Interphex 2012 Coverage

 

Articles & Preshow

   























New Product Showcase

metrics  Metrics Inc.: Booth 1119
Metrics will discuss the capabilities of its Greenville, N.C. commercial manufacturing facility, which is FDA and QP inspected and registered, and follows cGMP, EC and JP guidelines. “Our analytical support includes release testing, stability, microbiology testing, and custom development and validation,” Metrics says. “We handle instant release tablets and capsules; modified release and matrix formulations; coated beads, extrusion and spheronization; and encapsulation on batch sizes of 450-plus kilos.”

DSM Pharmaceuticals  DSM Pharmaceuticals: Booth 1424
DSM is a global provider of finished dosage form manufacturing and related services, with capabilities in aseptic filling of liquid and freeze-dried cytotoxic and non-cytotoxic compounds, tablets, capsules, pharmaceutical development services and clinical trial material manufacturing—all centered at Greenville, N.C. DSM representatives will answer any and all questions about the 1.5-million-square-foot, 640-acre facility. (E.g., did you know the average staff tenure is 13 years?) “Our unparalleled expertise, combined with the advanced way the facility is engineered and operated, make DSM Pharmaceuticals one of the leading finished dosage CMO's in the industry,” the company says.

Fette Fette Compacting: Booth 1524A
Fette will camp out in the Excellence United Pavilion for the first full-scale North American unveiling of its “game-changing” new tablet press, the FE55. The FE55’s "Tri.Easy" design concept showcases new technological features aimed at simplifying the three primary aspects of tablet press use—changeover, operation and maintenance. “With up to 87 stations in a footprint requiring less than two square meters of space, it completely re-defines efficiency and speed in tableting,” the company says. It will “raise more eyebrows than Lady GaGa.”

Vaisala  Vaisala: Booth 1570
Vaisala will showcase its varied monitoring, measurement and validation systems for regulated and GxP environments, for humidity, temperature, CO2, differential pressure, and more. Expect, Vaisala says, “gap-free data and industry-best accuracy.”

fitzpatrick  Fitzpatrick: Booth 1653
Fitzpatrick, a Division of IDEX Material Processing Technologies, will be exhibiting the latest in roll compaction and size reduction equipment. A special focus is on highly-contained processing systems, including CIP configurations and inert processing applications.

BW Tek 

B&W Tek: Booth 1878
Handheld materials ID devices are hot, and B&W Tek says its new NanoRam handheld Raman spectrometer is “the most sensitive and consistent tool for identifying non-conforming materials.” Designed for non-technical users, the company says, it is 21 CFR part 11 compliant and consistent with USP/EP guidelines.


Budzar Industries: Booth 2037
Budzar will highlight its Director Series Reactor Temperature Control Systems, for process vessel control from -80°to 250°C.” The heart of the Director Series, says Budzar, is a PLC control system that includes a graphic, touch-screen HMI; functionality for data collection and trending are included. The series also uses a seal-less magnetic drive pump controllable by an optional variable frequency drive to allow jacket delivery pressure to be maintained from 4 to 50 PSI.

 Freeman Freeman Technology: Booth 2136
The latest version of the Freeman’s FT4 Powder Rheometer software will be on display and in action. The FT4 and its software uses patented dynamic methodology, a fully automated shear cell and several bulk property tests, including density, compressibility and permeability to quantify powder properties in terms of flow and processability. The information aids efficient plant design and supports the effective troubleshooting and optimization of powder handling processes.

Bosch Bosch: Booth 2227
Bosch will use this year’s Interphex to relaunch the FLT small-batch vial filler, now with a 100-percent checkweigh option. The relaunch “requires minimal size parts and impresses with a small footprint and reduced change-over times,” the company says. Change-over of the vial diameter requires only three guideparts, for example. The FLT filler handles containers ranging from 2 to 100 millilitres and processes up to 30 vials per minute. Bosch will also introduce the new GKF 702 capsule filler for clinical trials and small batches.

 MG America MG America: Booth 2241
180,000 capsules per hour! That’s the claim of MG America, which will premiere its AlterNova Capsule Filler at Interphex. The filler is designed to be flexible so that growing companies can easily increase production or change product forms and sizes, MG says. “The AlterNova is the only intermittent motion capsule filler with a basic output of 105,000 capsules per hour that can be efficiently upgraded to speeds up to 180,000 capsules per hour.” The AlterNova can dose any oral pharmaceutical form – solid or liquid – and can combine up to four different kinds of products into the same capsule.

