Unused equipment for sale: Unused Bausch+Ströbel Aseptic Vial Filling and Closing Line, FFV8024 with ME520 Tray Loader

Aseptic Fill And Finish
Bausch+Ströbel FFV8024 + ME520
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Specifications

SKU
5059-1
GSKU
12026009630
Condition:
New or unused
Location:
Year of construction:
2022
Certification
Designed to EU GMP Annex 11 and 21 CFR Part 11 user management
Cleaning
Integrated CIP/SIP, recipe-driven CIP, SIP and combined cycles
Control
18.5 in stainless steel touchscreen HMI, up to 500 recipes, audit trail, alarm handling, user management
Delivery terms
EXW, Incoterms 2020, already crated for transport
Documentation
Manufacturer operating manuals, revision V.0
Equipment Type
Vial Filling and Closing Machine
Manufacturer
Bausch+Ströbel Maschinenfabrik, Ilshofen, Germany
Manufacturer job numbers
32922 (FFV8024), 32921 (ME520)
Model
FFV8024 + ME520
PLC
Siemens S7-1500 with Ethernet, MES/SCADA capability and remote diagnostics
Product contact
AISI 316L, electropolished to Ra 0.5 micron or better
Tray loader
Two-lane ME520; up to 2,400 transfers/h, container 16-70 mm diameter, max 180 mm height (manufacturer type data)
blueprints
container type
vials
filling heads
8
material of construction
Stainless Steel
serial number
See Description
Barrier system
Laminar flow only. Single-pane safety glass machine guard with electrical door interlocking; not RABS and not an isolator
Closures
Lyo stopper 13 mm, and rubber / West vacuum stopper. Closure diameter max 32 mm. Sorting bowl approx 380 mm diameter, electropolished, double welded and sterilizable. Vacuum pump included
Container range
Vial diameter 14 to 55 mm, height max 110 mm
Dosing range
Rotary piston pumps. 3 ml vial 0.7-1.6 ml; 10 ml vial 0.7-5.5 ml; 20 ml vial 5-15 ml; 50 ml vial 10-30 ml
Drive
FFV8024 infinitely variable servomotor; ME520 infinitely variable three-phase motor
In-process control
Fully automatic IPC, weighing range below 120 g. Robotic tare and gross weighing on separately mounted precision scales, with automatic adjustment of metered quantity when the regulation limit is reached
Nitrogen flushing
Not fitted. The machine is designed to close vials without N2 filling
Safety standard
Machine guarding to DIN EN ISO 13857
Set output
Up to 24,000 vials/h for a 3 ml vial of 16.75 mm diameter, set output per DIN 8743. Approximate, established with HIPRA containers and water
Tray range
Width 200 to 400 mm, length 350 to 600 mm

