Embed Size (px)
DESCRIPTION
Pharmaceutical Daily News - April 23, 2013 - New York - distributed during the first day of INTERPHEX 2013
Citation preview
HAMO, a leading innovator of high tech cleaning equip-ment for the pharmaceutical and manufacturing industriesis once again positioning itself to become the industryleader in the USA. Amsonic – Hamo AG announced thereformation of HAMO USA in February 2013. The U.S.market will again have direct factory support for the pur-chase of Hamo products and accessories. This will includesupporting current Hamo product owners with improvedprocess developments, product upgrades and introduction
of the latest technologi-cal advances available.
In addition to rein-troducing the Hamo 210
continued on page 21
HAMO Can Solve Your UniqueCleaning Challenges
Tuesday
April 23, 2013
1st EDITIONNew York • FREE
continued on page 12
What if you could purchase an entire fill finish systemfrom a single supplier? Each component would be de-signed by the same team to work seamlessly together.Programming would all be compatible, and all of thecomponents would perform as a single unit. Footprintswould be smaller and the entire unit would be fully testedprior to delivery to ensure operational effectiveness.
Bosch Packaging Technology has long been a pre-mier supplier in thepharmaceutical pack-aging and processingmarketplace. They arewell known for their
continued on page 12
Bosch, Making the‘One Supplier’ Model Work
Pharmaceutical cleanrooms have gone through drasticchanges in recent years as mergers, acquisitions, facilityclosures, drug patent-cliffs, and other industry dynamicshave forced manufacturing facilities to continually adaptto remain both competitive and compliant with U.S. Food
and Drug Administration(FDA) regulations. The oneconstant element of Clean-rooms is the FDA requirementfor monitoring non-viable par-ticle counts in clean-rooms to
Hach Particle Counting Division:Cleanroom Data ManagementChallenges and Solution!
In 1996, Glenn Spencer invented and patented theSpencer Strainer while developing the self-cleaning de-sign for Colgate. The challenge was to create a sanitary,permanent device that would filter toothpaste, a very
abrasive compound, while eliminatingthrow-away type filters that also wasted ex-pensive product during changes. The equip-ment was successful, and it quickly becameapparent that the unique design would workwell in many different industries, includingpharmaceuticals, food, beverage, coatings,chemicals, waste water and waste oils.
In 2007, Spencer Strainer Systems was
continued on page 24
Spencer Strainer SystemsSelf-Cleaning Filtration Solutions
StaMixCo manufactures a wide variety of static mixerswith no moving parts for the continuous processing ofpolymers, liquids, gases, slurries and solids.
This Process Intensification Technology allows forvery compact equipment volumes in unit operations of
mixing, reaction and heat& mass transfer with cap-ital equipment and oper-ating costs much lowerthan that of conventional
continued on page 24
Process IntensificationTechnology with No Moving Partsfor Unit Operations of Mixing,Reaction, Heat & Mass Transfer
Waters UltraPerformance Convergence Chromatography(UPC2) is a new category of separations science that takescomplex analysis and makes them routine – and analyti-cal laboratories around the world are rapidly adopting this
powerful technology. The Waters ACQUITY
UPC2 System expands theboundaries of reverse-phase liq-uid chromatography (LC) and ofgas chromatography (GC) sepa-rations and offers a replacement
continued on page 24
Waters UPC2 Technology:Expanding the Boundariesof LC and GC Separations 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 yourbusiness today. What is your focus?
A: Thank you for the opportunity to speak with you. FirstANDRITZ is a world-wide company selling tomany different industriesand companies with over$6 billion in sales last
continued on page 29
KMPT / Frautech is nowANDRITZ Separation, Inc.
Your Next Manufacturing LocationWhat is it about South Carolina that medical device andpharmaceutical companies are benefiting from in theirmanufacturing operations? Could it be lower productioncosts, proximity to markets, an eager workforce, trans-portation advantages or streamlined permitting? Perhapsit is the combination of all these advantages, with the sup-
port of South Carolina’s pro-business state and localgovernments, which make thestate attractive to U.S. and inter-national companies seeking aplace to serve the growing eastcoast market.
continued on page 29
Why South Carolina?
Watson-Marlow’s range of peristalticpumps for metering, transferring and dos-ing are the ideal choice for the Biopharmindustry. Their peristaltic pumphead de-sign is engineered for error free tube load-ing, lowest-shear pumping, stableperformance and reliable tube life. Wat-son-Marlow pumps combine reliability,performance and ease of use into a singlepackage. Their breadth of manual, auto-matic, digital, and PROFIBUS pump op-tions help customers optimize their
process at any scale. Focused on ensuring the highest pu-
rity fluid path, Watson-Marlow is the onlyperistaltic pump manufacturer to produceits own range of USP Class VI tubing.Pumpsil platinum cured silicone is post-cured for lowest extractables and is laseretched for ultimate traceability in singleuse systems. For chemical processes,Watson-Marlow’s Bioprene TPE is opti-mized for high chemical resistance andlong pumping life. Watson-Marlow’s
4 PHARMACEUTICAL DAILY NEWS 1st Edition • Tuesday, April 23, 2013
An independent publication not affiliated with any other organization
Pharmaceutical Daily News is published by Source Group LLC ©2013.
