Bausch & Stroebel TUM 9070, DVE 9070, SFM 5072, NTS 8140

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 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