OPTIMA for Syringes and Cartridges EXCELLENCE in PHARMA

Filling and Closing Machines OPTIMA for Syringes and Cartridges EXCELLENCE IN PHARMA

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1 OPTIMA pharma – Leading in Quality and Diversity

Optima Pharma specialises in development, design and manufacture of machines and lines in the field of sterile filling technology. Lines for syringes and syringe systems offer you the ideal solution for your application:

f Safety in the application and maximum product protection f High quality in sterile production Contents f Efficiency in production

The machines for processing pre-sterilized dis- 04 Washer posable glass and plastic syringes both nested and in bulk forms, and cartridges are constantly 05 Sterilization Tunnel developed based on the continuous dialogue with customers and on the changing require- 06 Syringe Handling ments within the industry. This results in innovative and proven machine concepts for a func- 08 Filling and Closing tional production process, which offers you a Nested Syringes number of advantages. 14 Filling and Closing Bulk Syringes

16 Filling and Closing Bulk Syringes UniJect

18 Filling and Closing Cartridges

20 Denesting

22 Renesting

24 Labelling/Plunger Rod Insertion

26 Backstop Assembly

28 Safety Device Assembly

30 Syringe Accumulator, Syringe Transport System, Paternoster System

32 Clean Production

34 Line Concept Integration Syringes/Vials/Cartridges

36 Line Concept Integration Cartridges

38 Service

39 Contact us

2 3 Washer Sterilization Tunnel The Perfect Solution for Wet Cleaning For all Purposes

Optima Pharma washers are completely made Optima Pharma sterilization tunnels are part of and infrared/hot air combination tunnels. De- of stainless steel, non-corrosive, pharma-con- a complete aseptic filling line designed to steril- pending on your application, Optima Pharma form material. The washers are designed in ac- ize and to depyrogenate glass containers such has the right tunnel for you. cordance with cGMP standards and have got a as syringes and cartridges – from cleaning to wide variety of usage. Product contact parts are aseptic filling a continuous operation mode in a easy to clean and are easily accessible. For the clean room environment. The tunnel program cleaning and treatment of containers, all clean- consists of Laminar-Flow (LF) hot air tunnels, ing media customary to the pharmaceutical industry can be used.

Type VWM 218 WMR 600 WMR 1800 WMR 2400 Technical Data: Heat sterilization of the cooling zone Fully automatic Machine type Fully-automatic continuous Type SHT/SHT IR Automatically lockable and heated intermittent f Conveyor belt width 300, 450, 600, 800, 1250, 1600 gas-tight tunnel door with sealing at the Containers Cartridges Syringes / Cartridges Syringes / Cartridges Syringes / Cartridges outfeed ot the tunnel Transport height 900 mm +/- 25 mm f Isolation of the cooling zone Container size range: One chamber cartridge Filter system HEPA filters - H13/H14 f Special fans Neck opening 1.5 and 3 ml > 5 mm > 5 mm > 5 mm Outer diameter 7–30 mm 7–30 mm 7–30 mm Output up to 44,000/h. bei 10H (depending on container) f Separate closed cooling circuit with Double chamber Max. height up to 115 mm up to 115 mm up to 115 mm recirculation pump and mixing valve for (depending on container shape) cartridge 3 ml Heating temperature output 20 – 200 KW (depending on output) the sterilizable cooling zone Cooling power 0.3 – 15 m3/h Spray position 1– 2 1 –4 1 – 6 1 – 8 f Sterilization program for sterilization Sterilizable cooling zone Optional implementing Output up to 4,800 pcs./h up to 12,000 pcs./h up to 18,000 pcs./h up to 24,000 pcs./h (depending on container shape)

Processing sequences 8 7 6 6

Ultrasonic infeed/Siliconization Optional Optional Optional Optional

Max. number 1 1 1 1 of recirculation stations

Infeed of containers Transport grippers Transport grippers Transport grippers Transport grippers

Model WMR 600

4 5 Syringe Handling Debagger Systems for Bags and Tubs

Type TRH Type TRR Type DBM Manual system with manual opening of the Fully-automatic cleanroom suitable robot sys- Manual system with manual opening of the bags using gloves. tem for Tyvek® lid and liner removal. The syringe bags using gloves. handling robot is specifically designed for clean Type TRS room applications. The handling robot peels off Type DBS Fully-automatic Tyvek® delid deliner. the Tyvek cover from the tub, removes the Semi-automatic system with manual opening Device to hold tubs during delid-deliner pro- Tyvek® liner and transports the tubs with a grip- of the bags using gloves. The bags are fed either cess. The Tyvek® adhesive is melted using heat- per. manually or automatically to the debagger. The ed jaws. After a preset time, the Tyvek® lid is re- bags are then opened semi-automatically and moved by means of a vacuum frame and disposed of. disposed into a bin.

