pharma 01 | 2012

The OPTIMA Magazine

New fOr clAss “A“ sTerIle rOOMsATEX and wide format range join forces

IsOlATOrs wITh cATAlyTIc AerATION Increasing efficiency and decreasing particle counts

rObOTIcsControl system for pharmaceutical liquids

editOrial

MAkIng ThE IMpossIblE possIblE

from Tradition to Innovation90 years of OPTIMA was cause for celebration in June! The head of the company, hans buehler, thanked all employees and clients for the accomplishments with a lively party. In his speech, he reported that fewer than 10 % of all companies will reach this dignified age. OPTIMA is a company with tradition.

QuoTE:

“Life is counted in years and measured in deeds.“(lao-Tse, chinese philosopher, around 600 b.C.)

The meaning of “tradition” stands for the preservation of characteristics and achievements, but also, in the sense of doing things the same way. It is exact-ly there, where danger lurks – especially for companies.

It is said – that companies need to continually re-invent themselves. This requires pragmatism when exploiting the use of new technologies. This is a characteristic that is shaping and was shaping the company over the years. In 1922, opTIMA changed its production from mechanical scales to electric scales. This created immense growth in produc-tivity for the first branded goods. Early on, opTIMA also profitably capitalized on implementing software and servo technologies.

besides these milestones in the mechanical engineering industry, it is often the small details that make the dif-ference for a client. At the AChEMA 2012, opTIMA pharma surprised visitors with a new robot control arm. specifics can be found on page 16. Are you familiar with catalytic ventilation of isolators? That is again a new milestone, as the time inten-sive ventilation stage is reduced by 50 % or more. More on page 14.

With all that – it is of less impor-tance for customers, if a company is 25, 50 or 100 years old – as long as the tech-nical experience and reliability – which is very important in the pharmaceutical engineering industry – as well as the strength of innovation are present.

by the way, at the 90-year celeb-ration tried and true entertainment was used: Two bands who knew how to cheer on the crowd of approximately 3000 guests, and varied and delicious foods from the region offered at the many stands. Common tradition prevailed, and the celebration continued late into the night. This can continue for a long, long time…

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cOMPAcT

4 news

5 Expanded technodrome – conditioned rooms

5 Definition: Terms used in robotics

sPOT

6–11 broad format range, constant high output, class A environment and ex-proofed

fOcus

20–21 sterile manufacturing – current trends and developments

shOwrOOM

12–13 production and batch preparation in parallel

ZOOM

18–19 six freeze dryers with centralized cooling

24–25 Clinical diagnostics – special weighing concept

26–27 backstop and safety Device

28–29 opTIMA pharma accelerates in China

NewcOMer

14 –15 Drastically reduced isolator decontamination cycles

16–17 robot expertise at OPTIMA pharma

PANOrAMA

22–23 Achema: The perfect link

30–31 Event review

OrGANIZer

31 Trade shows

New for class “A“ sterile roomsATEX and wide format range join forces

Isolators with catalytic aeration Increasing efficiency and decreasing

particle counts

roboticsControl system for

pharmaceutical liquids

Imprinto-com is the actual Communication service of the opTIMA packaging group gmbh

AddressopTIMA packaging group gmbhsteinbeisweg 2074523 schwaebisch hallgermany

editorFelix henningopTIMA pharma gmbh

otto-hahn-straße 174523 schwaebisch hallgermany

opTIMA pharma gmbhVor dem langen loh 835075 gladenbach-Mornshausengermany

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cOntent

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optima continues interna-tional expansion with a new site in India. optima pharma sees India as an interesting and growing market for its products. The sale of machines and lines will be the main focus of opTIMA India packaging machines pvt. ltd. The subsidiary is located in bangalore, the capital of the south West Indian province of karnatka with a population of 61 million. bangalore has recently developed into a high-tech location. not only Information Technology (IT) but also biotechnology has seen rapid growth in this city.

ApprEnTICEshIp

OPTIMA apprentices video and blog

nEW nAME

change of name at OPTIMA pharma

InTErnATIonAl

OPTIMA goes India

Who better to give advice to apprentices, than other apprentices? In new films, apprentices present the career they are learning at optima. The conceptual design and films were initiated and produced largely by the apprentices themselves, supported and guided by optima’s marketing department. The premiere took place in a cinema in schwaebisch hall.

Along with the film, the new blog made its web debut in which apprentices give account of their activities and experiences throughout their apprenticeship. These range from a service visit in Turkey with experi-enced service technicians, apprentice grill parties or apprentice fairs in which apprentices show “their” company. both projects, the apprentice film and the blog, are designed to help young people in their decision for the app-renticeship best suited to them.

Ever since the initial implemen-tation of the new corporate design at the beginning of the year, the market strategy of the optima group has become visible. The change of name as of July 1st reinforces the integration of subsidiaries and provides for a clear structure. not only do the optima com-panies worldwide now have a common logo, but also use the same name.

The optima name is modified by the respective business unit. The pharma business is now known as opTIMA pharma gmbh. The 3 further business units in which optima ope-rates consist of consumer, nonwovens and life science. The change in name has more specifically affected the con-sumer and life science units.

cOmpact

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For CusToMIZED TEsT TrIAls

expanded technodrome – conditioned rooms The new cleanrooms at Optima Pharma offer customers an innovative testing center for filling trials. for customers involved in clinical diagnostics and life sciences, and who often deal with molecular products, preliminary testing to prove scaleability from lab to full-scale production is becoming more important.

In these cases, dosing systems, newest IpC with weigh cells, cameras and sensor technologies for contactless fill level verification can be used to perform tests at production speeds. The technodrome is now located in a larger, purpose renovated area at optima pharma. Customers can make use of 2 independently climate controlled Iso 7 rooms, in which fill trials can take place

Degrees of freedom is used to describe the number of freely definable, independent parameters of a system. The system must have the following characte-ristics:

• It must be uniquely definable through the parameter specifications

• If a parameter is omitted, the system is no longer defined

• Each parameter can be changed without changing another parameter

The number of independent pa-rameters or freedoms forms a distributed parameter system. A mathematical point,

under production conditions. The rooms are sealed and the entire area is covered by laminar flow. The differential pressure between the anteroom and the 2 separately

controlled rooms can be individually adjus-ted. (personnel airlock and anteroom: +15 pa. Filling rooms: +30 pa).

Furthermore, the temperature and humidity of each room can be controlled indepen-dently. next to the cleanrooms, a generous

DEFInITIon:

Terms used in robotics

for example, has 3 freedoms of translation, also known as spatial coordinates (X-Y-Z). It can move in the X-Y-Z coordinates, but lacks any axis of rotation. A point of mass, however, has 3 freedoms of translation and 3 freedoms of rotation, and thus has 6 freedoms of movement.

