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Key Considerations for Selecting Vial Filling Machines in Veterinary Injectable Production

Key Considerations for Selecting Vial Filling Machines in Veterinary Injectable Production

2014-04-08

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).

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News Details
Created with Pixso. Home Created with Pixso. News Created with Pixso.

Key Considerations for Selecting Vial Filling Machines in Veterinary Injectable Production

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).