Pharmaceutical Daily News - April 23, 2013 - New York by Source Group LLC

1st EDITION

Tuesday April 23, 2013

New York • FREE

Bosch, Making the ‘One Supplier’ Model Work

What if you could purchase an entire fill finish system from a single supplier? Each component would be designed by the same team to work seamlessly together. Programming would all be compatible, and all of the components would perform as a single unit. Footprints would be smaller and the entire unit would be fully tested prior to delivery to ensure operational effectiveness. Bosch Packaging Technology has long been a premier supplier in the pharmaceutical packaging and processing marketplace. They are well known for their continued on page 12

Spencer Strainer Systems Self-Cleaning Filtration Solutions

In 1996, Glenn Spencer invented and patented the Spencer Strainer while developing the self-cleaning design for Colgate. The challenge was to create a sanitary, permanent device that would filter toothpaste, a very abrasive compound, while eliminating throw-away type filters that also wasted expensive product during changes. The equipment was successful, and it quickly became apparent that the unique design would work well in many different industries, including pharmaceuticals, food, beverage, coatings, chemicals, waste water and waste oils. In 2007, Spencer Strainer Systems was continued on page 24

Waters UPC2 Technology: Expanding the Boundaries of LC and GC Separations

Waters UltraPerformance Convergence Chromatography (UPC2) is a new category of separations science that takes complex analysis and makes them routine – and analytical laboratories around the world are rapidly adopting this powerful technology. The Waters ACQUITY UPC2 System expands the boundaries of reverse-phase liquid chromatography (LC) and of gas chromatography (GC) separations and offers a replacement continued on page 24

Hach Particle Counting Division: Cleanroom Data Management Challenges and Solution!

Pharmaceutical cleanrooms have gone through drastic changes in recent years as mergers, acquisitions, facility closures, drug patent-cliffs, and other industry dynamics have forced manufacturing facilities to continually adapt to remain both competitive and compliant with U.S. Food and Drug Administration (FDA) regulations. The one constant element of Cleanrooms is the FDA requirement for monitoring non-viable particle counts in clean-rooms to continued on page 12

HAMO Can Solve Your Unique Cleaning Challenges

HAMO, a leading innovator of high tech cleaning equipment for the pharmaceutical and manufacturing industries is once again positioning itself to become the industry leader in the USA. Amsonic – Hamo AG announced the reformation of HAMO USA in February 2013. The U.S. market will again have direct factory support for the purchase of Hamo products and accessories. This will include supporting current Hamo product owners with improved process developments, product upgrades and introduction of the latest technological advances available. In addition to reintroducing the Hamo 210 continued on page 21

Process Intensification Why South Carolina? Technology with No Moving Parts Your Next Manufacturing Location What is it about South Carolina that medical device and for Unit Operations of Mixing, pharmaceutical companies are benefiting from in their Reaction, Heat & Mass Transfer manufacturing operations? Could it be lower production

StaMixCo manufactures a wide variety of static mixers with no moving parts for the continuous processing of polymers, liquids, gases, slurries and solids. This Process Intensification Technology allows for very compact equipment volumes in unit operations of mixing, reaction and heat & mass transfer with capital equipment and operating costs much lower than that of conventional continued on page 24

KMPT / Frautech is now ANDRITZ Separation, Inc.

Todd Marshall, Business Development Manager North America for Andritz Separation, Inc.

Q: Please start by telling us a bit about the company, a brief history of ANDRITZ and an overview of your business today. What is your focus? A: Thank you for the opportunity to speak with you. First ANDRITZ is a worldwide company selling to many different industries and companies with over $6 billion in sales last continued on page 29

costs, proximity to markets, an eager workforce, transportation advantages or streamlined permitting? Perhaps it is the combination of all these advantages, with the support of South Carolina’s probusiness state and local governments, which make the state attractive to U.S. and international companies seeking a place to serve the growing east coast market. continued on page 29

PHARMACEUTICAL DAILY NEWS

E Packaging & Fullfillment Company Chosen for Business Development Project in Chicago

CHICAGO—The Lawndale Business and Local Development Corporation has selected E Packaging & Fulfillment Company to participate in a business de-

velopment project located on the great west side of Chicago on 11 acres of land. E Packaging & Fulfillment will build a 100,000 square foot facility with the purpose of generating jobs and employment in a HUB (Historically Underutilized Business) zone. The scheduled

