multinational companies. - interpack · PDF filetube vials-din/iso 8362-1 thousands / hour size d h w stc25 st00 st0 st1 st2 st3 st4 st5 st6 st7 st8

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The portfolio of robotic and standard products includes:• Rotary Washing Machines• Depyrogenating Tunnels• Filling & Capping Machines• External Surface Decontaminating Machines• LAF, cRABS, oRABS, Isolators

Thanks to its strong focus on R&D, Innovation, Quality, Customer Care and Consulting services, Steriline has been able to expand worldwide with Export representing today more than 90% of the total turnover.

Steriline is one of the most successful and trusted global designer, manufacturer and supplier of Aseptic processing equipment for the pharmaceutical industry to serve from small to big size multinational companies. Established in 1989 in the Lake Como area, where Steriline still has the Headquarter and the production, the company currently offers a wide range of high quality, reliable, flexible and modular solutions for the primary packaging (from single machines to complete lines).Each single solution is developed to meet and satisfy the customer tailored needs providing economic and profitable answers, improving efficiency and increasing safety.

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MACHINES OVERVIEW

COMPACT LINES 6

ROTARY WASHING MACHINES 8

DEPYROGENATING TUNNELS 12

FILLING MACHINES 16

CAPPING MACHINES 18

ROBOTIC EXECUTION 20

DECONTAMINATING MACHINES 26

cRABS 28

ISOLATORS 30

SERVICES

CUSTOMER SUPPORT 38

LABORATORY WORK 40

54

7

STERILINE has developed a new design for small footprint sterile processing lines which integrates: RA compact washer, STC compact tunnel and VFM liquid containers filling machine. The filling machine VFM integrates a small feeding table, allowing for the best linear design. STERILINE COMPACT LINES currently represent the ideal solution for R&D, Clinical Trials, Bio-Tech and pilot scale production. Easy changeover of format parts, ease of use, reduced power and increased utilities efficiency all come together to make STERILINE COMPACT LINES cost effective during daily operations. Compactness also makes the difference in many applications, especially if cRABS or ISOLATORS are needed. STERILINE COMPACT LINES embrace a range of capacities up to 120 pcs/min and include an integrated control system with PLC and synoptic HMI display. All STERILINE COMPACT LINES are in compliance with cGMP, GAMP and 21CFR Part11 requirements.

Washing, Depyrogenating, Filling, Stoppering & Capping Lines

6

COMPACT LINES

1710

mm

1131 mm

976

mm

1500 mm

500

mm

1476

mm

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ROTARY WASHING MACHINES

The STERILINE rotary washing machines RA series are designed to process containers with a capacity up to 9.000 pcs/h using intermittent motion. All parts in contact with the interior of the containers and process fluids are made of AISI 316L stainless steel. Other parts, such as the frame, shafts, and bearings are made of AISI 304 stainless steel. The washing cycle can include ultrasonic bath, recycled water, new water, compressed air, siliconization, hot air drying and other options as required.Pressure and temperature of the various fluids are monitored to assure constant performances. Vials are processed in unidirectional way, avoiding any potential contamination.The integrated control system, which includes PLC and HMI, automatically controls all the functional parameters of the machine, according to various glassware sizes and types. Parameter data are stored in different recipes, which are password protected and accessible only by supervisor and authorized personnel. These RA washing machines with our Compact Sterilizing Tunnel are the ideal solution for Clinical Manufacturing, Laboratory and for R&D application, thanks to their advanced compact design.All STERILINE washing machines are in compliance with cGMP, GAMP and 21CFR Part11 requirements.