All rights reserved.Business License #45-4600703
6979 East Broadway Blvd., Suite 109Tucson, AZ 85710
phone: (520) 722-2000fax: (520) 722-2014www.sourceg.net
newest tubing, PureWeld, is a weldable,high purity TPE designed specifically forperistaltic pumping and overcomes thehigh spallation seen in other commer-cially available weldable tubes. A flexi-ble supplier offering reliable delivery forany production scale, Watson-Marlow of-fers its range of tubing in boxes, spools,or bulk-packs.
For more information, visitwww.wmpg.com, call 800-282-8823 orstop by Booth #2833.
Watson-Marlow PeristalticPumps and Single-Use TubingINTERPHEX Booth #2833
continued on page 29
CHICAGO—The Lawndale Businessand Local Development Corporation hasselected E Packaging & FulfillmentCompany to participate in a business de-
velopment project located on the greatwest side of Chicago on 11 acres of land.E Packaging & Fulfillment will build a100,000 square foot facility with the pur-
pose of generating jobsand employment in aHUB (Historically Un-derutilized Business)zone. The scheduled
completion date is 2015.“I was born and raised on the south
side of Chicago. After 20 years workingin senior management in large corpora-tions throughout the U.S., I returned toChicago in 2007 to start E Packaging &Fulfillment. I am proud of being fromChicago and proud to be the founder andCEO of the first woman and minorityowned pharmaceutical packaging com-pany in the United States. It is an honorto be selected to be part of the LawndaleBusiness Development project. This willallow us to build a larger facility, expandour capacity, and expand the number of
E Packaging & Fullfillment CompanyChosen for Business DevelopmentProject in Chicago Gary Cox
Publisher
Steve CoxSenior Associate Publisher
Michael HarrisNational Sales Director
Don BomeislRichard Mandziak
James MartinJohn McQuaig
Bill MorrisAndrew Oseman
Deborah YarbroughAssociate Publishers
Valerie WilsonArt Director
Elena CruzEditor
Fernando BarreraTrade Show Coordinator
Monique CarterJulie Evans
Courtney LudwigTiffany WebsterAdministration
PHARMACEUTICALDAILY NEWS
12 PHARMACEUTICAL DAILY NEWS 1st Edition • Tuesday, April 23, 2013
ensure that the manufacturing of injectabledrugs is performed in a safe, sterile envi-ronment.
Current Practice Challenges:1.Measure air particle counts at the sam-pling location utilizing a portable air par-ticle counter.2.Print the data with the particlecounter’s built-in thermal paper printer. • Note: Thermal printers are the industrynorm, as thermal printers generate theleast amount of particles, but are not par-ticle free. 3.Cleanroom operators review the print-out data set to ensure there are no alarm
conditions (high particle counts or othersampling excursions) 4.Remove the printer paper by tearing itfrom the portable air particle counter. 5.Tape the print-out to an 8 ½ x 11 sheetof paper. 6.Cleanroom operators provide a writtensignature across the print-out and thesheet of paper to assure the original datais compliant to 21 CFR part 11 data se-curity requirements. 7.Upon exiting the cleanroom, operatorstake the print-out affixed to the sheet ofpaper and scan the document as a secureelectronic record or create a physical hardcopy. • Note: The step of copying the print-out affixed to a sheet of paper is re-quired, as thermal printer paper data
will fade over time. The FDA requireshard copy records to be legible andstored for a minimum of 20 years.These records may be requested duringFDA inspections to validate cleanroomoperational quality. 8. The final step is performed when thisprint-out data is manually entered intoan Excel spreadsheet or directly intoLIMS for electronic storage of the dataset.
Solution:MET ONE 3400 Simply PaperlessSave time, money and eliminate data er-rors immediately with MET ONE SimplyPaperless! Air Particle counting data goesdirect to PDF! Automatically exportsdata direct to a USB memory stick!
HACH(continued from page 1)
• Save at least 2 hours per day and stopmanually tearing, scanning and copyingyour particle counting print-out data.• Stop manual data entry; use MET ONEsimply paperless with direct export to anyExcel compatible file.• Go from particle counting direct to PDFwith no software required.• The MET ONE simply paperless PDFensures your data is safe, secure and 21CFR part 11 compliant• MET ONE simply paperless offers theindustry's first embedded secure PDF datatransfer
Hach – Particle Counting Division seethem at Booth #1863!
