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Packaging System for Liquids Blow-Fill-Seal Technology

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Page 1: Packaging System for Liquids - 4.imimg.com4.imimg.com/data4/PY/XW/MY-22844417/bp-bottelpack-blow-fill-seal... · Packaging System for Liquids ... by this process, ... The cleaning

Packaging System for LiquidsBlow-Fill-Seal Technology

rommelag_Englisch_09.indd 17 03.04.2009 13:23:36 Uhr

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Innovative packaging with bottelpack®

Blowing, Filling, Sealing – and much more!

02 | 03

bottelpack® packaging systems are used worldwide for many decades for the aseptic packaging of liquids in plastic containers.Blowing the containers, fi lling and sealingin one operation cycle results in maximum product safety, user-friendly packaging design, low production cost and high output.

We are well qualifi ed to assist you, from the selection of the appropriate packaging to the development of the most cost effective pro-duction line.

rommelag_Englisch_09.indd 2 03.04.2009 8:49:12 Uhr

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Pages 04 | 05 With bottelpack®in one operating cycle:Blowing, fi llingand sealing –and much more!

Pages 06 | 07 Transparent, fl exible containersmade of Polyethylene (PE)or Polypropylene (PP)for sterile, particle- andpyrogen-free pharmaceuticals

Pages 08 | 09 Unit dose and multi dose inmultiblock and single containers:Easy to box, easy to marksecurely, easy to use

Pages 10 | 11 | 12 Ready-to-use containerswith formed pipettes,droppers, withdrawing systemsor re-closures

Page 13 bottelpack® Packaging System,Cap Welding Unit and Leak Detector

Pages 14 | 15 Development, Design,Production and Customer Servicein the hands ofhighly qualifi ed personnel.

rommelag_Englisch_09.indd 3 03.04.2009 8:50:53 Uhr

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04 | 05

For decades, bottelpack® is the proven,versatile and cost effective packagingsystem for liquid and viscous products.

In over 70 countries, well known companies trust their daily packaging tasks to the bottelpack® system.

Continuous innovation, highest production standards, as well as worldwide customer service, guarantee years of successful ope-ration at the highest degree of quality.

Whether canisters, plastic bottles, tubes, vials, droppers, bellow design or portionpackagings – whether pharmaceuticals,still drinks or household cleaners –whether Polyethylene or Polypropylene – whether 100 pieces/h or 30,000 pieces/h – all requirements can be fulfi lled with bottelpack®. Hourly, daily, by the millions, worldwide.

Blow moulding, fi lling, and sealing in one automated machine. Space required is only a fraction as compared to what other methods entail. The storage of empty containers is eliminated and the work force is reduced.

The international standards for aseptic packaging are met for the pharmaceutical as well as the food industry.

rommelag® does not limit itself to the sale of state-of-the-art packaging systems but also offers its partners package design development, stability trials, as well as test production.

With bottelpack® and bottelpack® aseptic-system in one operating cycleBlowing, Filling, Sealing – and much more!

Extruding.The plastic parison, extruded frompolymer, is accepted by the opened blow mould and cut below the die of theparison head.

Moulding.The main mould closes and simultaneously seals the bottom. The special mandrel unit settles onto the neck area and forms the parison into a container, using compressed air. Small containers are formed by vacuum.

Filling.By way of the special mandrel unit, the product, precisely measured by the dosing unit, is fi lled into the container.

Sealing.After the special mandrel unit retracts, the head mould closes and forms the required seal by vacuum.

Mould opening.With the opening of the blow mould,the container exits from the machineand the cycle repeats itself. Transferfor further processing is achieved by means of conveying systems.

rommelag_Englisch_09.indd 4 03.04.2009 8:51:53 Uhr

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InsertsBefore the fi lled container is sealed,it is possible to automatically insertparts. This could be a dropper or a rubber stopper, a cannula or any other special part.

The pictures illustrate the insertion ofa part by a vacuum gripper. Afterwards the head mould closes and seals the in-serts while simultaneously forming the hermetic seal.