LB Bohle LB Bohle: Booth 2253
Bohle will showcase its new tablet coater, which it calls the industry’s fastest. “The Bohle Tablet Coater (BTC) provides high-quality tablet coating while reducing processing times up to 35% compared to conventional tablet coaters,” the company claims. “The BTC yields significant cost savings and improved campaign efficiency while maintaining cGMP standards required by pharmaceutical manufacturers.” L.B. Bohle’s patented air flow bed technology eliminates spray drying, thereby reducing waste while lengthening campaigns between cleanings.

GEA Pharma  GEA Pharma Systems: Booth 2421
GEA has become “the leading international supplier of advanced processing technologies for the manufacturing of oral and parenteral dosage forms for the pharmaceutical industry.” Among the many products on display will be the FlexStream (patent pending), a new fluid bed coating system that offers multiple processing from a single bowl; MODUL and PERFORMA tablet presses; and Consigma, a continuous granulation, drying and tableting process that “drastically reduces time to market of new medicines and enables the move to a 6-Sigma process.”

Sani-Matic Sani-Matic: Booth 2437
The company will feature a variety of products, including the new Ultra-Flow 45—a self-contained, portable system that is easily programmed to accommodate a wide variety of single-use, recirculated CIP applications. “Designed for highly critical cleaning situations, the Ultra-Flow can supply a wide range of CIP rates and pressures while meeting cGMP and ASME-BPE standards,” Sani-Matic says. “The Ultra-Flow 45 is the ideal solution for facilities with limited utilities and floor space as well as plants without permanent supply and return lines.”

malvern  PSL, Malvern, Sturtevant, Schenck: Booth 2443
Four vendors will join together to feature ARTMiS, or Automated RealTime Milling System within Powder Systems Ltd's (PSL) containment unit. ARTMiS is billed as a “secure, advanced processing solution for those dealing with highly potent and/or high value materials.” ARTMiS brings Sturtevant’s Micronizer Jet Mill together with a Malvern Insitec particle size analyzer and the Schenck AccuRate PureFeed Feeder. The technology “delivers a closely controlled, consistent product with minimal manual intervention.”

 Thermo Scientific Thermo Scientific: Booth 2753
Given its size, Thermo Scientific always has several new products to introduce. This year, expect a focus on new analytical instruments and contaminant detection systems, as well as innovations in single-use technology, bioprocess production products, and handheld spectrometers.

 xcellerex Xcellerex: Booth 2807
Xcellerex always has an impressive Interphex booth, this year showcasing its XDR bioreactors (including the 2000-Liter model) and its XDM mixers. Experts will also discuss details of the FlexFactory modular, portable production train—e.g., how it incorporates single-use technologies and facilitates advanced process automation.

Meissner Meissner Filtration: Booth 2817
Meissner will be showing off its new BioFlex line of  tubing assemblies, which “provide secure and convenient fluid paths for use within single-use systems and will easily scale with your process to accommodate flow rates in excess of 100 L/min.” The assemblies can also be used in conventional or hybrid facilities to connect single-use and stainless steel processing equipment, the company says.

Asahi Kasei Asahi Kasei Bioprocess: Booth 2834
To overcome downstream bioprocessing bottlenecks, Asahi Kasei’s IBD In-Line Buffer Dilution systems “generate accurate, reproducible 1X buffers on demand. Unique process analytical technology (PAT) provides conductivity and pH feedback control to accommodate ternary blends while the compact footprint can replace large buffer tanks with more economical disposable buffer bags.” Such robust buffer production accelerates capture, polishing, virus filtration, and fill/finish, says the company. Additional benefits of IBD include the flexibility to customize individual systems based on specific process requirements and seamless integration with existing bioprocess chromatography equipment.

watson marlow  Watson-Marlow: Booth 2833
The company will showcase its Flexicon FF15 semi-automatic peristaltic filling system. “Compact enough to fit in the tight space of a biosafety cabinet, the FF15 vial filling system uses new Flexicon AsepticSU single-use fluid path technology to simplify validation and deliver effortless changeover for a variety of fills.”

EMD Millipore EMD Millipore: Booth 2841
The Life Science division of Merck KGaA recently expanded its Mobius CellReady Bioreactor portfolio with the 50-L single-use stirred tank bioreactor for process development and pilot scale mammalian cell culture. “With this introduction, biopharmaceutical manufacturers now have a wider range of scalable single-use bioreactors offered by EMD Millipore, from three liters to two hundred liters, to support their needs from process development to clinical scale,” says Paul Chapman, Vice President of Biopharm Process Solutions. The Mobius CellReady system is available as a turn-key system complete with Finesse automation or as a modular system that can be integrated with a customer’s platform of choice.