Visit www.particle.com for details orcall 800-866-7889 ext. 6508.
Protecting your customers and yourbrand is as important as producing qual-ity products. But all of that investment isquickly lost in the event of one safety re-call. Developing and maintaining an ef-fective, verifiable inspection program isno longer an option. To assist you, Heatand Control has the equipment, experi-ence, and technical support to create theoptimal inspection system for packagedand non-packaged tablets, powders, liq-uids, and other pharmaceutical products.
CEIA Metal DetectorsThe world’s largest manufacturer ofmetal detectors, CEIA is a leader in de-tection technology. CEIA PH21-Seriespharmaceutical metal detectors deliverunparalleled accuracy and sensitivity toall metals, high throughput rates, requireno preventive maintenance, and areFDA 21 CFR Part 11 compliant for datasecurity, integrity, and traceability.CEIA’s Validation Solutions include cal-ibration standards, manuals, service,compliance tools, and online productiondata validation.
Standard features include continu-ous embedded self-calibration, Auto-Learn, one-button settings preview,stainless steel case and keyboard withconformal coated circuit boards for su-perior moisture resistance and durabil-ity, Bluetooth and Ethernet connectivity,and user name/password access for mul-tiple operators.
Ishida X-Ray Inspection GoesBeyond Foreign Objects X-ray inspection is expected to accu-rately detect and reject product contain-ing foreign objects such as metal, plastic,and glass. But Ishida IX-GA X-ray tech-nology can further enhance your productsafety program by also detecting imper-fections unrelated to contamination.Identify and reject packages with brokenor missing product pieces. Also detect
product caught in packaging seals. Evenverify your product’s weight and sizemeet specifications.
Ishida X-ray system setup is auto-matic and requires no routine calibration.Machine warm-up takes only 90 secondsfor quick production start-ups. The water-proof conveyor is easily removed withoutusing tools, and models are available forwashdown and large carton applications.
Ishida Dual Weight Range Check-Weigher Delivers Speed and VersatilityIshida DACS-G checkweighers providetwo weight ranges to verify packageweight or content count. Repeatable accu-racy of up to +0.1 gram at 3 sigma, andspeeds to 440 packages/minute provideunbeatable inspection efficiency. Ishida’s3-D digital filter eliminates noise interfer-ence based on product size, weight, andspeed resulting in unbeatable accuracy.Real-time weighing data can be saved andmanaged using your personal computer soyou can conveniently monitor productiv-ity. The checkweigher’s stainless steelbody is durable, easy to clean, and com-pliant with GMP standards.
Superior Pre- and Post-Sale Customer SupportAs with any equipment purchase, you
Heat and Control Improves ProductSafety with Ishida and CEIA Inspection Systems! Manufactured from polished stainless
steel, the METTLER TOLEDO SafelineTablex-PRO metal detection system isbuilt to meet the demanding quality re-quirements of the pharmaceutical indus-try while also meeting the strict hygienedemands of pharmaceutical environ-ments. At INTERPHEX 2013, it will beexhibited by METTLER TOLEDO inBooth #3007.
Tablex-PRO is designed to detect allpossible metal contamination encoun-tered in pharmaceutical manufacturingprocesses, including ferrous, non-ferrousand even the most difficult-to-detect non-magnetic stainless steels and minutesieve wires. Contaminants smaller than0.3 millimeters in diameter can be readilydetected and rejected. These heightenedlevels of detection are delivered through
unique Safeline technology that includesultra high frequency operation as well asnormal and advanced Boost algorithmsfor heightened sensitivity.
A compact footprint allows the
Tablex-PRO Meets BothQuality and Compliance Needs
continued on page 29
continued on page 21
filling systems for both aseptic pharma-ceuticals, and capsules, but what may notbe as well known is that Bosch is muchmore than that. Bosch has been expand-ing in three ways throughout recentyears, with the goal of being your singlesource supplier.
Bosch has expanded the depth oftheir offerings by continuing to developsystems that compliment the liquid fillingprocess. This includes inspection sys-tems, sterilization technology, isolators,washers, checkweigh systems, and othercomplementary technologies. This allowsBosch to provide a more complete solu-tion ensuring compatibility and peak per-formance of the entire system.
Bosch has also been adding to theircore competencies by growing the typesof products offered. Bosch now offers asignificantly expanded portfolio of prod-ucts to the solid pharma market by ac-quiring Huettlin and Manesty. Bosch nowoffers tablet presses and solid particleprocessing systems to compliment their
BOSCH(continued from page 1)
capsule filling machine business.When Bosch can’t supply a certain
part of the system, they will source themissing technology from a third partypartner, ensuring the unit is compatibleand fully integrated prior to delivery tothe customer site. This third party sourc-ing is seamless to the customer.