Description

Bausch+Ströbel FFV8024 aseptic filling and closing machine supplied together with its matched ME520 tray loader, offered as one lot. Built in 2022 by Bausch+Ströbel Maschinenfabrik, Ilshofen, Germany, under manufacturer job numbers 32922 (FFV8024) and 32921 (ME520). Factory acceptance testing was completed and the line was then delivered to the buyer, where it has remained unpacked ever since. It is new and unused: never installed, commissioned or run, and still in its original factory packaging. Because it has never been installed it cannot be demonstrated running; viewing is of the packaged machine and the manufacturer documentation. Already crated, so no dismantling or rigging is required. PERFORMANCE AND SIZE RANGE. Set output to DIN 8743 of up to 24,000 vials per hour for a 3 ml vial of 16.75 mm diameter; capacity figures are approximate and were established using the original buyer's containers with water. Vial diameter 14 to 55 mm, height up to 110 mm. Closure diameter up to 32 mm. Trays from 200 to 400 mm wide and 350 to 600 mm long. Dosing by rotary piston pumps across four documented vial formats: 0.7 to 1.6 ml on a 3 ml vial, 0.7 to 5.5 ml on a 10 ml vial, 5 to 15 ml on a 20 ml vial, and 10 to 30 ml on a 50 ml vial. FFV8024 FILLING AND CLOSING MACHINE. Eight-position machine for aseptic production in hygienic GMP construction. Machine base in aluminium and stainless steel, top table plate in aluminium with an AISI 316L stainless cover plate, and an infinitely variable servomotor drive. Rotary infeed with automatic container detection and controlled feeding, free-hanging container transport for gentle positioning, and no container - no filling - no closure interlocking. Eight independent rotary piston dosing stations with servo-controlled pumps and automatic volume adjustment; the dosing system is CIP/SIP capable in place, without removal from the machine. In-process control is fully automatic, with a weighing range below 120 g, allowing dosing volumes to be checked without loss of production or reduction in capacity. A robot with container grippers removes a container under programme control for tare weighing and a second robot returns it to the transport system; gross weighing follows the same principle. The precision scales are mounted separately from the machine base so that machine vibration cannot affect the result, and the metered quantity is adjusted automatically when the regulation limit is reached. Closing station for insertion closures, with an electropolished sorting bowl of approximately 380 mm diameter, double welded and sterilizable, quick-action fastening and electric height adjustment. Closures are supplied from the machine rear, transferred single lane into an indexing wheel and inserted gradually by a vacuum insertion pin in a smooth continuous movement. The required vacuum pump is included. A level monitor activates the hopper system when the sorting bowl runs low, and a supply monitor stops the machine on closure shortage. Documented closures are a 13 mm lyo stopper and a rubber West vacuum stopper. Integrated CIP/SIP with recipe-driven CIP, SIP and combined cycles, an eight-litre dosing vessel with automatic level control and load cells, a Metenova Zero-g magnetic mixer and sterile filtration, electropolished 316L product contact at Ra 0.5 micron or better, and monitoring of temperature, pressure, valve position, conductivity and filling-needle cleaning under safety interlock. Siemens S7-1500 PLC with Ethernet, MES/SCADA integration capability and remote diagnostics. 18.5 inch stainless steel touchscreen HMI with recipe management for up to 500 recipes, audit trail, alarm handling and user management designed to EU GMP Annex 11 and 21 CFR Part 11. Two documented operator positions, a control terminal on the personnel side and a separate stopper loading station, and seventeen individually identified guard doors in the machine base structure. BARRIER SYSTEM. Laminar flow only. The machine guard is mainly single-pane safety glass with electrical door interlocking, so doors can be opened only after the interlock is released at the operating panel. The air exit in the guard below the container transport is enlarged to improve laminar air flow and reduce fan speed, in compliance with DIN EN ISO 13857. This is not a RABS installation and not an isolator. Nitrogen gas flushing is not fitted; the machine is designed to close vials without N2 filling. ME520 TRAY LOADER. Two-lane tray loader. Machine base in aluminium and stainless steel, top table plate in aluminium with an AISI 316L cover plate, driven by an infinitely variable three-phase motor. Special machine guard for use in a sterile room, mainly single-pane safety glass, with doors giving access to all work stations and permanent monitoring that stops the machine immediately if a door is opened during production. Each lane has its own upright-object sensing, fallen-object ejection and outlet accumulation control, so a fault on one lane does not stop the other. Two tray placement systems fed by an object conveyor, with row stops, object transfers and sliders moving each row into the tray, and a transfer-full sensor that counts objects and signals when a transfer is loaded. Variable-speed drive with Siemens PLC, real-time production monitoring, machine diagnostics, Ethernet and secure remote service, and an 18.5 inch Bausch+Ströbel OVD touchscreen with recipe and user management, audit trail and alarm handling. Two emergency stop positions, at the control terminal and at the rear of the machine. DOCUMENTATION. Full documentation is available, including the manufacturer operating manuals for both machines at revision V.0.

About the manufacturer Bausch+Ströbel


Bausch+Ströbel is a renowned German company specializing in the design and manufacture of high-quality pharmaceutical filling and closing machines, as well as complete aseptic processing lines. Based in Ilshofen, Germany, the company has established itself as a leader in the pharmaceutical machinery industry, serving clients worldwide with innovative and reliable solutions. Founded in 1967, Bausch+Ströbel has a long-standing reputation for excellence and precision engineering. The company focuses on providing advanced machinery for the filling and packaging of vials, ampoules, syringes, and cartridges, ensuring that pharmaceutical products are handled with the utmost care and precision to maintain sterility and efficacy. Bausch+Ströbel's product portfolio includes a wide range of equipment designed to meet the diverse needs of the pharmaceutical industry. Their offerings include filling machines, closing machines, labeling systems, and inspection units, all of which are designed to integrate seamlessly into complete aseptic processing lines. The company's solutions are known for their flexibility, scalability, and compliance with stringent regulatory standards, making them ideal for both small-scale operations and large pharmaceutical manufacturers. With a strong commitment to innovation, Bausch+Ströbel invests heavily in research and development to continuously enhance their technologies and meet the evolving demands of the pharmaceutical sector. Their dedication to quality and customer satisfaction has earned them a loyal client base and a reputation as a trusted partner in the industry. In addition to their cutting-edge machinery, Bausch+Ströbel offers comprehensive support services, including installation, training, maintenance, and technical assistance, ensuring that their clients receive the highest level of service and support throughout the lifecycle of their equipment. Overall, Bausch+Ströbel stands out as a leader in the pharmaceutical machinery industry, known for their precision engineering, innovative solutions, and unwavering commitment to quality and customer satisfaction. ...read more


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