Sources: www.wikipedia.org

Kinematics describes the mechani-cal structure of a robot, meaning the spatial relationship of the axes of movement in se-quence and configuration. It deals with the geometry and the time dependent aspects of motion. Individual joints of an industrial

robot include linear guides and rotating joints which combine to form a kinematic chain. The elements, joints and their drives form the axes of the robot.

(Source: Beuth Hochschule für Technik Berlin, Prof.

Dr.-Ing. Heinrich Linnemann: „Robotertechnik“)

The term “robot” originates from the Czech ”robota” and was coined by the artist Josef Čapek in 1920. With it, he describes forced labor and socage. In the theatre piece r.u.r., there are vats of bred, artificial, yet humanoid beings made to take over manual labor. but these “robota” begin to revolt…

office space for work outside of the clean area exists for customer use. Further non-conditioned areas are also available, includ-ing a special testing room for robotics.

All rooms can be booked irrespec-tive of current or running projects. general access to

the technodrome is restricted using coded locked doors.

Degrees of freedom Kinematics robot

Personnel airlock and anteroom

+15 Pafilling rooms

+30 Pa

cOmpact

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specific requirements – special solutions. A line for flammable (alcohol based), sterile, liquid and viscose fluids with a broad format range up to 1000 ml is a rarity in pharmaceutical manu-facturing. The first of its kind is going into service at schülke & Mayr Gmbh.

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FIrsT rATE unIFICATIon:

broad format range, constant high output, class A environment and ex-proofed

It is the combination of special product characteristics that led to this line with so many special solutions. For example, the alcohol content of the liquids: the low sur-face tension of the liquids in combination with the high filling volumes and relatively high output requires a large diameter filling nozzle. To prevent drippage, special closable filling nozzles were implemented. other gel-like products are sensitive to shear forces, and needed to be filled with a higher degree of accuracy. Due to the large range of dosing volumes and product containers, in addition to the fact that there was not weighing equipment available that could

meet the build criteria, a mass flow metering system proved to be the ideal solution. These and other fine details are part of a complete line based on the kugler linoclean and lin-oline platforms.

“Special...” in every possible wayspecial solutions can already be found in the sorting units which receive plastic bottles via an elevator. This type of sorting unit was first implemented in this line, for large format bottles being processed in a grade “b” environment. All containers are sorted centrifugally. In order to erect the horizontal lying bottles, tensioned belts are

used. “righting fingers” which are typically used instead, could not be used due

to the room classification and pro-cessing environment. once the bottles have been set upright, a

rotation station triggered by an optical sensor, turns incorrectly oriented asymmetric bottles, so

that their orientation is uniform when entering the process machines.

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The first process machine is the linoclean air rinsing unit. To obtain the best rinsing results and ensure a validatable process, the bottles are upended on the rinsing nozzles. upon completion of the rinsing, bottles are set upright onto a conveyor and queued up to the 2-up linear transport system of the linoline. This explosion proof machine is encapsulated by rAbs, whereby the filling area is accessed through two glove ports. Filling is performed by 12 filling nozzles which dive into the containers and advance with the bottles in an intermittent transport mode. Each of the 12 mass flow meters is dedicated to the filling of its respective bottle. The servo driven transport system utilizes a user programmable acceleration/deceleration algorithm to minimize the swash of liquid in the bottles during trans-port, and to maximize output.

The mass flow metering system makes best use of its strengths given the particu-lar challenges in this project. The system utilizes a process of constant readjustment during the filling process to achieve and surpass the required dosing accuracy of 0.5 % standard deviation. Furthermore, mass flow metering is a closed system, and compared to peristaltic systems, hoses are not subject to mechanical stresses and fatigue. This was an important factor for the explosion proof protection. For the same reasons, potentially damaging shear forces on the product also remain low. At the same time, the dosing system is also capable of handling medium viscosity products, such as wound gels. one last advantage: all for-mat sizes from 40 ml up to 1000 ml are filled by the dosing system without the need for additional dosing size parts.

Closable filling nozzles, mentioned at the

beginning of the article, are one case of innovative thinking. The cone at the open-ing of the nozzle is pulled closed at the completion of every dosing cycle. Elastome-ric seals are not required, as each nozzle and cone are mated and honed as a pair. When gels are being filled, these tend to draw stringers. When the sealable nozzles close, they effectively “cut” the stringers which would otherwise threaten to drip onto the machine or soil the bottles. In some cases, when filling under the fill level of the bottles to prevent foaming, drops of product will remain on the exterior of the filling nozzle. In this case, after the nozzles have retracted from the bottles, a drip tray is automatically positioned under the nozzles to capture any drops during lateral movement of the nozzle bridge. both of these functions – the closable filling nozzles and the drip tray – serve to ensure a clean fill, a clean machine and a clean final product.

ATEX-certificationIn addition to the passive measures taken to fulfill the explosion proof criteria in the filling area, active measures such as air evacuation in the filling zone have been implemented. Aerosols created during the filling process are thus removed. upon request by schülke & Mayr, optima additi-onally installed gas warning sensors in the machine substructure. These devices force a shut-down of the machine before a potenti-ally explosive mixture of flammable aerosols form, and alleviate the need for other com-plicated explosion proof measures, while further enhancing the EX classification of the machine.

The linoline can do more than just filling. Within the same machine frame, closing of

the bottles also takes place. In the case of schülke & Mayr and the current bottles and closures, 3 closing steps are required. spare room for the later addition of a 4th closing station was part of the design. Closures are fed into the machine by an elevator and sorting unit. The closures are separated and lightly screwed on the bottles by a pick-and-place station. A second station finishes torquing the closures to a pre-defined and measurable torque value. spray pumps can also be processed. The special feature here, is that the dip tubes on the spray pumps are actively straightened and centered over the bottle opening during the pick-and-place process. Depending on the type of closure, the 3rd station is used to pick-and-place a protective dust cap on the previously applied screw cap or pump. Control features consist of a color sensor which detects cap color, and a device for determining skewed or cross-threaded caps. bottles which do not meet the criteria of the control features are rejected within the explosion proof area.

Manual working positions have been integrated into the line and can be used to process special formats or small batches. A further feature is the incorporation of a sampling function, in which a product can be drawn directly from the product piping for QA control. The initial setup is manual, in which a valve with a sampling bottle is put into the liquid product path. The operator initiates the sample function on the hMI and the sampling bottle is filled.

The entire media path, including sterile filtration and sample valve can be cleaned and sterilized in place (CIp / sIp). All product and non-product contacting removable parts, including those on the linoclean air rinsing machine, are autoclavable.

40 ml up to 1000 ml are filled without the need for additional dosing size parts

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Mr. Alexander, to begin with, a back-ground question: One could assume that products used for disinfection are per se sterile, and that sterile production is therefore not necessary. Why has Schülke & Mayr invested in a sterile production line?