Type DBA The bags are automatically fed and opened. The tub is automatically removed from the opened bag. The bag is then automatically disposed of.

Type Type DBM Type DBS Type DBA

Machine description Manual bag debagger Semi-automatic bag debagger Fully-automatic bag debagger

Syringe systems All commercially available nested syringes in tubs and bags Type Type TRH Type TRS Type TRR

Semi-automatic Tyvek® Fully-automatic Tyvek® Fully-automatic Tyvek® lid and liner Machine description removal box heating system removal robot system

Syringe system All commercially available nested syringes in tubs and bags

6 7 Nested Syringes, Vials Nested Syringes, Vials and Cartridges For Small Batches – Type SV 122 For Medium Output – Type SV 125

A fully-automatic filling and closing machine to Advantages Advantages With the SV 125 it is possible to process three The filler can be rounded out with tertiary process dispos able, nested syringes. Format different container types on a single machine. equipment such as debagger or Tyvek lid and range up to 50 ml. An output up to 4,800 syring- f Compact construction Slim and compact design liner removal for full line automation. f es/hour can be reached with the 2-lane model. f Reputable service f High speed machine technology The SV 125 can be made to process nested sy- High dosing accuracy by means of continuous f Highest dosing accuracy and design ringes, nested vials and nested cartridges. Equipped with isolator technology, the highest operation rotary piston pumps. The SV 122 can f Superior construction 2- 5- or 10-lane dosing system levels of sterility are achieved. f be quickly retrofitted to process vials. The SV f High dosing accuracy It is also possible to integrate up to three differ- 122 is also available for use with isolator tech- f Quick changeover time Optional ent types of filling systems, such as peristaltic, Sized Output: nology, vacuum filling and stopper insertion of format parts f Vacuum filling and stopper inserting rotary pump and time-pressure, to meet a 5,700 syringes/h. (2-lane) (optional). f Prepared for the processing of vials broad range of product requirements. Filling 12,500 syringes/h. (5-lane) Optional and closing with vacuum is also optionally 20,000 syringes/h. (10-lane) Vacuum filling and stopper available. f insertion f IPC Switching over from one container type to an- f Pre- and post gas flushing other is comparable to a conventional format f Machine can be quickly change on the machine. retrofitted to process nested vials and cartridges f Isolator design

8 9 Nested Syringes, Vials and Cartridges Nested Syringes, Vials and Cartridges High Reliability with Type H4–10 High Reliability with Type H6–10

The new filling and closing machine, model H4– Regardless whether oRABS, cRABS or isolator, Advantages With the H6–10 it is possible to process three Advantages 10 meets customers’ requirements for simple all systems can be economically fitted to the different container types on a single machine. operation, ease of accessibility, reliability and standardized machine baseplate. f Modular an cost optimized f Highest dosing technique either with compact design. Nested syringes, vials and f High speed machine technology and design The machine can be made to process nested sy- > rotary piston pumps cartridges are all processed. The transport system of H4-10 ensures particu- ringes, nested vials and nested cartridges. > time pressure dosing system larly careful handling of the containers. A high Optional > peristaltic dosing system Automated Tyvek ® lid and liner removal can be output rate of up to 24,000 objects/h. is achie- It is also possible to integrate up to three differ- f Linear and vertical processing of tubs integrated if required. Space for the robot is fo- ved. Retrofitting can also increase output to f Output can be increased to 36,000 objects/h. ent types of filling systems, such as peristaltic, f Linear transport system allows the reseen on the filling machine, thereby saving 36,000 objects/h. f IPC rotary pump and time-pressure, to meet a combination of the H10–16 with other space. f Pre- and post gas flushing broad range of product requirements. Filling machinery The same applies to upgrading of in-process f Easy retrofit of: vacuum filling and and closing with vacuum is also optionally avail- f Slim design for use with an isolator For filling, a ten-position system is provided. For control (IPC), vacuum filling and vacuum stop- stopper insertion able. filling flexibility and simple format changes, ro- per inserting. f All containment systems – oRABS, cRABS, Optional tary piston pumps as well as peristaltic or time- Isolator can be economically mounted on Output: : f Vacuum filling and stopper inserting pressure filling systems can be added at any Output: the standardized machine table top plate. 36.000 syringes/h. (10-lane) H6–10 f 100 % IPC time. 24,000 syringes/h. (10-lane) f Machine can be quickly retrofitted to process nested vials and cartridges f Integration of all containment systems: oRABS, cRABS / Isolator

10 11 Nested Syringes, Vials and Cartridges Nested Syringes, Vials and Cartridges High Reliability with Type H10–16 Technical Data

