Give me fi ve! Intelligent system solutions for processing different types of autoinjectors and devices

The Customer Magazine by Harro Höfl iger

Edition 2 | April 2016 Shaping the future The new technology center in Backnang Page 14

Give me fi ve! Intelligent system solutions for processing different types From nose of autoinjectors and devices to brain Nasal application for absorbing brain-active substances Page 22 CONTENTS EDITORIAL

4 Flexible aseptic fi lling Cooperation project with Bausch+Ströbel 6 Smart hybrid solution Separating and labeling autoinjectors and devices

9 5 wins Palletizing systems for easy tray handling ear Readers and Business Associates 11 New drive: Harro 2020 When our one thousandth employee recently signed on the dotted line, Harro Höfl iger offi cially Passionate – close – inventive – reliable D entered a new league. We have a good line-up, our thinking and actions focus on customer centricity and are the 14 Shaping the future basis for our success. And we’re a little bit proud of the fact The new technology center in Backnang that we’ve doubled all our KPIs in the space of just fi ve years. That is both an incentive and commitment to remain true to our 16 Transparency for operators promise [ALL YOU NEED]. We aim to put all our efforts and passion into addressing A new Human- Interface sets standards new goals and tasks in the upcoming years, while continuing to clearly focus on our customers. We will be increasing dy- 19 “We don’t sell , namics and reaction speed with higher throughput rates and we generate projects” optimized processes. Based on our high quality standards, we Swabian mindset on the Chinese market offer solutions with a technical edge. All of this is at the heart of our strategy 2020. In this second issue of the Harro magazine, we give you a 21 Focus on new markets preview of the measures we intend to implement as part of this Hisun banks on Harro Höfl iger for diversifi cation strategic plan. We are also opening our factory store to you at our new production facilities in Backnang. Visit us there and see 22 From nose to brain how we are already setting our course for the future. Our China Nasal application for absorbing brain-active substances representative, Daning Zhao, reports on how current and future market success can only be achieved through sustained global commitment. 24 High speed capsule fi lling Welcome to the second issue of our magazine. We hope it Modu-C HS — excerpt from the product family makes inspiring reading.

26 Fast solution for eye drops Pressed for time: producing a line for Pharma Stulln Best regards

4 Harro Höfl iger News 29 Trade fair calendar

Thomas Weller Chief Executive Offi cer Harro Höfl iger Verpackungsmaschinen GmbH

Imprint HARRO, the magazine for customers, interested parties and friends. Editor: Harro Höfl iger Verpackungsmaschinen GmbH;Publisher: Thomas Weller, CEO; Overall responsibility: Andreas Streicher, Director Creative Marketing; Editorial management and consulting: Oliver Naucke, nokey communication by Oliver Naucke, Laichingen; Editorial planning and coordination: Denise Dreher, Productional coordination: Farina Hatami; Editorial assistance: Arthur Fabian, Dr. Susanne Koschatzky, Dr. Claudia Mattern, Sebastian Rittner; Stefan Bernsau, Fabian Elsässer, Hannes Fischer, Norbert Hiller, Tina Hofmann, Ulrike Klauss, Felix Nink, Steffen Schiele, Dieter Schüle, Yuan Su, Thomas Weller, Daning Zhao, Roberto Zürcher; Concept and implementation: pr+co GmbH, Stuttgart; Translation: STAR Deutschland GmbH, Böblingen; Editorial Expert: Rosemarie Christ; : Druckhaus Götz GmbH, Ludwigsburg; Repro: Raff Medien, Riederich; Editor’s address: Harro Höfl iger Verpackungsmaschinen GmbH, Helmholtzstraße 4, 71573 Allmersbach im Tal, harro.magazine@hoefl iger.de; Circulation: 7,700 (2,700 in German, 5,000 in English) Credits: Title: monsitj/iStockphoto.com, spxChrome/iStockphoto.com; Cover fl ap: Tom Philippi, Christoph Kalscheuer; Page 2/3: Oliver Naucke, Atelier Lünig, Christoph Kalscheuer, Tom Philippi

2 HARRO Edition 2 HARRO Edition 2 3 4 chemical engineering industry. the L-Trolley withVarioSys filling aseptic Flexible Model cooperation:ExcellenceUnitedpartnersBausch+Ströbel and Harro Höfl igerhavedevelopeda exible fl production solutionfor medical, consumergoods, cosmeticand tion ofhospitalsamples,fillingactive Aseptic work stages in sterile conditions L-Trolley create fl exible production pos- umes are fi lledintoawiderangeofdos- ative studies.TheVarioSys agents forstudypurposesandcompar- are a common feature in the produc- a compactsysteminwhichdiffering vol- quirements are clear:pharmacistsneed sibilities in a standard isolator. The re- All-round partnerforthepharmaceutical, 40 Years supplier ofcustomized systemsolutions. The Harro Höfl igersuccess storyspans of Success ment from usedmachinerytradertoglobal trate thecompany’s dynamicdevelop- four decades.Selectedmilestonesillus- ® systemand ® . with activeagents. thanks toshortretooling times.Ifanother fi llingampules,,syringesorIVbags Bausch+Ströbel and Harro Höfliger in batches canbeprocessed inanisolator cialist Skan: a modular fl exible system for developed byExcellenceUnitedpartners age formsin anisolator. Thesolution was cooperation with the Swiss isolator spe- Many different packagingmaterialsand Allmersbach imTal. the factorymovesto Four yearslater: cartoning machines. trading inreconditioned Company foundation, 1975-79 to the existing isolator at any time. Both fi rsttrolley. Furthertrolleys canbeadded unchanged. Asurrounding infl atablegas- invests onceinastandard isolatorand inside theisolator. Thecustomerthusonly ket system guarantees sterile conditions is simplyswapped.Theisolatorremains product istobefi lled,the VarioSys can befi lledandsealed. standard and non-standard receptacles 1987-90 sectors. industry thanforother the pharmaceutical machines are builtfor the fi rsttimemore program. 1990:For standard machine Development ofa system over themodular quickly andfl exibly vials canbefi lled ampules and times: IVbags, Short retooling HARRO Edition 2 ® trolley