Firstly, even bacteria can survive in an environment which would normally be lethal to it. As spores, they can live for decades without requiring nourish-ment or energy. When the environment becomes conducive to life, metabolic processes are reinstated, and a spore reverts to viable bacteria again. Well known examples of such spores are bacilus anthracis (Antrhax), Clostridium tetani (Tetanus), and bacillus cereus or Clostridium perfringens which are responsible for food poisoning. spores are resistant to alcohols and should therefore not be allowed into the pro-duct. For this reason, all skin, hand and wound disinfection must, depending on their product group, be processed in clean room environments A, b or C. our sterile surface disinfecting agent perform®, manufactured for the phar-maceutical industry are manufactured under hygienic class ”A” conditions. Even

the packaging materials are gamma ste-rilized and brought in through deconta-mination airlocks.

Which types of products are manufactured on the Kugler line?

Currently, packaging of 3 different product types is planned. Alcohol based hand and skin disinfectant, wound disinfectant and surface disinfectants for the pharmaceutical industry.

What was the main reason for investing in new production technology?

our products which required ”sterile” class “A” manufacturing environments were previously outsourced to contract manufacturers. With our new structure, manufacturing and filling have merged together, also with respect to the auto-mation we have implemented. We are now capable of highly efficient manu-facturing of these products ourselves.

I presume that a defined User Requirement Specification existed before the project began, which outlined what the new equip-ment needed to be capable of. Were you already then certain that everything was possible with just one production line?

Interview with Jörn Alexander, in charge of process technolo-gy and operations at schülke & Mayr gmbh

core project data:class ”A” sterile processing in a class “b” room. | 100 bottles/minute

output across the entire automatic processing range | 12 formats for

liquid and semi-viscous products currently processed. Further room for

expansion on the machine, and a reserve area for a further closure |

contractual filling accuracy of 0.5 % standard deviation was met and

surpassed in filling trials. | The project duration from purchase order to

fAT was 15 months.

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based on our project management sys-tem, the specific requirements for capi-tal equipment to be purchased needs to be scoped out by our team and written into a requirement specification. This is usually the most time consuming part of a project. We look at which processes currently cause us problems, and how we can optimize. The crucial part of our requirements was to be able to process different containers ranging in size from 40 ml to 1000 ml at an output of 100 bottles per minute. only 2 suppliers were up to the task. opTIMA’s presented solution essentially fulfilled all of our performance requirements laid out in the specification.

Where did you have to make compromises?

As I said, essentially all of the require-ments were fulfilled. In individual points we made some compromises, such as where our specifications for visualiza-tion on the operator terminal differed from the opTIMA standard. We looked for solutions together, and found them. on the one hand we had a technolo-gically advanced equipment line with a degree of standardization, and on the

other hand a specific user interface which we wanted for fast localization (…of problems). We simply made use of both advantages.

Were there items in the specification to which you had a specific idea in the be-ginning, but to which you were convinced of a different solution which OPTIMA offered?

generally speaking, we look forward to points for discussion. They allow both parties to develop further. And yes – there were such points. We were quickly convinced by the proposed linear rake transport system. The more boxy containers get, the more transport scrolls and wheels are prone to fail. The chosen solution proved itself to be the right solution in test runs.

What were the three most important criteria for you in the user specification?

First on the

list was compliance

with the clean room classifications. next were the

high output of 100 bottles per minute for all formats and a technically flexible line which includes fast changeovers and things which are ultimately closely related to fast changeovers such as the automatic cleaning concept and the CIp/sIp.

How many different bottle and cap formats are you processing?

There are 11 different bottle formats and 7 unique closures. There are round bottles and square bottles ranging from 40 to 1000 ml. The closures consist of different hinged flip-caps with tamper evident rings, and spray pumps which are screwed on or pressed on, both with tamper evident rings. There are also normal tamper evident screw caps and measuring cups or press-on spouts.

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spOt

From a technical standpoint, were there any solutions on the line which took you by surprise?

The bottle unscrambling and bottle righting really surprised us. originally, we saw a solution from optima Consumer, developed for use in the cosmetics industry. The unit functioned on a basic mechanical principle. granted – we were a little skeptical. The unit was technically and hygienically re-engineered and brought to pharmaceutical standards. The result that optima provided was simply fantastic. The origin of the ma-chine from the cosmetics sector is not recognizable. In my opinion – as far as practicable – simple solutions are often better and more reliable that complex electronic solutions.

A significant factor in this project also in-volved cooperation with further vendors...

Yes. At schülke we also had project ma-nagers for the different sections of the project. For instance, for manufacturing, automation, monitoring etc. were all re-presented. We communicated closely for decision making. In the same way, other companies involved in site construction cooperated well with one another to cla-rify important interfaces ahead of time. All companies worked together with a view to success.

How happy are you with the overall success of the project? Is it too early for verifying feedback?

We all very much enjoyed working together with optima. Everyone working on the project was focused and dedica-ted – heart and soul. You could feel the vigor and enthusiasm. sAT is scheduled to be completed by the end of August. In 4 weeks we’ll be taking acceptance of the line which we speci-fied in our user requirements. It already looked good at the FAT.

»The crucial point of our requirements was to be able to process

different containers ranging in size from 40 ml to 1000 ml at an

output of 100 bottles per minute. only 2 suppliers were up to the

task«

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The company, founded in 1889, played a key role in combating the hamburg cholera epidemic in 1892 with its‘ Iysol® product. lysol is considered to be the first branded disinfectant. In 1990, octenisept® was in-troduced to the market as a non-stinging wound disinfectant for both professionals and consumers. Today, schülke & Mayr, with

its’ headquarters in norderstedt (near hamburg), has a ma-nufacturing portfolio of more than 200 different specialty pro-ducts for wound care, antisepsis, disinfec-tion and specialized chemicals, is involved in research and development, develops pro-

prietary active ingredients and

holds more than 190 international pa-

tents. last year, the company had a turnover of approx. Eur 180 million, and has been a part of the Air-liquide group since 1996.

A shorT sYnopsIs

schülke & Mayr Gmbh

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shOwroom

buYIng TIME

Production and batch preparation in parallel

This line concept has a bright future ahead of it. Two parallel, identi-cal filling lines for vials feed 3 freeze drying units. The freeze dry-ers are accessible from both sides and operate on a pass-through principle. This constellation allows the first line to produce, while the second line is prepared for the following batch. The lines use an open rAbs concept. The area around the loading tables is a crAbs with a nitrogen environment.

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• The first line is in production while the second line is prepared for the following batch.

• Time-pressure dosing system with in-process control and statistical reporting.

• Fully automatic loading and unloading of the freeze dryer. loading tables equipped with crAbs and nitrogen environment.

• One freeze dryer can be unloaded while the next is loaded.

Vial diameters

16 to 32 mm

Vial height

35 to 58 mmoutput up to

24,000 vials/hr.

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NewcOmer

MorE TIME For proDuCTIon

Drastically reduced isolator decontamination cycleswith the use of catalytic aeration, M + P is able to reduce the duration of the aeration phase in isolators by about 50 %. The aeration phase is the most time consuming cycle during h2O2 decontamination. Decontamination with VhP (Vaporous hydrogen Peroxide) regularly takes place prior to production. existing M + P isolators can also benefit from this development with a simple upgrade. A patent has been applied for.