Finally, outside of the packagingarm of the company Bosch offers anumber of other product lines key to fa-cility design. Bosch can provide accesscontrol and monitoring systems throughtheir security branch. The solar groupoffers solutions for generating electric-ity and heat for facilities. The ThermoFinally, the drives and controls divisioncan provide energy efficient solutions todrive and control upgrades saving com-panies money.
When you partner with Bosch youtruly partner with a company that cantake care of all of your needs. A singlesupplier eliminates finger pointing andprovides the best possible solution in theshortest time possible. Stop by the BoschBooth #2227 to see why a comprehensivepartner is the best solution for you.
21PHARMACEUTICAL DAILY NEWSTuesday, April 23, 2013 • 1st Edition
and 420 machines, Hamo has devel-oped the brand new PG 800 and PG1300 washers with circulated finalrinse systems. These “Pharma Grade”machines exceed all cGMP require-ments for chamber design with no pos-sibility of liquid retention andcontinuous closed media loop forcleaning liquids and pure water rinses.Zero liquid retention in the chamber,sump or piping assures the highestlevel of cross contamination preven-tion. Integrating the entire liquid andair drying piping further assures no liq-uid remains post process. These wash-ers are also appropriate inbio-containment applications. Totalbarrier control, with no atmosphericleakage, maintains air quality integritywith no requirement of additionalclean air production.
Hamo is also introducing highpressure cleaning as an alternative tothe current CIP process. This is theworld’s first cleaning process capableof meeting or exceeding cGMP require-ments. It has a precision designed, hy-draulically rotating head that will cleanthe inside of containers, drums andpipes with 100 percent repeatable re-sults. This is accomplished while con-serving nearly 90 percent of the purewater currently required in the standardCIP processes. The key to this savings
HAMO(continued from page 1)
is the use of high pressure water systemthat penetrates and washes away allcontaminants without the need to floodthe containers, as in traditional washingtechniques. Most testing and customerusage has shown cleaning chemistry isnot necessary, providing additional costsavings. As with all Hamo washers,this high pressure system includes aPLC control system to assure repeat-able documented results.
“What really sets Hamo apart fromother washer manufacturers is the levelof documentation and collaborationHamo offers on all of its machines,”says Hamo USA Managing DirectorMarvin Royal. “The quality supportdocumentation available with all of our‘As Built’ machines includes materialcertificates up to 3.1 as well as calibra-tion certificates for all process parts.IQ/OQ validation documentation andexecution is available, along with PQconsultative support. All of our PLCcontrol systems with HMI touchscreens are GAMP 5 compliant. FAT(factory acceptance testing) and clean-ing process development is available inour ISO 9001:2008 certified facility inBiel, Switzerland.”
Hamo is the company that cansolve your unique cleaning challenges.The ability to adapt to specific require-ments ensures that Hamo will remainthe industry leader.
For more information, stop byBooth #1963 or visit www.hamo.com.
Plastikon Healthcare delivers “Ideas forToday and Tomorrow” with capabilitiesthat set them apart from the competition.
Plastikon Healthcare contract de-velopment and manufacturing lever-ages their industry leading knowledgeof plastics technologies, developed, re-fined and expanded through their 30-plus years of manufacturing excellence.Their Blow/Fill/Seal technology resultsin process efficiencies, more accurateunit dosing, contamination prevention,quality assurance, better product per-formance and cost-effectiveness. Theirfull spectrum of global integrated plas-tics manufacturing, analytical chem-istry lab support, PMP accreditedspecialists, design engineering, label-ing, packaging, and logistics servicesmakes them a one-stop resource fromconcept through distribution, fromstock to dock.
B/F/S technology offers microbio-logical contamination control, easierprocess validation, reduced container
defects, customized filling systems, andreduced utility consumption. During onecontinual process, plastic is extrudedand formed into the shape of the con-tainer, filled and then sealed. Plasticampoules provide a convenient, un-breakable drug container. It’s a fully au-tomated process that takes only secondsto complete. The human element is re-moved from the process, eliminatinghuman intervention, known to be themajor cause of sterility failures in allcritical processes.
Plastikon Healthcare provides dedi-cated customer service, development andcommercial scale capabilities, full tech-nology transfer, process optimization andvalidation. Plastikon’s machines are de-signed to manufacture container sizes
Plastikon Healthcare: Your Sourceof Expert, Reliable, Economical,Customized Blow/Fill/SealPackaging Solutions forLiquid Sterile Manufacturing
The ChallengeThe manufacturer required afully automated, disposable chro-matography system which wasPLC controlled and designed foruse in a cGMP environment. Therequired applications for thechromatography system includedcontamination removal, and concentra-tion and purification of biologically de-rived proteins used in the production ofresearch and clinical materials. Finally,there was a requirement that all productcontact surfaces be completely dispos-able, single-use applications.
