Disposable irrigation-suction devices are critical surgical instruments with complex structures (e.g., handles, tubing, valves) and diverse materials (polymers, silicone, metals). Their sterilization and packaging processes must address the following aspects to ensure patient safety and clinical efficacy:

1. Sterilization Method Selection and Validation

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2. Method Compatibility

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• Ethylene Oxide (EtO) Sterilization: Preferred for heat-sensitive polymers (e.g., ABS handles, silicone tubing). Parameters: temperature (40-60°C), humidity (40-80% RH), exposure time (2-6 hours).

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• Gamma Radiation: Suitable for all materials but requires validation of dose effects (25-50 kGy) on polymer integrity (e.g., silicone embrittlement, PC yellowing).

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• Steam Sterilization Limitation: Contraindicated for devices with heat-sensitive components (e.g., electronics, precision valves).

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4. Sterilization Efficacy Validation

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• Biological Indicators: Use Bacillus atrophaeus spores (ATCC 9372) to confirm Sterility Assurance Level (SAL≤10⁻⁶).

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• Penetration Testing: For multi-lumen tubing, place chemical indicators internally to verify EtO gas penetration.

2. Residual Control

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2. EtO and Byproducts

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• Limits: EO≤4 μg/g, ECH≤9 μg/g (ISO 10993-7).

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• Aeration Process: 48-72 hours at 50-60°C with forced ventilation to accelerate residual release.

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4. Radiolysis Byproducts

• Gamma radiation may generate formaldehyde from polymers. Detect via headspace GC (limit≤10 ppm).

3. Packaging System Design

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2. Material Selection

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• Primary Packaging: Medical-grade paper + PET/PE film compliant with ISO 11607 (breathability, microbial barrier).

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• Secondary Packaging: Corrugated boxes with compressive strength≥300 N/cm² to prevent damage during transit.

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4. Seal Integrity

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• Heat Seal Parameters: Temperature 150-170°C, pressure 0.3-0.5 MPa, time 1-2 seconds. Seal strength≥3.5 N/15mm (ASTM F88).

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• Leak Testing: Use dye penetration or vacuum bubble tests to validate seal integrity.

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4. Aging Validation and Shelf Life

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2. Accelerated Aging

• Conditions: 55°C±2°C for 6 weeks (equivalent to 3 years). Test package seal strength and device performance.

• Real-Time Aging: Conduct long-term stability studies (25°C/60% RH) in parallel.

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4. Performance Stability

• Post-sterilization validation of handle actuation force, tubing flow rate (±10% deviation), and valve sealing (leak rate≤1 mL/min).

5. Labeling and Traceability

1. Label Information

• Specify sterilization method, expiration date, batch number, UDI, and contraindications (e.g., "Do not re-sterilize").

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3. Traceability System

• Establish data linkage from raw materials to finished products for rapid batch recall.

6. Risk Control for Special Features

1. Multi-Lumen Tubing

• Conduct lumen pressure tests to confirm no EtO residue retention.

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2. Precision Valves

• Disassemble or protect valves before sterilization to prevent lubricant degradation by EtO.

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3. Electronic Handles (if applicable)

• Use radiation sterilization to avoid circuit corrosion from EtO.

Conclusion

Sterilization and packaging of disposable irrigation-suction devices require a holistic approach focusing on material compatibility, sterilization efficacy, and packaging robustness. Manufacturers should conduct extreme condition tests (e.g., over-temperature sterilization, mechanical vibration) and adhere to ISO 13485 for end-to-end quality control. Future trends include low-temperature plasma sterilization, smart packaging (indicator-based alerts), and biodegradable materials.