Key Considerations for Selecting Vial Filling Machines in Veterinary Injectable Production

Key Considerations for Selecting Vial Filling & Sealing Machines in Veterinary Injectable Production

1. Precision Dosing & Material Compatibility

• Accuracy: Prioritize machines with ≤±1% filling deviation (e.g., LYAGF achieves ±1% accuracy for 1-10ml ampoules) to ensure consistent dosing for varying animal weights and drug potencies.
• Viscosity Adaptability: Verify compatibility with thick suspensions (e.g., antibiotics) or shear-sensitive biologics (e.g., vaccines), requiring adjustable piston pumps or peristaltic filling systems.

2. Sterility Assurance

• Aseptic Processing: Opt for Class 100 cleanroom-compatible systems with integrated sterilization modules (e.g., dry heat sterilization at 300°C in LYAGF12).
• Closed Systems: Select isolator technology or RABS (Restricted Access Barrier Systems) to prevent cross-contamination during lyophilized powder handling.

3. Container Versatility

• Size Range: Ensure support for 1-30ml containers (e.g., LYAGF12 handles 1-10ml ampoules, while LYKXGF2-30 processes 2-30ml vials).
• Material Adaptability: Validate compatibility with amber vials (light-sensitive drugs) and Type I glass/plastic prefilled syringes.

4. Regulatory Compliance

• GMP/ISO Certification: Mandate machines compliant with FDA 21 CFR Part 11 (e.g., LYAGF12 meets GMP standards for electronic batch records).
• Traceability: Integrate barcode/RFID tracking for serialized veterinary product batches, critical for pharmacovigilance.

5. Operational Efficiency

• Speed: Balance throughput (e.g., LYAGF12 achieves 24,000 ampoules/hour) with changeover flexibility for small-batch veterinary generics.
• Energy & Gas Optimization: Evaluate liquefied gas consumption (1.5-2.5 m³/h for LYAGF12 sealing) and nitrogen protection systems to reduce operational costs.

6. Post-Market Support

• Validated Protocols: Demand suppliers provide IQ/OQ/PQ documentation for veterinary-specific validation (e.g., bacterial endotoxin reduction reports).
• Modular Upgrades: Prefer systems allowing future integration with labeling/packaging lines (e.g., Suzhou Lingyao's Washing-Drying-Filling-Sealing Line).