Technical requirements for sealing vacuum sterilization bags for medical devices

Sealing Temperature and Time
Temperature Requirements: The sealing temperature should be within 165–205°C. This range is determined based on the melting point and heat-sealing properties of the sterilization bag material, ensuring that the sealing area is fully melted and tightly bonded to form a robust seal.
Time Requirements: The sealing duration should be 1–3 seconds. The required time depends on temperature, pressure, and material characteristics. Insufficient time may compromise seal strength, while excessive time may damage the material or affect sterilization efficacy.

Sealing Pressure
Sealing pressure should be maintained between 0.15–0.3 MPa. Appropriate pressure ensures tight bonding of materials at the seal, enhancing strength and sealing integrity.

Sealing Materials
The sealing materials used for medical sterilization bags must comply with relevant national and industry standards (e.g., ISO, ASTM), which strictly regulate physical properties, chemical stability, and biocompatibility.
The sealing material must be compatible with the primary material of the sterilization bag to ensure seal durability and integrity.

Sealing Quality Inspection
Each sterilization bag must undergo post-sealing quality checks, including:

• Visual inspection: Ensure the seal is smooth, defect-free, and aesthetically consistent.
• Seal integrity testing: Methods such as dye penetration or bubble emission tests to detect leaks.
• Strength testing: Use tensile testing machines to verify seal strength meets requirements.

Additional Requirements

• Labeling: Clearly display production date, expiration date, manufacturer, batch number, and usage instructions for traceability and proper use.
• Ease of opening: The seal should be easy to open, with a user-friendly design to prevent contamination during access.
• Material transparency: Packaging materials must allow visibility for internal item inspection.
• Clean environment: Maintain a dust- and contaminant-free workspace during sealing to prevent quality defects.

Summary
The technical requirements for sealing medical instrument vacuum sterilization bags encompass temperature, time, pressure, material compliance, quality inspection, and auxiliary specifications. These standards ensure seal quality aligns with regulatory and safety benchmarks, safeguarding the sterility and efficacy of medical devices.