGING

Packaging Innovations on Display at Interphex

Innovations include multimedia packaging and improved filling systems.
/ read more /

EDITOR'S PICKS

Modular Aseptic System Fills Syringes or Vials

The Dara SFL Syringe Filling and Plugging machine from NJM Packaging is an aseptic filling and plugging system for syringes or vials in a nest or tray.
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EXPERT

INTERVIEW

American Association of Pharmaceutical Scientists (AAPS) Executive Director, Walt Marlowe, speaks with Pharmaceutical Technology about AAPS.

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Pharm Tech TV
Interphex

Software Enables Real-Time Acquisition and Analysis of NMR Spectra

Bruker's InsightMR software for on-line NMR analysis enables real-time data analysis and acquisition control for process monitoring.
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Sight Flow Indicators Shorten Cleaning Cycles

Flow indicators maximize the view into sterile processes.
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Machine Efficiently Washes Filled and Closed Containers

Bosch Packaging Technology's RAN 3080 exterior washing machine removes product residue and other contamination from filled and closed glass containers using a new, efficient, high-pressure cleaning process.
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New ISO 8 Processing Suite for dry powders
Jet Pulverizer Co. has enhanced their cGMP services by building a new ISO 8 (Class 100,000) classified processing suite for micronizing Pharmaceuticals, Nutraceuticals, Cosmetics, and Foodstuffs. Various processing services are available such as jet milling, hammer milling and screening at cGMP level protocols. The cGMP level includes enhanced cleaning procedures, cleaning verification, and documentation for strict FDA requirements. FDA registered and inspected facility.
FDA registered and inspected facility.


SHOWCASE (sponsored)

Leistritz manufactures twin screw extruders and systems for continuous mixing/devolatilization of API's with carriers. Both lab scale and production scale equipment is available, and applications include melt extrusion and granulation. Pelletization and film/sheet downstream equipment is available. Services include a process NJ development laboratory and ongoing training/workshops.
Learn more

A world-leading tablet compression solutions provider, Natoli Engineering Company uses the highest quality materials to create efficient, durable and highly performing tablet compression tooling. We manufacture all punch configurations including single-tip, multiple-tip, micro tab, exotic shapes, IMA Comprima, die table segments and more, from a variety of high-quality steel types and specialty coatings. Request a quote and view informative content on our website.
Learn more

Federal Equipment has been a trusted source of pharmaceutical processing equipment for more than 50 years. Our pharmaceutical team has extensive market knowledge, so we consistently exceed clients' needs with our extensive inventory, stored in climate- controlled, pharma-dedicated warehouses, as well as fast, accurately-appraised liquidations. Contact Federal Equipment for more information on how we can help with your equipment needs. email us at [email protected]
Learn more

Tablet Press for Premum Large Batch Production

Fette Compacting America's FE75 Tablet Press is a double-sided rotary press that can be equipped with up to 115 punch stations to produce more than 1.6 million tablets per hour. Ideal for the premium production of large batches, the FE75's four compression rollers feature a special control system for direct compression, enabling the machine to operate with two intermediate pressures.
Learn more

INTERPHEX PLANNING GUIDE (sponsored)

VAI's Wipers

VAI features a complete range of sterile wipers for use in any cleanroom environment. All of our wipes are knitted with continuous monofilament polyester, cut using "FocusEdge" cutting technology, have validated sterility via gamma irradiation at 10-6 SAL, and are ready-to-use. Our wipes are available in a multitude of varieties including dry, saturated with HYPO-CHLOR®, STERI-PEROX®, USP IPA WFI ALCOH-WIPES®, or our DECON-CLEAN® residue remover. Veltek Associates, Inc., 15 Lee Blvd, Malvern, PA 19355, USA • tel. 610.644.8335 • INTERPHEX Booth # 2521
/ www.sterile.com /

