In the complex landscape of healthcare, ensuring the safety and integrity of medical device packaging stands as a pivotal aspect of patient care. The role of packaging extends far beyond a mere container, serving as a critical barrier against contamination and deterioration. Within this framework, visual inspection emerges as a crucial step, acting as the first line of defense that medical device manufacturers can take in their role in guarding against potential risks of sterility loss and patient infections. Technological advancements have paved the way for innovative solutions, and one such standout is the VIU® system by Van der Stähl Scientific.

The importance of meticulous visual inspection cannot be overstated. Medical packaging is not merely a protective shell; it is a key player in ensuring the safe and effective delivery of drugs, devices, and other medical products. Early detection of defects through visual inspection is instrumental in upholding the sterile delivery of medical devices, directly impacting patient safety. The VIU® (visual inspection unit) is principally designed to help packaging technicians catch medical pouch sealer failures when packaging their medical devices. 

Van der Stahl Scientific’s President Charlie Webb CPPL says “I am always surprised that visual inspection is downplayed as only a marginally valuable quality assurance tool. Human visual keenness and the interpretive brain behind it is unmatched in most environments. High-level machine-driven vision systems have their place, however at the point of packaging this would be an impractical assessment tool. Native Americans had only their vision and manual dexterity to create perfectly straight arrow shafts and to sharpen arrowheads through percussion chipping. With our patented targeted low angle light and 3X magnification to support human visual inspection, it can be one of the most valuable pieces to a medical device packaging group’s quality assurance tool kit.”

The Role of VIU System in Visual Inspection:

Van der Stähl Scientific’s VIU® system goes beyond conventional inspection methods, offering a comprehensive solution that standardizes and enhances the visual inspection process. What sets it apart is the ability for line operators to evaluate raw visual seal performance right at the point of packaging. The system aligns with industry standards for visual inspection, notably the ASTM F1886 visual standard which is used to determine the integrity of seals for flexible packaging by visual inspection (Standard test method, n.d.). 

The standard underscores the significance of visual seal characteristics and defects in providing evidence of package integrity and production sealing problems. The VIU® system’s ability to standardize visual inspection under the same lighting and magnification conditions aligns with the principles outlined in the ASTM F1886 standard, further emphasizing its robust capabilities. This system ensures that all inspectors, irrespective of their individual factors, assess seal conditions under consistent lighting and magnification and introduces a standardized approach to visual inspection, a feature that significantly elevates the reliability and accuracy of the entire process. In addition to aligning with the ASTM F1886 standard, the systems additional benefits include:

1. Standardization and Consistency:

The VIU® system introduces a level of standardization previously unmatched in visual inspection. Consistent lighting and magnification across all inspections contribute to reliable and reproducible results.

2. Data Logging and Traceability:

In addition to its visual inspection capabilities, the VIU® system excels in data management. Line-item data includes vital information such as date, time, operator name, failure identification, or pass/fail conditions and the ability to enter the sealers serial number that created the seal. The insertion of lot numbers allows for traceability, creating a comprehensive record invaluable for internal audits.

3. Ease of Use and Ergonomic Design:

User experience is prioritized with the VIU® system’s simple menu steps and a pass/fail button reduces the likelihood of input errors, making the system user-friendly for operators of varying expertise levels.

4. Integration with Testing Processes:

For testing labs that need tinsel testing the VIU® system is integrated with the PTT-100V seal strength testing device, providing a comprehensive solution for both destructive and nondestructive pouch performance testing. Calibration according to ISO 17025 standards ensures the reliability and accuracy of testing processes.

5. Reference Database for Seal Anomalies:

SEAL STATS® integration enriches the VIU® system’s capabilities by providing access to a comprehensive visual seal reference database. Packaging engineers can efficiently compare visual seal anomalies against known failures, facilitating the identification of specific issues and optimal solutions. Van der Stähl Scientific also offers an iPhone app Seal Stats® that provides quick access to potential seal failure modes.

6. Data Purge for Efficient Records Management:

After a medical packaging run, the VIU® system allows for the purge of stored inspection events. Line events can include markers such as lot number, date of inspection, pass/fail, operator name, and failure codes. This record serves as an important reference for internal audit archives, streamlining record management and ensuring a thorough historical perspective.

Enhancing Safety, Compliance, and Efficiency 

The VIU® system is not just a tool; it’s a cornerstone for enhancing safety, ensuring compliance with regulatory standards, and streamlining efficiency in medical device sterile packaging. Regulatory bodies, including the FDA, impose stringent guidelines for medical packaging to uphold the highest standards of safety. Non-compliance with these standards can lead to severe consequences, including packaging recalls. The VIU® system offers a proactive approach to compliance, ensuring that medical packaging meets and exceeds these stringent regulatory benchmarks.

Investing in medical packaging testing, including the VIU®   System, may incur costs, however the potential consequences of neglecting this crucial step far outweigh the associated expenses. The VIU®   system is not just an investment in equipment; it is an investment in patient safety and the reputation of the organization, as well as the efficiency of healthcare packaging processes.

In the dynamic landscape of healthcare, where patient safety, regulatory compliance, and environmental consciousness are non-negotiable, the VIU®   system emerges as an indispensable asset for medical device manufacturers and healthcare facilities alike. By offering a standardized, efficient, and technologically advanced approach to visual inspection, Van der Stähl Scientific’s VIU®   System sets a new standard in medical packaging integrity. 

As the healthcare industry continues to evolve, embracing innovative solutions like the VIU®   System becomes imperative for safeguarding patient well-being, maintaining the integrity of medical devices, and meeting the highest standards of quality and compliance. In an era where excellence is not just a goal but an expectation, the VIU®   System paves the way for a safer, more compliant future in medical device packaging.


 Standard test method for determining integrity of seals for flexible packaging by visual inspection. F1886/F1886M. (n.d.).