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Sterilization Process Evaluation
Testing support for evaluating the effectiveness of applicable sterilization processes.
Laboratory testing to support the evaluation and verification of sterilization processes and the microbiological condition of applicable medical devices and surgical instruments.
Overview
Sterilization is a critical consideration for medical devices and surgical instruments intended to be supplied in a sterile condition or subjected to sterilization before use.
Sterilization testing provides laboratory information that can help manufacturers evaluate the effectiveness and consistency of applicable sterilization processes.
Our testing approach is structured around the device, sterilization method, applicable requirements, and requested testing scope.
Testing Scope
Testing activities are selected according to the device, materials, intended use, applicable requirements, and testing objectives.
Testing support for evaluating the effectiveness of applicable sterilization processes.
Laboratory evaluation of applicable samples for evidence of microbial growth under defined test conditions.
Testing and documentation related to microbiological conditions associated with sterilized medical devices.
Structured reporting of test samples, methods, observations, results, and applicable conclusions.
ISO 11737 series
Applicable sterilization standards
Applicable microbiological testing requirements
Customer-specific sterilization requirements
Our Approach
A structured process helps ensure that testing requirements, samples, methods, and reporting are clearly defined.
Review the device, packaging condition, sterilization method, and requested testing requirements.
Receive, identify, and document samples submitted for testing.
Perform the applicable sterilization or sterility evaluation according to the selected method.
Evaluate laboratory observations and results against the applicable criteria.
Issue a documented report containing sample information, test methodology, results, and relevant observations.
Sterilization-related testing requires appropriate sample identification, controlled laboratory conditions, and documented test procedures. Results are recorded and reviewed against the requirements applicable to the selected testing method.
The resulting documentation can support manufacturers' quality records and technical documentation relating to sterilization and microbiological safety.
Sterilization testing involves laboratory evaluation associated with the effectiveness or microbiological condition of products subjected to a sterilization process.
The applicable testing approach depends on the sterilization method and the specific product. The testing scope should be confirmed before sample submission.
Not necessarily. Sterility testing is a specific microbiological test, while sterilization evaluation can involve broader assessment of the sterilization process and its effectiveness.