The Technical ProblemThere were a number of problems with
the original valve set-up for thechromatography system thatneeded to be addressed with anoperational solution. The closurecapability of the existing valveand tubing combination was un-predictable and the durometertolerance variations within the
elastomer tubing sets led to frequentvalve failures, or leak-by. This also oc-curred when the valves were unable toovercome the operational pressure resist-ance generated within the system. If theywere able to close, it was at a very lowpressure for both the tubing and thevalve. When the pressure issues werecombined with tubing durometer vari-
A Disposable Valve for ProcessChromatography Case Study
continued on page 29
continued on page 24
are entering into a long-term relation-ship that should include up-front appli-cation assistance, training, parts andservice support.
Heat and Control maintains demon-stration centers where you can test theirequipment. They are applications expertsand can manufacture accessory equip-ment to suit your product handling andinstallation requirements. They also sup-
HEAT AND CONTROL(continued from page 12)
port you with sales, parts, service, train-ing programs, and on-going technical as-sistance from locations throughout Northand South America. In fact, their servicetechnicians are located in 10 states acrossthe country to provide fast response toany service issue.
For more details on their equipmentand services, please contact Heat andControl today at 800-227-5980 or 510-259-0500, [email protected],www.heatandcontrol.com or stop byBooth #3616.
24 PHARMACEUTICAL DAILY NEWS 1st Edition • Tuesday, April 23, 2013
granted certification of compliance with3A Sanitary Standards, the only self-cleaning filter/strainer to be 3A approved.
Spencer Strainer Systems is also a re-cipient of the Indiana Environmental Excel-lence Award, and, in 2010, was nominatedfor the Frito-Lay Innovation of the year.
Today, Spencer Strainers are in use
globally, in an ever-growing list of appli-cations. Their customers include:
UnileverProcter and GambleJ.M. SmuckerADMPPGGeneral MillsSherwin WilliamsAnheuser Busch
HormelTropicanaKellogg’s
Do you have a filtration application thatneeds cost containment? Are you stoppingyour process to use wasteful filter media,and throwing away expensive product?Do you have to open your process to theatmosphere during filter changes?
Spencer Strainer Systems can meet
SPENCER STRAINER SYSTEMS(continued from page 1)
your filtration challenges. Let them tailortheir equipment to your application, ordevelop a design for you, if necessary.They offer sealed, self-cleaning, ultrasanitary, permanent filtration. It is alsowell suited as pre-filtration with cen-trifuges and membranes, extending thecycles of these devices.
Please contact them at 800-801-4977,or www.spencerstrainer.com. Visit theirBooth, #2789 at INTERPHEX 2013.
rotating equipment.Unit operations include
mixing/blending of materials with simi-lar and large differences in viscosity and
volumetric flow rate; continuous plugflow reactors; creating immiscible liquidand gas-liquid dispersions for masstransfer enhancement; in-line heat ex-changers; and fluid flow conditioningfor creating flat velocity and pressureprofiles in front of process equipment
and instrumentation thatare sensitive to inlet flowconditions.
Sizes range from 1.7
millimeter diameter for use in laboratoryand proof of concept bench scale re-search, to many feet in diameter for com-mercial installations.
Materials of construction includeplastics and metals. Typical plastic mate-rials include PTFE Teflon, Polyethylene,Polypropylene, Acetal and PVC. Standardmetals include 316L S/S, Hastelloy, In-conel, 17-4PH S/S, Titanium and Tanta-lum.
STAMIXCO(continued from page 1)
Industries served include pharma-ceutical; biotechnology; medical; cos-metics; electronics; polymermanufacture; plastics extrusion and in-jection molding; adhesives, sealants &resins processing; chemical; food; petro-chemical & refining; water & waste-water treatment; and many other fluidprocessing industries
For more information, stop by Booth#1957 or visit www.stamixco-usa.com.
from 0.02 milliliters to 1000 milliliters atproduction rates of up to 15,000 units perhour using Weiler 624 machines withvariable precision heads, and multi cavityand single cavity clinical developmentproduction tools. For liquid filling andpackaging, they offer bottom to bottomtransfer capabilities, recirculation capa-
bilities with filtration and homogenizeroptions, and inline filtration with clean inplace and steam in place systems in alltanks.
