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Selecting the right partner for medical device packaging is not just a business decision, it’s a matter of patient safety, regulatory compliance, and long-term reliability. At Van der Stähl Scientific, we understand that every seal, every test, and every validation step contribute to protecting patients from exposure to non-sterile devices. With over 30 years of […]
In sterile medical device packaging, safety is engineered long before a device ever reaches the surgical suite. The sterile barrier system is not simply a wrapper; it is a functional component of the device itself. Its design determines whether sterility is maintained through sterilization, distribution, storage, and ultimately the moment of aseptic presentation. ISO 11607 […]
Vacuum packaging has become an essential part of modern medical device manufacturing, especially for products that require a stable, sterile, and tightly controlled environment. As devices become more complex and sensitive, particularly drug‑device combination products, the need for advanced sterile barrier protection continues to grow. Vacuum sealing offers a powerful solution by removing harmful ambient […]
Hospital Sterile Processing Departments (SPDs) are the final checkpoint between a sterile medical device and the patient. While sterilization processes often receive the most attention, the integrity of the sterile barrier system is equally critical. A single weak or inconsistent seal can compromise sterility, trigger a recall, or put a patient at risk. For this […]
Human factors have become one of the most critical considerations in medical device packaging validation, sterile barrier design, and the overall safety of medical devices. While packaging materials and sealing technologies continue to advance, the human element remains a major source of variability, risk, and potential failure. Research shows that humandevice interaction, cognitive load, and […]
Self-sealing pouches and heat-sealing pouches are both widely used in hospitals and sterile processing departments, yet they are not equal in terms of control, repeatability, or compliance with modern sterile barrier expectations. As medical device packaging continues to evolve, hospitals are increasingly expected to align their practices with the same rigor that medical device manufacturers […]
Medical device packaging shelf life is a critical component of patient safety and regulatory compliance. A sterile barrier system must maintain integrity from the moment it is sealed through sterilization, distribution, storage, and ultimately to the point of use. ISO 11607 and FDA guidance define the framework for proving that your packaging system can reliably […]
Medical device packaging is more than a protective shell, it’s a sterile barrier system, a regulatory requirement, and a critical component of patient safety. This guide breaks down the major types of medical device packaging, the materials used, and how to select the right system for your device to ensure sterility and support compliance with ISO 11607.
Visual inspection is a critical, non‑destructive first line of defense for medical pouch seal integrity, guided by ASTM F1886. It catches visible defects early, informs root‑cause analysis, and should be part of a layered testing strategy to protect patients and reduce recall risk. Importance of Visual Inspection Visual inspection provides immediate, low‑cost detection of gross […]