Rotary Washing Machines RA series for vials & cartridges

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RA-V4 VIALS

2-4R 6-8R 10-15R 20-30R 50H 100H

pcs/min 100 100 100 70 30 15

RC-V

4 (1

900

mm

)17

00

RC-V4 (2380 mm)RC-V8 (2600 mm)

RC-V

8 (2

500

mm

)

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The STERILINE rotary washing machines RC series are designed to process containers with a capacity up to 24.000 pcs/h. The machine works with continuous motion. All parts in contact with the interior of the containers and process fluids are made of AISI 316L stainless steel. Other parts, such as the frame, shafts, and bearings are made of AISI 304 stainless steel. The washing cycle can include ultrasonic bath, recycled water, new water, compressed air, siliconization, hot air drying and other options as required.Pressure and temperature of the various fluids are monitored to assure constant performances. Containers are processed in unidirectional way, avoiding any potential contamination.The integrated control system, including PLC and HMI automatically controls all the functional parameters of the machine, according to various glassware sizes and types. Parameters are stored in different recipes, protected by password and accessible only by supervisor and authorized personnel. Alarms are automatically displayed on the screen.All STERILINE washing machines are in compliance with cGMP, GAMP and 21CFR Part11 requirements.

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RC-V VIALS

2-4R 6-8R 10-15R 20-30R 50H 100H

RC-V4 (pcs/min) 250 200 200 150 100 80

RC-V8 (pcs/min) 400 300 300 250 200 150

ROTARY WASHING MACHINES

Rotary Washing Machines RC series for vials & cartridges

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DEPYROGENATING TUNNELS

STERILINE offers a wide range of depyrogenating tunnels appropriate for any production requirement. The models feature a variety of production capabilities for processing ampoules, carpoules, vials and syringes. The ST series cover the entire range of needs from our very compact tunnels to our biggest models for very high speed production. Our ST series depyrogenating tunnels have been designed to sterilize and to depyrogenize glass containers with a continuous process, maintaining an ISO5 environment throughout the length of the three chambers: inlet chamber, hot chamber, cooling chamber. The thermal cycle is designed to assure a pyrogens reduction of 3 or 6 log, minimum.Sterilization of the cooling chamber, closed tunnel and automatic air balance are only a few of the various tunnels features.All STERILINE tunnels are in compliance with cGMP, GAMP and 21CFR Part11 requirements.

Depyrogenating Tunnels with Sterilizable Cooling Chamber

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ST1 TUNNELHEAT PENETRATION IN VIALS

ST SERIES STC25 ST00 ST0 ST1 ST2 ST3 ST4 ST5 ST6 ST7 ST8 ST9 ST12 ST12.1 ST12.2 ST14 ST15 ST18 ST19 ST20

LENGTH mm 1382 1368 1670 1980 2280 2280 2800 3075 2930 3260 3560 3870 3160 3460 3918 4220 4560 4680 6325 7720

WIDTH mm 1485 1260 1260 1470 1470 1700 1700 1700 1905 1905 1905 1905 2440 2440 2440 2440 2440 2795 2795 2795

CONVEYOR BELT WIDTH mm 250 300 300 450 450 600 600 600 800 800 800 800 1250 1250 1250 1250 1250 1600 1600 1600

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TUNNELS OUTPUT(for a Pyrogens reduction by 3 Log)

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TUBE VIALS-DIN/ISO 8362-1 THOUSANDS / HOURSize D H W

STC25 ST00 ST0 ST1 ST2 ST3 ST4 ST5 ST6 ST7 ST8 ST9 ST12 ST12.1 ST12.2 ST14 ST15 ST18 ST19 ST20[mm] [mm] [g]