About Plastikon Healthcare For more 30 years, they’ve been commit-ted to providing the best quality productsand turnkey services at globally compet-itive prices. They’re a technology driven,diagnostics, pharmaceutical, contract de-
PLASTIKON HEALTHCARE(continued from page 21)
velopment and manufacturing companyfor Blow/Fill/Seal and liquid filling ofliquids and creams for a broad range ofpharmaceutical applications. Their facil-ities operate under international and U.S.codes of cGMP and a Quality Manage-ment System that allows their formula-tion scientists to assist with development.All facets of production are performedwithin Class 10K or 100K clean room en-vironments. They understand medical in-
dustry manufacturing standards, and com-ply with all FDA requirements. For moreinformation about their capabilities, facil-ities, and the pharmaceutical manufactur-ing solutions they can provide to you,please contact Eugene Udoh, Director ofHealthcare Business DevelopmentSales at 510-400-1147, visit Plastikon |Markets | Medical & Healthcare athttp://bit.ly/WHLHle or stop by Booth#3684.
option for normal-phase chromatography.This new technology marries the unreal-ized potential of SFC with Waters’proven UPLC technology and expertisein the management of fluids, temperature,and pressure.
ACQUITY UPC2 provides scientistswith an indispensable new tool for tack-ling tough-to-analyze compounds includ-ing hydrophobic and chiral compounds,lipids, thermally-labile samples and poly-mers across a wide range of applications.
Pharmaceutical relevance: UPC2 foranalysis of extractables in packaging
For example, in the pharmaceuticalindustry, extractables from packagingmaterials are a concern. Packaging mate-rial manufacturers need to control andmonitor their product to ensure that nopotential risk exists from extractable andleachable material.
In controlled extraction studies, the
nature of extractable profiles from criticalcontainer closure system components areinvestigated qualitatively and quantita-tively. Testing involves solvent extractiontechniques encompassing a range of po-larity, solvent compatibility studies, andmultiple analytical techniques. One of thelimitations encountered in these studiesinvolves matching the solvent extractswith the appropriate analytical technique.For example, non-polar solvent extractscan be directly injected into a GC systembut must be evaporated and reconstitutedwith a solvent compatible with an LCsystem. Likewise, water extracts must beback-extracted into a non-polar solventfor analysis by GC.
Streamlining multiple extractablesanalyses on one UPC2 system
UPC2, built on the principles of SFC,allows different types of extraction sol-vents to be injected for separation on onesystem for analysis, thereby saving timeand reducing sample preparation efforts.
Waters tested UPC2 for extractables
WATERS CORPORATION(continued from page 1)
analysis using four different types ofpackaging material, including a high den-sity polypropylene pill bottle (HDPE), alow density polypropylene bottle(LDPE), an ethylene vinyl-acetateplasma bag (EVA), and a polyvinyl chlo-ride blister pack (PVC). The extractswere screened for 14 common polymeradditives. A single UPC2 technique wasfound to be compatible for all extracts ofdifferent packaging material. This al-lowed for a streamlined, simplified sam-ple preparation workflow with betterasset utilization, since all of the solventextracts can be directly injected onto theACQUITY UPC2 System. Using otherseparation techniques, such as LC andGC, some extracts are not compatible re-quiring additional processing steps priorto analysis.
In this extractables study, UPC2 of-fered better information for non-volatileand thermally labile compounds than GCdue to lower analysis temperatures. TheUPC2 analysis provided a two-fold im-
provement in run time compared toUPLC, and an eight-fold improvement inrun time compared to GC.
Built upon proven Waters UPLCtechnology
The exceptional reliability, robustness,sensitivity and throughput of the WatersACQUITY UPC2 System can be attributedto its roots within the ACQUITY UPLCTechnology platform. Specifically de-signed to manage mixtures of compressedCO2 and organic modifiers, the ultra-lowdispersion ACQUITY UPC2 System is ina class all of its own. With unparalleled se-lectivity choice through column and mo-bile phase selection, the ACQUITY UPC2
System is the ultimate solution for makingthe complex, routine.
For more information, stop by Booth#2477, visit www.waters.com or call 800-252-HPLC.
Waters, ACQUITY, UltraPerfor-mance Convergence Chromatography,UPC2, ACQUITY UPLC, and UPLC aretrademarks of Waters Corporation.
3C! Packaging will be exhibiting at IN-TERPHEX 2013, Booth #3939. Visitorswill have the opportunity to learn of3C!’s latest investment in “State of theArt” label manufacturing equipment.
Management will be on hand to illustratethe various types of visions systems uti-lized throughout their manufacturing cen-ter of excellence.
In addition, attendees will have the
opportunity to schedule an “in-house”seminar on 3C!’s successful color con-trol program known as “3C!’s Color-by–Numbers,” This program approachescolor in a digital spectrophotometricspace that assigns L.A.B. values; thuseliminating a human subjective inter-pretation of color.
Customers of 3C! have experi-enced many successes and benefits ofthis program including tighter colorcontrol, streamlined proofing and the
3C! INTERPHEX 2013Launch Experts are Exhibiting at Booth #3939
elimination of “light-medium-dark”color swatches.