A fully-automatic filling and closing machine to Advantages Type SV 122 SV 125 H4-5/H4-10 H6-10 H10-16 process disposable, commercially available 0.5 ml - 50 ml(syringes) 0.5 ml - 20 ml (syringes) nested syringes. Format range up to 20 ml. An f Highest dosing technique either with 0.5 ml - 50 ml(syringes) Syringe size range up to 50 ml (vials) up to 50 ml (vials) output up to 60,000 syringes/hour can be > rotary piston pumps or up to 50 ml (vials) 3, 5, 10 ml (cartridges)) 3, 5, 10 ml (cartridges)) reached with the 16-lane version. The machine > time pressure dosing system or is equipped with an infeed and a discharge con- > peristaltic dosing system Dosing value (depending on 0.1 - 50 ml 0.1 - 20 ml veyor belt for the tubs. f Linear and vertical processing of tubs selected pump size) f The linear transport system allows the combination of the H10-16 machine with Dosing system Rotary Piston Pumps, Time Pressure Filling System, Peristaltic Pumps other machinery 2-lane 2-, 5-lane (on request) 10-lane f Slim design Filling heads 2-lane 5-lane 10-lane 10-lane 16-lane f Isolator suitable 10-lane

Optional 5,700 (2-lane) 4,800 24,000 36,000 60,000 Output (Syringes/h) 12,500 (5-lane) f Vacuum filling and stopper inserting (2-lane) (10-lane) (10-lane) (16-lane) 20,000 (10-lane) f 100 % IPC f Machine can be quickly retrofitted to process nested vials Vacuum filling and Vacuum filling and stopper inserting and cartridges stopper inserting Option Pre- and post-gas flushing f Integration of all containment systems: Pre- and post-gas IPC oRABS, cRABS / Isolator flushing

12 13 Bulk Syringes Bulk Syringes Filling Systems Technical Data

Bulk syringe filling places high demands on ma- Syringe Filling and Closing Machine Medium Sized Output Type VSVM 3000 VSVM 4000 VSVM 600 VSVM 900 VSVM 1200 VSVM 1800 chine design concepts. The complexity of entire for Small and Medium Output Fully-automatic syringe filling and closing ma- lines make them technically the most demand- Fully-automatic syringe filling and closing machine to process bulk, glass and plastic syringes Fully-automatic Fully-automatic Fully-automatic Fully-automatic Fully-automatic Fully-automatic ing challenge in the pharmaceutical industry. chine to process bulk, glass and plastic syringes with two filling heads. Output of the VSVM 4000 syringe filling syringe filling syringe filling syringe filling syringe filling syringe filling Machine With Optima Pharma you can be certain you with one filling head. Output of the VSVM 3000 machine up to 7,200 syringes/hour. The dos ing and closing and closing and closing and closing and closing and closing description have chosen the right partner. machine up to 3,600 syringes/hour. Dosing vol- volume ranges between 0.1 ml and 20 ml. machine machine machine machine machine machine ume: 0.1 ml - 20 ml. 1-lane 2-lane 1-2-lane 3-4-lane 3- 6-lane 8-lane High Sized Output Syringes Glass and plastic syringes Fully-automatic syringe filling and closing machine to process bulk, glass and plastic sy- Transport system Star-wheel Oval race track ringes with three to eight filling heads. Output Dosing volume 0.1 - 20 ml 0.1 - 50 ml of the VSVM 1800 machine up to 18,000 syringes/hour. Dosing volume: 0.1 ml - 50 ml. 0.5 - 20 ml 0.5 - 20 ml syringes syringes 0.5 - 3 ml 0.5 - 20 ml syringes Syringe max. max. syringes Advantages max. ø 21,5 mm size range ø 21.5 mm ø 21.5 mm max. max. length 125 mm max. length max. length ø 10.85 mm f IPC 125 mm 125 mm f Combination of different working stations for assembly of syringe applications Filling head 1 2 1 - 2 3 - 4 3 - 6 4 - 8

Output (depending up to 3,600 up to 7,200 up to 6,000 up to. 9,000 up to 12,000 up to 18,000 on product syringes/h syringes/h syringes/h syringes/h syringes/h syringes/h characteristics and syringe)

14 15 Bulk Syringes UniJect Bulk Syringes UniJect Filling System Technical Data

UniJect™ “Prefill Injection Device” is heat sealing module. Process data, like time, Type UJ 120 UJ 150 UJ 300 a cost efficient, non-reusable and high quality temperature and pressure are continuously injection unit for intramuscular and subcutane- monitored and adjusted. Machine description Fully-automatic filling and closing machine ous applications. The model UJ guarantees a Syringe systems UniJect™ ”Prefill Injection Device“ safe operation process, flexibility, a compact Optional design and combines these features with a f Semi-automatic debagger Application High speed processing of UniJect devices in a clean room high output – the UJ 120, UJ 150 and UJ 300. f RABS execution Infeed Manual feeding of rolls into machine