2R 16 35 5 4 5 6,61 12,55 15,13 20,19 24,59 28,05 32,76 37,40 - - - - - - - - - -

4R 16 45 6,1 4 5 6,61 12,55 15,13 20,19 24,59 28,05 32,76 37,40 - - - - - - - - - -

6R 22 40 8,3 2,2 2,50 3,46 6,55 7,91 10,55 12,85 14,66 17,13 19,55 21,97 24,40 26,78 30,52 34,26 38,08 - - - -

8R 22 45 9,4 2,3 2,50 3,46 6,55 7,91 10,55 12,85 14,66 17,13 19,55 21,97 24,40 26,78 30,52 34,26 38,08 - - - -

10R 24 45 10,2 1,8 1,80 2,86 5,41 6,53 8,71 10,62 12,11 14,14 16,15 18,16 20,15 22,10 25,16 28,31 31,45 34,60 - - -

15R 24 60 12,8 1,9 1,80 2,86 5,41 6,53 8,71 10,62 12,11 14,14 16,15 18,16 20,15 22,10 25,16 28,31 31,45 34,60 - - -

20R 30 55 17,4 1,1 1,20 1,80 3,42 4,12 5,51 6,71 7,65 8,93 10,20 11,47 12,73 13,94 15,90 17,85 19,89 21,85 27,97 - -

25R 30 65 20,2 1,1 1,20 1,80 3,42 4,12 5,51 6,71 7,65 8,93 10,20 11,47 12,73 13,94 15,90 17,85 19,89 21,85 27,97 - -

30R 30 75 22,7 1,1 1,20 1,80 3,42 4,12 5,51 6,71 7,65 8,93 10,20 11,47 12,73 13,94 15,90 17,85 19,89 21,85 27,97 - -

LIGHT INFUSION BOTTLES-ISO 8536-1 THOUSANDS / HOURV D H W

STC25 ST00 ST0 ST1 ST2 ST3 ST4 ST5 ST6 ST7 ST8 ST9 ST12 ST12.1 ST12.2 ST14 ST15 ST18 ST19 ST20[ml] [mm] [mm] [g]50 46 68 55 0,3 0,3 0,38 0,73 0,87 1,17 1,42 1,62 1,90 2,16 2,40 2,64 2,96 3,36 3,76 4,16 4,56 5,92 8,24 10,40

100 49 104 95 0,18 0,18 0,33 0,62 0,74 0,99 1,21 1,38 1,60 1,84 2,00 2,24 2,48 2,80 3,20 3,52 3,92 5,04 7,04 8,88

250 68 125 170 - - 0,16 0,31 0,38 0,50 0,61 0,69 0,80 0,92 1,03 1,12 1,36 1,44 1,60 1,76 1,92 2,48 3,52 4,40500 78 177 290 - - 0,12 0,22 0,26 0,35 0,43 0,50 0,58 0,66 0,74 0,80 0,88 0,96 1,12 1,28 1,36 1,76 2,48 3,12

1000 95 230 510 - - 0,06 0,12 0,14 0,19 0,24 0,27 0,32 0,37 0,40 0,45 0,50 0,56 0,64 0,70 0,78 0,96 1,36 1,76

INFUSION BOTTLES-DIN 58363-1 THOUSANDS / HOURV D H W

STC25 ST00 ST0 ST1 ST2 ST3 ST4 ST5 ST6 ST7 ST8 ST9 ST12 ST12.1 ST12.2 ST14 ST15 ST18 ST19 ST20[ml] [mm] [mm] [g]100 49 108 120 - - - - - 0,88 1,02 1,16 1,28 1,44 1,76 1,92 2,24 2,64 2,88 3,52 3,84 4,96 6,72 8,16250 66 140 230 - - - - - 0,45 0,52 0,60 0,68 0,76 0,88 0,96 1,12 1,28 1,44 1,68 1,92 2,40 3,20 4,00

500 78 188 375 - - - - - 0,32 0,37 0,42 0,48 0,53 0,64 0,68 0,80 0,96 1,12 1,28 1,40 1,76 2,40 3,041000 95 238 600 - - - - - - - - - - - - 0,48 0,56 0,64 0,72 0,96 1,36 1,44 1,92

MOLDED VIALS-DIN/ISO 8362-4 THOUSANDS / HOURSize D H W

STC25 ST00 ST0 ST1 ST2 ST3 ST4 ST5 ST6 ST7 ST8 ST9 ST12 ST12.1 ST12.2 ST14 ST15 ST18 ST19 ST20[mm] [mm] [g]