Bausch+Ströbel, Harro Höfl iger, Stoll von Gati HARRO Edition 2 people. Höfl igeremploys200 9001. 1998:Harro system toDINISO quality management Introduction ofa national expansion. Beginning ofinter- 1991-98 € 90million. generate revenues of Around 500employees tem designcapacity. create additionalsys- development centerto Extension ofthe 2008 for thepharmaceuticalindustry. Products inbothliquidandpowderform Excellence Unitedmember Bausch+Ströbel designs, buildsandsellspackingproduction systems in primarypackaging. performance machinestoverycomplexhighsystems–precision portfolio rangesfrom semi-automaticequipment forlaboratoriesandmedium can bereliably andcarefully processed onthesystems.TheBausch+Ströbel 2010 Höfl iger. teme, GlattandHarro Uhlmann Pac-Sys- Bausch+Ströbel, Fette Compacting, cooperation between Excellence United Foundation ofthe remains unchanged new product –theisolator L-Trolley isswappedfora Fast andeasy:onlythe 2015 employee isinsight. one thousandth € 200million.The years. Revenueof doubled withinfi ve All relevant KPIs HARRO HÖFLIGERNEWS 5 BEST PRACTICE 6 solution Smart hybrid Harro Höfl igerteamedupwithawell-knownSwisspharmacist devices. ArthurFabian,PrincipalEngineerDeviceTechnology, on aproject forseparatingandlabelingofautoinjectors reports onthechallengesofproject andprocess. HARRO Edition 2

Atelier Lünig, Oliver Naucke, I.D. Medienhaus The tight schedule was a very critical as- The systemispartofanoveralllinewith The machinewasplannedanddeveloped vember 2015according toplan. What’s specialisthatwe’re talkingabout was commissioned,successfullyqualifi ed which hasbeenonlinesinceNovember What challengesdidyouhaveto top loaderandendpackagingmachine, these phasestoourfactory. Andthatwas tion at their own sites and not move one of the relevant activeagentinliquidform. take ontogether? 2015 fi vedaysaweek,inthree-shift op- HARRO Edition 2 The fl exiblehybridsysteminaction is easyforusthankstofastretooling. Mr. Fabian,whatexactlydoyou bination product, ahandlingdevicewith pect of the project. Nevertheless we de- at the supplier’s factory, so we stayed on and validatedwithoutahitch.Thefacto- absolutely therightdecision.Thesystem chain attemperatures from +2°Cto+8°C. cessed andthenshippedinafi xedcold chilled products that have to bepro- check autoinjectors,needlesafetyand at ourrequest toseparate,labeland devices perminute,dependingonthe eration. Itoperatesatarateof15to40 cided togivethesupplierstimethey needed for development and implementa- ry acceptance test was also conducted schedule andwentintooperation in No- shape ofthedevice.Changingproducts stacks. Thesedevicesare partofacom- self-injection devices,suppliedintray process ontheline? Principal EngineerDeviceTechnology to fastretooling." products iseasy for usthanks "Changing Arthur Fabian, Fully automatedproduct handlingforpenlabeling The systemautomaticallyconveysthe The Harro Höfl igerteamdefi nedinterfac- workpiece receivers are already integrat- without anyproblem. What doeshybridmeaninthis turned out to be a flturned exible fully automat- the twosuppliersadetailedinterfacede- the machine,updaterequirements inthe the project wasusedtofurtheroptimize tion isamasterpieceonthepartof technical issuesorobstacles? URS (UserRequirement Specification) Some technical aspects were complete- It pointstothefactthatalldifferent important, based on correct on-site ly new, bothtoHarro Höfligerandour- in thesystemwithnoneedforretooling. loader-cartoning machine. Together with ing withthedownstream system,atop Does linkagetothedownstream Did theproject poseanyspecial bel allfi vedifferently contoured devices context? planned asasemi-automaticsolution perts. Experience gained in the course of different devicestotherightreceiver in engineers. We cannowconveyandla- ed into the system. This idea and solu- ed hybridsystem. es. Theeffort paid off. Whatwasinitially and improve packingmaterialintwocas- analysis and input from our in-house ex- scription wasdraftedandimplemented selves. Makingtherightdecisionswas system work? 7 BEST PRACTICE

wins

A program consisting of fi ve palletizing systems enables fl exible handling of product components in trays.

