Connecting Across Competencies: Leveraging Best Practices for Processing.

Area of Science:

• Medical Device Manufacturing
• Analytical Chemistry
• Regulatory Compliance

Background:

• The Association for the Advancement of Medical Instrumentation (AAMI) working group ST/WG 93 is developing the AAMI ST98 standard.
• This standard focuses on the cleaning validation of reusable medical devices, building upon AAMI TIR30:2011/(R)2016 guidance.
• Current practices for test method suitability in cleaning validation involve one positive control and extraction efficiency testing.

Purpose of the Study:

• To explain the rationale behind the proposed change in the AAMI ST98 standard.
• To discuss the impact of increased replicates on cleaning validation for manufacturers.
• To highlight the importance of understanding variability in method extraction during suitability testing.

Main Methods:

• The article discusses analytical best practices considered for the AAMI ST98 standard.
• It examines the shift from one to three replicate test samples for method suitability.
• The impact of validation parameter variation on accuracy and precision is analyzed.

Main Results:

• Increased replicates in method suitability testing are proposed for the new standard.
• Understanding variability in method extraction is crucial for cleaning validation.
• The change will affect manufacturers' validation processes.

Conclusions:

• Multiple replicates are essential for robust cleaning validation of reusable medical devices.
• The proposed AAMI ST98 standard aims to enhance the accuracy and precision of cleaning validation.
• Manufacturers need to adapt to new requirements for method suitability testing.