5H 20,8 41,3 14 2,2 2,15 3,33 6,30 7,61 10,14 12,36 14,10 16,47 18,80 21,13 23,46 25,68 29,36 32,96 - - - - -

7H 22,1 40,8 13 2 2 2,90 5,50 6,63 8,85 10,78 12,30 14,37 16,40 18,43 20,46 22,40 25,60 28,80 32,00 35,12 - - -

8H 23 46,8 16 1,8 1,9 2,76 5,23 6,31 8,42 10,26 11,70 13,66 15,60 17,54 19,47 21,36 24,32 27,36 30,40 33,44 - - -

10H 25,4 53,5 21 1,3 1,3 1,77 3,35 4,05 5,40 6,58 7,50 8,76 10,00 11,24 12,48 13,68 15,60 17,52 19,44 21,44 27,44 - -15H 26,5 58,8 24 1 1,15 1,57 2,98 3,59 4,79 5,84 6,66 7,78 8,88 9,98 11,08 12,16 13,84 15,52 17,28 19,04 24,32 34,00 -20H 32 58 29 0,7 0,7 1,03 1,96 2,36 3,15 3,84 4,38 5,11 5,84 6,57 7,29 8,00 9,12 10,24 11,36 12,48 16,00 22,32 28,1625H 36 58 30 0,5 0,5 0,82 1,56 1,88 2,50 3,05 3,48 4,06 4,64 5,22 5,79 6,32 7,20 8,08 9,04 9,92 12,72 17,76 22,3230H 36 62,8 35 0,45 0,45 0,78 1,47 1,78 2,38 2,90 3,30 3,86 4,40 4,94 5,49 6,00 6,80 7,68 8,56 9,36 12,00 16,80 21,2050H 42,5 73 50 0,35 0,35 0,54 1,02 1,23 1,64 2,00 2,28 2,66 3,04 3,42 3,79 4,16 4,72 5,28 5,92 6,48 8,32 11,60 14,64

100H 51,6 94,5 89 0,17 0,17 0,30 0,56 0,68 0,90 1,10 1,26 1,47 1,68 1,89 2,10 2,24 2,56 2,88 3,28 3,60 4,56 6,40 8,08

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The modern design of STERILINE filling machines takes into consideration the newest requirements of the filling process:• In line transport and small width, suitable for the application of RABS and isolators, reduce the volume to be monitored

and sterilized; • Continuous monitoring of the viable and non viable particles;• Filling by peristaltic and/or volumetric pumps actuated by servomotors, that allow precise filling and easy adjustment of

the pumps by means of the HMI;• Nitrogen purging inside the containers before, during and after the filling;• 100% IPC (In Process Control) of the weight and statistical Check Weighing system with feedback to the dosing pumps;• Possibility of performing prefilled syringes, loaded from the nests;• Vibration generator for the bowl of stoppers inside the mechanical volume, below the process area;• Capping station designed to reduce particle generation, by rotating the vials under the blades.

According to the GMP conform modular design of STERILINE filling machines, filling and closing stations can be arranged in one single machine platform. This advanced design enables STERILINE to customize the process by combining in one common base machine:

• VIALS and SYRINGES • VIALS and CARTRIDGES • VIALS, SYRINGES and CARTRIDGES All STERILINE filling machines are in compliance with cGMP, GAMP and 21CFR Part11 requirements.

Filling Machines with Intermittent & Continuous Motion

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FILLING MACHINES

1918

CAPPING MACHINES

The modern design of STERILINE capping machines takes into consideration the newest requirement of the sealing process:

• In line transport and small width, suitable for the application of RABS and isolators, reduce the volume to be monitored and sterilized;

• Capping station designed to reduce particle generation, by rotating the vials under the blades;• Continuous monitoring of the viable and non-viable particles;• Vibration Generator for the bowl of aluminum caps inside the mechanical area, below the process area;• Possibility to seal flip-off or tear-off caps;• Possibility to install different closing station (i.e. Screw caps; press-on

caps);• Possibility to monitor the applied pressure during sealing process;• In line control, for cap presence detection. No vial – No caps & No rubber

stopper – No caps available in the basic design;• Available with standard protection hood, LAF, CRABS or ISOLATOR• Ease of access and ease of format change allow efficient operation with

reduced downtime.