Examples of safety sealsEach container is hermetically sealed,whereby functional seals are formed.

The Twist-off Closure is utilized by themillions as a very economical closurewhich can be used with many products.

The Cutting Ring Closure is one wherea ring inside the cap cuts a large opening into the top of the container.

The KME-Closure is augmented by ascrew cap with a pin. Turning down the cap with the pin results in an openingfor drops or spray.

The Euro-Closure combines the hermeti-cally sealed container with a Euro-cap and is specially designed for the requirements of Infusion bottles (I.V. bottles).

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rommelag_Englisch_09.indd 5 03.04.2009 8:55:10 Uhr

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The extruded plastic, rendered sterile by this process, in conjunction with the immediate container production, provides the basis of the bottelpack® aseptic-system with its blow-fi ll-seal (BFS) technology.

The indispensable cleaning and steriliza-tion processes, essential with prefabrica-ted containers are thereby eliminated. In addition, the risk of particle contamination is considerably reduced when comparing prefabricated with empty bottles. The safe-ty of aseptic production is thus increased considerably.

The complete fi lling path, including the dosing system, is designed for CIP/SIP*. All product lines are cleaned, rinsed with distilled water, sterilized with saturated steam and dried with sterile air, by means of automatic operating programs.

Compared to glass, containers made ofPolyethylene or Polypropylene have substantial advantages. Extreme fl exibi-lity when choosing a design should be mentioned, as well as immense weight advantages, extensive shatter resistance, particle-free production and neutralityto the fi ll product.

The almost unlimited design of fl exible containers with the bottelpack® process, leads to entirely new user-friendlypackages which could never be achievedwith rigid containers.

*Cleaning-in-place Steaming-in-place

Transparent, fl exible containers made of Polyethylene or Polypropylenefor sterile, particle- and pyrogen-free pharmaceuticals

06 | 07

The picture on the left showsan aseptic-system with easilyaccessible air and product fi lters.

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These are ready-to-use, sterile inhalation containers with sterile air ventilation/perfusion system in the bottom, ascen-ding tube, thread for adapter, formed nozzle and twist-off.

I.V. bottles are equipped with the required closures and formed, foldable hangers.

The Euro-cap has been developed asa universal closure for bottelpack®containers and is ideally suited for intro-ducing medications.

Irrigation bottles with unique closure: Upon turning down the speciallydesigned cap, the seal at the fractureline breaks, resulting in a large opening for pouring, with the possibility ofre-closure.

I.V.s in collapsible PE-bags can also be administered without a vent fi lter. The needle remains in a small rest volume which prevents air from entering.

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rommelag_Englisch_09.indd 03.04.2009 8:5 :04 Uhr

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TThe aseptic fi lling with the Blow-Fill-Seal technology in one operational cycle leads to the highest sterility assurance level at remarkably low production costs.

The standard time-/pressure dosing sys-tem can be adjusted by 1/1000 second steps for each individual fi lling needle. The system is without moving parts and consequently, works without wear.

The aseptic bottelpack® system is ideally suited for the packing of pharmaceutical products:

• The modular concept allows the sepa-ration into dark/white side areas.

• The pack manufacturing takes place in an extremely small area.

• An integrated clean room in class A quality (US-class 100) offers the high-est possible safety in sterility.

Unit Dose, Multi Dose and Multiblockeasy to box, easy to mark securely, easy to use

08 | 09

The picture shows abottelpack® installation type 4010Mwith the white side installation area.

• The operator does not need to interfere in the aseptic area during production.

• The equipment is compliant with GMP/PICS/FDA requirements as well as other authorities guidelines.

Beside operating and maintenancemanuals, standard protocols for IQ/OQ/PQ for FAT/SAT procedures can be made available.

rommelag_Englisch_09.indd 8 03.04.2009 8:5 :42 Uhr

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Sterile solutions for injectables arepacked free of pyrogens and particles in bottelpack® systems. The autoclaving of Polypropylene (PP) ampoules can take place at 121°C.