Isolators are considered to be the safest method for guaranteeing a sterile filling environment in pharmaceutical pro-duction. In isolators, a vaporizer combined with a distribution system takes over the automated decontamination. M + p long

ago decided on a system with distribution nozzles for dispersion of the h2o2. This deci-sion also proves to be a decisive advantage for the newly developed catalytic aeration. other isolator manufacturers use fans to distribute h2o2 in the process area (filling

and capping). When recirculation fans are used, however, catalytic aeration cannot be performed without simultaneously nega-ting the decontamination cycle.

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The functional principlesDecontamination of isolators with

vaporous h2o2 takes place in 3 process steps, which begins with the conditioning of the temperature and humidity. next follows the sterilization phase, in which a vaporized h2o2 fog kills off any viable micro-bes. Even in low concentrations, h2o2 can be detrimental to pharmaceutical products, so the final phase, aeration with fresh air, must be thorough and complete. Without the use of catalytic aeration, and depending on the allowable residual concentrations (usually <1ppm – 10ppb; largely dependent on the pharmaceutical product), the average time required for aeration is between 3 and 12 hours. using catalytic aeration, the aeration phase can be shortened by more than 50 %.

The unique construction and decon-tamination process of M+p isolators allow the use of catalytic aeration. The microbial kill-rate of the h2o2 during decontamination is not influenced by the catalytic converter. The time advantage of catalytic aeration is of particular benefit the smaller the residual concentration to be achieved. The efficiency increases. A further advantage is that the catalytic converters are also effective during the production phase. As experience has shown, h2o2 diffuses into plastic parts such as format parts during the Vhp phase and adsorbs over time. Even after the aeration phase and during production, this adsorp-tion can cause an increase in the residual h2o2 concentration of the air. This increase in concentration is only slowly flushed out

with time. The catalytic aeration employed by M+p is effective during the production phase and prevents increases in residual h2o2 concentration because the isolator continuously re-circulates air through the catalytic converter.

A pharmaceutical company has been successfully using catalytic aeration for over a year. Further units will be installed shortly. M+p has also carried out retrofit projects. For over 2 years, M+p also carried out tests with catalytic conversion on a research isolator. The efficiency of the catalytic converters remained at 100 %, and degeneration is not expected.

Additional benefits for the pharmaceutical industry shortened isolator decontamination cycles have multiple advantages for the pharmaceutical industry:

The number of biotech products being developed is increasing, while batch sizes are decreasing. This means that format and product changes on the machine take place more often. With catalytic aeration of the isolator, the equipment can be readied for the next batch much more quickly. Downtimes are drastically reduced.

More and more toxic and high potency drugs are being developed and pro-cessed. The operators must be protected as well as possible, so the number of isolators is also increasing.

pharmaceutical companies are trending towards fewer allowed particle counts (ppm) during production. This can be achieved with an isolator.

pharmaceutical manufacturers are spe-cifying isolator decontamination cycle times of between 5 and 3 hours

The relatively high difference in capital cost between isolators and rAbs has been criticized in the past. These should, however, be viewed relative to the higher operational costs of high classification clean rooms, which sometimes also require crAbs. As long as class “A” or “b” cleanrooms are not already present in a facility, the higher cost of an isolator versus a class “A” clean room is usually amortized in 2–3 years. The amortization time is further significantly reduced when catalytic aeration is used.

Isolator, RABS and regulatory bodies

generally speaking, the automation and the validatability of a decontamination process are the central advantages of iso-lator technology. To validate, bioindicators are placed in different locations in the filling area from time to time. These indicators are analyzed after each decontamination cycle. This procedure would be nonsensical where manual cleaning is used in rAbs, for instance, because the operators are directly involved in the cleaning process. A further uncertainty is whether or not the operators performing the cleaning have followed the sops exactly. Monitoring or validating this would be impractical. Thus, regulatory bodies such as the FDA prefer the use of isolators.

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NewcOmer

proprIETArY ConTrol, lIQuID hAnDlIng AnD MorE

robot expertise at OPTIMA pharma

A new robot control developed by Optima Pharma specifically developed for handling pharmaceutical liquids provides new and fle-xible methods for pharmaceutical use. It un-derscores the highly developed competencies at Optima Pharma.

robots break new ground in me-chanical engineering. Different stations in a machine can be reached in a flexible way. since the introduction of robots which can withstand h2o2 sterilization, from a hygienic standpoint, nothing stands in the way of other applications in sterile environments. Yet, it is the product, liquid or powder drugs, that set the technical hurdles for handling so high. The closer the distance between the liquid level and the bottle opening in uncapped bottles, the more difficult it be-comes to prevent liquid from swashing out. This needs to be prevented at all cost.

The key to this is in robotic control of fast and secure transport of pharmaceuti-cal liquids in vials and other containers. The goal is to maintain (as best as possible) the geometric volume between the liquid level

and the bottle ope-ning (head space), regardless of how the robot moves. Each liquid is unique in its dynamic motion in a vial, based on viscosity, surface tension and filling volume (mass). At optima, we asked the question of how liquids can be mathematically cal-culated and how this mathematic model can be implemen-ted in the control software.

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liquids as a mathematical modelA solution was found for the

mathematic description of the dynamic behavior of liquid, as well as its translation into control systems and robotics. When the viscosity of a liquid changes, for example, only a parameter in the mathematical model needs to be changed. The question on how to move the robot to keep the head space constant involves complex mathematical transfor-mations. A robot with six axes, and as many servo motors, requires the calculation of six dynamic joints and their angles.

The robotic control system deve-loped by optima programmers controls a robot so that the operational speed is no longer limited by the physical parameter “liquid”. In this way, open vials can be trans-ported at a high rate of speed, resulting in reduced cycle times.

optima has good reason to put em-phasis on robotic competencies. The same programming is not available from manu-facturers of robotic components. The se-

quence of movement for the robot with six axes is a product which sets optima apart. When specific motions or adjustments are required, optima is there to support. The

customers’ advantage spreads out beyond the project, as optima is the direct contact, and excepting the

mechanical portion of the robot, indepen-dent of suppliers.

