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:
- Filling: the stopper is pierced by a specially designed needle dispensing the product inside the container
- Closing: the puncture trace is re-sealed by a laser shot on the stopper
- 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).
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
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
- Very limited space required: footprint is approximately 1 sq. m. (~ 10 sq. ft.)
- Different vial entry procedures and barrier systems according to project specifications and product requirements
- Only electricity is required to operate the equipment
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
- Flexibility: 1 equipment 3 containers
- Short changeover time to switch to another container type
- Very limited space required: footprint is approximately 1 sq. m. (~ 10 sq. ft.)
- Different vial entry procedures and barrier systems according to project specifications and product requirements
- Compatible with L-Flange of SKAN PSI-L Isolator
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
- One single equipment
- Limited space required as the total equipment footprint is approximately 16 sq. m. (172 sq. ft.)
- Loading of vials performed by a robotic unpacking system to prevent the vials from contamination
- 100% In Process Control (IPC) and Process Analytical Technology (PAT) ensuring proper and effective filling, closing and capping
| Crystal® Filling Lines | Crystal® M1 Filling Station | Crystal® L1 Robot Line | Crystal® SL1 Robot Line | Crystal® PX Filling Line | ||
|---|---|---|---|---|---|---|
| *1 Ready-to-fill nested containers. | ||||||
| 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 |
||
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