Scaling-up solutions for your aseptic fill & finish: from R&D to commercial batches.
Crystal® M1 Filling Station
-Manual equipment
Crystal® L1 & SL1 Robot Line
-Robotic equipment
-Multicontainer equipment
Crystal® PX Filling Line
-Fully automated line
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.
Straightforward scaling-up, identical processing, tools and disposables are used at all capacity levels.
To support the approval of your products, complete Validation Master Plan (VMP) is provided with every Crystal® Filling Line.
Optimized for batch size ranging from a few up to 1,500 vials, the Crystal® M1 Filling Station is designed to fill typically research lots, stability batches and niche commercial products.
Advantages
The Crystal® L1 Robot Line is an automated equipment designed to perform filling of stability batches, clinical batches and niche products production. The equipment can fill up to 600 AT-Closed Vials® per hour.
Advantages
The multicontainer Crystal® SL1 Robot Line is designed to face the challenge of flexible small scale pharmaceutical filling with a capacity going up to 700 units/hour, typical batch size reaches 6,000 units per shift.
Fully compliant with cGMP requirements, the Crystal® SL1 Robot Line is able to process different kind of containers (all formats) with minimum change-over time. All operations are performed by the Robot equipped with specific tools.
Advantages
The Crystal® PX Filling Line has been designed to address the large scale pharmaceutical filling, with a filling speed ranging from 100 vials/min (4 heads) up to 180 vials/min (8 heads).
Fully compliant with cGMP requirements, the Crystal® PX Filling Lines are able to easily process all sizes of ready-to-fill AT-Closed Vials®, from 1ml up to 50m. In Process Control (IPC) and Process Analytical Technology (PAT) are part of the design, ensuring proper and effective filling, closing and capping. Batch reports and audit trails are automatically generated.
The Crystal® PX Filling Line equipment only requires electricity (no WFI, no wet utilities, no compressed air).
Advantages
| 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 m2 11 ft2 |
1,5 m2 16 ft2 |
1,5 m2 16 ft2 |
12-18 m2 130-195 ft2 |
| Closing IPC | 100% | 100% | 100% | 100% |
| Utilities WFI: | - | - | - | - |
| Utilities Vacuum: | - | - | - | - |
| Utilities Electricity: | Yes | Yes | Yes | Yes |
(1)Ready-to-fill nested containers.
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