Watson-Marlow Peristaltic Pumps and Single-Use Tubing INTERPHEX Booth #2833

Watson-Marlow’s range of peristaltic pumps for metering, transferring and dosing are the ideal choice for the Biopharm industry. Their peristaltic pumphead design is engineered for error free tube loading, lowest-shear pumping, stable performance and reliable tube life. Watson-Marlow pumps combine reliability, performance and ease of use into a single package. Their breadth of manual, automatic, digital, and PROFIBUS pump options help customers optimize their

process at any scale. Focused on ensuring the highest purity fluid path, Watson-Marlow is the only peristaltic pump manufacturer to produce its own range of USP Class VI tubing. Pumpsil platinum cured silicone is postcured for lowest extractables and is laser etched for ultimate traceability in single use systems. For chemical processes, Watson-Marlow’s Bioprene TPE is optimized for high chemical resistance and long pumping life. Watson-Marlow’s

1st Edition • Tuesday, April 23, 2013

completion date is 2015. “I was born and raised on the south side of Chicago. After 20 years working in senior management in large corporations throughout the U.S., I returned to Chicago in 2007 to start E Packaging & Fulfillment. I am proud of being from Chicago and proud to be the founder and CEO of the first woman and minority owned pharmaceutical packaging company in the United States. It is an honor to be selected to be part of the Lawndale Business Development project. This will allow us to build a larger facility, expand our capacity, and expand the number of continued on page 29

PHARMACEUTICAL DAILY NEWS

An independent publication not affiliated with any other organization Gary Cox Publisher Steve Cox Senior Associate Publisher Michael Harris National Sales Director Don Bomeisl Richard Mandziak James Martin John McQuaig Bill Morris Andrew Oseman Deborah Yarbrough Associate Publishers Valerie Wilson Art Director Elena Cruz Editor Fernando Barrera Trade Show Coordinator

newest tubing, PureWeld, is a weldable, high purity TPE designed specifically for peristaltic pumping and overcomes the high spallation seen in other commercially available weldable tubes. A flexible supplier offering reliable delivery for any production scale, Watson-Marlow offers its range of tubing in boxes, spools, or bulk-packs. For more information, visit www.wmpg.com, call 800-282-8823 or stop by Booth #2833.

6979 East Broadway Blvd., Suite 109 Tucson, AZ 85710 phone: (520) 722-2000 fax: (520) 722-2014 www.sourceg.net

PHARMACEUTICAL DAILY NEWS

Heat and Control Improves Product Safety with Ishida and CEIA Inspection Systems! Protecting your customers and your brand is as important as producing quality products. But all of that investment is quickly lost in the event of one safety recall. Developing and maintaining an effective, verifiable inspection program is no longer an option. To assist you, Heat and Control has the equipment, experience, and technical support to create the optimal inspection system for packaged and non-packaged tablets, powders, liquids, and other pharmaceutical products.

CEIA Metal Detectors The world’s largest manufacturer of metal detectors, CEIA is a leader in detection technology. CEIA PH21-Series pharmaceutical metal detectors deliver unparalleled accuracy and sensitivity to all metals, high throughput rates, require no preventive maintenance, and are FDA 21 CFR Part 11 compliant for data security, integrity, and traceability. CEIA’s Validation Solutions include calibration standards, manuals, service, compliance tools, and online production data validation. Standard features include continuous embedded self-calibration, AutoLearn, one-button settings preview, stainless steel case and keyboard with conformal coated circuit boards for superior moisture resistance and durability, Bluetooth and Ethernet connectivity, and user name/password access for multiple operators.

Ishida X-Ray Inspection Goes Beyond Foreign Objects X-ray inspection is expected to accurately detect and reject product containing foreign objects such as metal, plastic, and glass. But Ishida IX-GA X-ray technology can further enhance your product safety program by also detecting imperfections unrelated to contamination. Identify and reject packages with broken or missing product pieces. Also detect

HACH

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ensure that the manufacturing of injectable drugs is performed in a safe, sterile environment.

