White Paper

Stainless-Steel Preservation: Mitigating Rouge White Paper

This white paper examines the best practices for establishing and evaluating a stainless-steel preservation and rouge mitigation process in pharmaceutical manufacturing.
2023-01-18

Key Takeaways:

  • Due to personnel, validation, disposal and other constraints, establishing a suitable stainless-steel preservation process for your facility is key.  
  • Rouge mitigation measures should be selected based on the equipment type and consequent risk level.
  • After your stainless-steel preservation and rouge mitigation process is established, it is important to periodically review your process to ensure continuous improvement.  
  • Predictive modeling uses lab or in-line testing to evaluate the risk of a passive surface this is negatively impacted by the manufacturing process. This information can be used to develop routine or preventive cleaning with an acid detergent to ensure stainless-steel preservation.  
  • For indirect or non-product contact surfaces, stainless-steel preservation remains necessary to reduce the risk associated with reactive cleaning.  

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