Microbiology & Sterilization Services

This page is under construction.

However, the following is an example of services available within the areas of sterilization & irradiation processes, filtration processes and cleaning (CIP/SIP). This includes autoclaves, isolator systems, lyophilizers, steam sterilizers, dry heat sterilizers, radiation sterilizers, ethylene oxide sterilizers, clean water, compressed air and HVAC.

• Preparation, review and approval of validation documentation, SOP's, quality specifications and purchase specifications.
• Risk analysis, Factory Acceptance Testing /Site Acceptance Testing, selection of supplier, system mock‑ups.
• Microbiological qualification and evaluation.
• Audits of manufacturers and processes.
• Specialist support for questions, e.g. from authorities or manufacturing sites regarding sterilization processes, filtration and cleaning. Review and approval of reports sent to authorities.
• Development and optimization of load configurations and processes for sterilization and cleaning.
• Development and evaluation of alternative sterilization technique (e.g. high energy visible light, gas plasma, gas, cryo-radiation).
• QA evaluation of sterilization deviations, and corrective and preventive actions.
• Enumeration of commercially available biological indicators. Development of sporulation methodology and preparation of spore suspensions. Spore resistance determinations for wet heat, e.g. steam sterilization, in different liquids (water, buffers, viscous solutions).