WWW.PHARMAMANUFACTURING.COM VOLUME 15, ISSUE 6

JULY

/AU

GU

ST

20

16

Creating Value fromSmart Manufacturing

P10

Pharmaceutical EquipmentBuying Trends

P14

Unlocking the Benefits ofIT Integration and

Data ExchangeP32

PM1607_01_Cover.indd 1 7/12/16 9:20 AM

18 JULY/AUGUST 2016 PHARMACEUTICAL MANUFACTURING • WWW.PHARMAMANUFACTURING.COM

By Karen Langhauser, Chief Content Director

Pharma’s all-startechnology leaders areswinging for the fences

PHARMACEUTICAL MANUFACTURING • WWW.PHARMAMANUFACTURING.COM JULY/AUGUST 2016 19

Leading off in thiscategory is Keit’smicroFTS, a FourierTransform Infrared (FTIR)spectrometer developed

with a novel optical designfor improved in-line process

monitoring. The instrumentwas originally developed forthe space program, making it

inherently smaller, lighter andmore rugged than current systems,

and able to function despiteextreme environmental vibration.

The microFTS has no moving parts,setting it apart from other FTIRs,

and enabling a new standard for real-time liquid-state analyses.

Pharmaceutical analysis experts,Chiralabs, ran tests using multiplecommon substances to find out howconsistently the microFTS wouldperform. The reports confirmedthe microFTS’ ability to detect andanalyze common solvents usedin pharmaceutical, chemical andpetro-chemical industries withhigh consistency.

BrightSpec has developed arapid and chromatography-freequantitative sampling method forthe ppm analysis of low volatilityimpurities in solid powders andcomplex liquids. This applicationof FT-MRR (Fourier transformmolecular rotational resonance)using millimeter waves in the 260-290 GHz range is the first purelyspectroscopic approach to a problemthat is usually constrained to therealm of Gas ChromatographyMass Spectrometry.

The BrightSpec product andservices portfolio uses FT-MRRspectroscopy in the microwaverange (2-8 GHz) to performthree essential chiral analysismeasurements: 1. Quantitativeanalysis of diastereomers producedin the synthesis of moleculeswith multiple chiral centers.

2. Quantitative enantiomericexcess measurements for chiralmolecules. 3. Determination of thethree-dimensional structure of achiral molecule.

Currently, each of these analysesrequires different measurementtechnologies that are expensive, timeconsuming and highly technical.In order to meet the needs of targetmarkets, BrightSpec is developinginstruments that can performthis analysis on molecules in drugdiscovery applications.

Batting in the power spot isWIKA’s Diaphragm MonitoringSystem. The system alerts operatorsimmediately if the diaphragm in aseal assembly fails, helping preventcontamination of the process mediaand unscheduled downtime.

Diaphragm seals are installedto help maintain the integrity ofprocess media for product safetyand quality. However, repeatedexposure to harsh chemicals andextreme conditions can weakenthe diaphragm membrane andcause it to fail. This failure can goundetected, leading to possibleprocess contamination.

WIKA’s monitoring systemis designed with primary andsecondary diaphragms. If theprimary diaphragm is breached,it will trigger a visual, audio orelectrical alert. The secondarydiaphragm will continue to function,providing reliable pressure readingsuntil repairs can be made.

BIOPROCESSINGBioprocessing equipment encom-passes bioreactor vessels and allrelated equipment needed to main-tain a streamlined reaction within asterile environment. As the demandfor biopharmaceuticals grows,drug manufacturers are looking fornew strategies to meet these globalneeds. Often this results in the need

to create more efficient bioprocess-ing systems and employ single-usetechnology to reduce cleaning andproduction costs.

First up, ITT Corporation’sEngineered Valves brand haslaunched a new line of hygienicdiaphragm valves — Pure-FloEnviZion — designed to dramaticallyreduce maintenance time andtotal cost of ownership for today’sbiopharma manufacturing facilities.

EnviZion’s embedded technologiesallow for a more streamlinedinstallation and maintenanceprocess, delivering less downtime,longer preventative maintenancecycles and greater productioncapacity. Assembled with a simplemount and turn motion, the valveis installed in approximately threeminutes without using special toolsor difficult torqueing procedures.The valve’s 360-degree activeseal protection provides leak-freeoperation, helping eliminate the riskof contamination and the need to re-torque after thermal cycling.