New Product Launch Experts Under one roof, 3C! Packaging designsand manufactures folding cartons, in-serts/outserts, and film/paper labels. To-gether with state of the art technologies,a well-documented process, and visionssystems, all being managed by onewell-seasoned team…………..OneLaunch Pad……One Mission Control!
year. ANDRITZ Separation, Inc. a divi-sion, concentrates on the separation of ma-terials from product streams. WithinSeparation we have specialists just for thechemical/pharmaceutical industry. Ourcomplimentary acquisition of KMPT/Frautech a couple of years ago allowed usto better serve the market. ANDRITZ hasalways had the philosophy of approachingeach project from a systems approach,meaning, we want to work from an overallsolution for our customer rather than justselling a piece of equipment. Whichbrings me to your question of what is ourfocus; this is always an easy answer –OUR CUSTOMER! In fact our mission
statement is based on the delivery of a so-lution to the customer that provides thebest overall cost effective resolution totheir needs or problems.
Q: Please tell us about the company’sproducts.
A: WOW – where do I start. Of course wehave the KMPT/Frautech line of HelixDryers and Pharma Peeler Centrifuges butwe have so much more to offer to cus-tomers now. A little ANDRITZ humor isthat we like to say we have you coveredfrom A to Z, of course that is true but wedo work from a solution standpoint andhave other centrifuges, separators, presses(belt and filter style), screens and even con-veyors. But what most people don’t know
is that we are one of the largest full linedrying system manufacturers in the world.Most specifically with our recent acquisi-tion of GMF/GOUDA this thoroughlycompliments our range of offerings to yourindustry. Finally, something that we are allvery proud of is that we has service capa-bilities for not only our own equipment butalso our competitors equipment and areable to offer this with five dedicated serv-ice centers within North America.
ANDRITZ SEPARATION(continued from page 1)
Q: How can our readers find out moreabout your company?
A: For more information, visit www.andritz.com/separation. However, I amold fashioned and feel that for the best re-sults you should call us at 800-433-5161or 817-465-5611 and ask for Pat Mc-Carty—he is the real expert. Of coursesince you are here at INTERPHEX juststop by our booth! Booth #2578
sciences, ZEUS, BD Vacutainer Systemsand many other national and internationalmedical device and pharmaceutical com-panies call South Carolina home.
South Carolina companies are withinone day’s drive to more than 55 millionpeople, and the state is the midway pointbetween Miami and New York City on I-95. To reach export markets, the Port ofCharleston can accommodate Post Pana-max ships with the most efficient opera-tions in the Southeast.
The support that companies receivefrom the state’s three research universi-ties often is cited as being critical in bothresearch collaboration and as a sourcefor degree specific graduates. The Uni-
A team from the State of South Car-olina at Booth #2032 is prepared to an-swer questions related to availablebuildings and sites, the state’s award-win-ning pre-employment recruiting andtraining program, tax advantages, energyincentives, environmental permittingsupport and other factors that impact sitelocation decisions.
South Carolina is home to more than572 medical device and life science com-panies employing more than 13,500South Carolinians. Nephron Pharmaceu-ticals Corp., who recently announced thebuilding of a 385,000 square foot facilityin Columbia, S.C. to produce respiratorymedications, cited state support in expe-diting the permitting process as one ofmany factors leading to their decision tolocate here. Roche Carolina, GE Health-care, Bausch & Lomb, Martek Bio-
versity of South Carolina, Clemson Uni-versity and the Medical University ofSouth Carolina (MUSC) all operate lifescience programs and business incuba-tors and are eager partners in researchand collaboration.
Twelve of the state’s 16 technicalcolleges have two-year associate degreeprograms in medical technology relatedfields. The state’s readySC pre-employ-ment training program is utilized to iden-tify, recruit and train prospectiveemployees at state expense prior to actualproduction commencing. Since its cre-ation in 1961 readySC has trained morethan 266,900 workers, many in the phar-maceutical and medical device industry.
Medical device and pharmaceuticalcompanies also require a reliable and af-fordable energy supply. The South Car-olina Power Team represents SanteeCooper, the state’s electric generationutility and the 20 electric cooperativesthat distribute Santee Cooper power to all
SOUTH CAROLINA POWER(continued from page 1)
46 counties. The SC Power Team willprovide a power cost estimate for yourmanufacturing operation and discuss sitesand buildings that meet your specificpower requirements. Among the advan-tages available from the SC Power Teamis a five-year economic development in-centive rate that represents a significantreduction in a new or expanding com-pany’s power cost.
The state incorporates a number ofincentive programs to locating and ex-panding companies. Incentives are basedon the number of jobs created, capital in-vestment, and geographical location andinclude Jobs Tax Credits, Fee-in-Lieu ofproperty taxes, Job Development Credits,and incentives for headquarters, R&D fa-cilities and clean rooms.