All Steriline capping machines are in compliance with cGMP, GAMP and 21CFR Part11 requirements.

Capping Machine for Vials

2120

ROBOTIC EXECUTION

Robotic Vial Filling Machine

This new complete aseptic Vials Robotic Filling Line for injectable products is fully under in-house engineered and manufactured Isolators integrated with the latest VHP technology.The line was designed and manufactured jointly with the German pharmaceutical company AqVida.

Here below the key features of this innovative line and in particular of the robotic filling, stoppering and capping machine:

• For the vial transport, filling, stoppering and capping units, STERILINE uses 3 VHP resistant robotic arms from STÄUBLI Robotics based in Switzerland;

• The Machine is equipped with peristaltic pumps actuated by servomotors, that allow precise filling and easy adjustment of the pumps by means of the HMI;

• The vials range that can be treated goes from 2ml to 100ml, without changing any format parts, with an estimated output of approx. 3.000 vials/h satisfying at the best the customer requirements in terms of flexibility on the one hand and efficiency on the other;

• This new STERILINE cost effective solution also follows a “no loss / zero waste philosophy” resulting in all missing stoppers / caps being collected and re-applied during the process;

• The 100% in-line Check Weighing System is integrated in the filling station.

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ROBOTIC EXECUTION

Robotic Filling Line for Nest

22

AW2B

This new complete aseptic Robotic Filling Line for injectable products can be fully under in-house engineered and manufactured Isolators integrated with the latest VHP technology or under oRABS and cRABS.The line consists of 3 sections:

• Bag removal section • Lid / Liner removal section • Filling section

Here below the key features of this innovative line and in particular of the robotic filling machine:3 existing models: RNFM 100 with 2 filling pumps, RNFM 200 with 5 filling pumps and RNFM 400 with 10 filling pumps For the De-lid / De-liner, glassware transport, filling and stoppering units , STERILINE uses 2 VHP resistant six axis robotic arms from STÄUBLI Robotics based in Switzerland

Other available technical features are: • Statistical check weighing system• Vacuum filling functionality• Vacuum stoppering functionality• Nitrogen gassing station• Viable and non-viable particle monitoring• Exchangeable pump systems (volumetric/peristaltic

2524

STERILINE has jointly developed a state-of-the-art robotic tray loading system, RTL, in collaboration with one of the world’s largest pharmaceutical companies, GSK. The RTL Tray Loader is composed of:

• Vial Loading Unit • Tray Loading Unit • Tray Moving Unit • Tray Discharge Unit

The RTL system is capable of an effective output speed of up 720 vials / minute. These can be fed into the RTL by means of a rotating table or transport conveyor, then the system guides the vials into the trays which can be acrylic, stainless or other material configurations based on the customer’s needs.

The robotic movements for the tray moving and positioning step are realized with a 4-axis DENSO Robotics solution, which is completely integrated into the mechanical and electrical design of the RTL system.This completely new development within STERILINE was realized in only 18 weeks from order placement to Factory Acceptance Test.

Robotic Tray Loader

ROBOTIC EXECUTION

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DECONTAMINATING MACHINES

STERILINE decontaminating machines are designed to clean the external surface of vials and ampoules with a capacity up to 48.000 pcs/h.Purified water, W.F.I., detergent and detergent mixtures are media options used for surface decontamination.Compressed air dries the decontaminated ampoules and vials. The washing fluids spraying nozzles are specifically designed and contoured to avoid process fluid introduction at the seal level. The compressed air blowing nozzles remove the residual washing fluids from the outer glass surfaces. Changeover parts consist only of star wheels, infeed and outfeed guides. Nozzles are adjustable.