Comecer offers a solution to smallbatch vial filling needs with theiraptly named Baby Phill machine.Baby Phill is ideal for producingbatches for clinical trials or for R&Daseptic filing, where the developmentof cytotoxic, liquid or lyophilizeddrugs in a sterile, contained, grade Aenvironment is needed.

The small aseptic filling machine isintegrated inside an isolator or RABSas part of a complete productionline. The filling line also offers one-button sterilization via a built-inVapor-Phase Hydrogen Peroxide(VPHP) generator.

The Cadence Acoustic Separator(CAS) from Pall Life Sciencesapplies acoustic wave separationtechnology in a novel single-useformat for the clarification of cellculture bioprocess fluids. The CASprovides robust, reliable cell and

20 JULY/AUGUST 2016 PHARMACEUTICAL MANUFACTURING • WWW.PHARMAMANUFACTURING.COM

COVER STORY

protein yields in a closed system.The technology provides a single-useprimary clarification solution thatdelivers quality that is equivalent tocentrifugation without the scaling,footprint and cleaning issuescommon with this solution.

Pall’s acoustic wave separationtechnology was introduced as anenabling tool for customers tobridge the critical gap between thebioreactor and the downstreamprocessing train.

The separator is an easy-to-usetechnology without the volumelimitations experienced by depthfiltration solutions that lead to largefootprint and buffer consumptionor the need for process additives toenhance the performance.

Batting cleanup in this categoryis GE Healthcare Life Sciences’KUBio Biomanufacturing Solution.KUBio consists of prefabricatedmodules equipped with the heating,ventilating, air conditioning (HVAC)system and all the piping necessaryto run a biomanufacturing plant.

The solution createsbiomanufacturing capacity bydelivering a fully functional, ready-

to-run facility in 14-18 months. Thefacility can be equipped with GE’sintegrated FlexFactory single-usebiomanufacturing platform, or ahybrid processing platform.

SOLID DOSE PROCESSINGOral solid dose — pharma’s mostmature dosage form — has contin-ued to find ways to stay relevant intoday’s pharmaceutical landscape. Inorder to best capitalize on market op-portunities, OSD manufacturers arerecognizing a universal need to rampup efficiency and reduce waste.

Pharmaceutical Manufacturingselected two heavy hitters forthis important category. Witha production output of up to400,000 capsules per hour, FetteCompacting America’s FEC40 setsnew standards in the efficiency ofcapsule filling machines. The fillingmachine accomplishes this elevatedproduction level in a remarkablysmall footprint, making machinereconfiguration due to floor spaceissues unnecessary.

The high ratio of performance-to-footprint is made possible by Fette’spatented Duplex Concept, whichenables the FEC40 to feature a dualcapsule filling process. The result issignificant production savings (up to30 percent per 1,000 capsules).

The FEC40’s productivity level is aresult of applying the principles thecompany used in the developmentof its double rotary tablet presses.With the FEC40, separate processsteps have been merged for capsulefilling, with the resulting freestations used for dual arrangementof the filling process in the machine,thereby doubling output. As thefilling process fully complies withestablished production standards,users can apply all tried-and-testedprocess parameters for capsulefilling and further optimizewhen necessary.

MG America’s next-generationPLANETA 200 Capsule Filler 200produces up to 200,000 capsulesper hour, but its primary advantageis flexibility — its modular designresults in a highly configurableplatform suitable for a wide array ofproduction requirements, includingan ability to fit several dosing unitssimultaneously, enabling one capsuleto be filled with differing products.

The capsule filler is also scalable.For example, it can initially beconfigured for medium speeds, thenupgraded later for maximum speeds,reaching different performancesdepending on the number and typeof dosing units installed. Its weightcontrol system also can be upgradedpost-installation. The machine canbe equipped with isolators satisfyingdifferent containment levels, as wellas various washing systems rangingfrom Wet-In-Place to Wash/Clean-In-Place automatic systems.

PACKAGING AND HANDLINGPharmaceutical manufactur-ers continue to need reliable andefficient packaging solutions thatenable traceability, quality assuranceand flexibility. Leading equipmentmanufacturers have been workingfull speed on new systems — and theindustry is now seeing the ground-breaking results of these efforts.