Unimagined applications

use of robotics in pharmaceutical applications has a great future. of that, optima is certain. A practical and closely related application within the optima pharma range of competencies deals with freeze dried liquids. The robotic control sys-tem allows vials to be transported without having liquid coat the inside walls of the head space. This liquid coating is known to produce an undesired thin haze of residue on the wall of the vial during freeze drying.

several different robotic appli-cations, mostly for pick-and-place, have

also been used at optima in the past. The available know-how expands the field of play for other applications, limited only by the physical range of motion.

optima machines and customer applications of the future will include ever more robotics, due mainly to the flexibility it offers. With the achieved milestones, further development in every direction is made possible, and questions to any application are welcomed.

high rate of speed

reduced cycle times

The nEXT gEnErATIon in rObOT MOTION

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ZOom

FoCus on blooD plAsMA

six freeze dryers with centralized coolingblood plasma has high significance to medicines. Infusions of blood plasma are life saving to hemophiliacs and patients with immune deficiencies. blood plasma is the basis of many drugs, and as a biological substance, must be handled with care. Optima recently secured a large scale combined project with a well known company, in which plasma products are filled, freeze dried and sealed. Tertiary upstream and downstream processes were also part of the scope. This article will describe a portion of the freeze drying process, in which six freeze dryers with a centralized cooling sys-tem are in production.

Donated blood plasma undergoes countless tests before being used for medi-cal purposes. This takes time. In germany, after the first tests, plasma must be stored in quarantine for 4 months before being re-tested for possible signs of infectious di-seases. Frozen or freeze dried, plasma has a shelf life of about 24 months. Aside from the risky and complex logistics for conventio-nally frozen blood plasma, thawing requires

specialized equipment and a controlled environment. The advantages of freeze drying, though, have proven themselves, as reconstituted plasma often shows more compatibility with the patient. (1).

The installed optima equipment, consisting in total of 6 freeze dryers, are compact versions with an integrated con-densing unit. The condensing unit and the

chamber with the freeze drying shelves are stacked atop one another, with the conden-sing unit positioned below the chamber, separated by a special wall. This wall houses the valve which is opened and closed as required during the drying process. This type of construction (Type C units) requires significantly less floor space than conventi-onal freeze dryers in which the condensing unit is next to, or behind the chamber.

Pass-through principle.

highly efficient and matched to the clean room concept.

The loading and unloading of the vials is arranged on a pass-through principle on all the freeze dryers. The advantage is that vials can be loaded into some of the freeze dryers, while, at the same time, other freeze dryers are unloaded to the capping station. by using this loading and clean room concept, it is ensured that liquid and freeze dried products are always in sepa-rate rooms. of the different closure types used, the lyoseal closures do not require crimping. These are considered, according to current pharmaceutical regulations, to be sealed when they leave the freeze dryer. lyoseal caps are put on the vials after filling,

before freeze drying, and are not complete-ly sealed. The freeze drying process requires that air and moisture be allowed to escape the vial during the process. At the end of the freeze drying process, the shelves stack onto one another, thereby pressing the lyo-seal into the closed position and effectively making it a sealed entity. As such, the clo-sing process remains free of any aluminum particles which commonly occur during classic cap crimping.

Cleaning of the freeze drying units is effected by a CIp/sIp system based on a dynamic cleaning process. nozzles within

the chamber are moved up and down the chamber. shelves are automatically positioned within the chamber during the process, so that these too are cleaned. Effici-ent cleaning and low media consumption are the achieved with this dynamic process. Aseptic conditions inside the chamber as well as the aseptic interface areas are steri-lized by clean steam (sIp).

Vials and infusion bottles up to 100 ml can be processed with this line.

(1) Source: Prof. Dr. med. Jürgen Bux, Dr. rer. nat. Albrecht Hoburg, Dieter Dickhörner, Dr. rer. nat. Edgar Scheel in „Hämotherapie“, 2009, Issue 13, page 33ff.

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When a cooling unit supplies several freeze dryers with cooling capacity, it is called a centralized cooling unit. The central cooling unit generally consists of a refrigeration unit and a loop system to distribute the cooling media to the connected freeze drying units. The cooling media in this case is silicone oil.

The cooling unit supplies the cooling loop of the shelves and the con-denser of each freeze dryer with cooled media. There is no direct connection between the shelf loop and the main loop. Instead, these are coupled to the main cooling loop via a heat exchanger.

centralized cooling – An overview.

In the condenser, however, the coolant flows directly through the piping loops of the condenser. In conventional designs, the shelves are cooled directly by an evapora-tive coolant.

Centralized cooling units generally use a cascading principle, in which ad-ditional liquefied nitrogen (ln2) is used. This combination allows sudden peaks in cooling demand to be met by the ln2 module. This design also allows the integ-ration of redundancy for operational safety. redundancy also allows for the continued operation of the freeze dryer during service or maintenance works on some of the components.

one important aspect in the de-sign of a centralized system is the proper calculation of the operational demand during production. This must consider not only the number of connected machines which will be simultaneously putting demand on the cooling system, but also the energy requirements for the individual process steps. Centralized cooling systems are generally managed by a single control system. In comparison to several (6) independent systems, the costs for software and validation of a single centralized cooling system are lower.

o-com Magazine 19

fOcus

bIoTECh CrEATIng nEW bloCkbusTErs?

sterile manufacturing – current trends and developmentsThe pharmaceutical industry is currently in a state of flux. The introduction of classic blockbusters is diminishing. At the same time, biotechnology is just be-ginning to discover its potential. Gene therapy and personalized medicines are further forms of therapy which are showing signs of a promising future. even now, this paradigm shift is showing a significant effect on automated sterile ma-nufacturing processes.

Aseptic production and manufactur-ing of pharmaceuticals is per se expensive, and is only then used when either impor-tant reasons suggest it, or when it is manda-ted. such reasons could include the specific application of the drug, or for reasons of formulation or shelf life.

The rationale for sterile manufactu-ring lies in the delivery of active ingredients into the human body. To achieve efficacy, many drug molecules need to circumvent

some of bodies’ natural defense mecha-nisms, including organs like the stomach. These types of drugs cannot be delivered orally. parenteral delivery, however, circum-vents many of the bodies’ natural defenses. The body does not have a chance to keep any bacteria or viruses, which may be con-taminating the drug, from directly accessing the (sensitive) circulatory system. sterility of drugs administered directly into the blood stream is therefore of eminent importance, even in a healthy body.

Protective concepts and monitoring

With the emergence of new drug types in the last few years, sterile manu-facturing has also had to take into closer consideration some new aspects of working with these products.

new, toxic and highly potent active ingredients necessitate that the drug not only be protected from foreign particles,

but also that the machine operators be protected from the product. both requi-rements, protecting the product from the operator and vice-versa, have made increased use of crAbs and isolators as barrier systems. At the same time, the number of disposable dosing systems, consisting of product tanks, hoses, nozzles and even pumps, are seeing increased use. pre-sterilized, single use product paths do not need to be cleaned or sterilized after a batch, so the risk of cross-contamination between batches is essentially zero. While the use of disposables reduces the up-front investment in costly CIp-sIp systems for ma-chines, variable costs and cost of validation increase.

