Sterilization Validation

No matter the method, we have experience developing processes, validating cycles, and assessing products to ensure process efficacy and product / material appropriateness

Back to our beginnings…

Every story has a beginning, this is ours. While time has brought diversification in experience and expertise, sterilization is where it all began. With decades of experience in every mainstream sterilization method, we’re confident we can support any of our client’s needs.

Common Sterilization Methods:

  • Ethylene Oxide

    Development and validation of an ethylene oxide sterilization process (especially from scratch) is as much art as it is science. Fortunately, with years of hands-on experience, engagement in the ISO 11135 standard development committees, and hands-on management of sterilization vendors - we’ve built a track record of success for our customers. From cycle development, validation protocol development, validation execution, cycle maintenance and change management - we’ve got you covered. There’s no job too small or too large in for Gezellig in EO sterilization.

  • Radiation

    Whether produced from Cobalt-60, a direct electron beam, or X-Rays, ionizing radiation is a tremendous method of industrial sterilization. As committee members and participants in the development of the ISO 11137 series of standards, we have a deep knowledge of the requirements associated with radiation sterilization and years of experience validating radiation sterilization processes. Get in touch today to discuss your radiation sterilization project and see how we might partner with you to bring about efficient and effective radiation validations and process maintenance.

  • Steam (Moist Heat)

    Steam sterilization is one of the oldest and most common forms of sterilization employed in healthcare today, especially at point-of-care facilities. Gezellig Scientific has a wealth of experience in validating these processes at both the industrial and end-user facility. Whether your looking to validate the steam sterilization of an elastomeric stopper for a drug container, or looking to develop end-user instructions for cleaning, disinfection, and sterilization of a medical device - Gezellig has you covered.

Fortunately (and unfortunately) there are a wide variety of less utilized sterilization modalities; each serving their own specific purpose or niche. If you need help understanding these methods, e.g., VHP, Gas Plasma, Noxilizer, Ozone, UV, etc., and how they may benefit a specific product or project you’re working on - let us know. We have experience working with and validating almost every standard or fringe sterilization technology available.

Ensuring your most critical processes are validated to the
highest standards.

The proper validation and maintenance of cleaning and sterilization processes are essential elements of ensuring patient safety and product performance. With over 30 years of combined experience in medical device sterilization and cleaning validation, Gezellig Scientific is positioned to provide the most up-to-date guidance on industry practices and requirements related to sterilization and cleaning whether terminally as part of manufacturing, or to support instructions within the directions for use carried out at the end-user facility.