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PENTAFILLPENTAFILL™™

““MONOBLOCK” MONOBLOCK”

A - SERIESA - SERIES

Automatic Filling & Sealing Machine for Lameplast®

monodose strip containers

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INTRODUCTIONINTRODUCTION

PENTAFILL™ A - SERIES automatic machine is designed to fill and seal a great variety of monodose strip containers with accurate dosing thanks to its special adjustable syringe pump station.

PENTAFILL™ consists of a central star wheel which carries the strip containers through several stages up to release on a conveyor a finished, sealed and filled monodose strip

This is a zoom on the central stage star wheel

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SIMPLE DESCRIPTIONSIMPLE DESCRIPTION

The PentaFill™ “Monoblock” automatic machine is designed for quick changeover and simplified operation and maintenance. It is composed of the following:

- Safety enclosure made up of glass doors framed with tubular anodised aluminium withsafety interlocks to prevent injury.- Strong and solid machine frame, with adjustable feet, made of welded tubular stainless steel (AISI 304), enclosed in removable stainless steel panels for easy access to drive units and other mechanisms- Variable speed main drive unit.- Central-station star wheel with composite pucks holding the strips.- Tray for loading of the strips with counterweight.- Pick & place system for automatic loading of strips into the star wheel.- Photocells with fibre optics to verify the presence of strips in the puck. No strip = no dose of the product.- Filling unit (volumetric type) composed by five volumetric syringe pumps. The dose iseasily adjustable by adjusting the stroke. Ball check valves control flow.- Product may be drawn directly from a bulk container or thru a batch tank type of set-up with automatic level control (not included) to one syringe pump and from the syringe pump the filling nozzle. By drawing from any combination of five bulk containers, up to five different products can be filled into each strip.

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- Set of 5 nozzles that go into the containers during the filling operations.- 2 pre-heat stages (outer and inner).- 3 Closing stages: 2 hot jaws and 1 cold/forming jaw.- Refrigerated air for final; cooling of strip prior to trimming.- Trimming stage removes excess plastic (depending on the design of the monodose strip)- Pick & place system for unloading on to the output conveyor.- Reject system for strips that remain under heating stages too long. Lock and key forpharmaceutical applications.- Central control panel with tube support, complete with all necessary switches, warninglights, start, stop and emergency push buttons.- Remote electrical enclosure for Cleanroom or sterile installations.- Corded remote jog button to assist in machine set-up.

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VERSIONS & TECHNICAL DATAVERSIONS & TECHNICAL DATA

PENTAFILL™ A 10 PENTAFILL™ A05

TECHNICAL DATA TECHNICAL DATA

Dosing capacity From 0,33 to 10 ml Dosing capacity From 0,33 to 5 ml

Production speed Up to 25 shots/min Production speed Up to 25 shots/min

Electrical supply 220/380 V 3PH 50/60 HZ

Electrical supply 220/380 V 3PH 50/60 HZ

Electrical power 12 KW Electrical power 10 KW

Compressed air 6 bar Compressed air 6 bar

Machine weight (estimated)

1200 kg Machine weight (estimated)

1000 kg

Cooling liquid 14°C consumption

600 l/h Cooling liquid 14°C consumption

600 l/h

Dimensions 2645X2100/3615* H 2150 mm*with unloading conveyor

Dimensions 2485X1915/3535* H 1915 mm*with unloading conveyor

Note: Specifications subject to change without notice

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General layout of the machine

PentaFill™ A 05

Front view of the machine with unloading conveyor

Conveyor

Central stage star wheel

Syringe Pump Station

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MANUFACTURING FLOW PROCESSMANUFACTURING FLOW PROCESS

Station # 1: Loading station: with a pick & place device the monodose strips are taken from their tray and put onto the first puck of the wheel station.

Station # 2: Control station. This step verifies that the strip has been inserted into the puck, and that the whole five vials are present. If this is not the case, the next filling station will not be activated.

Station # 3: Filling station. This is composed of five needles, connected to the five syringes of the pump station, that deliver the product directly inside each one of the vials of the strip.

Station # 4: Alternative / second filling station (Optional - same as above); this is used only in case of very viscous products that require a filling procedure in two steps.

Station # 5: Lateral hot air blow (optional): this is a pre-heating station, necessary only for hard and fragile containers such a polypropylene ones.

Station # 6: Inside hot air blow: hot air is blown against the upper inside part of the strip to warm it up so that it is softened and this makes it easier the next step.

Station # 7: Hot clamping (in two steps); first step: a hot clamp crimps the monodose strip

Station # 8: Hot clamping (two): same as above: it is necessary to repeat this same step in two phases to assure good sealing of the container

Station # 9: Cool clamping: a cool clamps crashes the sealed monodose container, so as to better define its lateral shape

Station # 10: Cool air blow station (optional): this station assures that the sealed area is perfectly cooled down: necessary for special heat sensible products

Station # 11: trimming station; a cutting device eliminates the upper side of the sealed area.

Station # 12: pick and place to unload the finished items on the conveyor when they are conform; on the closed box when they are scraps

9Marked in yellow: optional stations

Station with the steel pump syringes for the

filling stepMarked in red: sealing steps

Trimming station necessary to perfectionate the upper side of the strips after the sealing steps

conveyor

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1. Detail of the Syringe Pump Station performing the filling of the monodose containers

2. Details of the 5 steel needles connected with the Pump Syringe

Station

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CONDITIONSCONDITIONS

Delivery: 6 months from the official order confirmation (+ 2 weeks for Christmas Holidays and 4 weeks for August Summer Holidays)

Forwarding: Ex works Lameplast S.p.A.’s facility in Modena state, Italy

Site Acceptance Test: Included: performed in Italy at Lameplast’s facility. The SAT will be carried out for a period of one working day and, at the end of the day, a SAT protocol will be settled. Customer’s contingent modifications request doesn’t interrupt the SAT approval. The date for the SAT will be communicated to the customer with sufficient advance so that the personnel in charge for the machine acceptance can take part in the procedure. The SAT will be considered as positive when during the SAT, the customer does not raise any objection.