Delighted with the successful 5 production fl ow

In response to the rising level of automation in the pharmaceutical industry Harro Höfl iger the right position, so there is no need and imprint are checked. The robot then launched development of palletizing systems, for manual retooling. Automated prod- collects the device and places it on the resulting today in a formidable line-up of fi ve uct changing saves us a huge amount of belt for conveying to the top loader. The different palletizing systems. Customized time and of course dramatically increas- empty trays are stacked and conveyed solutions can thus be confi gured to permit "The idea of es the efficiency of the whole produc- to the discharge point for manual re- easy fl exible loading and unloading of prod- tion process. The tray loader and rotary moval. A special feature of the system is uct components onto and off trays. For inha- preinstalling all the indexing assembly machine were also monitoring via motion sensor. It detects lators, pens or autoinjectors it is no longer a necessary workpiece combined on one platform to take up whether a person is reaching into the matter of purely plastic product components less space. machine so we can protect operators that require assembly. Now highly sensitive receivers is a from potential injury. pharmaceutical components like ampules or masterpiece on the Can you describe the production pre-fi lled syringes are processed in the fi nal fl ow in the machine for us? How did you feel about the assembly of the fi nished products. The tray part of the engineers." The stack of trays with the devices is cooperation? loaders are equipped with the same control inserted into the system manually. The Harro Höfl iger was always very fast and system and proven user navigation as all

Arthur Fabian system collects a tray, conveys it to to the point. Everything went very quickly other Harro Höfl iger systems – and of course the pick-up point for the robot, which from taking stock of the situation, anal- come in a GMP-compliant design. Interfac- carefully places the device in the right ysis and the drafting and implementa- es are clearly defi ned, the customer only has receiver. The device is then transport- tion of a solution proposal. That’s why one point of contact, and in the event of a ed through the system and labeled at we look forward to working with Harro service deployment everything is provided a station, where both placement Höfl iger on further projects. from a single source – quickly and profes- sionally. Distinguishing the various palletiz- ing systems is less a matter of the technology inside than the implementation of systems and devices to meet the project require- ments. Camera systems, marking stations and other accessories can thus be ideally complemented. Suddenly completely new solution approach- es can now be realized, as illustrat- About the user ed by the examples of the hybrid version described in greater detail in the The Swiss company has belonged to a large American group since 1959. It focuses One of fi ve tray on the aseptic production and packing of parenteral products (pre-fi lled syringes loader versions: overleaf. Widely known and proven in many Classic model and vials) and associated combination products. With around 1,200 employees the completed projects are the three classic pal- pharmaceutical company is the largest employer in Schaffhausen canton. letizing types for tray sizes up to 400 mm x 600 mm. Atelier Lünig Oliver Naucke

8 HARRO Edition 2 HARRO Edition 2 9 THEMA STRATEGY

Tray loader versions

1 2 3 Classic Speed Smart New drive:

Optimally combines a compact de- Always the fi rst choice when speed A very fl exible machine type, which sign with high processing rates and is of the essence. With tray chang- can be customized to suit specifi c Harro 2020 product handling times of up to three ing times of under four seconds this material and tray fl ows. It is very well seconds. version is frequently found in high suited in cramped conditions. speed systems.

Pa ssio nate – clo se – in 4 ventive – reliable Hybrid

As the name indicates, this version combines a tray loader with fl exible assembly and inspection processes in one machine. Benefi t: minimum space requirement and reduced What a development: in the space of fi ve years Harro Höfl iger Höfl iger intends to continue complexity. This version is directly has doubled its revenues, and the workforce record of 1,000 offering everything from a single integrated into the machine frame employees has been surpassed. Capitalizing on the dynamics source and always set the benchmark in in- and forms a highly fl exible effective generated by growth, Harro Höfl iger aims to continue ensur- ternational comparisons. Thomas Weller continues: “We aim to unit when equipped with a servo ing customer satisfaction and top quality as part of its Strategy increase our dynamism and speed of reaction and thus pre- axle or robotic system. 2020. Despite its new size, the company intends to take up the serve our fl exibility. Market managers and business units are to future challenge of preserving fl exibility and customer closeness. be incorporated into an interdisciplinary organization structure As CEO Thomas Weller admits: “We are conscious of the fact in the future. Our new structure is based on a 3D matrix.” that we have to manage growth and our new size. We will have To ensure that projects run smoothly, Harro Höfl iger offers to take a closer look at many routine processes. It’s the only over-arching shared services, for instance in Global Sales, 5 way to increase customer satisfaction and loyalty.” For Harro Pharma Service or Controlling. Rondo

Specially designed for the standard- ized Rondo tray in combination with cylinder ampules and is used for instance in assembly systems for insulin pens. It is designed for the medium output range and thanks to its slimline format, also takes up very The trays can take both individual little space. As an alternative to the components or pre-assembled units of inhalators, pens or injectors Rondo tray, syringes in tubs can also ready for assembly be reliably handled.

Harro Höfl iger Harro Höfl Philippi Tom At Backnang effi ciency is guaranteed by organization and optimized intralogistics

10 HARRO Edition 2 HARRO Edition 2 11 STRATEGY

“We aim to increase our dynamism and speed of reaction. We’re never more than a call away.”