With the model UJ almost no extra size parts UniJect Size 0.3 ml - 2 ml are required to process all UniJect™ devices. Filling heads 4-lane 6-lane 12-lane The UniJect™ devices are smoothly processed by means of an unwinding and rewinding de- Output vice in a custom designed transport system. (Syringes/min.) depending on up to 120 syringes/min. up to 150 syringes/min. up to 300 syringes/min. The filling station of the UJ is designed for dif- product characteristics, ferent filling systems: time pressure, rotary pis- fill volume and filling system ton pumps or peristaltic pumps. This allows Machine dimensions (L x W x H) 2,100 x 1,800 x 1,900 mm 2,300 x 1,800 x 1,900 mm 2,300 x 1,800 x 1,900 mm you to process various media. Program mable fill movements permit an optimal output. Pa- Machine finish Stainless steel and hard coated aluminium rameters of different products and filling vol- Working height 1,000 mm +/- 30 mm umes are set simply by means of a teach-in function. The UniJect™ devices are sealed by a

16 17 Cartridges Cartridges Technical Data

Type VKVM 3000

The machine is available as a stand-alone model Technical Data: or integrated in a complete line. Type VKVM 3000

Functional operation: Machine description Fully automatic illing and closing machine A machine that encompasses: the infeed of stoppers, insertion of stoppers, pre-filling, final Containers One chamber cartridge filliing with product retraction device, pick-up Double chamber cartridge of aluminum caps and crimping. Several control Infeed Inclined chute / Scroll (Stand Alone) functions are available. Vibratory table / scroll (Line)

Filling volume 0.1–3 ml Two-lane discharge into trays or reject station for improperly processed cartridges – fail/safe Container size range One chamber cartridge system. 1.5 and 3 ml

Double chamber cartridge 3 ml

Output (Containers/h.) up to 3,600

Operators 1

18 19 Denesting Denesting Denester to Process Syringes Technical Data

Denester to Process Denester to Remove Technical Data: Denester Tubs Nested Syringes Syringes from Rondo Trays The aseptically filled and stoppered syringes are The syringes are automatically removed from Type SH 110 SH 120 SH 210 SH 230 SH 260 automatically removed from the nest and the tray and placed onto a dis charge track. The Machine description Fully-automatic Denester placed into a discharge track. The tub can be Rondo tray stacks are placed manually on the placed manually or automatically onto the in- infeed conveyor belt of the machine. Syringe systems Nested syringes feed conveyor of the machine. The following The following process is fully automated. The Sterile, filled and closed syringes (without plunger rod), process is fully automated. The empty nest is Rondo trays are automatically destacked. Each Application as well as sterile, empty syringes transported by means of an intermittent con- tray is transported past the removal station uti- veyor belt to the stacking device and automati- lizing a carrier device and the syringes are re- Infeed Manual infeed in tubs Automatic infeed in tubs cally stacked. The tubs and nests in the stack are moved into a discharge track. The empty Rondo Syringe size range 0.5-20 ml then manually removed. Discharge can be one trays are automatically stacked and transported or two laned. onto a discharge conveyor belt. Output (syringes/h) depending on up to 7,200 syringes up to 12,000 syringes up to 12,000 syringes up to 24,000 syringes up to 36,000 syringes syringe size and nest configuration

Technical Data: Denester Rondo Trays

Type TD 210 TD 230 TD 240

Machine description Fully-automatic Denester

Syringe systems Syringes in Rondo trays Safety Device

Sterile, filled and closed syringes (without plunger rod), Application as well as non-sterile and unfilled syringes

Infeed Semi-automatic infeed

Syringe size range 0.5 ml-20 ml

Output (syringes/h) depending on syringe size and Max. 10,000 Max. 18,000 Max. 24,000 Rondo tray configuration

20 21 Renesting Renesting Renester to Insert Syringes Technical Data Renester Tub