Training: Included, if performed in Italy (at Lameplast S.p.A.’s facility) during the SAT (maximum 2 days). When requested after the installation, it is to be invoiced at our prices in force (see page “Technical Assistance”).

Payment: to be agreed upon with the customer; it will be stated in the official offer.

Validity: 60 days

Documentation: 1 Operator manual for instructions and maintenance, in English.

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Guarantee: Lameplast S.p.A. guarantees the machine parts, ex works Italy (Modena state), for a period of 12 months from date of delivery, as stated on fiscal delivery documents, or from the date of invoice. The guarantee is based on a machine working time of a 8-hour shift per day (except for electrical components, which are not part of this guarantee).

This guarantee is not valid when the machine is repaired without the approval of Lameplast S.p.A.; when non-authorized components are employed; when the machine number label is removed during the warranty period.

If the customer requests for guarantee replacement or repair which proves to be unjustified, Lameplast S.p.A. will charge the customer with all the expenses for such intervention and/or necessary spare parts.

The guarantee does not include accidental damages for transport, negligence, bad handling or improper use, non-observance of the specific instructions supplied with the machine, or any other cause independent from the normal use of the machine.

The intervention of a technician from Lameplast S.p.A. to replace or repair a mechanical part (falling into this guarantee) does not include the expenses of replacement or repair, but just includes the cost of the part itself.  The expenses of travel, board, lodging and delivery of the goods will then be charged the customer.

The guarantee is not valid whenever the customer does not fulfil all the agreement clauses as stated in the Supply Agreement.

Lameplast S.p.A. is not responsible for damages to people or things caused by lack of maintenance and  improper use of the machine

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Setting up (at the customer’s facility): not included; when requested by the customer, the setting up is to be invoiced at our prices in force (see page “Technical Assistance”).

Should the Setting up be effected at the customer’s plant, within the agreed period, the following services must be assured:  - Electric power and compressed air necessary to the equipment fitting and running  - The clearing of the installation areas  - Motor/vehicles for unloading procedure  - Lifting systems (at least a forklift capacity 5.000 Kg), with the help of at least one person able to drive it plus one hodman  - Lighting and electric plugs as per standard  CEI 64.8/7  - Cooperation to establish the correct equipment placement.  - Pneumatic connection  - Electrical connection from the general electric system to the machine board.

Testing materials: One set of 1.000 monodose strips will be delivered free of charge for customer’s testing. Each exceeding set quantity of 1.000 monodose strips will be charged at a forfeit price of 250,00 euros.

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Mark: The offered machine is built according to European and National rules, and will be supplied with the «CE» mark

Conformity: Lameplast S.p.A. supplies the conformity statement EN60204-1, concerning the contract specific work. It means that:

a) The environment must be in accordance and prearranged to that application field, in order to perform with the adequate security.

b) The connection point to the electrical panel must be in accordance with the CEI 64.8 rules (concerning the electrical feeding and earthing) and fitted with differential switch

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PRICE LISTPRICE LIST

PENTAFILLPENTAFILL™™ A 05 A 05Automatic filling and sealing machineFor format ranging from 0,33 ml to 5,00 mlProduction speed: up to 25 shots per minuteBase price: € 293.000,00

PENTAFILLPENTAFILL™™ A 10 A 10Automatic filling and sealing machineFor format ranging from 5,00 ml to 10,00 mlProduction speed: up to 25 shots per minuteBase price: € 322.000,00

The machine is supplied with one format only ٭

MAIN FILLING OPTIONS:

● Additional set of 5 standard syringes € 8.500,00● Set of 5 syringes with pneumatic valves for viscous products € 16.150,00● “Time Pressure” system to obtain a high precision dosing of un-sterile liquid solutions € 54.000,00● Set of 5 peristaltic pumps for sterile products € 74.500,00

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OTHER PENTAFILL™ A SERIES OPTIONS:

Item Amount € Note

Complete strip format 13.400,00 For one different size/design of monodose strip

Set of 12 steel pucks 13.200,00 For higher level of cleanness - autoclavable

Setting for nitrogen flow 6.290,00 With a set of special needles placed before the filling step – nitrogen flow necessary when filling products that can polymerize or oxidize

Optional cooling station 6.460,00 Cool hair blow before unloading for heat sensible products

Validation documents, testing protocols, I.Q; O.Q.; P.Q.

13.600,00 For pharmaceutical application (in English only)

Wooden case for air transport Approx

2.000,00

Dimensions approx: 258 x 198 x 245 cm

Wooden case for sea transport Approx 2.200,00

Dimensions approx: 258 x 198 x 245 cm

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TECHNICAL ASSISTANCETECHNICAL ASSISTANCE

Technical Assistance within Europe:

1 specialised technician for one day

(inclusive of meals; excluded trip and hotel stay) = € 1.020,00

Technical Assistance outside Europe:

1 specialised technician for one day

(inclusive of meals excluded trip and hotel stay) = € 1.370,00

Last Revision April 2007