Automated Aseptic PFS Filling Solution
Debagging (Material Entry)
Purpose : Introduce sterile (RTU) syringe tubs into the clean environment
- Outer bags removed in lower-grade area (Grade D/C)
- Inner sterile bag transferred into Grade B via airlock
- Final opening under Grade A (RABS/Isolator)
Key controls:
- Environmental monitoring (particles, viable)
- Operator gowning discipline
- Material transfer SOPs
De-nesting & Infeed
Purpose : Separate syringes from tubs for processing
- Tub opened automatically
- Nest lifted and syringes extracted via:
- Robotic arm or
- Mechanical pick-and-place
- Syringes transferred onto transport system (star wheel / conveyor)
Critical points:
- Avoid glass contact damage
- Maintain sterility (Grade A zone)
Aseptic Filling
Purpose : Fill drug product into syringes
- Syringes positioned under filling needles
- Filling via:
- Peristaltic pumps (common for biologics)
- Time-pressure systems
- Optional nitrogen purging (oxygen-sensitive drugs)
Controls:
- Fill volume accuracy (±1–2%)
- No-drip/no-foam filling
- In-process weight checks (IPC)
Stoppering / Plunger Insertion
Purpose : Seal the filled syringe
- Sterile plungers fed from bowl or nest
- Inserted to predefined depth
- Vacuum or mechanical insertion ensures tight seal
Critical parameters:
- Plunger position accuracy
- Container closure integrity (CCI)
- Avoiding particle generation
Re-nesting / Outfeed
Purpose :
- Prepare syringes for downstream processing
- Syringes placed back into nests/tubs OR
- Sent via conveyor to next stage
Visual Inspection (often inline or separate)
Purpose : Detect defects
Checks:
- Particles (visible)
- Fill volume
- Cosmetic defects (cracks, scratches)
Systems:
- Automated vision inspection machines
Labeling
Purpose : Apply product identity and compliance info
- Syringes fed into labeling machine
- Wrap-around or flag labels applied
- Print/verify:
- Batch number
- Expiry date
- Serialization (if required)
Controls:
- Vision system for label presence & correctness
- Barcode verification
Blister Packing
Purpose : Protect and present finished syringes
- Syringes placed into thermoformed blister cavities
- Blister formed using PVC/PET or medical-grade material
- Sealed with Tyvek or foil backing
- Cutting and discharge
Optional:
- Leaflet insertion
Cartoning after blistering