WHEATON boasts a true“utility player’ when it comes todrug packaging. The company’sbreakthrough technology allows forthe manufacture of plastic exteriorcomponents with complete interiorcoverage of pure glass. The newtechnology fits the bill for applicationswhere having both materials in oneproduct has long been needed.

The innovative concept results inpackaging products that have the bestof both worlds: the lightweight, breakresistant properties of plastic withthe barrier qualities and inert inner

FEC40 CAPSULE FILLER

FETTE

PM1607_18_21_CoverStory2.indd 20 7/12/16 10:03 AM

PHARMACEUTICAL MANUFACTURING • WWW.PHARMAMANUFACTURING.COM JULY/AUGUST 2016 21

surface of pure glass. The technologyis broadly applicable across the bulkof the company’s product range.

The Videojet 7510 50-Watt fiberlaser marker offers high contrastmarking on robust plastic packaging,metal containers and other industrialproducts even at fast line speeds up to440m/min. Small in size yet powerfulin performance, the 7510 enablesmanufacturers to mark crisp, clearcodes to meet demands for increasedthroughput and more code content.

The laser marker helpspharmaceutical and medical devicecompanies navigate traceabilityrequirements. In addition, its high-speed capability and large markingwindow directly address the growingneed for increased lines speeds andmaximized throughput

INFORMATION TECHNOLOGIESToday’s pharmaceutical companiesare dealing with a data explosion.Forward-thinking manufacturershave realized that this data — whethergenerated internally or externally — isa tremendous asset with many uses.Suppliers are responding by offeringnew data analytic capabilities which,when used correctly, can transform acompany’s business model.

Along these lines, our first IT AllStar goes to Veeva Systems. Veeva’sVault QMS is intended to replacedisparate, on-premise qualitysystems to manage global qualityprocesses across an organization —including external partners.

While the majority ofmanufacturers have implemented aquality management system, thesesystems often are only applicablewithin a company’s four walls. TheVault QMS application incorporatesexternal partners into the fullspectrum of quality processes,including deviations, complaints,internal and external audits,corrective and preventive actions,and change control. This reducescompliance risks and eliminatesproduction bottlenecks.

PLM Direct, a new solution fromMettler Toledo, offers a cost-effectiveway to implement serializationin manufacturing plants. It’s anideal introduction to serializationfor companies that do not requireaggregation and do not use multipleproduction lines in parallel. It is alsoa potential tool for contract packersneeding a short-notice serializationsolution to fulfill an order.

PLM Direct offers serializationcapability that involves nomajor integration investmentor restructuring of complexproduction lines, while stillenabling pharmaceuticalcompanies to implement the latestanti-counterfeiting guidelines.The software solution networksindividual stations easily anddirectly with manufacturers’ existingMES, ERP and cloud solutions forserialization purposes.

RESEARCH & DEVELOPMENTLast, but certainly not least, a cat-egory that is crucial to the long-termsuccess of the pharmaceutical indus-try. As manufacturers are looking to

accelerate development and reducerisk in early phases, there are manyearly phase development challengesto overcome.

One of the challenges thatcomes with developing a newchemical entity is determining thepath forward for bioavailability-challenged compounds. Catalent’sOptiForm Solution Suite platformintegrates multiple technologies tomatch the best and most innovativedrug delivery technologies to eachdevelopmental molecule. Theplatform utilizes an acceleratedparallel screening and developmentapproach, based on rigorous scienceand scientific expertise.

The service enables moleculesto be evaluated across multipletechnologies for a fixed price. In just12 weeks, a dedicated adviser fromCatalent will provide a recommendedpath forward for a company’smolecule based on data, shipping toits facility the necessary animal PKstudy materials to enter animal trialswith an optimal product faster.

And there you have it: The 2016Pharmaceutical ManufacturingAll-Star lineup. Congratulations andthank you for your contributions tothe pharma game!

PLANETA 200 CONTINUOUS MOTION CAPSULE FILLER

MG AMERICA

VIDEOJET 7510

VIDEOJET

PM1607_18_21_CoverStory2.indd 21 7/12/16 10:03 AM