STERILINE decontaminating machines’ main features are:• High washing efficiency;• Highly effective drying;• Protection of the seals;• Flexible transport system;• Short and reliable changeover time;• Longer processing time.

All STERILINE decontaminating machines are in compliance with cGMP, GAMP and 21CFR Part11 requirements.

External Decontaminating Machines

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MODELDIMENSIONSLxWxH (mm)

OUTPUT (pcs/min) WASHING FLUIDS CONSUMPTION

(l/h)

COMPRESSED AIR CONSUMPTION

(Nm3/h)2-4R 6-15R 20-30H 50-100H

EDM-C 990x750x2100 100 60 30 10-20 150 30

EDM1 1350x1390x2100 400 200 150 80 400 60

EDM2 1350x2000x2100 800 300-400 250 160 600 80

EDM3 1560x2190x2100 800 300-400 250 160 800 80

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STERILINE closed Restricted Access Barrier Systems (cRABS) are designed for the production of sterile products, either potent or non-potent. These systems provide protection both for operator from product and for product from operator and they prevent contamination by keeping the production process enclosed in a confined area. The cRABS enclose a space where HEPA filtered, unidirectional air vertically flows over the process area. Pressure difference between the interior and the exterior is maintained by the exhaust fan. The exhaust air is HEPA filtered by “Bag-in Bag-out” (BIBO) filters.cRABS shall be installed in Class B rooms.

STERILINE cRABS’ main features are:• AISI304L stainless steel for metal contact surfaces with finishes of at least Ra=0,5µm;• AISI304L stainless steel for panels, guards, etc. not in contact with the product and sanitizing solution;• AISI316L stainless steel for cleaning solution piping with tri-clamp fittings;• Doors made of thick security glass and sealed with inflatable gaskets. Gaskets are made of either silicone, Viton or

EPDM;• Gloves are incorporated into the design for aseptic applications. The quantity and position of gloves are determined

during the mock-up test;• CIP of the internal surfaces is achieved by means of spray gun fed by WFI or WFI mixed with inactivation agent;• Continuous monitoring of viable and non viable particles.

The integrated control system of cRABS and isolators is composed of PLC and touch screen operation panel for operator interface (HMI). The electrical cabinet can be located in the technical area, while the HMI is located close to the process unit. 21CFR Part11 compliance is achieved by means of a separate PC.

Closed Restricted Access Barrier Systems

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cRABS

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STERILINE isolators can be installed in Class C or D rooms. They are specially designed for fully integrated aseptic production line, in compliance with cGMP regulations.The Isolators are designed for production of sterile products, either potent or non-potent, maintaining uncompromised, continuous isolation of its interior from the external environment. ISO5 environment is achieved by HEPA filtered, unidirectional air that vertically flows over the process area. Pressure difference between the interior and the exterior is maintained by the exhaust fan. The exhaust air is HEPA filtered by BIBO filters.STERILINE isolators’ main features are:• AISI316L stainless steel for metal contact surfaces with

finishes of at least Ra=0,5µm;• AISI304L stainless steel for panels, guards, etc. not in contact

with the product and sanitizing solution;• AISI316L stainless steel for cleaning solution piping with tri-

clamp fittings;• Doors made of thick security glass and sealed with inflatable

gaskets. Gaskets are made of either silicone, Viton or EPDM;• VHP sanitization by condensation or by VHP in vapour status;

Filling Line Isolators

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ISOLATORS

VHP Sanitization Theory1500

1000

500

0

Preparation Conditioning Sanitization Aeration

VH

P [p

pm

]

3332

• Gloves are incorporated into the design for aseptic applications. The quantity and position of gloves are determined during the mock-up test;

• Rapid Transfer Ports (RTP) are available in 105mm, 190mm, 270mm, 350mm diameters;• CIP of the internal surfaces is achieved by means of spray gun fed by WFI or WFI mixed with inactivation agent;• Continuous monitoring of viable and non viable particles.The integrated control system of isolators is composed of PLC and touch screen operation panel for operator interface (HMI). The electrical cabinet can be located in the technical area, while the HMI is located close to the process unit. 21CFR Part11 compliance is achieved by means of a separate PC.