Current Practice Challenges: 1. Measure air particle counts at the sampling location utilizing a portable air particle counter. 2. Print the data with the particle counter’s built-in thermal paper printer. • Note: Thermal printers are the industry norm, as thermal printers generate the least amount of particles, but are not particle free. 3. Cleanroom operators review the printout data set to ensure there are no alarm

product caught in packaging seals. Even verify your product’s weight and size meet specifications. Ishida X-ray system setup is automatic and requires no routine calibration. Machine warm-up takes only 90 seconds for quick production start-ups. The waterproof conveyor is easily removed without using tools, and models are available for washdown and large carton applications.

Ishida Dual Weight Range CheckWeigher Delivers Speed and Versatility Ishida DACS-G checkweighers provide two weight ranges to verify package weight or content count. Repeatable accuracy of up to +0.1 gram at 3 sigma, and speeds to 440 packages/minute provide unbeatable inspection efficiency. Ishida’s 3-D digital filter eliminates noise interference based on product size, weight, and speed resulting in unbeatable accuracy. Real-time weighing data can be saved and managed using your personal computer so you can conveniently monitor productivity. The checkweigher’s stainless steel body is durable, easy to clean, and compliant with GMP standards.

Superior Pre- and Post-Sale Customer Support As with any equipment purchase, you continued on page 21

conditions (high particle counts or other sampling excursions) 4. Remove the printer paper by tearing it from the portable air particle counter. 5. Tape the print-out to an 8 ½ x 11 sheet of paper. 6. Cleanroom operators provide a written signature across the print-out and the sheet of paper to assure the original data is compliant to 21 CFR part 11 data security requirements. 7. Upon exiting the cleanroom, operators take the print-out affixed to the sheet of paper and scan the document as a secure electronic record or create a physical hard copy. • Note: The step of copying the printout affixed to a sheet of paper is required, as thermal printer paper data

1st Edition • Tuesday, April 23, 2013

Tablex-PRO Meets Both Quality and Compliance Needs Manufactured from polished stainless steel, the METTLER TOLEDO Safeline Tablex-PRO metal detection system is built to meet the demanding quality requirements of the pharmaceutical industry while also meeting the strict hygiene demands of pharmaceutical environments. At INTERPHEX 2013, it will be exhibited by METTLER TOLEDO in Booth #3007. Tablex-PRO is designed to detect all possible metal contamination encountered in pharmaceutical manufacturing processes, including ferrous, non-ferrous and even the most difficult-to-detect nonmagnetic stainless steels and minute sieve wires. Contaminants smaller than 0.3 millimeters in diameter can be readily detected and rejected. These heightened levels of detection are delivered through

BOSCH

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filling systems for both aseptic pharmaceuticals, and capsules, but what may not be as well known is that Bosch is much more than that. Bosch has been expanding in three ways throughout recent years, with the goal of being your single source supplier. Bosch has expanded the depth of their offerings by continuing to develop systems that compliment the liquid filling process. This includes inspection systems, sterilization technology, isolators, washers, checkweigh systems, and other complementary technologies. This allows Bosch to provide a more complete solution ensuring compatibility and peak performance of the entire system. Bosch has also been adding to their core competencies by growing the types of products offered. Bosch now offers a significantly expanded portfolio of products to the solid pharma market by acquiring Huettlin and Manesty. Bosch now offers tablet presses and solid particle processing systems to compliment their will fade over time. The FDA requires hard copy records to be legible and stored for a minimum of 20 years. These records may be requested during FDA inspections to validate cleanroom operational quality. 8. The final step is performed when this print-out data is manually entered into an Excel spreadsheet or directly into LIMS for electronic storage of the data set. Solution: MET ONE 3400 Simply Paperless Save time, money and eliminate data errors immediately with MET ONE Simply Paperless! Air Particle counting data goes direct to PDF! Automatically exports data direct to a USB memory stick!

unique Safeline technology that includes ultra high frequency operation as well as normal and advanced Boost algorithms for heightened sensitivity. A compact footprint allows the continued on page 29

