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EO sterilization is a critical process that extends beyond the sterilization chamber, encompassing important considerations throughout the post-sterilization lifecycle.

Medistri’s facility in Székesfehérvár, Hungary operates under an ISO 14001-certified Environmental Management System, extending our structured approach to environmental management across our sterilization infrastructure.

Medistri has expanded its Laboratory Services webpage with a new digital platform designed to make it easier for healthcare companies to explore testing capabilities, identify relevant analyses, and initiate laboratory projects.

As one of the leading international events for the pharmaceutical industry, CPHI Europe brings together organizations and professionals from across the pharmaceutical supply chain to exchange expertise, explore new technologies, and discuss developments shaping drug development and manufacturing.

As medical devices continue to evolve in complexity and innovation, sterilization strategies are increasingly being tailored to individual product characteristics. Device geometry, material composition, packaging systems, and load configurations all influence sterilization performance and contribute to the development of robust, product-specific processes.

The regulatory landscape for medical devices and pharmaceutical products has evolved significantly in recent years. New regulations, increasing scrutiny from notified bodies, and higher expectations regarding process understanding have transformed regulatory compliance into a strategic business function.

At Medistri, Sterilization Validation Review Services help manufacturers review their existing validation strategy, understand how it has evolved over time, and prepare for future industrialization activities. This includes the review of validation documentation and, when appropriate, practical requalification activities.

This article examines the physical chemistry behind post-aeration EO desorption, the two distinct regulatory frameworks it engages, and how a structured characterization programme can close the gap.

Before a medical device reaches industrial production, development activities require packaging configurations capable of supporting product protection, transportation, sterilization evaluations, laboratory testing, and clinical preparation.

Medical device manufacturers frequently manage products composed of multiple components that must be grouped, packaged, identified, and delivered as a single finished system. Whether intended for surgical procedures, hospital use, clinical evaluations, or commercial distribution, kit packaging plays a central role in ensuring that products are prepared according to their intended use, regulatory requirements, and distribution constraints.