Company Services

Watson-Marlow Fluid Technology Group is the leading manufacturer of peristaltic pumps, Flexicon aseptic filling solutions, high-purity tubing, and BioPure single-use fluid path components. Offering a contamination-free single use fluid path and a range of products from benchtop to production, Watson-Marlow is the first choice for fluid transfer, metering, dispensing, and filling. Watson-Marlow Fluid Technology Group, 37 Upton Technology Park Drive. Wilmington, MA 01887 • tel. 800.282.8823 • INTERPHEX Booth # 2833
/ www.wmftg.com /

Company Services

Weiler Engineering, Inc.'s corporate focus is to provide advanced aseptic liquid processing technology through application of customized ASEP-TECH® Blow/Fill/Seal machinery and services. ASEP-TECH® Blow/Fill/Seal machines incorporate the three-step process of blow molding, aseptic filling, and hermetic sealing of liquid products in one compact machine frame. Weiler is located in a 140,000-ft2 plant near Chicago O'Hare International Airport in the USA. Weiler Engineering, Inc., 1395 Gateway Drive, Elgin, IL 60124, • tel. 847.697.4900 • INTERPHEX Booth # 1234
/ www.weilerengineering.com /

Company Services

EtQ is the leading FDA Compliance, Quality, EHS, and Operational Risk Management software provider for identifying, mitigating, and preventing high-risk events through integration, automation, and collaboration. EtQ's modules are tightly integrated to deliver a leading FDA compliance solution. Key modules include Corrective Action, Audits, Risk Management, Complaint Handling, and more. EtQ
/ www.etq.com /

Clinical Material Manufacturing

Lyophilization Technology, Inc. is a Contract Development and Manufacturing Organization providing development, clinical manufacturing, and technical services focused on lyophilized products. The comprehensive range of services includes thermal analysis, formulation development, process engineering, cytotoxic/high potent APIs, pre-clinical to Phase II clinical material preparation for freeze dried pharmaceuticals, biologics, and biopharmaceuticals. Technical services encompass consulting, compliance support and training. Lyophilization Technology, Inc., 30 Indian Drive, Ivyland, PA 18974-1431 USA • tel. 215.396.8373
/ www.lyotechnology.com /

Tooling storage box

Natoli's tooling storage boxes are intended for storing, transportation, and cleaning of tooling while being safely secured in a single container. Unlike other boxes, the secure-fit lid allows safe stacking. The removable tray with optional Handle & Leg Kit can be transferred directly into ultrasonic cleaning units and other applications, and the patented design protects tooling from rust and water spots. Natoli Engineering Company, St. Charles, MO • tel. 636.926.8900
/ www.natoli.com /

Dispersers

Ross Bow Tie Dispersers, or High Viscosity Dispersers, are heavy-duty mixers designed for heavy pastes and viscous liquids up to several hundred thousand centipoise, with stainless steel 304 wetted parts. An explosion-proof inverter-duty motor helps the mixers incorporate solids into liquid vehicles in a consistent manner without running at high speeds. Ross, Charles & Son Company • Hauppauge, NY • tel. 800.243.ROSS
/ www.mixers.com /

Charging Hopper

Ross' high-efficiency charging hopper for High Shear Mixers with Solids/Liquid Injection Manifold (SLIM) Technology is designed for high-speed powder injection into liquids and eliminates the need for eductors or pumps. The design improves the rate of feed delivery at a steady pace and prevents the bridging of bulk solids, which include: fumed silica, CMC, guar gum, carbon black, carrageenan, xanthan gum, talc, alginates, pectin, titanium dioxide, calcium carbonate, starch, clays, alumina, carbomers, sugar, salts, and dye powders. Ross, Charles & Son Company • Hauppauge, NY • tel. 800.243.ROSS
/ www.mixers.com /

ACQUITY UPLC H-Class System

The ACQUITY UPLC® H-Class System combines the chromatographic performance of UPLC® with the flexibility of quaternary solvent blending. Designed to accommodate both UPLC and legacy HPLC assays, the ACQUITY UPLC H-Class System facilitates existing HPLC methods, or the transfer to full UPLC separations when you are ready. www.waters.com/hclass. Waters, Milford, MA • tel. 508.478.2000
/ www.waters.com /

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