Thomas Weller, Chief Executive Offi cer, Harro Höfl iger

On the horizon: the new Structure 2020 The new Factory 5 in the ‘Pharma Solid’ business unit serves as the prototype for the new organization. Thomas Weller comments: “We’re working here on Unchanging: the values of Harro Höfl iger Harro Höfl iger is steadily adapting its organization to accommo- how the entire company is going to be organized in the future. If you like, it’s a true test run that is going to set benchmarks.” date growth and increased size. Already launched, the process [ ALL YOU NEED ]. As Thomas Weller emphasizes: “Harro is due to reach completion in 2020 to preserve the company’s Höfl iger’s key qualities, the core competencies that made us what dynamism, speed of reaction and customer centricity. The aim we are today, a successful major player, remain unchanged.” This is top quality with perceptibly shorter throughput times. As part also applies to continued efforts to support business partners as far of Strategy 2020 Harro Höfl iger is setting up seven business as possible across their process and value chain. The customer’s units, which will operate as independent units within the com- product determines the production process and machine design pany. Thomas Weller: “We need agile expert teams that act concept. Precisely customized product solutions are the result. with purpose in their core business and respond promptly to changes.” In large-scale turnkey projects the competence of Passion for the job. Unconventional ideas, getting down to work the individual units can be called upon as required in multidis- and making what seemed absolutely impossible, possible are ciplinary efforts. qualities that have always put Harro Höfl iger in a league of its own. Harro Höfl iger continues to pursue this passion and ac- Process-optimized. Process optimization models will be the cepts no compromises. norm in all seven units. However, the individuality that makes Harro Höfl iger so special will be preserved. Harro Höfl iger is aim- Customer closeness. The global network of around 150 sales ing for less red tape, optimized material supplying and the best advisors and key account managers gives the company a lead- possible assembly processes. ing edge in the market. In close contact with customers these experts ensure that only the best solutions are implemented to Consolidated. The business units will gradually grow together. meet requirements. The interaction between developers, control engineers, project managers and assembly planners will be intensifi ed, thus improv- Inventive. Swabian inventors with a bold unconventional spir- ing and speeding up communication and boosting team spirit. it will continue to create unique solutions in the future. Harro Höfl iger engineers set benchmarks for the industry. The unique The focus, however, remains on the customer’s product. Every

interaction of engineering and pharmaceutical experts remains solution is geared towards specifi c requirements, true to the Welcome to Backnang Felix Nink (second on right) and his team in Backnang depart from well-trodden

one of the company’s key USPs. motto: [ALL YOU NEED]. Philippi Tom Philippi Tom paths to pioneer new ground and thus achieve optimum effi ciency

12 HARRO Edition 2 HARRO Edition 2 13 14 14 HARRO Edition 2 Shaping thefuture within theyear. UnitmanagerFelixNinkandhisteamplanto At thenewBacknangtechnologycenterHarro Höfligeroptimizestheproduction All sectorsofthePharmaSolidbusinessunitare combinedin HARRO Edition 2 and assemblyofcapsulefillingmachines. 3,500 square metersofproduction andoffice space.Devel us toidentifyimprovement potentials.” in concertwithsales,project andproduct managementand jective: leadtimesat Pharma Solidare tobereduced byhalf departments close together underoneroof, makingit easier for cess. AsMr. Ninkremarks enthusiastically:“Nowwehaveall achieve thisinsmallsteps,withanon-goingimprovement pro greater efficiency andcustomercloseness. An ambitiousob customer serviceunderoneroof. Thegoalisclear:toachieve opment, design,production andassemblydepartmentswork - - - very quicklywhentheDesign Department isrightnextdoor to team spiritamongtheapproximately 80employees inthebusi Control Engineering.Harro Höfliger regards theBacknangsite Following themoveinMay2015manymeasures intheassem logistics. Newlydefinedassemblyflowsminimizeerror rates picked subassemblies in material shuttles speed up internal picked subassembliesinmaterialshuttlesspeedupinternal bly area were successfully implemented during the first few as apilotproject forfuture companyrestructuring. and short distances facilitate communication. Since the move, ness unit has improved perceptibly. Ideas can be exchanged months. The central warehouse andimplementation of pre- STRATEGY - - 15 15

Tom Philippi Atelier Lünig INNOVATION

Transparency for operators

Harro Höfl iger’s HMI interface has long been regarded as a benchmark. Development of a new user interface began back in 2013 to guarantee that competitive edge. Currently all new machines and systems are equipped with it.

The new beginning was the achieve- because the new HMI is not only meant to ment of Fabian Elsässer (see ) and support operators, but also make things his team along with external partners. As easier for control engineering. Mr. Elsässer explains: “An outside view broadens your horizon.” Harro Höfliger Learning about what matters Fabian Elsässer designed and developed the new HMI The basis for the new user interface was (on right) and his (Human-Machine Interface) together with an intensive analysis phase and feedback colleague are pleased with the CaderaDesign, a specialist in industrial rounds with users and developers of the operating terminal and user interface design, usability and existing HMI system. The project mem- they developed together user experience. Mr. Elsässer continues: bers then cataloged the operator tasks, “The experts at CaderaDesign are by no examined the various machine types and means impractical creatives, but down- jointly rated their functions and benefi ts. to-earth industrial designers, who under- The next step involved outlining ideas