capsule filling machine business. When Bosch can’t supply a certain part of the system, they will source the missing technology from a third party partner, ensuring the unit is compatible and fully integrated prior to delivery to the customer site. This third party sourcing is seamless to the customer. Finally, outside of the packaging arm of the company Bosch offers a number of other product lines key to facility design. Bosch can provide access control and monitoring systems through their security branch. The solar group offers solutions for generating electricity and heat for facilities. The Thermo Finally, the drives and controls division can provide energy efficient solutions to drive and control upgrades saving companies money. When you partner with Bosch you truly partner with a company that can take care of all of your needs. A single supplier eliminates finger pointing and provides the best possible solution in the shortest time possible. Stop by the Bosch Booth #2227 to see why a comprehensive partner is the best solution for you. • Save at least 2 hours per day and stop manually tearing, scanning and copying your particle counting print-out data. • Stop manual data entry; use MET ONE simply paperless with direct export to any Excel compatible file. • Go from particle counting direct to PDF with no software required. • The MET ONE simply paperless PDF ensures your data is safe, secure and 21 CFR part 11 compliant • MET ONE simply paperless offers the industry's first embedded secure PDF data transfer Hach – Particle Counting Division see them at Booth #1863! Visit www.particle.com for details or call 800-866-7889 ext. 6508.

PHARMACEUTICAL DAILY NEWS

Tuesday, April 23, 2013 • 1st Edition

Plastikon Healthcare: Your Source of Expert, Reliable, Economical, Customized Blow/Fill/Seal Packaging Solutions for Liquid Sterile Manufacturing

Plastikon Healthcare delivers “Ideas for Today and Tomorrow” with capabilities that set them apart from the competition. Plastikon Healthcare contract development and manufacturing leverages their industry leading knowledge of plastics technologies, developed, refined and expanded through their 30plus years of manufacturing excellence. Their Blow/Fill/Seal technology results in process efficiencies, more accurate unit dosing, contamination prevention, quality assurance, better product performance and cost-effectiveness. Their full spectrum of global integrated plastics manufacturing, analytical chemistry lab support, PMP accredited specialists, design engineering, labeling, packaging, and logistics services makes them a one-stop resource from concept through distribution, from stock to dock. B/F/S technology offers microbiological contamination control, easier process validation, reduced container

defects, customized filling systems, and reduced utility consumption. During one continual process, plastic is extruded and formed into the shape of the container, filled and then sealed. Plastic ampoules provide a convenient, unbreakable drug container. It’s a fully automated process that takes only seconds to complete. The human element is removed from the process, eliminating human intervention, known to be the major cause of sterility failures in all critical processes. Plastikon Healthcare provides dedicated customer service, development and commercial scale capabilities, full technology transfer, process optimization and validation. Plastikon’s machines are designed to manufacture container sizes continued on page 24

A Disposable Valve for Process Chromatography Case Study The Challenge The manufacturer required a fully automated, disposable chromatography system which was PLC controlled and designed for use in a cGMP environment. The required applications for the chromatography system included contamination removal, and concentration and purification of biologically derived proteins used in the production of research and clinical materials. Finally, there was a requirement that all product contact surfaces be completely disposable, single-use applications. The Technical Problem There were a number of problems with

HAMO

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and 420 machines, Hamo has developed the brand new PG 800 and PG 1300 washers with circulated final rinse systems. These “Pharma Grade” machines exceed all cGMP requirements for chamber design with no possibility of liquid retention and continuous closed media loop for cleaning liquids and pure water rinses. Zero liquid retention in the chamber, sump or piping assures the highest level of cross contamination prevention. Integrating the entire liquid and air drying piping further assures no liquid remains post process. These washers are also appropriate in bio-containment applications. Total barrier control, with no atmospheric leakage, maintains air quality integrity with no requirement of additional clean air production. Hamo is also introducing high pressure cleaning as an alternative to the current CIP process. This is the world’s first cleaning process capable of meeting or exceeding cGMP requirements. It has a precision designed, hydraulically rotating head that will clean the inside of containers, drums and pipes with 100 percent repeatable results. This is accomplished while conserving nearly 90 percent of the pure water currently required in the standard CIP processes. The key to this savings

