AFG 3000 Series from Bosch Filling and closing machines for sterile powder

Transcription

1 AFG 3000 Series from Bosch Filling and closing machines for sterile powder

2 Safety begins with the choice of a partner Pharmaceutical manufacturers are aware of the problematic nature of their products, such as sticking, bridging or resistance to flow. Often highly effective substances also create special situations for the health and safety of the personnel. Your strong partner - Bosch Packaging Technology The many years of practical experience that Bosch has gained in the area of powder processing, have been focused into solutions for the development of the AFG 3000 series. These machines not only process difficult powders efficiently and reliably, but they also fulfill all current safety and handling requirements. Owing to intelligent servo technology, the machines are extremely user-friendly and flexible in their application. Fields of application Dosing of sterile powders into injection vials and infusion bottles, and closing with rubber stoppers.

3 AFG head dosing, LF-system 3

4 Modul media supply with steril filters Stoppering station AFG 3000 The solution for your powder production Container infeed A turntable and one or two-lane infeed belts feed the containers into the conveying system by way of an infeed star wheel. Conveying system With great care and precision, the cell conveyor carries the containers through the machine. If necessary, the cells may be exchanged very simply and without tools, an optional automatic cell change system is available. The very core the dosing system This system operates by the vacuumcompressed air principle - single-head up to 160/min (AFG 3010) - two-head up to 320/min (AFG 3020). The system processes an extraordinarily broad spectrum of powders dust free and with great precision. Owing to the very small and easily manageable design of the dosing wheels a changeover operation is now child s play. For example, this unique system allows you to change the dosing wheel during a batch run while still maintaining sterility, without losing powder. Operating principle dosing The product in the powder supply chamber is kept in constant motion with the help of an individually adjustable agitator. The agitator is driven by a separate servo motor. The powder is taken by vacuum into a dosing chamber and dosed with sterile compressed air into the container. After each dosage the dosing chamber is purged with additional sterile compressed air. As with all other parts that come into contact with the product, the dosing wheel can be simply cleaned and sterilized. The fully automatic check weigh system (In-process control) continually monitors the dosing weight of the individual dosing stations. If a trend in weight change is determined, the dosing amounts are automatically adjusted on the basis of measured weights. This action is logged. Two mutually independent dosing stations Through the complete separation of the two dosing stations, the AFG 3020 is ideally suited for the dosing of two different powders with different dosing amounts into the same container.

5 Outfeed of containers to rearside Stoppering station infeed of rubber stoppers Clean Feed To minimize the risk of particles, the rubber stoppers are fed horizontally from the supply hopper to the base of the orienting bowl with the Clean Feed system (patent pending). Rubber stoppers are pressed-in reliably with a horizontally operating vacuum wheel. Dosing system principle Dosing wheel change without product loss Dosing different products Discharge The discharge operates by the activepass philosophy : All pass -containers are actively pulled by vacuum into the pass discharge line, all others move on to the reject station. CleanFeed - stopper feed system Fully automatic system for in-process control of fill weights

6 AFG 3020 LF equipment with dust tight machine guarding and air circulation User-friendly, reliable and safe User-friendliness The new automation and visualization concept of the AFG series not only means additional security, reproducibility and flexibility but also provides a clear increase in operating comfort. The workflow varies depending upon dosing quantity and product. In order to provide the greatest possible adjustment range almost all movements are controlled by servo motors. Depending upon specific product requirements, the operator has the possibility to freely set production parameters such as container formats, dosing volumes, multiple dosages etc. 6 The operator can easily enter the filling parameters, save them, and for future usage call them up from the control panel by the push of a button. Outfeed 90 rearwards Powder feeding from outside machine guarding for docking of powder container for non-stop production

7 U-shape configuration with wall installation and directly coupled capping machine Wall intallation with U-shape configuration Due to the continuous operation method at the outfeed, containers are directly routed to the down-stream capping machine, with container tracking and allocation of signals for reject of bad containers on the capping machine. The outfeed 90 rearwards through the sterile wall enables most space saving configurations and smallest possible clean rooms. Compact and ergonomical The development focused on GMP-compliant engineering and an ergonomic design. The traditional horizontal construction method provides for an extremely compact machine. Further advantages are the clear arrangement of all components and the good accessibility allowing for simple cleaning. Installation and Clean Room variants - Laminar Flow (LF) hood - LF system with recirculating air and air-conditioning module - Wall installation - C/RABS (Closed/Restricted Access Barrier System) - Isolator technique Safe navigation total ease of maintenance and upkeep A touchscreen with operator prompting provides the user interface. The control panel provides easy navigation through the respective processes as well as the ability to call up maintenance information. If necessary, and after permission is granted by the customer, a Bosch service technician can dial online into the system in order to determine the actual status for diagnostic or support purposes. Innovation and technology compliance with guidelines The control software is written to conform to the quality guidelines GAMP4 (Good Automated Manufacturing Practice), thereto optionally counts also the preparation for compliance to 21 CFR Part 11 with the technological requiremets of authentication, electronical signature and archival storage. Operating panel touchscreen

8 PA/MKT 03/08 1,5 EN bodensee medienzentrum Paper: natural white, without chlorine All rights reser- Technical data AFG up filling 2-up filling Container-Ø max. 33 mm 9600/h 6000/h Container-Ø max. 55 mm 6000/h 00/h AFG up filling 2-up filling Container-Ø max. 33 mm 19200/h 12000/h Container-Ø max. 55 mm 12000/h 8400/h Processing range: 250 ml injection vials and infustion bottles, Ø 68 mm, height 125 mm Germany Robert Bosch GmbH Packaging Technology Division Product Division Pharma Liquid D Crailsheim Phone: Fax: pa@boschpackaging.com USA Bosch Packaging Technology Inc. Pharma Divison Minneapolis, MN Phone: Fax: sales@boschpackaging.com Japan Bosch Packaging Technology K.K. Tokyo Phone: Fax: vtjp@boschpackaging.com