Tom Philippi, Harro Höfl iger Höfl Philippi, Harro Tom stand machines.” An important aspect and developing and assessing layout concepts. Mr. Elsässer sums up: “We came up with the fi rst structural designs of the user interface very quickly and User-oriented Station-oriented Task-oriented fleshed out and honed the drafts step by step in workshops. The basis was of As intuitive as a smartphone course multi-touch technology, which is common today. Our clear aim was to of- The new operating terminal for all future Harro Höfl iger machines and fer operators maximum user-friendliness systems impresses with the highest ergonomic standards. All functions and transparency – without incurring ad- can be conveniently controlled from the touch display. Preserving the ditional costs for the customer.” proven station overview eases transition to the new HMI, along with swipe The requirements dictated a naviga- or zoom functions that are long-familiar from smartphones or tablet PCs. tion structure with as few nesting levels as possible and a standard look and feel on all levels. It was already settled that implementation would be in-house at

16 HARRO Edition 2 HARRO Edition 2 17 STRATEGY

Harro Höfliger with the existing HMI/SCA- duction mode (set up production, start DA solution zenon by COPA-DATA. As Mr. production, run machine until empty, end Elsässer explains: “Only we know our production) and depending on the role “We don’t sell requirements with regard to project plan- “Dispensing with assigned to him. The user profiles store ning. And it’s imperative that this know- the frills, the new which actions may be initiated by defined how stays with the machine builder.” users and which machine function they HMI focuses on may use. Preserving the station overview machines, Combining task and station essentials and reliably proven in the preceding HMI eases sys- orientation tem handling. Operators familiar with the navigates the In addition to station orientation, which old HMI system therefore intuitively find we generate projects” was already familiar from the previous operator through the their way around the new terminal with- HMI, Harro Höfliger also opted for task out training. orientation as an operating and interac- menus.” tion principle. This was due to the com- Customizing for clarity plexity of the machines. Thanks to this The new HMI ensures that during produc- Daning Zhao, Chief Representative Officer China task orientation in the HMI the operator tion the operator only receives the infor- at Harro Höfliger, describes how the Swabian mindset is supported in all the activities that he mation he needs for his respective role. performs on the machine. The HMI there- Machine data are displayed in widgets copes with Chinese market practices. fore prompts the operator situationally, on the main screen. Drawing on a ma- regardless of whether he has to set up chine-specific box, every operator can a machine or retool, load a new recipe pick out the widgets relevant to his tasks or launch batch recording. The operator and thus create a customized home is assigned tasks according to the pro- screen.

Sebastian Rittner, Project Engineer Assembly, Boehringer Ingelheim microParts GmbH

Promising future for talent Careers at Harro Höfliger

He is 27 years old, ambitious and single-minded: Fabian swelled to eight software experts and is still growing. What Elsässer has headed strategic planning and development of makes him the man for the job, is not only his dynamism and HMI and SCADA systems at Harro Höfliger since determination, but also his well-founded experi- 2013. Experts like Mr. Elsässer are welcome at ence. Following an integrated degree program in Harro Höfliger. And it is part of the company’s electrical engineering, in the midst of the global innovative culture that they quickly gain respon- financial crisis in 2009, he began his career as sibility, for according to Höfliger, technical prog- a developer of HMI and SCADA systems with a ress flourishes best in a climate of trust. In Mr. machine builder specializing in the pharmaceuti- Elsässer’s it was the immense task of ori- cal and cosmetic industry in Crailsheim. In 2013 enting the Human-Machine Interface (HMI) for the man from Backnang took up the challenge all systems even more closely to the operator at Allmersbach. Back on home ground Fabian

and his tasks. His original team of three has now Elsässer has found his future. Philippi Böhringer Ingelheim, Tom Chunhai Cao/iStockphoto.com Christoph Kalscheuer,