HEAT AND CONTROL (continued from page 12)

are entering into a long-term relationship that should include up-front application assistance, training, parts and service support. Heat and Control maintains demonstration centers where you can test their equipment. They are applications experts and can manufacture accessory equipment to suit your product handling and installation requirements. They also sup-

the original valve set-up for the chromatography system that needed to be addressed with an operational solution. The closure capability of the existing valve and tubing combination was unpredictable and the durometer tolerance variations within the elastomer tubing sets led to frequent valve failures, or leak-by. This also occurred when the valves were unable to overcome the operational pressure resistance generated within the system. If they were able to close, it was at a very low pressure for both the tubing and the valve. When the pressure issues were combined with tubing durometer varicontinued on page 29

is the use of high pressure water system that penetrates and washes away all contaminants without the need to flood the containers, as in traditional washing techniques. Most testing and customer usage has shown cleaning chemistry is not necessary, providing additional cost savings. As with all Hamo washers, this high pressure system includes a PLC control system to assure repeatable documented results. “What really sets Hamo apart from other washer manufacturers is the level of documentation and collaboration Hamo offers on all of its machines,” says Hamo USA Managing Director Marvin Royal. “The quality support documentation available with all of our ‘As Built’ machines includes material certificates up to 3.1 as well as calibration certificates for all process parts. IQ/OQ validation documentation and execution is available, along with PQ consultative support. All of our PLC control systems with HMI touch screens are GAMP 5 compliant. FAT (factory acceptance testing) and cleaning process development is available in our ISO 9001:2008 certified facility in Biel, Switzerland.” Hamo is the company that can solve your unique cleaning challenges. The ability to adapt to specific requirements ensures that Hamo will remain the industry leader. For more information, stop by Booth #1963 or visit www.hamo.com. port you with sales, parts, service, training programs, and on-going technical assistance from locations throughout North and South America. In fact, their service technicians are located in 10 states across the country to provide fast response to any service issue. For more details on their equipment and services, please contact Heat and Control today at 800-227-5980 or 510259-0500, info@heatandcontrol.com, www.heatandcontrol.com or stop by Booth #3616.

PHARMACEUTICAL DAILY NEWS

3C! INTERPHEX 2013 Launch Experts are Exhibiting at Booth #3939

3C! Packaging will be exhibiting at INTERPHEX 2013, Booth #3939. Visitors will have the opportunity to learn of 3C!’s latest investment in “State of the Art” label manufacturing equipment.

Management will be on hand to illustrate the various types of visions systems utilized throughout their manufacturing center of excellence. In addition, attendees will have the

SPENCER STRAINER SYSTEMS

globally, in an ever-growing list of applications. Their customers include:

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granted certification of compliance with 3A Sanitary Standards, the only selfcleaning filter/strainer to be 3A approved. Spencer Strainer Systems is also a recipient of the Indiana Environmental Excellence Award, and, in 2010, was nominated for the Frito-Lay Innovation of the year. Today, Spencer Strainers are in use

STAMIXCO

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rotating equipment. Unit operations include mixing/blending of materials with similar and large differences in viscosity and

PLASTIKON HEALTHCARE (continued from page 21)

from 0.02 milliliters to 1000 milliliters at production rates of up to 15,000 units per hour using Weiler 624 machines with variable precision heads, and multi cavity and single cavity clinical development production tools. For liquid filling and packaging, they offer bottom to bottom transfer capabilities, recirculation capa-

WATERS CORPORATION (continued from page 1)

option for normal-phase chromatography. This new technology marries the unrealized potential of SFC with Waters’ proven UPLC technology and expertise in the management of fluids, temperature, and pressure. ACQUITY UPC2 provides scientists with an indispensable new tool for tackling tough-to-analyze compounds including hydrophobic and chiral compounds, lipids, thermally-labile samples and polymers across a wide range of applications. Pharmaceutical relevance: UPC2 for analysis of extractables in packaging For example, in the pharmaceutical industry, extractables from packaging materials are a concern. Packaging material manufacturers need to control and monitor their product to ensure that no potential risk exists from extractable and leachable material. In controlled extraction studies, the

opportunity to schedule an “in-house” seminar on 3C!’s successful color control program known as “3C!’s Color-by –Numbers,” This program approaches color in a digital spectrophotometric space that assigns L.A.B. values; thus eliminating a human subjective interpretation of color. Customers of 3C! have experienced many successes and benefits of this program including tighter color control, streamlined proofing and the

1st Edition • Tuesday, April 23, 2013 elimination of “light-medium-dark” color swatches.

New Product Launch Experts Under one roof, 3C! Packaging designs and manufactures folding cartons, inserts/outserts, and film/paper labels. Together with state of the art technologies, a well-documented process, and visions systems, all being managed by one well-seasoned team…………..One Launch Pad……One Mission Control!

