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1,4-Butanediol diglycidyl ether (BDDE, CAS No. 2425-79-8) is a chemical compound widely used as a crosslinking agent in the manufacture of hyaluronic acid (HA)-based dermal fillers. Its primary function is to enhance the durability and longevity of these products by binding to HA molecules, increasing their resistance to enzymatic degradation. Given its extensive use in medical and cosmetic applications, ensuring the safety and quality of BDDE-crosslinked products is essential. A key aspect of this assurance lies in the accurate detection and quantification of residual BDDE in HA-based dermal fillers.

In Sterilisation, the configuration of the load plays a decisive role in ensuring the effectiveness, safety, and consistency of the process. At Medistri, we support our customers by delivering sterilisation solutions that offer controlled flexibility - always in full compliance with industry and international standards. Managing load variables effectively means not only meeting regulatory requirements but also gaining operational efficiency and efficacy throughout the supply chain.

Medistri is proud to expand our comprehensive testing capabilities to include specialized food contact material testing - a critical requirement for manufacturers across the food and packaging industries. Drawing on our established expertise in laboratory testing and quality assurance, we've recently developed this new service to address growing market needs.

As the medical industry advances, devices are becoming more compact & connected. Many of today’s innovations include integrated electronics - microchips, sensors, batteries, or embedded software, that allow for monitoring, adjustment, or data transmission. These features improve patient outcomes, but they also create new challenges when it comes to sterilisation.

Medical Device and Pharmaceutical companies must ensure their products are safe for use and compliant with international regulations. Extractables and Leachables (E&L) testing plays a key role in this effort, as outlined in standards such as ISO 10993 and the United States Pharmacopeia (USP). At Medistri, we provide comprehensive E&L analyses to support product development, regulatory submissions, and patient safety.

Sterilization is a critical process for ensuring the safety and efficacy of pharmaceutical products, particularly in packaging and injectable solutions. Medistri offers contract sterilisation services that meet rigorous pharmaceutical manufacturing standards. 

We are pleased to announce that Medistri has expanded its scope of services under the Swiss Accreditation Service (SAS). Since its founding in 2006, Medistri has grown into a leading provider of contract sterilization and laboratory services for healthcare companies, becoming a trusted partner for businesses in the pharmaceutical, medical device, and biotechnology sectors.

At Medistri, we recognize the critical importance of cytotoxicity testing in the development and approval of medical devices. These tests are not merely regulatory checkboxes but are fundamental to ensure that materials used in medical devices are biocompatible and safe for direct human contact. This blog delves into the sophisticated methodologies we employ and the standards we adhere to, ensuring the highest level of safety and compliance.

Steam sterilization is an efficient and reliable method for decontaminating medical devices and pharmaceuticals. By exposing products to saturated steam at temperatures between 121°C and 134°C, this process ensures thorough microbial eradication while preserving product integrity. Carefully controlled temperature, pressure, and humidity provide an optimal environment for steam to effectively sterilize every surface. The result is a trusted solution that maintains the functionality of your products while ensuring their safety.

At Medistri, we specialize in the precision-driven assembly, packaging, and sterilization of medical devices or pharmaceutials, catering to both emerging startups and established companies. Our process is designed to support the unique needs of each client, from prototype development to routine large-scale production.