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Glossary Term
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Packaging Validation

Definition

Packaging validation is the process of ensuring that the packaging system for a medical device or pharmaceutical product is capable of maintaining the required product integrity throughout its shelf life. This includes verifying that the packaging protects the product from contamination, damage, and degradation during storage, transport, and use. Packaging validation ensures that the packaging materials, design, and sealing processes meet regulatory requirements and that they perform as intended under real-world conditions.

Relevance to the MedTech Industry

Packaging validation is critical for ensuring the safety, sterility, and effectiveness of medical devices and pharmaceutical products. It provides assurance that the packaging will protect the product from external factors such as moisture, temperature, light, and microbial contamination. Proper validation is required to comply with regulatory standards such as ISO 11607, FDA regulations, and other quality standards, helping manufacturers maintain patient safety and product efficacy.

Additional Information & Related Terms

Related Terms

  • Sterility Assurance: Packaging validation is a key component of sterility assurance, ensuring that sterile products remain uncontaminated throughout the product’s lifecycle.

  • ISO 11607: A set of standards outlining packaging requirements for medical devices, ensuring that packaging systems maintain product sterility and integrity.

  • Packaging Integrity Testing: Often part of packaging validation, this involves specific tests to assess the protective qualities of the packaging, such as seal strength or leak detection.

  • Quality Management System (QMS): Packaging validation is an integral part of a QMS, ensuring that packaging processes and materials consistently meet quality standards and regulatory requirements.

  • Barrier Systems: These systems are packaging mechanisms designed to protect medical devices or pharmaceuticals from external factors such as moisture, light, or contaminants, critical to packaging validation.

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