Hormel Tropicana Kellogg’s

Do you have a filtration application that needs cost containment? Are you stopping your process to use wasteful filter media, and throwing away expensive product? Do you have to open your process to the atmosphere during filter changes? Spencer Strainer Systems can meet

your filtration challenges. Let them tailor their equipment to your application, or develop a design for you, if necessary. They offer sealed, self-cleaning, ultra sanitary, permanent filtration. It is also well suited as pre-filtration with centrifuges and membranes, extending the cycles of these devices. Please contact them at 800-801-4977, or www.spencerstrainer.com. Visit their Booth, #2789 at INTERPHEX 2013.

volumetric flow rate; continuous plug flow reactors; creating immiscible liquid and gas-liquid dispersions for mass transfer enhancement; in-line heat exchangers; and fluid flow conditioning for creating flat velocity and pressure profiles in front of process equipment and instrumentation that are sensitive to inlet flow conditions. Sizes range from 1.7

millimeter diameter for use in laboratory and proof of concept bench scale research, to many feet in diameter for commercial installations. Materials of construction include plastics and metals. Typical plastic materials include PTFE Teflon, Polyethylene, Polypropylene, Acetal and PVC. Standard metals include 316L S/S, Hastelloy, Inconel, 17-4PH S/S, Titanium and Tantalum.

Industries served include pharmaceutical; biotechnology; medical; cosmetics; electronics; polymer manufacture; plastics extrusion and injection molding; adhesives, sealants & resins processing; chemical; food; petrochemical & refining; water & wastewater treatment; and many other fluid processing industries For more information, stop by Booth #1957 or visit www.stamixco-usa.com.

bilities with filtration and homogenizer options, and inline filtration with clean in place and steam in place systems in all tanks.

About Plastikon Healthcare For more 30 years, they’ve been committed to providing the best quality products and turnkey services at globally competitive prices. They’re a technology driven, diagnostics, pharmaceutical, contract de-

velopment and manufacturing company for Blow/Fill/Seal and liquid filling of liquids and creams for a broad range of pharmaceutical applications. Their facilities operate under international and U.S. codes of cGMP and a Quality Management System that allows their formulation scientists to assist with development. All facets of production are performed within Class 10K or 100K clean room environments. They understand medical in-

dustry manufacturing standards, and comply with all FDA requirements. For more information about their capabilities, facilities, and the pharmaceutical manufacturing solutions they can provide to you, please contact Eugene Udoh, Director of Healthcare Business Development Sales at 510-400-1147, visit Plastikon | Markets | Medical & Healthcare at http://bit.ly/WHLHle or stop by Booth #3684.

nature of extractable profiles from critical container closure system components are investigated qualitatively and quantitatively. Testing involves solvent extraction techniques encompassing a range of polarity, solvent compatibility studies, and multiple analytical techniques. One of the limitations encountered in these studies involves matching the solvent extracts with the appropriate analytical technique. For example, non-polar solvent extracts can be directly injected into a GC system but must be evaporated and reconstituted with a solvent compatible with an LC system. Likewise, water extracts must be back-extracted into a non-polar solvent for analysis by GC. Streamlining multiple extractables analyses on one UPC2 system UPC2, built on the principles of SFC, allows different types of extraction solvents to be injected for separation on one system for analysis, thereby saving time and reducing sample preparation efforts. Waters tested UPC2 for extractables

analysis using four different types of packaging material, including a high density polypropylene pill bottle (HDPE), a low density polypropylene bottle (LDPE), an ethylene vinyl-acetate plasma bag (EVA), and a polyvinyl chloride blister pack (PVC). The extracts were screened for 14 common polymer additives. A single UPC2 technique was found to be compatible for all extracts of different packaging material. This allowed for a streamlined, simplified sample preparation workflow with better asset utilization, since all of the solvent extracts can be directly injected onto the ACQUITY UPC2 System. Using other separation techniques, such as LC and GC, some extracts are not compatible requiring additional processing steps prior to analysis. In this extractables study, UPC2 offered better information for non-volatile and thermally labile compounds than GC due to lower analysis temperatures. The UPC2 analysis provided a two-fold im-

provement in run time compared to UPLC, and an eight-fold improvement in run time compared to GC. Built upon proven Waters UPLC technology The exceptional reliability, robustness, sensitivity and throughput of the Waters ACQUITY UPC2 System can be attributed to its roots within the ACQUITY UPLC Technology platform. Specifically designed to manage mixtures of compressed CO2 and organic modifiers, the ultra-low dispersion ACQUITY UPC2 System is in a class all of its own. With unparalleled selectivity choice through column and mobile phase selection, the ACQUITY UPC2 System is the ultimate solution for making the complex, routine. For more information, stop by Booth #2477, visit www.waters.com or call 800252-HPLC. Waters, ACQUITY, UltraPerformance Convergence Chromatography, UPC2, ACQUITY UPLC, and UPLC are trademarks of Waters Corporation.

