Impulse Sealers for Medical Device Packaging: ISO 11607 Compliance Guide

Medical device packaging is one of the most demanding applications for heat sealers. The seal is part of the sterile barrier system — if it fails, the device is no longer sterile, and patient safety is compromised. ISO 11607 sets the framework for packaging validation, and the sealer you choose must support every requirement.

What ISO 11607 Requires from Your Sealer

ISO 11607 (Parts 1 and 2) requires that sterile barrier packaging be validated through a defined process. For heat-sealed packaging, this means:

• Process parameters must be defined and controlled — temperature, pressure, and dwell time must be set, measured, and maintained within validated ranges
• Seal integrity must be verified — peel testing (ASTM F88), burst testing (ASTM F2054), and dye penetration testing must confirm the seal meets specifications
• The process must be reproducible — the same parameters must produce the same results across shifts, operators, and production runs

Impulse Sealers vs. Constant Heat Sealers for Medical Packaging

Both impulse and constant heat sealers are used in medical device packaging. The choice depends on your materials and production requirements:

Impulse sealers heat only during the seal cycle. This means no continuous hot surfaces, no burn risk to operators, and no heat degradation of temperature-sensitive products between cycles. Fujiimpulse OPL series sealers with ONPUL add direct temperature measurement and control at the seal surface.

Constant heat sealers maintain temperature continuously. They are typically used for sealing Tyvek pouches and other materials that require sustained heat and pressure.

IQ/OQ/PQ Validation Process

Installation Qualification (IQ): Verify the equipment is installed correctly, utilities are connected, and the machine meets its design specifications.

Operational Qualification (OQ): Test the equipment across its operating range. For ONPUL-equipped sealers, this includes verifying temperature accuracy, pressure consistency, and timer precision at multiple settings.

Performance Qualification (PQ): Run production-representative cycles and verify that the sealed packages meet seal strength, integrity, and sterile barrier requirements.

Why Medical Device Companies Choose Fujiimpulse

Fujiimpulse sealers serve medical device packaging operations at companies including Medtronic, Stryker, and other leading manufacturers. The ONPUL temperature control system provides the process control that validation protocols demand.

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