A Right-To-Work state, South Car-olina’s favorable business tradition andregulatory climate enable new companiesto get up and running quickly. Visit Booth#2032 for more information.
services we provide. It also allows usparticipate in giving opportunities to thisunderserved community,” says AndreaPeters, CEO and founder.
E Packaging & Fulfillment is a con-tract pharmaceutical packaging companythat specializes in the packaging and re-packaging of solid dose prescription
drugs. Its core services are blister pack-aging and bottling of tablets and capsules,sachet packaging of powders, and label-ing of each. Their clients are the toppharmaceutical manufacturers in thecountry. Once they move to their new fa-cility, they will expand services to in-clude sterile packaging and liquids. Formore information, you can visitwww.goepack.net or stop by Booth#4079.
E PACKAGING & FULFILLMENT(continued from page 4)
29PHARMACEUTICAL DAILY NEWSTuesday, April 23, 2013 • 1st Edition
Tablex-PRO to be installed in areas wherespace is restricted. Robust, low profile,fully-rotating castors provide ease of mo-bility, allowing the system to be used inmultiple locations. For further flexibility,the detection head can be adjusted easilyin all three axes without the need for tools,to suit any configuration of process equip-ment. The system is available with achoice of two interchangeable reject de-vices to suit all product types, applicationsand configurations, Tablex-PRO divertersinclude built-in reject confirmation tech-nology and failsafe design.
Lift-flap diverters provide high-
throughput, gentle product handling andstraight-line product flow. Compact, side-divert systems are suitable for use in in-stallations where system height isrestricted. All reject devices are designedand constructed to meet the demands of21 CFR parts 210 and 211.
Tablex-PRO metal detectors supportfull compliance with the FDA 21 CFRpart 11 standard with dedicated softwareto capture electronic signatures and othercritical process data. All detector settingsare password-protected and details of allmetal detector access activities are auto-matically logged to establish when andby whom the system was accessed, help-ing manage process cells and ensuringcompliance.
METTLER TOLEDO(continued from page 12)
ances, it was difficult to determine whichcomponent was to blame. Additionally,there was often product degradationcaused by convective heat transfer fromthe actuation of the valve through theliner, and into the product stream. Theseissues alone compromised the system’soverall integrity and ability to function asneeded. Other significant process issuescaused by the unpredictable valve opera-tion were associated with the manifoldconstruction. The poor spacing in theoriginal valve manifold—that was re-quired for traditional hand fabricationand over-molding of the liner assembly—led to irregular center-line dimensionswith a minimum of 3.5 inches. This ledto significant hold-up volume concerns,and combined with the buffer/productprecolumn admixing affects ultimately,ended up negatively impacting productyield.
The Resolution The manufacturer chose the patentedARTeSYN Arterial Process Module—amultiple pinch-valve array designed toproduce low hold-up volumes and com-pact actuation. The directional flow pathcontrol for the automated cGMP chro-matography system was achieved usingthe ARTeSYN multiple pinch-valve arraymodules. The valve array modules are acompact, pneumatically actuated designusing single-use silicone tube liners for
quick replacement. The compact designminimized the risk of unwanted solutioncross-mixing and virtually eliminates anypossible deadlegs within the process flowpath. This was accomplished by movingthe valve closure points of the flowpathas close to the main trunk line as possible.The valve also solved the problem ofnominal operational pressures exceeding30 psi. These pressures had previouslybeen very difficult to achieve—and sincethe installation of the ARTeSYN multiplepinch-valve array modules are no longera problem. This was accomplished by in-jection molding the entire flowpath in thepinch- valve array module, thereby sup-porting the entire circumference of theliner assembly.
The valve has been proven to close con-sistently in excess of 1000 cycles on thematched molded liner.
According to the manufacturer, theARTeSYN process module has led to su-perior overall system performance andhas virtually eliminated:• Unpredictable closure capability• Product yield losses caused by valveleak-by• Deadlegs• Product degradation caused by heattransfer from valve actuation• Product yield losses caused by pre-col-umn mixing
For more information, visit www.artesynproducts.com, call 818-350-0423 orstop by Booth #3077.
DISPOSABLE VALVE(continued from page 21)
![New York Daily Tribune.(New York, NY) 1861-03-27 [p 4]. fileNew York Daily Tribune.(New York, NY) 1861-03-27 [p 4]](https://img.pdfslide.us/doc/110x75/5ca55cbe88c993af5d8b605f/new-york-daily-tribunenew-york-ny-1861-03-27-p-4-york-daily-tribunenew.jpg)
![New York Daily Tribune.(New York, NY) 1850-11-29 [p 4]. · 9i,'0i](https://img.pdfslide.us/doc/110x75/5ffc9da7d95d7b58756a09e4/new-york-daily-tribunenew-york-ny-1850-11-29-p-4-9i0i-.jpg)
