Key Requirements for Pre-Filled Syringe (PFS) Filling Equipment
🚀 Ensuring Precision & Compliance in Pre-Filled Syringe Production
Pre-filled syringes (PFS) demand high-precision filling equipment to meet stringent pharmaceutical standards. Here are the critical requirements for PFS filling machines:
- Accuracy & Consistency
- Minimal deviation in fill volume (e.g., ±1% for biologics).
- Advanced dosing systems (peristaltic pump, time-pressure, or rotary piston) to handle viscous drugs.
- Aseptic Processing
- ISO Class 5 (Grade A) environment compliance.
- Sterile barrier systems (e.g., isolators/RABS) to prevent contamination.
- Gentle Product Handling
- Low-shear filling to protect sensitive formulations (e.g., proteins, vaccines).
- Siliconization control for smooth plunger movement.
- Flexibility & Speed
- Quick changeover for different syringe sizes (1mL–10mL) and materials (glass/plastic).
- Output: 10,000–30,000 units/hour (depending on automation).
- Regulatory Compliance
- Adherence to cGMP, FDA 21 CFR, and EU Annex 1 guidelines.
- Full traceability with serialization capabilities.
💡 Pro Tip: Opt for equipment with in-process checks (weight verification, vacuum leak testing) to reduce rejects.
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