Unilever Procter and Gamble J.M. Smucker ADM PPG General Mills Sherwin Williams Anheuser Busch

Tuesday, April 23, 2013 • 1st Edition

SOUTH CAROLINA POWER

PHARMACEUTICAL DAILY NEWS

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A team from the State of South Carolina at Booth #2032 is prepared to answer questions related to available buildings and sites, the state’s award-winning pre-employment recruiting and training program, tax advantages, energy incentives, environmental permitting support and other factors that impact site location decisions. South Carolina is home to more than 572 medical device and life science companies employing more than 13,500 South Carolinians. Nephron Pharmaceuticals Corp., who recently announced the building of a 385,000 square foot facility in Columbia, S.C. to produce respiratory medications, cited state support in expediting the permitting process as one of many factors leading to their decision to locate here. Roche Carolina, GE Healthcare, Bausch & Lomb, Martek Bio-

ANDRITZ SEPARATION (continued from page 1)

year. ANDRITZ Separation, Inc. a division, concentrates on the separation of materials from product streams. Within Separation we have specialists just for the chemical/pharmaceutical industry. Our complimentary acquisition of KMPT/ Frautech a couple of years ago allowed us to better serve the market. ANDRITZ has always had the philosophy of approaching each project from a systems approach, meaning, we want to work from an overall solution for our customer rather than just selling a piece of equipment. Which brings me to your question of what is our focus; this is always an easy answer – OUR CUSTOMER! In fact our mission

E PACKAGING & FULFILLMENT (continued from page 4)

services we provide. It also allows us participate in giving opportunities to this underserved community,” says Andrea Peters, CEO and founder. E Packaging & Fulfillment is a contract pharmaceutical packaging company that specializes in the packaging and repackaging of solid dose prescription

METTLER TOLEDO

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Tablex-PRO to be installed in areas where space is restricted. Robust, low profile, fully-rotating castors provide ease of mobility, allowing the system to be used in multiple locations. For further flexibility, the detection head can be adjusted easily in all three axes without the need for tools, to suit any configuration of process equipment. The system is available with a choice of two interchangeable reject devices to suit all product types, applications and configurations, Tablex-PRO diverters include built-in reject confirmation technology and failsafe design. Lift-flap diverters provide high-

sciences, ZEUS, BD Vacutainer Systems and many other national and international medical device and pharmaceutical companies call South Carolina home. South Carolina companies are within one day’s drive to more than 55 million people, and the state is the midway point between Miami and New York City on I95. To reach export markets, the Port of Charleston can accommodate Post Panamax ships with the most efficient operations in the Southeast. The support that companies receive from the state’s three research universities often is cited as being critical in both research collaboration and as a source for degree specific graduates. The Unistatement is based on the delivery of a solution to the customer that provides the best overall cost effective resolution to their needs or problems. Q: Please tell us about the company’s products.

A: WOW – where do I start. Of course we have the KMPT/Frautech line of Helix Dryers and Pharma Peeler Centrifuges but we have so much more to offer to customers now. A little ANDRITZ humor is that we like to say we have you covered from A to Z, of course that is true but we do work from a solution standpoint and have other centrifuges, separators, presses (belt and filter style), screens and even conveyors. But what most people don’t know drugs. Its core services are blister packaging and bottling of tablets and capsules, sachet packaging of powders, and labeling of each. Their clients are the top pharmaceutical manufacturers in the country. Once they move to their new facility, they will expand services to include sterile packaging and liquids. For more information, you can visit www.goepack.net or stop by Booth #4079. throughput, gentle product handling and straight-line product flow. Compact, sidedivert systems are suitable for use in installations where system height is restricted. All reject devices are designed and constructed to meet the demands of 21 CFR parts 210 and 211. Tablex-PRO metal detectors support full compliance with the FDA 21 CFR part 11 standard with dedicated software to capture electronic signatures and other critical process data. All detector settings are password-protected and details of all metal detector access activities are automatically logged to establish when and by whom the system was accessed, helping manage process cells and ensuring compliance.

