Sterilisation Validation
Sterilisation Validation
At Normec, we ensure your sterilization processes meet the highest standards for sterile products, so you can produce with confidence.
Working together towards a compliant and optimized sterilization process
We support you throughout the entire validation process – from initial evaluation and cycle development to ongoing requalification. Our experts work with you to create a tailored plan with clear milestones and timelines, giving you a structured and efficient approach to ensure continuous compliance and process optimization.
Tailored Sterilization Validation Solutions
At Normec , we ensure that your equipment complies with the strictest regulations, using calibrated measuring equipment to verify that the required temperatures are consistently maintained throughout the entire sterilization process. To further confirm sterility, we perform biological validation using biological indicators.
Our Sterilization Validation Services
Our sterilization validation services are designed to meet the specific needs of your organization and processes. We offer, among other things:
Cycle Development: Designing sterilization cycles tailored to your product and process requirements.
Load Development: Optimizing load configurations during sterilization to achieve the best results.
Thermal Mapping: Validating temperature distribution within your sterilization equipment to ensure consistency.
Biological Challenge Testing: Using biological indicators to confirm sterilization effectiveness.
Accurate Testing Equipment: We use calibrated measuring devices to guarantee precise measurements during the validation process.
Our Approach
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Phase 1: Let’s Get to Know Each Other
In this first phase, we take a deep dive into your sterilization process. What are the specific requirements of your products and operations? Which sterilization methods and loads are best suited? Together, we create a customized solution that fully meets your needs, with the right equipment and regulatory framework, complete with milestones and timelines.
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Phase 2: Tailored Sterilization Validation
Our experts develop a solution that seamlessly fits your needs. We evaluate risks, benefits, and budgets to determine the most suitable sterilization method and provide a detailed validation plan.
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Phase 3: Cycle and Load Optimization
We optimize your sterilization cycle and load configurations to ensure everything operates efficiently and compliantly. At the end of this phase, you will have a fully developed cycle, ready for qualification.
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Phase 4: Qualification and Validation
We qualify your sterilization process to ensure compliance and effectiveness. Through thermometric and biological testing, we verify that your sterilization process meets all requirements.
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Phase 5: Ongoing Requalification and Support
We provide ongoing support with requalification and process updates to keep your sterilization operations compliant and efficient, ensuring that you always meet the latest regulatory standards.
Compliant Solutions, Every Step in Life Sciences
Sterilization validation is a crucial component of your production and quality processes. With Normec as your partner, you are assured of a reliable and flexible solution fully tailored to your needs. We guide you through the entire process, ensuring that your sterilization operations meet the highest standards, now and in the future.
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