18 HARRO Edition 2 HARRO Edition 2 19 BEST PRACTICE

ow does a Chinese academic end up in try. Ultimately, what counts is that a perfect product drops Allmersbach? off the production line. Interest in detail is only peripheral. Daning Zhao: Through the Steinbeis Founda- We create a basis for trust with quality and reliability. Once tion. Interested academics were specifical- trust is established, we rely on the machine suppliers to do ly recruited to facilitate SMEs market entry their bit. So actually we don’t sell machines, but generate Focus on new markets Hin China. The Steinbeis Foundation arranged an integrated projects. degree program for this purpose in cooperation with Danube University Krems. I seized the opportunity in 1998 and then That sounds like high expectations of consulting expertise? Hisun aims to extend its market base with new dosage forms. Due to came to Allmersbach. My technically and pharmaceutically fo- Absolutely. Know-how transfer is very important. You’re not its diversification, the Chinese enterprise has opted specially for Harro cused biology degree suits Harro Höfliger at least as well as only buying a machine, but expertise. That’s why we listen that of a mechanical engineer. very closely first of all, then discuss the details on a sound Höfliger know-how. technical basis and stake out the technical scope. There is Did you originally come with the intention of staying? a lively interest in practical tips, market assessment and de- Well, I certainly hoped to forge bridges between Europe and Chi- tailed knowledge, including examples of successes to date. The Chinese pharmaceutical industry is girding several platforms and developing alternatives to na. Nobody could safely predict that a two-year integrated degree This shows customers that we’re not talking through our hats, itself to make up lost ground. Mainly engaged in tablets and capsules. The group management is program was going to turn into one-and-half decades. At any but really do deliver what we promise. We open up new per- producing generics so far, Chinese manufactur- therefore interested in new dosage forms. And in- rate, during my studies I was already working on a concept allow- spectives to our customers and occasionally new markets as ers are planning to make a name for themselves deed ‘new drug delivery systems’ are deemed to ing my employer Harro Höfliger to tap the market in the Middle well. For instance, we are assisting Chinese API manufacturer with new products and dosage forms in the future. be THE growth market. Products like transdermal Kingdom. It went on to become the subject of my Master thesis. Hisun to develop new dosage forms. This also applies to Zhejiang Hisun Pharmaceuti- plaster, oral or buccal film strips and inhalators are cal (or Hisun for short), China’s largest manufac- the dosage forms of the future. They make the ad- What is the key to business success in China? Is it accurate to say that the systems for new dosage turer of active pharmaceutical ingredients (APIs). ministration of medicine easier and safer – and thus The crucial basis for doing business in my country of birth are forms define your business with China? In addition to its joint venture with Pfizer in 2012, increase user-friendliness for patients. trust and good personal relationships. And initially, you need That’s right. We also aim to stay true to our niche. We have the blue chip company is also well-known outside Inhalation applications are Hisun’s current prior- patience. You have to invest a lot of time building up networks. virtually no local competition when it comes to systems for the pharmaceutical industry. The pharmaceutical ity. Ordered in autumn 2014, a production line for In Chinese ‘Guanxi’ means an established circle whose mem- transdermal plaster, orally soluble film, mucoadhesive film group is working to reposition itself with a metic- inhalers was installed in Fuyang, China in November bers are bound by particularly close relationships. Our strength strips for mucosal resorption or inhalators. We have the ulously planned strategy. Diversification is Hisun’s 2015 – built and assembled by Harro Höfliger. Other within the team is that we are at home in both cultures. We field to ourselves with specialized machines and customized chosen path to counter the increasing price pres- lines for producing transdermal plaster, orally sol- see ourselves as bridge-builders and relationship managers. solutions. sure on the market for pharmaceutical substanc- uble film strips and autoinjectors will be delivered Speaking personally, I have long felt at home in Allmersbach. es. The strategy involves supporting business on step-by-step in 2016. So much so in fact that I don’t offer ‘Made in Germany’ but What’s coming up next on the Chinese market? ‘Made in Swabia’. Our business associates regard the indus- We will continue to cooperate with our trade partner Riecker- trial belt around Stuttgart as a symbol of German quality and mann as distributor and first-level support and moderately thoroughness. Germany still enjoys an excellent reputation for extend our own team in Shanghai. We still see a lot of poten- quality. And it is something we can build on. tial across our portfolio, because we keep the pharmaceutical market moving and help our customers to tap new business What do customers expect of you as machine providers? fields. After all, Chinese enterprises are always on the look-out Standards are high in the Chinese pharmaceutical indus- for something new.

Daning Zhao and his team represent Harro Höfliger in China. From left to right: Frank Zheng, Tony Jing, Daning Zhao, Lily Yao, Yuan Su

Dosage forms of the future: transdermal plaster, oral and

Harro Höfliger Harro Jongsirikul/fotolia.com Atelier Lünig, Chunhai Cao/iStockphoto.com, Narong buccal film strips, inhalator DPI blister strips and autoinjectors

20 HARRO Edition 2 HARRO Edition 2 21 BEST PRACTICE

Besides local use to treat colds or allergies nasal applications also permit administra- Properties of ideal tion of brain-enhancing molecules. They for nasal administration: reach the brain directly via different nasal paths. In this case, it is vital that the active • Easy administration (compliance) • Exact dosing agent, formulation and applicator are • Attractive design perfectly matched. • Protection from external contamination (single-use doser) • Extractables/leachables* compliance

The new nasal device is a unit dose with practical pin that * satisfi es requirements for leaking and extractable substances simply twists off for application

Höfl iger for M et P. The individual processes for fi lling the unit tropic oil formulation with a viscosity of 3,000 to 10,000 mPa · sec dose device were fi nally optimized in the system at the M e P for exact doses. The material composition also posed a chal- laboratory. Today the prototype system is used in the lab to lenge for the applicator. A low-density enriched with

produce material for clinical studies and commercial samples. titanium dioxide (TiO2) as additive was selected. At the same time experience from this system is used in the The prototype system went into operation in 2012. Today the planning and development of the fi rst production line. patented line fi lls and seals around 5,000 applicators daily. An The controlled fi lling process and reliable sealing of the two- additional commercial scale production system is currently be- part device with ultrasound fulfi lls the highest technical stan- ing assembled at Harro Höfl iger and is due to go into operation dards. Harro Höfl iger’s liquid fi ller successfully fi lls the thixo- at the end of 2016. From nose to brain