versity of South Carolina, Clemson University and the Medical University of South Carolina (MUSC) all operate life science programs and business incubators and are eager partners in research and collaboration. Twelve of the state’s 16 technical colleges have two-year associate degree programs in medical technology related fields. The state’s readySC pre-employment training program is utilized to identify, recruit and train prospective employees at state expense prior to actual production commencing. Since its creation in 1961 readySC has trained more than 266,900 workers, many in the pharmaceutical and medical device industry. Medical device and pharmaceutical companies also require a reliable and affordable energy supply. The South Carolina Power Team represents Santee Cooper, the state’s electric generation utility and the 20 electric cooperatives that distribute Santee Cooper power to all

is that we are one of the largest full line drying system manufacturers in the world. Most specifically with our recent acquisition of GMF/GOUDA this thoroughly compliments our range of offerings to your industry. Finally, something that we are all very proud of is that we has service capabilities for not only our own equipment but also our competitors equipment and are able to offer this with five dedicated service centers within North America.

DISPOSABLE VALVE (continued from page 21)

ances, it was difficult to determine which component was to blame. Additionally, there was often product degradation caused by convective heat transfer from the actuation of the valve through the liner, and into the product stream. These issues alone compromised the system’s overall integrity and ability to function as needed. Other significant process issues caused by the unpredictable valve operation were associated with the manifold construction. The poor spacing in the original valve manifold—that was required for traditional hand fabrication and over-molding of the liner assembly— led to irregular center-line dimensions with a minimum of 3.5 inches. This led to significant hold-up volume concerns, and combined with the buffer/product precolumn admixing affects ultimately, ended up negatively impacting product yield.

The Resolution The manufacturer chose the patented ARTeSYN Arterial Process Module—a multiple pinch-valve array designed to produce low hold-up volumes and compact actuation. The directional flow path control for the automated cGMP chromatography system was achieved using the ARTeSYN multiple pinch-valve array modules. The valve array modules are a compact, pneumatically actuated design using single-use silicone tube liners for

46 counties. The SC Power Team will provide a power cost estimate for your manufacturing operation and discuss sites and buildings that meet your specific power requirements. Among the advantages available from the SC Power Team is a five-year economic development incentive rate that represents a significant reduction in a new or expanding company’s power cost. The state incorporates a number of incentive programs to locating and expanding companies. Incentives are based on the number of jobs created, capital investment, and geographical location and include Jobs Tax Credits, Fee-in-Lieu of property taxes, Job Development Credits, and incentives for headquarters, R&D facilities and clean rooms. A Right-To-Work state, South Carolina’s favorable business tradition and regulatory climate enable new companies to get up and running quickly. Visit Booth #2032 for more information. Q: How can our readers find out more about your company?

A: For more information, visit www .andritz.com/separation. However, I am old fashioned and feel that for the best results you should call us at 800-433-5161 or 817-465-5611 and ask for Pat McCarty—he is the real expert. Of course since you are here at INTERPHEX just stop by our booth! Booth #2578 quick replacement. The compact design minimized the risk of unwanted solution cross-mixing and virtually eliminates any possible deadlegs within the process flow path. This was accomplished by moving the valve closure points of the flowpath as close to the main trunk line as possible. The valve also solved the problem of nominal operational pressures exceeding 30 psi. These pressures had previously been very difficult to achieve—and since the installation of the ARTeSYN multiple pinch-valve array modules are no longer a problem. This was accomplished by injection molding the entire flowpath in the pinch- valve array module, thereby supporting the entire circumference of the liner assembly.

The valve has been proven to close consistently in excess of 1000 cycles on the matched molded liner. According to the manufacturer, the ARTeSYN process module has led to superior overall system performance and has virtually eliminated: • Unpredictable closure capability • Product yield losses caused by valve leak-by • Deadlegs • Product degradation caused by heat transfer from valve actuation • Product yield losses caused by pre-column mixing

For more information, visit www.arte synproducts.com, call 818-350-0423 or stop by Booth #3077.