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Crystal® Filling Lines Scaling-up solutions for your aseptic fill&finish: from R&D to commercial batches.




Crystal ® Filling Lines 手動/自動/機械臂充填機
應用領域 / Fields of use

Crystal ® M1 Filling Station

Biological
  • Manual equipment

Crystal ® L1 & SL1 Robot Line

Potent
  • Robotic equipment
  • Multicontainer equipment

Crystal ® PX Filling Line

Cryostored
  • Fully automated line
步驟說明 / Process

The overall filling process of the ready-to-fill AT-Closed Vials ® is made of very few steps:

  1. Filling: the stopper is pierced by a specially designed needle dispensing the product inside the container
  2. Closing: the puncture trace is re-sealed by a laser shot on the stopper
  3. Capping: simple snap-fit of plastic cap, inside the barrier.

"Scaling-up"

Straightforward scaling-up, identical processing, tools and disposables are used at all capacity levels.

The Crystal ® M1 Filling Station has been developed to meet small scale cGMP pharmaceutical filling.

Being manually operated, the filling capacity goes up to 180 vials/hour depending on product characteristics, with batch size ranging from less than 10 up to 1,500 vials (two operators).

Potent

Advantages

  • Manual equipment
  • Easy-to-deploy: at your site in 8 weeks, qualified in 1 day
  • Installed in Biosafety Cabinet or Isolator
  • Very limited space required
  • Higher quality assurance of aseptic filling thanks to the ready-to-fill AT-Closed Vial ® supplied clean and sterilized
  • Only electricity required to operate the equipment
規格 / Specification
 
Crystal ® Filling Lines Crystal ® M1 Filling Station Crystal ® L1 Robot Line Crystal ® SL1 Robot Line Crystal ® PX Filling Line
Container AT-Closed Vial ® AT-Closed Vial ® AT-Closed Vial ®,
Prefilled Syringe,
Open Glass Vial *1
AT-Closed Vial
Max. output 180 u/h 600 u/h 600-700 u/h 6.000-10.800 u/h
Containment BSC or Isolator RABS or Isolator RABS or Isolator RABS or Isolator
Typical footprint 1 m 2 (11 ft 2) 1,5 m 2 (16 ft 2) 1,5 m 2 (16 ft 2) 12-18 m 2 (130-195 ft 2)
Closing IPC 100% 100% 100% 100%
Utilities
WFI
Vacuum
Electricity



Yes



Yes


Yes
Yes



Yes
*1 Ready-to-fill nested containers.

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DEMO5

Crystal® Filling Lines Scaling-up solutions for your aseptic fill&finish: from R&D to commercial batches.

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