So far there are very few approved nasal applications for Drugs like ‘Tescum/Tescum Junior’ are one example of a new Dr. Claudia Mattern brain-enhancing substances. Despite obvious advantages – nasal application development of testosterone for men. Like easy administration for children instead of parenterals, in emer- all nasal applications, in its existing formulation ‘Tescum/Tes- is co-founder of the Swiss M et P Pharma AG, which gencies for asthma or epilepsy patients or poor venous access cum Junior’ needs a container to ensure perfect administra- specializes in nasal application. She has headed in the case of older patients – nasal application has enjoyed tion. Multi-dose containers for multiple administration do not Pharmaceutical Development since 1998 and held the little support thus far. The development of such nasal applica- satisfy these demands. Although most multi-dose containers scientifi c chairmanship since 2002. In this capacity she developed a galenic platform for nasal applications. She tions often swings back and forth between optimism and dis- now operate without preservatives, contamination of the appli- is responsible for medicine production and implemen- appointment. M et P has been engaged in the effects of medi- cation tip was not taken into account for these containers. At tation of feasibility and pre-clinic studies in humans. cine administrated over nasal application for many years. This the same time, depending on the formulation, exact dosing is Claudia Mattern completed her PhD at the Humboldt also includes consideration of the optimum application aids. As not always guaranteed for multi-dose containers. M et P began University, Berlin on the subject of “Development of sta- CSO Dr. Claudia Mattern comments: “Nasal application is the development of a suitable solution for this challenging process ble dosage forms of the coenzyme NADH for peroral and direct way of absorbing brain-enhancing substances. It is the and chose Harro Höfl iger as a competent system builder for parenteral administration”. In 2013 she was vested with focus of our research.” fi lling and sealing their devices. an extraordinary chair at the Oceanographic Center of Nova Southeastern University in Florida. With a track The development and successful use of brain-enhancing The nasal device for ‘Tescum/Tescum Junior’ is a unit dose record already including 200 patents, she is a member of nasal dosage forms however only works, as noted, when the container, whose pin is easily twisted off for application. The several scientifi c associations, has several publications three factors active agent, formulation and applicator are op- product contains no preservatives and features long-term to her name and is an expert for scientifi c journals. timally matched. Newly developed delivery systems and brain stability. Dosing accuracy is +/- 5 percent. In cooperation with research fi ndings make nasal application an increasingly inter- Harro Höfliger, M et P conducted a large-scale trial series.

esting alternative. Based on the results, a pilot system was developed at Harro Christoph Kalscheuer Atelier Lünig, M et P

22 HARRO Edition 2 HARRO Edition 2 23 TOP INNOVATION

The new Modu-C HS (High Speed) enhances the capsule fi lling machine series in the high speed range. With an output of up to 200,000 capsules per hour the system opens up a new dimension in reliable high effi ciency production. With the addition of the Modu-C HS, Harro Perfect Höfl iger offers capsule fi lling machines for every requirement from laboratory development to combination high speed production. Optimum cleaning Along with the Accura-C capsule weighing machine the Modu-C GMP-compliance, an ergonomic design and best HS forms the perfect combination accessibility permit optimum ease of cleaning. Filling for effi cient capsule production stations can be prepared in advance on changeover High speed that meets the highest quality trolleys, thus minimizing tooling and downtimes. standards. The feedback loop en- ables automatic trend controlling capsule fi lling of the fi lling weight.

Application diversity

Modu-C A wide range of fi lling stations on family product trolley systems are available to match product requirements: pow- features der, pellets, tablets and capsules. Various fi lling combinations are of From lab to production course also possible. Equipped for Low speed up to 25,000 present and future applications. capsules/hour Mid speed up to 100,000 capsules/hour High speed up to 200,000 capsules/hour

• Flexibility via dosing trolley system • Precise dosing • Simple intuitive operation Patented dosing • 21 CFR Part 11-compliant Fast and easy • 100% inline control trolley system • Operator protection (containment) Besides a rugged machine design the main focus is • Full turnkey supplier on easy operation and fast format changeover times. Thanks to the trolley system the Modu-C HS achieves maximum fl exi- Operators quickly fi nd their way around the intuitive menu bility and productivity. The basic machine offers the option – depending For more details of on the modern HMI (Human-Machine Interface). The on the required fi lling medium – of deploying the appropriate dosing the Modu-C family visit machine also offers interfaces for automation concepts trolley in a plug & play procedure for short tooling and cleaning times. www.hoefl iger.com along the lines of continuous manufacturing. Additional dosing units can be retrofi tted at any time. Atelier Lünig

24 HARRO Edition 2 HARRO Edition 2 25 BEST PRACTICE

Fast solution for eye drops

Harro Höfliger produced a labeling and packaging line for Pharma Stulln – a GMP-compliant production line with all components from a single source – within a very tight deadline. The limited space available required special line planning.