The human factor

Most of the isolated incidents of microorganisms found in filling and closing equipment have been proven to have originated from humans. It is therefore understandable that institutions such as the FDA and machine manufacturers strive to automate as much as possible and thereby remove the human factor as a potential source of risk of contamination. At the same time, automated process controls are broa-

dened. human intervention in a process is being reduced or completely eliminated in fully automated processes. Manual interventions are only then performed (or allowed) during a machine stoppage, and any product in process during the interven-tion is usually also automatically rejected.

optical and sensoric inspection, weight monitoring, particle counting etc., are used to secure the pharmaceutical pro-cess during filling and closing, as well as in secondary packaging. If, for example, glass breakage is detected as soon as it occurs, the risk of contaminating the machine or an operator can be quickly mitigated. The pos-sibility to electronically trace processes using

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marking and codes is another example of securing the pharmaceutical process. such data can be collected and operationally analyzed using Erp (Enterprise resource planning) software.

smaller batches and high-value drugs

The pipeline for classic blockbuster drugs is thinning out. biotech companies as well as small- to midsized pharmaceutical manufacturers see potential though, in pro-gressive blockbusters and high value drugs. lower output, a considerably expanded range of products and expensive, high-value drugs also require new technology and types of manufacturing equipment. This market constellation at the same time requires the presence of contract manufac-turers. Whether a pharmaceutical company fills and finishes their product themselves, or has a contract manufacturer perform this work, the trend towards flexibility over output capacity remains the same.

Dosing technology has adapted to the new need for versatility, in which filling equipment is designed to operate with three different filling systems, such as rotary piston pumps, peristaltic pumps and time-pressure systems. The dosing systems are installed as interchangeable modules. Disposables work hand in hand with these modules by simplifying changeovers while ensuring the safe change in product. To make best use of this quick change of do-sing system, and to reduce the turnaround time between batches, format changeovers have also been optimized.

barrier technologies also ensure the safety of the product when different

drugs are being manufactured. When equipment is not already placed in Class “A” cleanrooms, then the reduced operational costs of an isolator (over the lifetime costs vs. cleanroom), usually justify the use of an isolator. The isolators recently introduced at the AChEMA 2012, with drastically reduced aeration times, are an important milestone in reducing the time between batches. Ca-talytic aeration allows one of the most time intensive phases of decontamination to be reduced by up to 50 %, as compared with normal aeration.

In the face of the trend to very expensive drugs, coupled with smaller bat-ches, it is becoming more and more impor-tant to get every last drop of a batch into a saleable vial or syringe. The use of gravime-tric IpC, from intermittent sampling IpC to 100 % IpC over the years has proven itself as an important basis for accurate filling and getting the most out of a batch of product. It is to be expected, that IpC systems will be used more often also in smaller machines.

Now or never – flexibilityEquipment manufacturers are

trending more and more towards modular construction so as to be able to include a broad range of functions into a single machine platform. some of these functions can also often be retrofitted at a later date. Machines to date were typically classified according to their output. Machines with the lowest output were often, even in a derogatory sense, classified as entry-level. Today though, even the smallest machines are equipped with some high-tech systems such as with isolators, or a range of other functions which can be added at a later date when required.

biotech based drugs are often required to be freeze dried, as the shelf life would otherwise be too short to be practi-cable. Freeze drying is also per se expensive, and is only then used when required. The optimum integration of freeze drying into the filling and finishing process requires comprehensive planning. The increasing numbers of turn-key projects which are in process are witness to this.

conclusionThe pharmaceutical industry is in a pro-

found state of flux. Cost pressures, higher safety requirements and a high demand on research are markers in this market. Equip-

ment for filling and finishing of these pro-ducts must take into account these im-

portant future developments.

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PanOrama

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PanOrama

rEVIEW oF ThE shoW

Achema: The perfect linkThe greatest visitor magnet at Optima was the processing line for blood plasma products. This line comprises all process steps from washing through to the final seal. A turn-key project that for the first time contains the new catalytic aeration system with which the isolator cycle times can be drastically reduced. Great interest was also evoked by the new robot control developed by Optima Pharma with “anti-swash effect”. This ensures that fluids in the containers, gripped by handling robots and moved quickly, always remain at a constant fill level.

And this is by no means eve-rything: Isolator-compliant pilot freeze drying units, flexible format and process systems with 100 % in-process control, modular processing plant for diagnostic agents, isolators for laboratories, and small scale systems for use with vials and pre-filled syringes was displayed. In addition the 3D box offered the possibility of 3D travel into filling and packaging machines provided the evidence for the extensive pharmaceutical competence of the company that presented itself on a much larger trade fair stand.

We showed our technical high-lights but also our extras – the desserts from the Molekool bar on our stand were

met with enthusiasm. The precision of this handcraft was extremely impressive; small sculptures were created and received enormous respect but in the end, they were eaten!

optima is extremely satisfied with the results of the Achema. Direct contact figures, as in 2009, were at the highest level. More important, however, is that interested parties often requested further information with respect to individual projects and these discussions were always conducted with qualified partici-pants. In addition, a very large amount of previously unknown visitors – many of whom were from Asian countries – were welcomed. The overall figures published

by the Achema Messegesellschaft reflect the same trend: The absolute number of visitors 167,000 is practically identical to figures published three years ago but the percentage of visitors from Asian countries has definitely risen.

A small survey at optima has shown that on the whole, visitors felt wel-come. The concept of an open stand was well received as this made it possible to just look around initially, without imme-diate and specific discussions. The quality of advice and overall competence was assessed as “very good” as was the sophis-ticated machine design and quality.

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ZoOm

“WEll” MATChED To ThE MAChInE

clinical diagnostics – special weighing conceptMultiwell cartridges are commonly used in clinical diagnostics. Often, these cartridges are proprietary in shape and construction, but their function remains the same. Individual cavities or “wells” of a single cartridge are filled with varying liquids in varying quantities. In the case of this machine, each cavity is weight controlled to satisfy the high quality demands – and it even surpasses these. An additional feature: The processed diagnostic liquids are put through the machine under uV protection, as some of these are uV sensitive.

The monoblock concept of the kugler linoline allows several functions to be combined in one basic machine frame. With that, space is saved, transfer and inter-face points are reduced, and a secure finish is guaranteed.

First, the cartridges are placed as bulk wares in an elevator, which introduces

them into a sorting machine. There, the multiwell cartridges are erected and che-cked if the open side is upward facing. If the direction is incorrect, then they are sorted out and returned into the sorting bowl.

on the way to the kugler linoline, the multiwell cartridges are spaced to a defined pitch between cartridges. The

lengthwise orientation of the containers is checked. If necessary, they are turned around on their vertical axis during trans-port. now, all the containers are doing “well”. A transport rake grabs the elongated containers at the top, and transports them through the machine.

A bakers’ dozen of weigh cells, if you please. Net weight per cavity

The multiwell cartridges contain up to twelve cavities. For each cavity a micro-dosing station and filling nozzle is available. The peristaltic pumps as well as the nozzle movements are individually servo controlled. Each cavity obtains a 100 % filling of the desired weight. Exact dosing of each cavity is of the utmost importance. Therefore, before filling, each cartridge is tare weighed to determine the exact weight of the empty cartridge. Thereafter, no less than twelve further scales are integrated. These measure the total weight of the cartridge including the liquid it contains. The control system uses the gross weight after each filling station and the previous gross (tare) weight to

exactly determine the net volume dosed at each station. The statistical evaluation of the net weight per station influences the exact filling of that stations’ peristaltic pump, and any necessary adjustments are automatic.

