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Sealer validation is integral to ensuring the reliability of medical device packaging, yet it is often perceived as complex and time-consuming. This process involves extensive parameter development, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Adding post-validation process verification further increases the complexity, as well as the need for long-term reliability. Each stage of sealer validation and verification comes with unique challenges that demand complementary and precise test methods to assess the quality of sealed packages.

Why Seal Quality Matters?

Seal quality is critical for ensuring the safety and efficacy of medical devices. Traditional inspection methods often fail to address the combined importance of seal consistency, strength, and integrity, creating potential quality gaps.

Heat-sealed packages for sterile or sensitive contents must meet stringent standards to maintain sterility and prevent contamination. Advanced inspection methods like vacuum decay or helium leak detection help ensure seal reliability and regulatory compliance. High-quality seals are essential for patient safety and maintaining product performance throughout its lifecycle.

Leveraging Deterministic and Non-Destructive Testing Technologies

A common misconception about adopting advanced technologies like deterministic and non-destructive testing (NDT) is that they involve significant costs and operational complexities. In reality, these technologies—particularly airborne ultrasound—offer a streamlined, cost-effective solution for validating heat seals without compromising on quality or efficiency.

Airborne ultrasound technology provides accurate, non-destructive inspection of sealed packages, enabling the detection of defects such as channel leaks, weak seals, or inclusions. By offering deterministic results, this method eliminates subjective interpretations and enhances confidence in the seal quality.

The Advantages of Outsourcing and Flexible Solutions

Outsourcing seal quality testing or temporarily acquiring the necessary equipment can significantly reduce the financial and operational burden of sealer validation. PTI’s Seal Quality Assurance Program delivers tailored services designed to meet both short-term and long-term needs, offering flexibility and scalability. This approach allows organizations to:

• Expedite the sealer validation process.
• Ensure compliance with regulatory requirements.
• Enhance the overall reliability of heat-sealed packaging.
• Minimize capital expenditures by utilizing outsourced expertise.

Airborne Ultrasound Inspection: A Game-Changer for Sealer Validation

PTI’s Seal Quality Assurance Program leverages the power of airborne ultrasound inspection to address the most complex challenges in sealer validation. Whether you require a one-time project solution or an ongoing testing partnership, our services provide high-quality results that align with the evolving demands of medical device packaging.

Through advanced inspection methods, we help organizations achieve unmatched quality, consistency, and reliability in their sealing processes. With a focus on flexibility and precision, PTI’s services are the cornerstone of modern sealer validation.

Airborne ultrasound inspection revolutionizes sealer validation by ensuring precision, compliance, and reliability in medical device packaging. PTI’s flexible solutions empower organizations to achieve superior seal quality with efficiency and confidence.