In-depth insights into the machinery and methods used in sterile packaging environments, from vacuum sealing benefits to choosing between heat-seal and self-seal pouching systems.
The Sealer decision that defines your validation choosing a pouch sealer for sterile medical device packaging is not simply an equipment decision, it is a quality system decision. The sealer you select defines your validation pathway, determines your throughput ceiling, influences your sterility assurance level (SAL), and shapes every FDA or EU MDR audit conversation […]
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 […]
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 […]
