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EN ISO 11607-2 complements Part 1 by focusing specifically on the validation and routine control of sealing processes used to create sterile barrier systems. It mandates that heat sealing and other closure processes must be validated to ensure consistent seal strength and integrity.
The validation framework includes:
- IQ(Installation Qualification): Verifying the sealing equipment setup
- OQ(Operational Qualification): Confirming process parameters operate within acceptable limits
- PQ(Performance Qualification): Demonstrating consistent performance under actual production conditions
To support our partners in meeting EN ISO 11607-2, Hopeway AMD provides Sealing Test Cards designed for routine OQ and PQ testing. The cards allow visual inspection of seal width, uniformity, and temperature exposure across the sealing jaw. We offer both 121°C and 134°C versions, suitable for use with rotary and impulse sealing machines.
Validation Tools:
- AMD Sealing Test Card (for Steam sterilization)
All sealing indicators are manufactured under ISO 13485 and validated in accordance with EN 868-4 and EN ISO 11140-1. Technical data sheets and test protocols are available upon request.
This technical framework ensures that seal integrity is not a matter of assumption, but a result of data-driven, documented validation.
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