STERILE FILLING. Products catalogue

Transcription

1 Products catalogue

2 Index PRODUCTS PORTFOLIO STANDARD RANGE Vials Filling Machines VFM 4 Vials Capping Machines VCM 6 Vials Filling Machines RVFM 8 Vials Capping Machines RVCM 10 Tray Loader RTL 12 Pulsed Light Sterilizer RPLS1 14 Nest Filling Line RNFM 16 ANCILLARY EQUIPMENT 18

3 PRODUCTS PORTFOLIO Machine type Container End product STANDARD RANGE Vials Filling Machines VFM vials - cartridges - syringes liquid - lyo Vials Capping Machines VCM vials - cartridges liquid - lyo Machine type Container End product Vials Filling Machines RVFM vials liquid - lyo Vials Capping Machines RVCM vials liquid - lyo Tray Loader RTL vials - cartridges liquid - lyo Pulsed Light Sterilizer RPLS1 tubs Nest Filling Line RNFM vials - cartridges - syringes liquid - lyo 2 3

4 STANDARD RANGE Vials Filling Machines VFM Design to process vials, cartridges and syringes. Linear transport system and reduced footprint, suitable for the application of RABS and Isolators. Filling by peristaltic and/or volumetric pumps actuated by servomotors, allowing precise filling and easy and independent adjustment of each pump by means of the HMI. CIP/SIP. Nitrogen purging inside the containers before, during and after the filling. 100% IPC or Statistical check weighing system with feedback to dosing pumps. Combo machines for vials, PFS and cartridges processing in bulk. Continuous monitoring of the viable and non-viable particles. Appropriate for water like and highly viscous, non-toxic and toxic products. Easy access and format change for efficient operation with reduced downtime. Compliance with cgmp, GAMP and 21CFR Part11 requirements. Capacity up to pcs/h Range 2R-100H vial, 1-3 ml cartridges Quick change-over 4 5

5 STANDARD RANGE Vials Capping Machines VCM Designed to process vials and cartridges. Linear transport system and reduced footprint, suitable for the application of RABS and Isolators. Capping station designed to reduce particles generating, vials rotation from the top with adjustable speed. Sealing blades parameters adjustable via HMI. Continuous monitoring of the viable and non-viable particles. Sealing of flip-off or tear-off caps. Sealing pressure control and monitoring. Closing with screw caps with torque control and monitoring and presson caps available. Stoppers and caps check with vision system. Easy access and format change for efficient operation with reduced downtime. Compliance with cgmp, GAMP and 21CFR Part11 requirements. Capacity up to pcs/h Range 2R-100H vial Quick change-over 6 7

6 Vials Filling Machines RVFM Designed for campaign production with containment technology. Vials transport with anthropomorphic VHP compatible STÄUBLI robot. Maximum of 4 open vials involved in filling and stoppering operations at the same time throughout the machine. Minimum format parts and electronic adjustment of all parameters for different vial sizes. Peristaltic pumps dosing system (volumetric piston pumps available). Handling of single-use disposable systems option. 100% IPC or Statistical check weighing system directly under the filling nozzles with feedback to dosing pumps. Re-fill up to target value for underfilled vials. No product waste during the product path priming. Nitrogen flushing before and during stoppering. Capping unit integration on the same monoblock with additional anthropomorphic VHP compatible STÄUBLI robot. Zero reject philosophy. Repeated operations on missing stopper or cap detection. Continuous monitoring of the viable and non-viable particles. Compliance with cgmp, GAMP and 21CFR Part11 requirements. Capacity up to pcs/h Range 2R-100H Minimum downtime 8 9

7 Vials Capping Machines RVCM Designed for campaign production with containment technology. Vials transport with anthropomorphic VHP compatible STÄUBLI robot. Maximum of 4 vials involved in capping operations at the same time throughout the machine. Minimum format parts and electronic adjustment of all parameters for different vial sizes. Capping unit with 4 heads. Zero reject philosophy. Repeated operations on missing alu-cap detection. Continuous monitoring of the viable and non-viable particles. Compliance with cgmp, GAMP and 21CFR Part11 requirements. Capacity up to pcs/h Range 2R-100H Minimum downtime 10 11

8 Tray Loader RTL End line, high output tray-loader designed for sealed vials and cartridges packing. Vials preparation on a dead plate in quincunx pattern according to a pre-set number of rows. Frame positioning over the arranged vials and their transfer in the tray using SCARA robot, and simultaneous preparation of the vials for the following tray. Quick changeover and electronic adjustment of all parameters for different vials sizes. Dedicated Robot Cleaning Position for easy cleaning Compliance with cgmp, GAMP and 21CFR Part11 requirements. Capacity up to pcs/h Range 2R-100H Quick change-over 12 13

9 Pulsed Light Sterilizer RPLS1 Designed to sterilize tubs, before entering the de-lid - de-liner station Compact and light weight Tubs handling with anthropomorphic VHP compatible STÄUBLI robot VHP sterilizable Suitable to be installed in ISO8 environment Completely airtight 6 log reduction on Up to 2 tubs per minute Suitable for all kind of tubs and trays No format change 14 15

10 Nest Filling Line RNFM Suitable for the applications under orabs, crabs and Isolators. Combo line for RTU nested syringes, vials and cartridges. Semi-automatic or Manual Debagging station. Single tool automatic tub handling, including tyvek lid and insert removal, with anthropomorphic VHP compatible STÄUBLI robot. Manual option available. Quick changeover and electronic adjustment of all parameters for different containers sizes. Nest handling through filling and stoppering operations with anthropomorphic VHP compatible STÄUBLI robot. Volumetric and/or peristaltic pumps dosing system. Handling of single-use disposable systems option. Statistical check weighing including feedback to dosing pumps. Nitrogen flushing during filling and before stopper insert. Vacuum stoppering. Vacuum assisted filling suitable for viscous products. Dedicated Robot Cleaning Position for easy cleaning in absence of traditional nest indexing manipulators. Continuous monitoring of the viable and non-viable particles. Compliance with cgmp, GAMP and 21CFR Part11 requirements. Capacity up to pcs/h Range all available nests Minimum downtime 16 17

11 ANCILLARY EQUIPMENT Ancillary equipments manufactured by SFM to complete the product range and to offer to customers a complete line from a single source supplier: De-bagging De-lid De-liner De-nester Tray loader 18 19

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13 SFM S.r.l. Via Lombardia 25/BIS Lomazzo - CO - Italy T sales@sfmsrl.com