Dr. Susanne Koschatzky sits at her desk with the What was new to the company was the planning of phone in one hand and a pen in the other. Concen- a fully automated process flow. As Dr. Koschatzky trating, she takes down notes on her pad. She ex- describes the task: “Our requirements could only be plains with a laugh: “Irregularities between different satisfied by continuous highly automated line pro- interfaces can be best dealt with over the phone. In- duction from sterile filling through to boxing.” And house developed risk assessment for handling good the deadline was extremely tight: just 15 months lay parts in the event of faults provides an additional between the initial meeting and system commission- The arrangement of the new safeguard, precluding any confusion between good ing. As Dr. Koschatzky assumed the role of central labeling and packaging line was optimally planned to suit the and bad parts.” The Head of Qualification/Validation coordinator, she was able to smooth the way and layout of the new pharmaceutical at Pharma Stulln took on project management for clarify matters, for instance when defining product production line at Pharma Stulln developing a system that produces eye drops in sin- orientation for machine-to-machine conveying. gle-dose containers 15 months ago. As central point However every bit as important to success were of contact she has since coordinated internal de- proven suppliers like Harro Höfliger. “There was no partments and external suppliers, convened meet- time for experiments”, stresses Dr. Koschatzky, “We ings and kept an eye on scheduling. “Holistic project have been working with Harro Höfliger for six years, planning is a lot of fun – but also a lot of work.” so we knew that we would be getting fast and good The blow-fill-seal production process has been solution approaches to state-of-the-art standard.”

Atelier Lünig part of Pharma Stulln’s core business for many years. Their Allmersbach partner was also able to help

26 HARRO Edition 2 HARRO Edition 2 27 Visit us:

Innovation Expo 2016 Technology & Trends Allmersbach im Tal, Germany, 19.04. – 20.04.2016

Pharmazing Days Laupheim, Germany, 19.04. – 21.04.2016

POWTECH/ TECHNOPHARM Nuremberg, Germany, 19.04. – 21.04.2016

Interphex New York City, USA, 26.04. – 28.04.2016

Koreapack Seoul, South Korea, 26.04. – 29.04.2016

Analytica State-of-the-art technology: cartoning machine, type MKT Line balancing belt for synchronizing the blow-fi ll-seal strips Closer look: lab inspection Munich, Germany, 10.05. – 13.05.2016

KIHE Almaty, Kazakhstan, 11.05. – 13.05.2016

Iran Health Tehran, Iran, 15.05. – 18.05.2016

CIBF Shenzhen, China, 24.05. – 26.05.2016

“We had no time to A3P Algiers, Algeria, 30.05. – 31.05.2016 experiment, which was EUFEPS why we opted for Istanbul, Turkey, 13.06. – 15.06.2016

a proven partner like CPHI China Harro Höfl iger.” Shanghai, China, 21.06. – 23.06.2016 Interphex Japan Pharma Stulln Tokyo, Japan, 29.06. – 01.07.2016 CPHI Pharma Stulln with the assem- sists of a redundant system with two Pharma Stulln GmbH has been producing eye drops São Paulo, Brazil, 25.08. – 27.08.2016 bly situation. As the existing pro- label dispensers connected in parallel. for more than 60 years. In 1953 it developed its fi rst duction facilities were working to If one label roll is fi nished, the dispens- major eye medication: the Stulln eye tonic for tired ILMAC full capacity, the warehouse was er switches to the other system. The eyes that still exists today in a slightly amended form. Basel, Switzerland, 20.09. – 23.09.2016 The company is headquartered in the Upper Palatinate converted into a clean room area. operation continues while an operator and currently employs 220 people. The eye drops are TOTAL Processing & Packaging Harro Höfliger designed several changes the roll for the fi rst dispenser. marketed internationally from this site. Birmingham, England, 27.09. – 29.09.2016 assembly versions for individu- Dr. Susanne Koschatzky, The bulk packer ensures serialization al machines and thus helped to Head of Qualifi cation/Validation, and identifi cation in the system. Eve- FACHPACK make the most of available space. Pharma Stulln ry product can be fully traced over Nuremberg, Germany, 27.09. – 29.09.2016 Harro Höfliger delivered a com- the track & trace process – enhancing CPhI/P-Mec Europe plete labeling and packaging line forgery protection. Barcelona, Spain, 04.10. – 06.10.2016 consisting of a high speed label- An additional bypass function in ing machine with camera inspection and picker cell for transfer- front of the labeling machine allows the manual introduction of PDA Universe Pre-fi lled syringes ring products to the packaging line. Plus a cartoning machine, acceptable parts. The system produces 33,000 ampule strips & injection devices serialization device and bulk packer. Dr Koschatzky adds: “That per hour or 3,300 folding . “Only our own product is Huntington Beach, USA, 17.10. – 18.10.2016 left us with a minimum of interfaces on the packing line – with produced on the system, our proven Stulln Mono eye drops”, The fi nished product: folding , package leafl et and two virtually everything from one supplier.” The packaging expert comments Dr. Koschatzky. They are used to treat asthenopia, a blow-fi ll-seal strips with 5 eye

developed the labeling machine specifi cally for the job. It con- weakness of the ciliary muscles. Atelier Lünig, Oliver Naucke Pharma Stulln, Atelier Lünig drop ampules each

28 HARRO Edition 2 HARRO Edition 2 29 Inventive. Qualifi ed. Reliable. BB Fotostudio Janine Kyofski

Committed to Perfect Process Performance.

Quality can be measured by consistent results. We continu- al product in terms of quality and effi ciency. Our values and ously improve the value added, reliability and quality of your standards are refl ected in our customer-centric approach and production. Taking a comprehensive view of our customers’ activities. At Harro Höfl iger interaction with all project stake- products we can develop customized production and pack- holders is characterized by openness and fl exibility. aging processes that are perfectly tailored to each individu-

Harro Höfl iger Verpackungsmaschinen GmbH · www.hoefl iger.com