Fully automatic system for filling nested disposable syringes and
closing with plunger stoppers, consisting of 4 Bausch+Ströbel
components:
TUM 9070 Tub unpacking machine for removing the cups from the bag
using a sliding device
DVE 9070 Cover and protective film removal
SFM 5072 Filling and sealing machine
NTS 8140 Transport system
Output max. 36,000 disposable syringes/h, infinitely adjustable
For disposable syringes 0.5 - 10 ml depending on format set
For plunger stoppers diam. 5.00 - 21.00 mm, H 7.00 - 15.00 mm
depending on format set
For 100 mm nest
For tub H max. 130 mm
Parts in contact with the product made of stainless steel AISI
316L
IQ/OQ qualification documentation in accordance with Annex D5 GAMP
5 and Annex 15 EU-GMP in English
Calibration (KAL) for all process-relevant measuring systems
Material specification
PLC Siemens
HMI Bausch & Ströbel OVD (Operation Visualisation Data collection
and evaluation with IPC)
Operating system Microsoft Windows
Menu languages DE, EN, FR
Fully automatic in-process control (IPC) with tare and gross
weighing
User administration in accordance with 21 CFR part 11 and Annex 11
EU-GMP
Recipe management for 500 recipes
Ethernet interface for secure and TÜV IT-certified remote
maintenance connection
Drive 230/400V/50Hz
Currently without CE declaration of conformity. However, a CE
B51261182 declaration of conformity can be issued by Bausch + Ströbel
at an additional cost after customisation work has been carried out
With format sets for:
- 100 nest
- Disposable syringe 1 ml standard according to DIN ISO 11040-4, diam.
10.85+/-0.1 mm x H 69.00+/-1.00 mm
- Rubber stopper diam. 9.20+/-0.1 mm x H 7.70+/-0.40 mm
- Rotary piston pumps for 10 filling stations for filling volumes 0.3
- 2.1 ml
The system is unused and is still packed in original wooden crates in
China near Hong Kong. The price is free loading ramp. The video shows
the FAT at Bausch + Ströbel. The photos show an assembled sister
system.
Німеччина