Fully-Automatic Renesting Machine for Fully-Automatic Renester to Insert Syringes Nested Syringes into Rondo Trays Technical Data: Renester Tub The completely processed syringes are manual- Using the fully-automatic renester, the syringes, Type SN 220 SN 240 SN 260 ly or automatically inserted into the nests. The which are fed with the aid of a feeding track and Machine description Fully-automatic renester syringes are fed single-lane into an oval trans- infeed wheels, are inserted into Rondo trays. port system and are spaced out respectively to The empty Rondo tray stacks are manually Syringe system Nested syringes fit the arrangement of the syringe nest. For the placed onto the infeed conveyor belt. The Ron- Nesting of empty syringes e.g syringe manufacturing and filled and closed syringes. single-lane nest transport, the oval stops short- do trays are automatically destacked. Each Ron- Application With and without label or plunger rod. ly to take out a row of format dependent syring- do tray is transported past the inserting station es by means of vacuum. For the two- and three- utilizing a carrier device, and the syringes are in- Infeed Automated, single laned infeed of single syringes lane nest transport 2 or 3 grippers take out one serted into the Rondo trays. The filled Rondo Nest infeed 1-lane 2-lane 3-lane row of syringes out of the continuously running trays are automatically stacked and transported oval transport. The grippers work independent- onto the discharge conveyor belt. 0.5 ml to 20 ml ly and the syringes are inserted in separetely Syringe size range Additional syringe size upon request. centered nests. Maximum tub height: 163.5 mm

Output (syringes/h) depending on syringe size and up to 15,000 up to 24,000 up to 36,000 Rondo tray configuration

Technical Data: Renester Rondotrays

Type TR 210 TR 230 TR 240

Machine description Fully-automatic renester

Syringe system Syringes in Rondo Trays

Sterile, filled and closed syringes (without plunger rod), Application as well as non-sterile and unfilled syringes

Infeed Semi-automatic infeed

Syringe size range 0.5 ml to 20 ml

Output (syringes/h) depending on syringe size and up to 10,000 up to 18,000 up to 24,000 nest configuration

22 23 Labelling / Plunger Rod Insertion Continuous or Intermittent

Continuous Motion Labelling Machine Intermittent Operation Labelling Fully-Automatic Finger Flange Assembly, Labeling, plunger rod insertion machine with The economical, compact solution for medium and Plunger Rod Inserting Machine Plunger Rod Inserting and Labelling safety device and finger flange assembly and large batches. This machine processes all The economical, compact solution for small Machine, Type EKM Model EKCS common glass and plastic syringes from 0.5 to batches. This machine processes all common Three functions integrated into one machine. Compact machine with multifunctional proces- 20 ml. The syringes are transported into the glass and plastic syringes from 0.5 to 20 ml. The The machine is designed to assemble finger sing of various components and continuous continous motion transport star-wheel using an filled and closed syringes are transported into flanges, insert plunger rods and label all com- force measurement at the assembly stations. inclined infeed and an infeed wheel. At the la- the transport star-wheel by means of a linear mon glass and plastic syringes. Syringe size pro- belling station the syringes are rotated using a feed-track. At the inserting station the plunger cessing range: from 0.5 to 20 ml. Continuous Operation Labelling roller band and the labels are glued on. A cam- rod is removed from the inclined feed-track us- and Plunger Rod Inserting Machines, era detects the presence of the label. On the la- ing grippers and inserted into the rotating sy- Fully-Automatic Labelling and Plunger Rod Type EKK bel dispenser a second camera controls the cor- ringe. At the following station the assembled Inserting Machine with Backstop Assembly, The economical and compact solution for medi- rect print of the label. Then, the syringes are syringes are labelled. On the label dispenser a Type EK/CM um and large batches. These machines continu- distributed via two vacuum wheels into the dis- second camera controls the correct print of the Labelling, plunger rod insertion and backstop ously process all common glass and plastic sy- charge / reject. label. Incorrectly processed syringes are rejected. assembly integrated into one machine. The eco- ringes. nomical compact solution for small batches. Syringe size range: This machine processes all common glass and EKK 62: from 0.5 ml to 50 ml plastic syringes from 0.5 to 10 ml. EKK 182: from 0.5 ml to 10 ml

24 25 Backstop Assembly Backstop Assembly Fully-Automatic Backstop Assembly Machine Technical Data

The working principle is either intermittent (CM 4) or continuous motion (CM 18). The syringes are directly fed into the machine via a chute to track guide syringes directly into the infeed star- track 12,000 (50 ml) assembly plunger rod plunger rod Intermittent 0.5 ml – 20 ml

wheel. Labelling and with backstop with backstop EKK 62/CM 12 Inclined infeed Inclined infeed inserting machine track or linear feed or linear feed track

While transfering the syringes from the transfer star-wheel into the main star-wheel the back stops are assembled onto the finger flange of CM18 (10 ml)

the syringe. Backstop 0.5 ml – 5 ml CM 4/CM 12/ 12,000 (CM 12) 12,000 (CM 18) 18,000 (CM Backstop infeed with linear feed track with linear feed infeed Backstop assembly machine The sorting/orientation of the backstops is 18) (CM Continuous 4 m2 done by means of a sorting bowl. The backstops are transported onto a rail to the point of assembly. The assembled syringes are guided out (10 ml)

of the main star-wheel for further processing. 0.5 ml – 5 ml CM 4: The fully assembled syringe is pushed late- - rally out of the starwheel into the discharge chute.

