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RTU cartridges maintain the highest quality to deliver greater value to the healthcare system.
The conventional configuration of aseptic fill & finish operations generates well-known risks that pharmaceutical companies need to manage.
Bulk aseptic filling process
1. Infeed
2. Washing, siliconization
3. Depyrogenation and baking
4. Stoppering, Filling, Crimping
5. Inspection
6. Packaging and assembly into device
Criticalities
Setting the siliconization profile to achieve good cosmetic appearance & gliding performances
Glass-to-glass and glass-to-metal contact generate particles and cosmetic defects
Crimping quality and associated integrity
Time-consuming format change
RTU aseptic filling process
1. Steribag opener and de-lidding module or infeed
2. Filling, stoppering
3. Visual Inspection
4. Packaging and assembly into device
The RTU aseptic filling provides many benefits over conventional processes, reducing the following risks:
Contamination due to glass particles
Rejections/ market recalls caused by glass and siliconization defects (waste of drug product)
Critical defects in crimping quality and associated integrity
Human errors on non-core activities