Pall Pall Life Sciences: Booth 3021
Always aiming to make a splash at Interphex, Pall has at least three new products it will be featuring: the Mustang XT Acrodisc Ion Exchange Chromatography Units for Laboratory Use and Process Development; the Allegro Single-Use Tangential Flow Filtration System; and the UpScale Program Toolbox. The later introduction, the Toolbox, is an “easy-to-use, and easy-to-restock sample cabinet that allows users to test a comprehensive range of scalable products for direct flow filtration, tangential flow filtration, and chromatography. The UpScale Toolbox can be used to find the best solution to meet application requirements in terms of quality, time, and cost reduction.” It contains encapsulated products to simplify filterability and scale-up trials, and differently-sized filters to meet the requirements of testing volumes from lab to pilot scale.

AdvantaPure AdvantaPure: Booth 3055
AdvantaPure will introduce the AdvantaTube Sealer and the AdvantaTube Sterile Welder. The two machines, designed for biopharma process applications, are preprogrammed to seal and weld the company’s biopharmaceutical grade TPE (thermoplastic elastomer) tubing, AdvantaFlex. “Customers have been asking us about welding and sealing equipment for AdvantaFlex,” says David Schwass, Director of Sales. “They wanted something that’s made to work with our TPE tubing, because it lets them use a single tubing material in their processes.”

Mettler Toledo Mettler Toledo: Booth 3133
MT’s Process Analytics Division recently introduced the 5000TOCi sensor with Intelligent Sensor Management (ISM) for continuous, fast, and reliable monitoring of total organic carbon levels in applications such as Water for Injection, reverse osmosis membranes, effectiveness of TOC destruct UV lamps, resin bed performance, organics shedding, and quality of final rinse water. The product combines “a proven and dependable TOC analysis platform with advanced user interface and Intelligent System Management sensor diagnostics,” says product manager Steven Carelli. “When combined with Thornton’s M800 multi-parameter transmitter, it integrates on-line TOC measurement with up to four sensors to save cost and complexity.”

GE Analytical Instruments  GE Analytical Instruments: Booth 3141
This GE division manufactures scientific instruments and is a leader in Total Organic Carbon (TOC) Analyzers to pharma with its Sievers product. GE says that it now offers a new science- and risk-based program for implementing real-time release (RTR) of pharmaceutical water. This involves transitioning TOC testing from the lab to the production floor in about six months.

3M 3M Purification: Booth 3155
3M will showcase the newest of its products for the separation, clarification, and purification of fluids and gasses. They include cartridge and lenticular style filters, single-use biocontainers, filter housings, test kits, quality monitoring technologies, validation services, filter membranes, air filters for commercial HVAC, vent filters, laboratory filtration devices, extraction discs, cartridges and 96-well plates.

Scilog  SciLog: Booth 3252, 3353
The company has been rapidly expanding its automated single-use platforms for biopharmaceutical production, for “sterile closed-loop purification in R&D, PD, Pilot, GMP manufacture.” SciLog sensors are used in applications such as ultrafiltration, diafiltration, virus removal, vaccines, and MAb purification. Company representatives tell us that major new products will be introduced at Interphex this year.

Crane CRANE ChemPharma Flow Solutions: Booth 3320
Crane will emphasize the introduction of its Saunders EX Endurance Diaphragm, as well as its Saunders S360 range of Actuators, launched late in 2011. The EX Endurance is designed as a niche solution for critical Life Science applications that require high-temperature performance for extended periods of time. The diaphragm can be used in steam distribution and supply, sterile barrier and block and bleed applications. The S360 Actuator is a compact, lightweight, piston-type pneumatic actuator with a modular range that delivers optimum dimensional envelope and closure performance. “The full 360° rotation capability of this range of actuators allows for flexible installation and air port alignment, and its smooth corrosion-resistant profile optimizes cleanability,” Crane says.

Hamilton ARC Hamilton Company: Booth 3564
Hamilton continues to offer new and varied technologies each year. This year the company will highlight the newest members of its ARC family of “intelligent sensors” for pharma and biopharma—all of the sensors feature 4-20mA and digital output in addition to wireless transmission of data. New is the Oxyferm FDA ARC electrochemical oxygen sensors for fermentation and other pharma processes, and its Conducell PWSE ARC for pure water applications. Conducell’s measurement range is from 0.01 to 2000 μS/cm.

Gemu Gemu Valves: Booth 3612
Gemu will be on hand to show what it calls the broadest range of Aseptic Diaphragm Valves and custom Multiport Valves for pharma and biopharma; “automation options include communication and control modules that facilitate commissioning and optimize diagnostic benefits of control network architecture.”

United Industries United Industries: Booth 3628
United manufactures laser-welded, stainless steel tubing for biopharma and pharma, which is “mechanically and electro-polished tubes sizes 1/2 inch to 8 inch, end capped and poly-sleeved supplied to current ASME-BPE standards.” The tubing is QS9000/ISO9002 certified.