The withdrawal of the product into the syringe with the use of a Luer-connection simplifi es the preparation for injection.The use of only one needle is a major advantage of this design.

Ampoules can be presented as unit doses and multi doses. They are safe for adminis-tration and are used for a broad spectrum of products, such as injectables, inhalation therapy, droppers, irrigation and other.

For the double administration of eye drops, nose drops and ear drops, unit dose ampoules with an integrated metering chamber have been developed. There isno need for preservatives.

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Syringes with a Luer lock are connecteddirectly to the ampoule after the ampoule tab has been twisted off. It is possibleto use the syringe without needle to withdraw the product. Oral products are designed for easy to squeeze use.

Fixed engravings and transparent plastic labels allow a good visual fi ll control. Product information such as lot number, expiry date and product name can be embossed indelibly. Colour coding helps to differentiate injectables.

rommelag_Englisch_09.indd 9 03.04.2009 8:58:32 Uhr

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TThe bottelpack® packaging systems are equipped with the most modern, easy-to-operate, freely programmable controls. The software is prepared indivi-dually for the specifi c characteristics of the product and machine design. When several formats are involved, we include the appropriate programs which make expensive input processes unnecessary. Operator instructions and a trouble shooting program are standard and the display offers various languages.

The cleaning and sterilization proces-ses required with aseptic machines are conducted automatically with the help of suitable CIP/SIP programs.

Relevant data from the machine prepa-ration stage and production are automa-tically recorded and can be printed out. Interfaces for recording operational data are also possible.

Ready-to-use containerswith formed pipettes, droppers or withdrawing systems

10 | 11

The operating panel with colour screen indicates the set of parameters bothalpha-numerically and graphically. There are password levels for individual access. The information is stored in various languages. Process datas are recorded ona hard disc.

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Variations for drop application:A puncture cone forms the drop orifi ce or a calibrated drop chamber can be formed. On request, conventional dropper inserts can also be moulded in. For the use ofre-closure caps, threads are moulded on to the neck of the bottle.

The user opens the warranty seal byturning down the cap with the conepin (KME-closure). For the cleaning and rinsing of contact lenses, sterile unit doses with twist-off tabs are available.

Picture leftBlock of ampoules produced by abottelpack® system and alternatelyfi lled with different cosmetics.

Picture rightIn case of orally administered ampoules, the shape is chosen so that the container can be squeezed easily. The mouthpieceis formed below the twist-off tab.

A great variety of small containersspecially designed for the administra-tion of medicines can be producedby the bottelpack® process.

Liquids and viscous contents can be squeezed out very easily from a bellows design. The formed cannula is designedto meet the needs of the specifi c applica-tion. For rectal or vaginal use, a cannula, an interlocking device for a catheteror threads to accept an applicator are moulded on.

rommelag_Englisch_09.indd 11 03.04.2009 9:00:01 Uhr

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Whether aseptic, acid-/lye or explosion proof –worldwide specific application

12 | 13

Our portfolio includes thousands of con-tainer designs in various shapes, sizes and applications. Square designs can increase the number of containers in a cardboard box by up to 20%. Mould inserts for different volumes reduce cost and change over time.Aseptically fi lled soft-drinks do notcontain any preservatives. The freedomof choice in designs may attract theinterest of specifi c consumer groups.

Worldwide, bottelpack® systems produce large numbers of containers for special applications for daily use. For example (see picture): pheromone hanger-packfor vines; ready for use bottles with integrated dosing chamber for a cleaning concentrate; cooling elements for ice boxes; single dose containers for technical products. Even combustible mixtures with ignition points above 250°C are packaged on explosion-proof bottelpack® lines.

rommelag_Englisch_09.indd 12 03.04.2009 9:01:02 Uhr

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rommelag® is the inventor and world-wide leading supplier of the blow-fi ll-seal machines known by the name of bottel-pack® for the packaging of liquids, creams and ointments.