Filled cartridges can be sealed with a choice of pE or aluminum foil. The rolls of foil are placed at the front of the machine for easy accessibility. The foil punch was installed on a special rotating trolley in order to make it easier to replace it. To change the format, a punch that was just used will extend, the trolley is rotated 180° and the new punch can easily be put into position.

For the sealing process, the punch cuts out two foils to format, which are then lifted by a vacuum arm, rotated and placed on filled cartridges and precisely pre-sealed. Then, the final sealing can take place using the appropriate temperature for the cartridge and foil types. setting of the temperature takes place automatically, the same way the volume of the filling and the syringe movements are obtained from the format recipe storage in the machine control system. After the sealing process, a sealing inspection follows. For this, several cartridges are selected in parallel and rotated into the va-cuum-inspection station. Faulty cartridges – either in weight or tightness- are immediately eliminated at the next station. All ”good” inspected containers receive a printed label whose printed information is received from the memory storage.

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Order by Scanning

production orders to be performed on this machine are printed out on paper by the production manager. This order contains a 2D barcode which contains all necessary information for setting the machine controls to process the batch. The operator scans the 2D-barcode into the machine and the labeling unit. With that, all format and order related data is available at the controls.

For protection of the products against contamination, the filling- and

sealing area is covered with a laminar flow unit. As mentioned earlier, some of the dia-gnostic liquids are uV-sensitive. These have to be processed under uV-protective glass. Various control sensors ensure processes are performing as they should.

Format Diversity

Formats up to 100 mm in diameter can be processed with the kugler linoline. The 100 %-in process control, performed on each single cavity and linked to the precise

dosing technology is a unique cornerstone of this piece of equipment. The current feasible filling range is between 0.5 and 100 ml – this also confirms the decidedly flexible concept of the type of machine. A performance between 5 and 30 cart-ridges/minute is achieved. The equipment has been in operation at the customers’ site since February 2012.

Diversity of formats laminar flow 1 × tare weighing,

12 × gross weighing uV protection Format change via scanned

2D barcode

1,800 units/hr. pre-sealing Exchangeable module for foil

punch and sealing inspection online labeling batch data transfer via scanner

at the operating unit

specifics at a glance

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It was a customer request that we add a backstop assembly and a safety device assembly for syringes including labeling. This was implemented by an Inova line.

A subsequent order: This project was preceded by an order for a labeling and piston rod insertion machine with back-stop assembly but without function for the safety devices. new, is that now a machine has these two variants – safety device and backstop assembly. optima has recently produced such a machine with the two modules for an international pharmaceuti-cal company.

controlled circulationThe synchronized line comprises

three interconnected transport star wheels, each having various functions. For the two processing variants – backstop or safety De-vice – an operator takes the finished glass syringes manually with the aid of a fork and places these suspended over a flange of the

feed conveyor. At the first station the piston rod is introduced via a sorting head and a transport track. The glass syringe unit is tur-ned in the transport star wheel in order to connect the piston rod with the syringe cap to be introduced. The second station is the labeling station that utilizes a luminescence key – this simultaneously checks if the label has been correctly attached to the object. here too, the syringes are revolved in the transport star wheel on their own axis so that the label can be consistently fixed.

Transfer to the second star wheel is “synchronized” with a slider. The backstops are led via a vibration sorter to the second transport star wheel in a feed guide. here the backstop clips can be selected indivi-dually by the module and pressed onto

the piston rod. optical controls check the presence of the clip. The good and bad rejection sensor is located directly on the second transport star wheel.

If only safety devices are installed, the syringes are transported further to the third star wheel – insofar as the automatic controls do not send out any error signals during piston introduction and labeling. In the event of an error, the syringes land in the reject section of the second transport star wheel before safety devices are moun-ted. These syringes always run through the backstop-assembly, without setting a backstop.

The transfer from second to third star wheel is by means of a gripper that

ZoOm

on onE MAChInE

backstop and safety Device

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picks the syringes and places them in the safety devices. The safety devices are taken beforehand manually from a rondo tray and put into a scraper and then fed automatically using a transport track to the third star wheel. For the actual connection, the syringe body is pressed into the safety device at another station. A height sensor monitors whether the syringe has been inserted correctly into the safety device.

without restrictions on the present Inova machine, for-

mat 1 ml syringes are exclusively processed. The system is prepared for all customary ready-to-use syringes made of plastic material and glass, from 0.5 ml to 20 ml and safety devices up to 2.25 ml. The customer is at present using safety devices from the ma-nufacturer ssI. The line also masters safety devices made by preventis and plastef.

An employee operates the system on the customer premises and supplies the material. The change of backstop to safety device assembly and vice versa can be carried out within 30 minutes. output of 4,000 pieces per hour was achieved. Within only seven months the project was put into practice up to the acceptance.

More safety in medicinal practice• Backstops for syringes give the

users more security when administering in-jections. A plastic part reduces the diameter of the syringe and thus in the first instance the piston is prevented from “sliding through” as can happen, for example, when taking up a solution of previously freeze-dried pharmaceuticals. At the same time the backstop enlarges the surface area for middle and index finger, and thus enables a gentle injection. The backstops are clipped to the syringe bodies by the machine.

• Safety Devices in the first instance increase the safety for medical personnel who use the syringes. After injection, the needle of the syringe is automatically en-cased in a plastic housing. The risk of infec-tion from used needles is thus considerably reduced. Injuries of this kind are a frequent occurrence in medical practice. specially automated assembly functions for safety Devices and backstops are available.

Ready-to-use syringes: Piston rod setting, labeling, backstop and safety device assembly – all in one system

Formats from 0.5 to 20 ml, plastic or glass ready-to-use syringes with safety devices to 2.25 ml

output 4,000 pieces/hr Control stations: presence of syringe

closure, piston rod, backstop and label. height sensor for the correct assembly of the safety device

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MArkET groWTh WITh hIgh DEMAnD

OPTIMA pharma accelerates in chinaPatrick Keung has been working now for Optima for 15 years. Together with Kristian slavik, Director of sales for south east Asia and the far east, they are working to further expand Optima in china. Patrick Keung provides a current summary on the setting up of business there.

