This service involves developing and validating sterilization cycles tailored to specific client needs. Cycle development ensures optimal performance of the autoclave across various loads and conditions, maximizing efficiency and compliance with standards.

Offering expert advice on Performance Qualification and Cycle Development, we help you understand and implement best practices that enhance autoclave effectiveness and compliance.

Our team authors comprehensive and compliant documentation for Cycle Development, Performance Qualification, and Requalification (RQ) of autoclaves. We ensure that all documentation meets regulatory requirements and supports effective validation strategies.

NIST Calibration services ensure that all measurement instruments used in the validation process are accurately calibrated according to the National Institute of Standards and Technology (NIST) guidelines. This service guarantees precision in all recorded data and compliance with industry standards.

Our VHP Cycle Development (CD) Execution service ensures that your sterilization process is implemented flawlessly. We manage the setup, operation, and monitoring of the VHP cycle according to the bespoke protocols detailed in the CD documentation. This hands-on approach guarantees that all aspects of the cycle development are adhered to, maximizing the efficacy and reliability of your sterilization processes.

In our Performance Qualification (PQ) Execution service, we oversee the practical application of the PQ protocols to ensure that your VHP sterilization system performs optimally when it matters most. This includes conducting rigorous testing and gathering data to validate the system’s performance against the defined acceptance criteria, providing you with the assurance that your equipment meets all necessary operational standards.

Performance Qualification is the final step in the validation process. This service tests the autoclave’s performance with maximum loads, ensuring it consistently delivers the required sterility assurance levels and adheres to all regulatory requirements.  We conduct maximum runs in triplicate, and include all temperature data and SAL analysis.  We also provide a final report.

Select the right Biological Indicators (BIs) for your sterilization processes with our expert guidance. We help you choose the most appropriate BIs based on your specific applications, ensuring effective monitoring and validation.

Manage your validation documents with our professional services, ensuring they are up-to-date, easily accessible, and compliant with current standards. We help organize and maintain your documentation to support ongoing compliance and audits.  Our company utilizes Box.com. 

Our VHP Cycle Development (CD) Document Authoring service provides a comprehensive guide for setting up your Vapor Hydrogen Peroxide sterilization processes. Tailored to meet your specific needs, this documentation includes detailed descriptions of cycle parameters, equipment setup, and safety protocols, ensuring a seamless integration into your operations and compliance with regulatory standards.

Performance Qualification (PQ) Document Authoring focuses on creating detailed procedures to verify that your VHP systems operate effectively under actual production conditions. Our service includes the development of validation protocols that detail the criteria for acceptance, testing methodologies, and documentation practices to confirm system performance and compliance with industry guidelines.