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Sterilization
Our experts can support you in the development, maintenance, or improvement of your sterility assurance program
Sterilization is the process of rendering product free from viable microorganisms, this is achieved through validated processes. Determination of sterility is based on a sterility assurance level (SAL), this is the probability of a single viable microorganism occurring on an item after sterilization.
Having an effective sterility assurance program in place ensures that product development, right through to product life cycle, yields safe and sterile medical devices.
We can support you with:
• Sterilization training
• Gap analysis
• Validation support (Installation Qualification, Operational Qualification, Performance Qualification)
• Qualification of new/additional sterilization provider(s)
• Execution of protocols and/or drafting of reports
• Annual sterilization review
• Strategy development
• Product adoptions/change assessments
• Project management
• Remediation support
• Auditing of sterilization and/or laboratory provider(s)
• Routine sterilization support e.g., deviations, routine release, record review
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