Bausch & Ströbel filling and sealing line for pre-filled syringes –
unused
Unused Bausch & Ströbel system, built in 2022, for fully automatic
filling of nested disposable syringes and sealing with plunger plugs.
The line includes the tub unpacking machine, the cover and protective
film removal, the filling and sealing machine and the transport
system.
According to available information, the system achieves up to 36,000
syringes per hour, depending on the product, filling volume and
format. A format set for 1 ml standard syringes in the 100 nest as
well as rotary lobe pumps for ten filling stations with a filling
volume of 0.3–2.1 ml are included.
The system is unused and packed in original wooden crates near Hong
Kong. A CE declaration of conformity is currently not available.
Plant data
Manufacturer: Bausch & Ströbel
Components: TUM 9070, DVE 9070, SFM 5072 and NTS 8140
Year of Make: 2022
Condition: unused, packed in original wooden crates
Location: near Hong Kong
Components of the line
TUM 9070: Tub unpacking machine for removing the tubs from the bags by
means of a sliding device
DVE 9070: Unit for covering and protective film removal
SFM 5072: Filling and Sealing Machine for Nested Syringes
NTS 8140: Transport System
Performance and Processing Range
Output: maximum 36,000 syringes/h, infinitely adjustable
Syringe sizes: 0.5-10 ml, depending on format set
Processing of 100 nests
Maximum tube height: 130 mm
Piston plug diameter: 5–21 mm, depending on the format set
Piston plug height: 7–15 mm, depending on the format set
AISI 316L stainless steel parts in contact with the product
Included format set and pump equipment
Format set for 1 ml standard syringes according to DIN ISO 11040-4 in
a 100 nest
Syringe diameter: 10.85 ± 0.10 mm
Syringe height: 69.00 ± 1.00 mm
Rubber plug diameter: 9.20 ± 0.10 mm
Rubber Plug Height: 7.70 ± 0.40 mm
Rotary lobe pumps for ten filling stations
Filling volume with the included pumps: 0.3–2.1 ml
The processing of other syringe sizes and filling volumes requires
testing of the necessary format and pump equipment.
Process control and operation
Fully automatic in-process control with tare and gross weighing
Siemens PLC
Bausch & Ströbel OVD operating system with IPC for visualization,
data acquisition and evaluation
Operating System: Microsoft Windows
Menu languages: German, English and French
User management according to 21 CFR Part 11 and Annex 11 EU-GMP
according to available information
Recipe management for up to 500 recipes
Ethernet interface for remote maintenance; according to available
information with TÜV-IT-certified connection
Documentation
English IQ/OQ qualification documentation in accordance with the
specified requirements of GAMP 5, Annex D5, and Annex 15 EU-GMP
Calibration documents for all process-relevant measuring systems
Material Specifications
Electrical connection
Specified supply voltage: 230/400 V
Mains frequency: 50 Hz
Delivery status and CE conformity
The system is offered unused and packaged in original wooden boxes. A
CE declaration of conformity is currently not available.
External support for the conformity assessment at the buyer's site can
be arranged at an additional cost. The required scope of testing,
documentation and, if necessary, adaptation as well as the
responsibility for issuing the declaration of conformity must be
clarified in advance.
Are you interested in this unused Bausch & Ströbel syringe filling
and capping system? Contact Jandl PharmaTech Solutions for further
technical information, an individual offer or to arrange a viewing by
arrangement.
Subject to technical changes.