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ISOLATORS

Due to the increasing market demand, STERILINE has developed a new range of STAND ALONE ISOLATORS for the following applications: • Quality Control • Sterility Testing • Dispensing • Weighing • Compounding • R&D

The Isolators are designed to work with sterile products either toxic or not-toxic, granting the highest safety level for product and operator.AISI316L stainless steel walls with high level surface finishing grant ease of cleaning and sanitization.ISO 5 environment is maintained inside the isolator with unidirectional or turbulent air flow according to process needs.The isolator is equipped with fans and HEPA filters to supply sterile air. In the return duct the exhaust air is filtered again by “Bag-In-Bag-Out” HEPA filters, easy to access for maintenance.The best components available on the market and the collaboration with the primary brands allow a complete integration for:

• Process automation • Air pressure control • VHP Sanitization

RTP ports enable In-Out product and waste transfer without safety or sterility failure. The cycle automation is achieved through the synoptic HMI for production phase, decontamination phase, aeration, integrity test and maintenance.Mock-up studies and tests allow perfect accessibility of the operator to all isolator functions.

The integrated control system is composed of PLC and touch screen operation panel for operator interface (HMI). All STERILINE isolators are in compliance with cGMP, GAMP and 21CFR Part11 requirements.

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Stand-Alone Isolators

36 37

3938

High standards in Customer Support technical assistance have always been relevant in STERILINE. Our Department is staffed by skilled people who, in response to any customers’ call, can provide an efficient and clear response to all types of query throughout the entire life-cycle of a machine.

Tailored service solutions, according to customer needs,are also available to satisfy the most demanding requirements and requests:

1 After-sales services Include all activities to prepare STERILINE prompt and immediate re-action to the customer inquiries.

2 Technical stages To collect from STERILINE team of experts, during the periodically training sessions organized in Como HQ, information

and ways of working to follow up locally, directly and independently in case of any problem.

3 Technical audit STERILINE customers care office is ready to welcome all customers technical inquiries in support with mechanical,

software and electrical senior engineers.

4 Remote service Thanks to new technologies STERILINE software team can immediately get in contact with customers machines on sites.

5 Spare parts • The fastest components supply service • The best quality materials in the market • A high professional products selection and check

6 Refurbishing The possibility to revamp your old STERILINE machine / line to the latest technology.

7 Preventive and strategic maintenance Accurate planning of periodical check visits performed by STERILINE specialists. 8 Pharma services (validation, qualification on site) IQ, OQ protocols preparation and execution according to the GMP rules.

9 Personnel training STERILINE engineers to support customers team learning process.

1 After-sales services2 Technical stages3 Technical audit4 Remote service5 Spare parts6 Refurbishing7 Preventive and strategic maintenance 8 Pharma services (validation, qualification on site)9 Personnel training

CUSTOMER SUPPORT

4140

Local agent contact data are available on the STERILINE web site:www.steriline.it

In addition to all our Customer Support services, microbiological and analytical works can be either included in the single projects or managed as independent activities to satisfy our customers requirements.

Machine on-board components calibration and settingWith this activity, before the machine installation, each single component is calibrated and set providing a turn-key solution to the customers perfect their machine:• Temperature probes• Pressure transmitters• PDI: pressure differential indicators• Thermo-couples

Machine hardware components calibration and setting• Inverters• PLC• Servomotors

Machine protocols validation and execution support (OQ, during pre-FAT and FAT)• Process tests (vial cleaning capacity, filling capacity, thermal cycle, air speed uniformity,

VHP sanitization, particles counter, etc.)• Performances tests (machine output, production speed, etc.)• Components control

[email protected] [email protected]

LABORATORY WORK

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STERILINE srl - Via Tentorio, 30 - 22100 Como - ITALY - Ph. +39 031 592 064