Bausch & Stroebel TUM 9070, DVE 9070, SFM 5072, NTS 8140 Disposable syringe filling and closing system

composed of 4 Bausch-Str.bel components:
TUM9070 Tube dashboard to remove the vessels from the bag using a sliding device.
DVE9070 Extraction of the cover and protective film
SFM5072 Filling and sealing machine.
NTS8140 Transport system
max yield. 36,000 pre-filled syringes/h, adjustable without staggering

For pre-filled syringes of 0.5 to 10 ml depending on formatting
For plunger diam plugs. 5,00 - 21.00 mm, height 7,00 - 15,00 mm depending on formatting game

100 mm nest
For cub height max. 130 mm
Pieces in contact with the AISI 316L stainless steel product

Qualification documentation IQ/OQ in accordance with Annex D5 GAMP 5 and Annex 15 EU-GMP in English

Calibration (KAL) for all measurement systems relevant to the process

Specification of materials
PLC Siemens
HMI Bausch & Str.bel OVD (Traoting process Collection and evaluation of CPI data)
Microsoft Windows operating system
Languages menu DE, EN, FR
Fully automatic control (CPI) with raw tare and weighing
User administration in accordance with 21 CFR Part 11 and Annex 11 EU-GMP
Recipe management for 500 recipes
Ethernet interface for a secure and secure remote maintenance connection

Drive 230/400V/50Hz
Currently without a statement of EC conformity. However, Bausch - Str.bel can subsequently issue a EC declaration of conformity at an additional cost after a personalisation work

With format games for:
- 100 nest
- Pre-filled syringe 1 ml standard according to DIN ISO 11040-4, diam. 10,85o/-0.1 mm x height 69,00 mm/ 1.00 mm
- Rubber diam cap. 9,20o/-0.1 mm x height 7,70o/-0.40 mm

- rotary piston pumps for 10 filling stations for filling volumes of 0.3 - 2.1 ml