CM 18: The fully assembled syringe is pushed Continuous 4) (CM Intermittent inserting machine tangentially into the discharge starwheel. clockwiseCounter Clockwise Labelling and plunger rod Labelling and plunger rod (50 ml)

EKCS EKK 62 EKK 182 and finger plunger rod plunger rod Labeling and flange assembly with safety devicewith safety insertion machine 1 Inclined track discharge all common syringes all common assembly plunger rod plunger rod EK 321/CM 4 CM 4/EK 321 Labelling and with backstop with backstop Backstop infeed with linear feed track with linear feed infeed Backstop inserting machine Inclined infeed track or linear feed track or linear feed track Inclined infeed track Inclined infeed Inclined infeed Inclined infeed track Inclined infeed track track EKM 321 EKM 331 assembly, assembly, Clockwise infeed with infeed plunger rod plunger rod Finger flange Finger Finger flange Finger inserting and 0.5 ml – 20 ml 0.5 ml – 10 ml 0.5 ml – 10 ml 0.5 ml – 20 ml linear feed track linear feed labelling machine (20 ml) plunger rod plunger rod Labelling and inserting machine 3 m2 4 m2 4,5 m2 36,000 4,000 3,600 4,000 3,600 12,000 36,000 4) 4,000 (CM ESK 91 EK 321 machine Labelling Continuous Intermittent 0.5 ml – 20 ml 0.5 ml – 10 ml Product infeedProduct track or linear feed track Inclined infeed Inclined infeed Operators Space requirements Syringe Syringe discharge Working direction Backstop/Finger flange infeed - Plunger rod rod Plunger infeed Output (syringes/h) Syringe systems Syringe size Syringe range Mode of operation Machine description 26 Type 27 Safety Device Assembly Safety Device Assembly Technical Data

The VSM is an assembly and labelling ma- The syringes are also fed into the machine using Type VSM 1200 VSM 1800 VSM 2400 chine for safety devices and is available in an infeed chute and separated using an infeed three different ranges of performance. wheel. The cam-controlled grippers pick the sy- Machine description Fully-automatic assembly machine for safety devices The safety devices are fed into the machine us- ringes and insert them into the devices. Then, Mode of operation Continuous ing an infeed chute. Depending on the product, the safety devices are transported to the inser- they are carried over by a single or double scroll, tion star-wheel. The syringes and plungers are Syringe systems All common syringes separated, and fed to the first labelling star- completely pushed into the devices. To ensure Safety device system All common safety devices wheel. The label dispenser can be equipped exact insertion of the syringes, they are cen- with different print and control systems, de- tered in the star-wheel via grippers. Then, the Size range Depending on safety device system pending on the customer’s requests. Then, the syringes are fed using two vacuum wheels to Output (syringes/h) 12,000 18,000 24,000 safety devices are transported to the assembly the discharge or reject stations. Manual safety star-wheel. device systems are available upon request. Syringe infeed Inclined feed track

Safety device infeed Inclined feed track

Safety device discharge Inclined feed track

Working direction Counter clockwise

Operators 1

Space requirements 3 m2 (6 m2 with 2 dispensers)

28 29 Syringe Accumulator Syringe Transport System / Paternoster System

SP 300/600/900 SP 2000/3000 Syringe Transport System Paternoster System Syringes are fed into a tray loading sytem using Syringe accumulation buffer – first-in, first-out The syringe transport system can be utilized as The paternoster system was developed for the a star wheel. The tray is filled row by row. The principle. The syringes are fed into the accumu- an infeed or discharge conveyor belt. Further- optimization of complete turn-key lines to pro- nest moves perpendicular to the infeed, with lation racks by gravity or pushed in and out of more, it can be used to connect individual ma- vide operators a passageway under the tub the row in front of the infeed being filled before the rack mechanically. Empty racks descend be- chines. Differences in height can be compensat- transport. The paternoster is available in vari- shifting to the next row. The individual lanes low the machine plate and are cycled back to ed with an infinitely adjustable crossing angle. ous designs and sizes. are filled and emptied by gravity, controlled by the infeed. a discharge finger and an accumulation sensor.

Type SP 300 SP 600 SP 900 SP 2000/3000 Type STS STS-0

Machine description Syringe accumulator Machine description Syringe transport system

Syringes from 0.5 ml to 50 ml. Max. length of syringes: 140 mm. Syringes 0.5 ml - 50 ml. Syringe types Syringe systems Additional syringe types upon request Max. length of syringes: 160 mm. Additional syringe systems upon request

Application Sterile filled and closed syringes, as well as sterile, unfilled syringes Sterile, filled and closed syringes as well as sterile, Suitable for horizontal syringe transport and Application empty syringes. Very suitable for bridging Output up to 300 syringes up to 600 syringes up to 900 syringes up to 3,000 syringes built to provide for syringe accumulation different heights

1,000 / 1,200 / 1,500 / 2,000 mm 1,000 mm Length Further length upon request Further length upon request

30 31 Clean Production Clean Production Triple Protection

Triple protection Clean room technology provides the basis to ensure a safe production environment for filling sterile drugs.

