Line Specifications
Was designed to run 3, 5, 10 and 20 ml vials
1.) Size parts included: 3ml vial d=16,25mm, h=37,0mm (for speed calulation 2R vial
assumed) included in the scope
2.) 3ml vial d=16,15mm, h=35,50mm (for speed calulation 2R vial
assumed) No size parts included, possible for future retrofit
3.) 5ml vial d=23,00mm, h=39,00mm (for speed calulation 6R vial
assumed) No size parts included, possible for future retrofit
4.)10ml vial d=24,75mm, h=46,75mm (for speed calulation10R vial
assumed) No size parts included, possible for future retrofit
5.)20ml vial d=29,50mm, h=56,60mm (for speed calulation 20R vial
assumed) No size parts included, possible for future retrofit
Stoppers and caps to be run: 13 mm
Product characteristics: water like, non-toxic
Vials are supplied to the washer by tray and removed at the end of the line by double tray
Electrics: 400 volt, 50 hz, 3 ph,
Siemens S7 PLC controls
Washer
Manufacturer: Bosch - Syntegon
Model: RRU-2043
Serial #: 729437
Year of manufacture: 2018
CE marked
For interior and exterior cleaning of cylindrical containers.
Processing range: vials per DIN/ISO 8362 up to 30R (Ø 30 mm, height 75 mm) or 20H (Ø 32
mm, height 58 mm)
Manual infeed of the containers via inclined chute (30° incline), inner width 310 mm
Scroll - helix style for container infeed spacing
Ultrasonic waterbath
Recirculating system to reduce the fresh water consumption
Standard washing sequence:
• Precleaning in the ultrasonic bath (infeed)
• Washing with recirculating water: 2 x inside, 1 x outside
• Sterile compressed air: 1 x inside
• Washing with incoming fresh water (Water for Injection): 1 x inside (max. 90°C)
• Sterile compressed air: 2 x inside (intermittent), 1 x outside
Depyrogenation Tunnel
Manufacturer: Bosch - Syntegon
Model:HQL-6120 S
Serial #: 729438
Year of manufacture: 2018
CE marked
Machine weight: 6,300 kgs
Conveyor belt width 600 mm - 1 loading module/ pre-heating module - 1 sterilizing module - 2 sterilizable cooling modules
Sterilizing tunnel, for drying, sterilizing and 3-log-depyrogenizing of glass containers
Working range: Designed for processing containers with a diameter of 8 - 100 mm and a
height of 30 - 210 mm
Belt speed control correlated to the output of the washing machine and the filler
HEPA filter for charging zone, heating zone, sterilizing zone, and cooling zone
Automatic overpressure control separately for the pre-heating zone, sterilizing zone and cooling zone for the balancing of pressure fluctuations
Shared HMI for the washing machine / tunnel
Vial Filler
Manufacturer: Bosch - Syntegon
Model: MLF-5044 CS
Serial #: 729439
Year of manufacture: 2018
CE marked
Processing range: Ø 16 -52 mm, height 32-95 mm, dosing range up to 100 ml,
filling station 4-head. High-performance and versatile, intermittent working
machine for GMP-compliant filling of liquid pharmaceutical products.
Four station pre-fill check weigh of vials
Four head in line filler
Bosch peristaltic pump for the filling of fluids with fully replaceable tubing (Disposable Filling System).
Fixed mounted, small pump heads (4 pieces) for the fill volume range 0.1 - 30 ml
Four station post fill check-weigh of vials
Automatic reject of all containers outside of the fill weight
Stopper insertion station for siliconized or Teflon coated liquid (mushroom) and lyo stoppers
Vibratory bowl style stopper feeding
Stopper inserting depth is manually adjustable by means of a digital position indicator
Stopper present detection, immediately after the stopper insertion station: when a stopper is not present, the container will be rejected at the reject station (additional equipment "reject station" is required) or the machine
will stop
UDAF System - system for the creation of a vertical, downward, low turbulance uni-directional
airflow (UDAF), in the area inside of the machine safety guarding of a machine.
RABS (Restricted Access Barrier System), consisting of: Machine safety guarding - 11 oval glove ports - 5 light barriers for monitoring glove port intrusions
Air lock system for aseptic stopper charging
Crimp Capper
Manufacturer: Bosch - Syntegon
Model: VRK-3080 BI
Serial #: 729440
Year of manufacture: 2018
CE marked
Infeed: helix scroll feeding 2 star wheels receive the vials from a single lane conveyor belt
8 capping positions - stations
Single crimp roller and rotating vial plate
Adjustable height capping head - turret
Vibratory cap feed bowl with cap track
Currently running 13 mm caps
Coding and inspection station
Vial infeed spacing by helix - scroll to spacing starwheel
Laser coding for the lateral application and inspection of codes on the caps.
Vision system for the inspection of previously applied printing, i.e. character verification (OCR/OCV) or code reading (1D/2D) consisting of: intelligent Cognex InSight camera and LED illumination
Automatic container reject with separate discharge conveyor
Includes a zone separation between the capping station and the coding and inspection station by means of a separation pane made of single-pane safety glass.
The machine is adjusted for container size Ø16,25mm x 37,0mm and one overseal cap type (differentiated for example by size, color or characteristics) Ø13mm 8,1mm
4 oval glove ports with 3 light barriers for monitoring glove port intrusion
Outfeed for good containers, 2-lanes, customer specified trays, without Shift Soft (instead of 1-lane outfeed).
Loading verification: Once the tray is full a corresponding message is displayed at the control
panel and a time-delayed machine stop will be triggered if no tray exchange has taken place.
