Filling of Pre-sterilized Syringes FXS 5100 Nested Syringe Filling

Transcription

1 Filling of Pre-sterilized Syringes FXS 5100 Nested Syringe Filling

2 FXS 5100 A technological work of art 2

3 The increased sales of single use syringes over the past few years has made the administration of parenteral drugs simpler and safer. Every day more and more medicines find their way into the single use syringe. These medicines cover a range from standard medicines (like Heparin) to complex biotechnological products for specialized therapy. A pre-condition for the successful implementation of this practical delivery method is proven filling technology whose precision and pharmaceutical reliability can be trusted. The FXS 5100 filling and closing machine has been specifically designed for the processing of presterilized, nested syringes such as SCF. It has been developed to meet current pharmaceutical industry requirements and address the needs of the end user. The very compact design reduces expensive sterile area space whether this is within a conventional clean room or within an isolator system. Additionally, the FXS 5100 has been designed to be serviced exclusively from one side. This reduces the time and effort during servicing and also minimizes the installation space requirements by allowing the unit to be wall mounted with no required rear access. Pre-sterilized syringes in a SCF -Tub 3

4 New and innovative the syringe transport system of the FXS 5100 Nest transport with recirculating transport carriages Infeed: Vacuum pick and place station The syringe transport system, derived from the successful MLD and FLS models, sets new milestones in process quality and stability: The individual transport carriages are moved individually by servo-drives accurately and independently from one another. This guarantees that the filling and closing of the syringes runs as a continuous motion. Even when there is a disturbance upstream or downstream of the machine, nests of syringes that are already in the machine will still be filled and closed without interruption. A safer process is simply not possible. 4

5 The Filling Station Continuous, repeatable, and accurate Continuous filling during nest change with the Bosch Pharma Handling Unit A new level of filling quality has been achieved by incorporating the the Pharma Handling Unit (PHU) from the FLS syringe filling machine. This precision robotic module has been utilized for the nozzle motion of the FXS 5100 and provides extremely accurate filling needle precision and adaptability to different formats and products. By using this design with the innovative transport system, this machine provides a robust and continuous filling motion yeilding the best conditions for reliable, accurate, and repeatable filling results. To complete the filling system, FXS 5100 uses precision rotary piston pumps (other options availible) to provide highly accurate filling volumes. The entire filling system is servo controlled allowing the critical motion parameters of the pump station, Pharma Handling Unit and transport system to be stored together as a complete recipe that can be securely stored and simply recalled by the machine operators. 5

6 Closing station: Easy acces in front Filling and immediate closing The closing station has been designed for optimal performance, pharmaceutical safety, and reliability. The sorting device is on the operater side of the machine allowing easy refilling of the system. Closing of the syringes takes place immediately after filling, row by row, and due to the innovative transport system this operation is not interrupted by nest changes. The stopper supply system also works continuously, further reducing the chances of a process disturbance. The stoppers are loaded into the cylindrical bores in the transfer plate. The plate is then accurately positioned over the syringes, and the stoppers are pushed from the transfer plate into the syringes. Because the stoppers are delivered using a moving delivery plate, the unidirectional flow of air around the syringe is only disturbed at the moment the stoppers are inserted providing the best enviromental condition for pharmaceutical processing. Outfeed: Vacuum pick and place station 6

7 Main Options Alternative Filling Systems In order to meet various product specifications, or when specially specified by the customer, the following filling systems can also be provided: Time-Pressure Filling system (TPF) Mass Flow Measurement (MFM) Rolling diaphragm pumps All systems can also be provided with CIP / SIP (Clean In Place / Sterilize Into Place) functionality. In-Process Control (IPC) Fully automated filling weight monitoring is available with the addition of another Pharma Handling Unit Tare and gross weighing of every filling position in each syringe row and analysis of each filling position RABS / Isolator The Bosch Integration Advantage The highest quality pharmaceutical environment and process quality can be achieved with barrier and isolator technology integrated with standard equipment: Restricted Access Barrier System (RABS, closed RABS) Isolator technology: integrated machine / isolator systems for the complete separation of production and personnel Individually Driven Rotary Piston Pumps Modification of the rotary piston pump filling system to include individual servo motors for each pump: Continuous, automatic adjustment of each individual pump stroke and filling weight during filling (IPC system required) Vacuum Stoppering Extremely gentle and precise, stopper insertion with significant pharmaceutical advantages: Minimum compression on the stopper, as may be necessarily for coated stoppers No transfer plate to deliver stoppers above the unclosed syringe. Minimal air bubble remaining in the syringe. Plunger Rejection Sorting Bowl Specially designed plunger sorting bowl to sort out joined or fused plungers, thereby minimizing process faults and stops due to plunger quality. FXS Your advantages in a glance Slim Design: space-saving and easily to clean, optimal for inline placement. Entire machine is operated from one side: optimal for inline and wall installation. The transport system is precise and adaptable to all process steps. Continuous filling and closing even during the nest change Flexible and adaptable filling needle movement Stopper supply without interferences: optimal for free airflow around the syringes during the entire process Technical Data Capacity to 30,000 Syringes / hour with 100 syringes in each nest All SCF Formats from 0.5ml to 20ml in glass and plastic All dimensions in mm. Subject to technical modifications. 7

8 FXS in line configuration with debagging, e-beam sterilization and fully automatic tub opening Locations world-wide Bosch Packaging Technology PA/MKT 01/06 1,0 E WA Iorio, Sulzbach Arnold, Deizisau Paper: natural white, without chlorine All rights reserved Headquarters Robert Bosch GmbH Packaging Technology Division Waiblingen Phone: Fax: pa@boschpackaging.com Brazil Sigpack Tecnologia de Embalagem Ltda. São Paulo Phone: Fax: sigpackbrazil@sigpack.com China Bosch Packaging Technology (Hangzhou) Co.Ltd. Hangzhou Phone: Fax: jens.mack@boschpackaging.com Denmark Moeller & Devicon A/S Sandved Phone: Fax: info@m-d.dk France Bosch Techniques d Emballage S.A.S. Reichstett Phone: Fax: pafr@boschpackaging.com Germany Robert Bosch GmbH Packaging Technology Division Product Division Pharma Liquid Crailsheim Phone: Fax: pa@boschpackaging.com Great Britain Bosch Packaging Services Ltd. Derby Phone: Fax: uk-hub@sigpack.com India Motor Industries Co.Ltd. Bangalore Phone: Fax: vtin@in.bosch.com Japan Bosch Packaging Technology K.K. Tokyo Phone: Fax: vtjp@boschpackaging.com Bosch Packaging Technology K.K. Chiba Phone: Fax: vtjp@boschpackaging.com Singapore Bosch Packaging Technology (Singapore) Pte. Ltd. Singapore Phone: Fax: sigpackasia@sigpack.com USA Bosch Packaging Technology Inc. Pharmaceutical operations Minneapolis, MN Phone: Fax: sales@boschpackaging.com