Our main products are bottelpack® ma-chines, developed and built to customer specifi cation, for single containers and ampoules in various designs and outputs, either as fi xed-cycle machines or rotary type high capacity machines.

The modular-designed machines allow optimum adjustment to extensive product applications in broad capacity ranges.

Our product range includes extensive auxiliary equipment, also for downstream, particularly cap welding machines and leak detectors for containers and ampoules.

Apart from the obligatory operation and maintenance manuals we can also provide our customers with additional qualifi cation documents for the validation.Competent rommelag® personnel will be pleased to assist you .

bottelpack®

packaging system, cap welding unit, leak detector

Packaging Systemwith one blow mouldThe blow mould is set up for a volume ranging from 0.1 ml to 10 litres, depending on the machine. A single mould can have up to 40 cavities.The output is determined by thevolume, the plastic, and the numberof possible mould cavities and ranges from 150 – 12.000 units/h.

Packaging systemwith two blow mouldsThe blow moulds are set up for volumes ranging from 0.1 ml to 2 litres, depending on the machine. A single mould can have up to 40 cavities.The output is determined by thevolume, the plastic and the numberof possible mould cavities and rangesfrom 700 – 24.000 units/h.

Packaging system withcontinuously revolving mould chainsThese high-output systems operate with15 sets of moulds, each mould can have up to 30 cavities. This results in an endless row of formed containers with volumes from 0.1 ml to 50 ml.The output is determined by the volume, the plastic, and the number of possible mould cavities per mould and ranges from 4.000 – 30.000 units/h.

Semi-automatic and fully-automaticCap Welding MachinesDepending on the type of cap welding machine, the transfer of the containers with Eurohead and Eurocaps for the welding process is carried out semi, or fully-automatically.The capacity depends on the plastic and the welding cavities and ranges from 1.100 – 4.000 containers/h.

Leak Detector for integrity testingThe rommelag® HVLD high voltage leak detector operates based on the high voltage test method and the electrical conductivityof the fi ll product packaged in a non-conduc-tive plastic ampoule. The system is designed for fully-automatic in-line leak testing.The capacity depends on the shape and type of the containers as well as the conductivity of the product and ranges up to 5.000 con-tainers or ampoule blocks/h.

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Development, design, manufacturing and customer servicein the hands of highly qualified personnel

14 | 15

Final assembly and preparation for theFAT at the factory of a bottelpack® system 4010M with external punching unit andLeak Detector.

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TThe design of the bottelpack® packing systems is based on a modular concept which is adapted to the customer and country specifi c requirements.A team of experienced design engineers is working on the development and construction with the latest CAD-systems. The construction data is directly transfer-red to CNC-controlled machine tools.The high precision is the basis for the extraordinary quality and product life of all bottelpack® machines.

A special R&D department offers a num-ber of machines and moulds for all kind of customer specifi c trials. Our contract packing sites allow the production of stability samples.

As part of our customer service we offer extensive training sessions during accep-tance runs.Our service personnel trains the operators and instructs maintenance departments at customer‘s site.

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engl

isch

07-14www.rommelag.com

rommelag agP.O. BoxCH-5033 BuchsSwitzerlandPhone: +41 62 834 55 55Fax: +41 62 834 55 00E-Mail: [email protected]

rommelag Kunststoff-MaschinenVertriebsgesellschaft mbHP.O. Box 16 11D-71306 Waiblingen/GermanyPhone: +49 7151 958 11-0Fax: +49 7151 155 26E-Mail: [email protected]

rommelag USA, Inc.27905 Meadow Drive, Suite 9P.O. Box 2530Evergreen CO 80437, USAPhone: +1.303.674.8333Fax: +1.303.670.2666E-Mail: [email protected]

rommelag Trading (Shanghai) Co., Ltd. Room 1501 Xinyin BuildingNo. 888 Yishan Road200233 Shanghai, P.R. ChinaPhone: +86 21 6432 0166Fax: +86 21 6432 0266E-Mail: [email protected]

rommelag_Englisch_09.indd 1 03.04.2009 9:19:3 Uhr