The Chinese location was opened in December 2007 as an ideal base for the optima nonwovens business unit. The first engineers arrived in 2010 and were specifi-cally hired for the pharmaceutical industry. Currently, the pharma team is comprised of 13 employees, who manage 14 Chinese pro-vinces and administration municipalities.

patrick keung reports that the development and opening of the Chinese market is closely related with the history of gMp in China. The first edition was pub-lished in 1988. A second edition followed in 1998, and the third, the current edition, became effective in 2011. For optima pharma, the entrance into the Chinese market fol-lowed in 1998 with a project for traditional Chinese liquid oral supplements. several

kugler machines were successfully sold and delivered. All this happened long before the founding of the Chinese subsidiary. In 1999, the first line for ready-to-fill syringes followed. Expectations rose synchronously with the gMp regulations in China, and the first lines for filling syringes under vacuum as well as high-speed lines followed. The vial business also developed rapidly, not in the least thanks to the turnkey lines with freeze drying equipment and isolators which optima pharma now provides.

International experienceDespite the substantial success in

the acquisition of key projects in the past few years, patrick keung still looks for new goals. he sees it as a challenge to further tailor after-sales service to Chinese expec-

tations and culture, to maintain and raise customer satisfaction.

For him, the highest priority is team-work. This counts for his Chinese collea-gues such as liu Chunyang or Jing Zhang who is new to the team, as well as with the pharma head office in germany. “We are all very proud of the leading technologies that optima can offer to customers. China is without a doubt a very large market. At the same time the competition is tough, so we won’t be letting up on our efforts. We’ll continue to make use of first class project management and validation of equipment. We’re very optimistic about the future.” patrick adds with determined resolve: “We are part of a booming market and will grow with our Chinese customers.”

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Grand opening: OPTIMA china in a new location

The new optima building in shanghai was inaugurated on August 8th during an opening ceremony. 120 guests, including business and political dignitaries followed up on the invitation. speeches by

Weiquiang Zhu (mayor of the Jiading district), owner hans bühler and kuno knobloch (Managing Director of optima shanghai) were followed by a tour of the facility for the guests, led by the 2 hosts. A several course menu provided the final golden touch on this important and significant event. Em-ployees at optima shanghai were treated to a grill party with international buffet and music on that same evening.

Source:http://www.gmp-navigator.com/nav_

news_2491_6986,6888,6863,6805.htmlMore information: http://eng.sfda.gov.cnwww.gmp-compliance.org

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cophex in review Cophex took place in south korea

from May 22nd to 25th, 2012. More than 34,000 visitors came to the shows in search of new trends in the pharmaceutical processing industry. optima also partici-pated as one of 650 exhibitors spanning 23 countries. several machine concepts were

presented, among them an Inova sV 125 syringe filling and closing machine and a pilot plant for freeze drying. over the course of the 4 day event, a total of

500 visitors came to the optima booth, many with specific projects.

OPTIMA at InterphexInterphex is one of the most impor-

tant shows for the American market. It took place from May 1st – 3rd. optima attended the fair with the ExCube in which visitors were treated to a 3D virtual tour into actual machines. A complete line for filling ready-to-fill syringes with gel-like products, a vial filler with a flexible processing range and a machine for processing diagnostic reagents and liquids into multi-chambered cartridges comprised the 3 presentations. Even re-presentatives from trade publications were thoroughly impressed with the voyage into

the inner-space of the machines. several individuals made return visits to partake in all 3 presentations. Countless visitors had questions about turn-key projects including freeze drying and containment systems, which could be discussed directly with optima specialists on the booth.

ccf and OPTIMA pharma at fce PharmaThe seventeenth FCE fair took place

from May 29th to 31st in sao paolo. optima has been a committed exhibitor at this fair since 2005, showing good results in terms of new contacts and projects. This year, pharma solutions of the CCF pharma Com-petence Center were presented alongside the optima consumer division at the 170 m2 booth.

CCF pharma is an alliance of leading companies such as Azo, Diosna, heino Ilsemann, korsch, Waldner, Zoatec, hager + Elsässer and optima pharma, whose goal is to provide a well rounded group of related equipment and services for pharmaceutical processes. CCF pharma is a single source for everything required for pharmaceutical production.

At the optima booth, visitors could view a VMW 218 vial and bottle washing machine destined for a brazilian custo-mer, and an sV125 nested syringe filler. A korsch Xl 200 au-tomatic rotary tablet press, a Diosna p1-6 vertical granulation unit for pharmaceutical substances and a Diosna Midilab fluid bed unit for process development rounded out the exhibits.

The trade fair drew in more than 20,000 visitors in search of new technolo-gies and solutions.

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CAlEnDAr

Trade Shows11-11-2012 –11-14-2012 IspE Annual Meeting san Francisco, California, usA

11-19-2012 –11-22-2012 Emballage paris nord Villepinte, France hall 5a, booth #g047

11-21-2012 –11-23-2012 p-MEC India Mumbai, India

11-26-2012 –11-29-2012 pharmTech Moscow, russia

02.-25-2013 – 02-26-2013 IspE Tampa Conference Tampa, usA

03-19-2013 – 03-20-2013 pharma Congress Duesseldorf, germany

03-19-2013 – 03-20-2013 pDA parenteral packaging berlin, germany

04-15-2013 – 04-19-2013 pDA Annual Meeting phoenix, Arizona

04-17-2013 – 04-19-2013 pharmintech Milan, Italy

04-23-2013 – 04-25-2013 Interphex new York, usA

PanOrama

90-YEArs AnD sTIll booMIng!

OPTIMA celebrates Admittedly, an unusual jubilee celebration: 90 years, that’s not a number that is usually achieved. And so, there was no elegant menu, no lengthy speeches, no brocade on this 16th of June. but instead, it was a really great party with live music and delicious food for employees and their family under the open sky.

The head of optima, hans buehler, explained in his brief opening remarks, how the 90-year-jubilee celebration came about: optima developed rapidly in the last two decades. The celebration was therefore a gesture, a “Thank-you” to the employees, for without them, the growth could not have happened. “It is to your credit and this is your party”, Mr. buehler exclaimed to the crowd. Together with the managers of the various business divisions, Mr. buehler leads the company in its third generation. At the same time he gave an overview for the coming 10 years, in which he sees great potential for continued growth.

The weather proved to be a little unsettled on this evening with strong winds and dark clouds – though it stayed dry in the hangars of the airport in schwaebisch hall. The bands played groovy classics, such as soul, blues and funk; at times indiscernib-le from the original version, at other times in a convincing interpretation. Approximately 3000 guests, employees with family, celeb-rated an all around successful party late into the night.

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birgit breitmoserTechnical draftswoman(Machine Engineering)

“Imperfections? I like them in people. OPTIMA equipment I like to be perfect.”

A filling line from opTIMA, puts you on the safe side right from the beginning. because we build complete lines that feature all the advantages: perfect machine performance made to order, consistent documentation, an ideal software solution including a central contact who is passionate about looking after your smallest concerns. The one thing we refuse to deliver is im-perfection. because we have understood that only perfection translates into absolute customer satisfaction.

OPTIMA pharma Gmbh | otto-hahn-strasse 1 | 74523 schwaebisch hall | germanyTelefon +49 791 9495-0 | Telefax +49 791 9495-2610 | E-Mail info@optima-pharma.com | www.optima-pharma.com