The filling technology provides for the precise dosing of drug products under the aspect of sterile product handling. Optima Pharma unites the required clean room technology with the state-of-the-art filling technology to help you market a high-value pharmaceutical product. The portfolio of Optima Pharma and the brands Inova and Metall + Plastic offer three different technical air protection systems: At first glance, all three systems work as a clean room micro plant. But as far as technology and regulation are concerned, the differences are quite considerable and have to be assessed for each individual project. We would be happy to recommend the correct protection system suit- f Restricted Access Barrier System ( RABS ) able for your application. f Closed Restricted Access Barrier System ( C-RABS ) f Isolator

Restricted Access Barrier Closed Restricted Access System ( RABS ) Barrier System ( C-RABS ) Isolator

To restrict the operator access to the process Ventilation concept Protection module area, our filling machines can be provided with The required process air is taken from the ma- The protection module consists of high-quality RABS equipment as an option. The restricted chine environment and filtered by means of a stainless steel materials. Doors, windows and access is in this case achieved by glove systems, HEPA filter. Variable speed-controlled ventila- other functional elements are integrated into and mock-up studies are used to determine in tors supply constant air volume to the unit. Air the modular sectional framework, as required advance the gloves‘ positions. distribution is achieved by means of a plastic for the individual machine. Intervention in the diaphragm, which ensures uniform air distribu- protection module is achieved by means of tion in the protected area with little turbulence. glove accesses that are integrated into the glass doors (tempered safety glass (ESG). System description/technical module The technical module consists of high-quality Possible operation parameters stainless steel materials and is located above f Air speed the protection module. It contains the complete f Pressure regulation (option) technical air equipment, such as ventilators, fil- f Air temperature (option) ters, cleanroom illumination and air distribution f Humidity diaphragm.

32 33 Filling and Closing Machine for Nested Syringes, Vials and Cartridges

Flexibility and Syringes Vials Cartridges standardization combined 0.5–20 ml up to 50 ml 3 ml

A new type of filling and closing machine: High-tech functions contribute to The Multiuse Filler OPTIMA H4 covers a great number of overall flexibility for the fundamental concept for the system. Extensive standardization in diverse applications. At the same time OPTIMA H4 fulfills Containment: the development of OPTIMA H4 allows the the customer wish for simple operation, ease of All systems – oRABS / cRABS / Isolator – pre-manufacture of modules, resulting in can be economically mounted on the standardized time and cost benefits. Nested vials, syringes accessibility, reliability and low space requirement. machine table top plate. and cartridges are all processed.

Automatic opening of Tyvek® lid and liner removal can be integrated if required. Space for the robot is foreseen on the filling machine, thereby saving space. Semi- automated systems can also be integrated. High speed There is also freedom of choice in respect of machine containment: Regardless whether oRABS, technology cRABS or isolators, all systems can be economically fitted to the standardized and design machine baseplate at low cost. For filling, a ten-position system is provided. For filling flexibility and simple format changes, rotary pistion pumps as well as peristaltic or time- pressure filling systems can be added and at any time.

The transport system of OPTIMA H4 originates from high performance machinery. It has been simplified mechanically but nevertheless ensures even and particularly careful handling of the containers. A high output rate of up to 24,000 objects/hr. is achieved. Retrofitting can also expand output up to 36,000 objects/hr. The same applies to upgrading of in-process control (IPC), vacuum OUTPUT: filling and vacuum stopper inserting. Both Up to can be supplemented at a later date without Modular and requiring changes to the machine baseplate. cost optimized 36,000 objects/hr., extendable

Easy retrofit of: vacuum filling and stopper insertion IPC

34 35 INOVA Processing line for carpules, consisting of VWM 218, SHT, VKVM 3041

Dosing volume Output 10 7 9 11 RABS up to 12 0.2–50 ml 3,600/h 8 4 3 13

Features - Smooth handling of the cartridges - Feeding system for stoppers and caps - Pre gas flushing / pre filling - Sorting of stoppers in one direction - Final filling with sensors - Pick and place crimp cap - Blocked needle testing Production process

1 Infeed scroll 2 Rotary washer 3 Product infeed sterilizing tunnel 4 Sterilizing tunnel 5 Infeed scroll 6 Transport star wheel 7 Stopper insertion 8 Stopper feeding via sorting bowl 14 9 Gas-flushing 10 Pre-filling 11 Final-filling 12 Pick and place crimp cap 15 13 Sorting crimps caps 14 Crimp station 15 Control station 5 16 Product discharge 1 17 16 17 Reject 6

