Guide for Choosing Right Automatic Sterile Eye Drop Filling and Capping Machines

Selecting the right eye drop filling and capping machine is critical for production efficiency, product quality, and regulatory compliance. Below are key purchasing considerations and a recommended selection process.

1. Key Factors in Equipment Selection

(1) Filling Accuracy & Speed

Filling Range: Must support common eye drop volumes (e.g., 0.5 mL single-dose, 5-15 mL multi-dose).

Accuracy Requirement: Tolerance ≤ ±1% (e.g., ±0.1 mL for a 10 mL specification).

High Accuracy Ceramic Peristaltic Pump Eye Drop Filling Capping Machine RVF2, RVF4 Series 

Material Adaptability: Supports LDPE/PET/PP bottles with varying neck diameters (e.g., 10-20 mm).

Quick Changeover: Modular design for fast mold switching (<15 minutes).

Torque Control: Adjustable range (0.5-3.0 N·m) to prevent over-tightening (bottle deformation) or under-tightening (leakage).

Seal Integrity Testing: Integrated vacuum leak detection or torque sensors to ensure ≥99.5% sealing success rate.

Cleanliness Compliance: Meets GMP Class C or higher (e.g., localized A/B-grade laminar airflow).

Sterilization Compatibility: Critical components (e.g., 316L stainless steel, medical-grade silicone) must withstand gamma/EO sterilization.

Certifications Required:

China: Compliant with GMP (Annex 1 for sterile products) and GB/T 19001.

International: FDA 21 CFR Part 11 (data integrity), EU GMP Annex 1.

Material Certifications: USP Class VI or ISO 10993 biocompatibility reports.

 

2. Recommended Key Features

• Functional Module    Recommended Configuration
• Filling System    Peristaltic pump/ceramic piston pump (prevents cross-contamination) with weight feedback (high precision).
• Capping Head    Servo motor-driven, real-time torque monitoring, automatic rejection of defective units.
• Aseptic Barrier    RABS (Restricted Access Barrier System) or isolator with VHP (Vaporized Hydrogen Peroxide) sterilization.
• Data Tracking    SCADA system for recording filling parameters (time, volume, torque), compliant with FDA ALCOA+ for electronic batch records.

 3. Supplier Evaluation Criteria

Availability of IQ/OQ/PQ validation documents (Installation/Operational/Performance Qualification).

Prior experience in eye drop production (case studies from reputable pharmaceutical companies).

After-Sales Support:

Response time (≤24 hours), spare parts inventory (e.g., filling needles, sealing gaskets).

Cost Transparency:

Clear breakdown of machine cost vs. consumables (e.g., filling nozzles, silicone tubing).

4. Common Issues & Solutions

Issue 1: Residual Liquid Contamination

→ Choose anti-drip nozzles + reverse suction function.

→ Opt for vision-guided alignment (corrects misaligned caps).

→ Require CIP/SIP (Clean-in-Place/Sterilize-in-Place) functionality, especially for multi-product lines.

5. Recommended Procurement Process

Define Requirements: Specify capacity, accuracy, sterility level, etc.

Compare Equipment: Evaluate at least 3 suppliers (use a comparison table).

Factory Audit: Inspect equipment operation and GMP compliance on-site.

Trial Testing: Conduct 72-hour continuous production tests with actual product (monitor OOS rates).

Selecting an eye drop filling and capping machine requires balancing precision, speed, sterility, and compliance. Prioritize suppliers with pharmaceutical industry experience and ensure scalability (e.g., expandable filling heads). Rigorous FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) minimize operational risks.