Sterilization: What is it? Any procedure that eliminates, destroys, or deactivates all life is called sterilization. The word “sterile,” which denotes the total absence of live microorganisms or microbes with the capacity to proliferate, is associated with sterilization. As a result, after being put in their final packing, sterile products that go through sterilization are…
Aseptic manufacturing: what is it? A number of aseptic procedures carried out in a sterile setting make up aseptic production. By keeping germs out, an aseptic procedure avoids contamination. In order to prevent microbiological contamination, aseptic healthcare goods are manufactured and packaged in controlled settings. In order to prevent medical devices or products from…
Tackling Field Inventory Visibility: Reducing Risk and Costs through Advanced Tracking Key Takeaways Field Inventory Visibility is a Major Challenge: Medical devices and loaner kits are spread across hospitals, sales reps, and regional storage, making real-time tracking difficult and increasing the risk of lost or underutilized inventory. Compliance with UDI and Traceability Mandates…
Key Takeaways Next-Generation Materials – Biodegradable and recyclable options are emerging but must meet strict sterility and durability standards. Waste Reduction Strategies – Optimized design and material efficiency reduce waste while ensuring protection and compliance. Eco-Friendly Sterilization Advances – New methods like e-beam and vaporized hydrogen peroxide offer sustainable alternatives to traditional sterilization.…
How to Validate Sterilization for Products Sterilized by Radiation What does “sterile” mean according to the US Food and Drug Administration (FDA)? According to the most stringent definition, a product or object is considered sterile if all living microorganisms—including bacteria, yeasts, viruses, and molds—are completely absent. Sterile is defined for regulatory reasons using…
Methods for Measuring Ethylene Oxide Residuals via Extensive Extraction EtO gas and EtO sterilization: what are they? The chemical gas ethylene oxide, sometimes known as EO or EtO, is frequently used to sterilize medical equipment and supplies. ethylene oxide is powerful and deeply penetrating alkylating agent. Because of these qualities, it works incredibly well as…
Why Proactive Risk Management is Critical in Medical Device Packaging Key Takeaways Common Packaging Risks – Early identification of material incompatibility, sterilization failures, and regulatory non-compliance prevents costly delays. Early Integration Benefits – Proactively assessing risks in packaging design streamlines validation and accelerates market readiness. Validation Strategies for Compliance – Implementing FMEA, environmental testing, and…
The High Cost of Inefficient Inventory Management In the medical device industry, inventory inefficiencies create significant challenges that affect costs, product availability, and patient outcomes. Traditional inventory management strategies often require keeping large stockpiles of products to address unpredictable demand. However, this approach can tie up working capital, increase storage costs, and struggle to…
What are medical devices? Numerous nonpharmaceutical products used for illness treatment, monitoring, or prevention are categorized as medical devices. For instance, the concept of a medical device includes mechanical devices, combination devices, and medical instruments (electronics). Certain combination devices contain biological, pharmacological, or chemical ingredients. Medical devices also include surgical instruments, implanted devices, and…
Key Takeaways Packaging and sterilization must be aligned to ensure sterility, compliance, and product integrity. Prevalidated sterile barrier packaging reduces validation delays and accelerates time-to-market. Material compatibility testing is essential when transitioning to new sterilization methods. Sterilization disruptions can impact packaging workflows, making contingency planning critical. The Critical Link Between Packaging and Sterilization Sterile medical…