36 37 Service Contact Us A Comprehensive Service Program The Safety of a Strong Partner

Process reliability is also a question of service. Even the best machines and lines are subject to a certain extent of wear. With our team of experts and the worldwide available service network of the Optima Pharma, you will reduce the risk of machine downtime to a minimum. Additionally, a 24-hour hotline as well as an extensive spare parts supply within a very short time are at your disposal. Electronic spare parts catalogs, comprehensive technical documenta- tion and operating instructions as well as the te- leservice, facilitate the competent handling of Innovative machine upgrades and individual re- trouble-shooting. Service already starts when trofitting packages of the Optima Pharma up- commissioning the machine. The Optima Phar- grade your machines to the state-of-the-art. OPTIMA pharma GmbH OPTIMA Machinery Corporation OPTIMA Japan Co. Ltd. ma offers you training specifically adapted to Ask us for a service package meeting your re- Otto-Hahn-Str. 1 1330 Contract Drive 362 Shimizu-cho your requirements. Incidentally, it is not always quirements. It will be our pleasure to assist you. 74523 Schwäbisch Hall Green Bay, WI 54304, USA Kawaramachi-dori necessary to invest in new machinery. Tel.: +49 791 9495-0 Tel.: +1 920 339-2222 Nijio-agaru, Nakagyo-ku Fax: +49 791 9495-2610 Fax: +1 920 339-2233 Kyoto 6040911, Japan [email protected] [email protected] Tel.: +81 75 223-1588 www.optima-pharma.com www.optima-usa.com Fax: +81 75 223-1595 [email protected] OPTIMA pharma GmbH OPTIMA packaging Vor dem Langen Loh 8 machines, S.A. de C.V. OPTIMA KOREA CO., LTD 35075 Gladenbach-Mornshausen San Jorge 198 SUITE 1107, 6 WIRyESEONG-DAERO, Tel.: +49 6462 91576-0 Col. Pedregal Santa Úrsula SONGPA-GU, SEOUL, KOREA, 138-827 Fax: +49 6462 91576-148 Del. Coyoacán Tel.: +82 2 414 7105 [email protected] C.P. 04600 México, D.F. México Fax: +82 2 414 1908 www.optima-pharma.com Tel.: + 52 55 5421-0271 [email protected] Fax: +52 55 5610-4452 www.optima-kr.com METALL + PLASTIC GmbH [email protected] Bodmaner Str. 2 www.optima-mex.com OPTIMA Packaging Machines 78315 Radolfzell-Stahringen (Shanghai) Co., Ltd. Tel.: +49 7738 9280-0 OPTIMA do Brasil Máquinas de No. 695 Fengmao Road Fax: +49 7738 9280-10 Embalagem Ltda. Malu Town, Jiading District [email protected] Rua Joana Foresto Storani, 500 Shanghai 201801, China www.metall-plastic.de 13280-000 Vinhedo - SP, Brazil Tel.: +86 21 6707 0888 Tel.: +55 19 3886-9800 Fax: +86 21 6707 0889 OPTIMA Packaging Machinery PLC Fax: +55 19 3886-9810 [email protected] 7 Loader Close [email protected] www.optima-cn.com Kings Worthy www.optima-bra.com Hampshire SO23 7TF, Great Britain OPTIMA PACKAGING MACHINES Tel.: +44 1962 620898 OPTIMA India packaging machines (M) SDN. BHD. Fax: +49 791 506 6500 Private Limited 5008 A 1st Floor [email protected] No. 2, 2nd Floor, Sree Datri Nivas Nag- Jalan Lunas, Batu 2.5 www.optima-gb.com wara Circle, Outer Ring Road 09000 Kulim, Kedah Opp. Manyata Softech Park Malaysia OPTIMA Packaging France S.A.R.L. Bengaluru – 560045 Tel.: +60 4 495 1619 Zone d´Activités de l´Energie Karnataka, India Fax: +60 4 495 1697 4, rue Ampère B. P. 9 [email protected] [email protected] 59559 Comines Cedex, France www.optima-ind.com www.optima-mal.com Tel.: +33 320 6306-48 Fax: +33 320 6306-41 [email protected] www.optima-fra.com

38 39 Otto-Hahn-Str. 1, 74523Schwaebisch Hall, Phone +497919495-0, Fax: +497919495-2610, [email protected], www.optima-pharma.com OPTIMA pharma GmbH www.optima-pharma.com More information:

10405383/4/EN Since we are constantly working on finding new ways to optimise our state-of-the-art machines, the texts, illustrations and figures in this prospectus are not binding and exemplar.