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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.
It is essential for pharmaceutical manufacturers to mitigate risk by evaluating factors that could impact product quality and manufacturing equipment performance. Due to its potential effect on product quality and facility equipment, stainless-steel equipment rouge is a significant risk concern.
This white paper examines the best practices for establishing and evaluating a stainless-steel preservation and rouge mitigation process in pharmaceutical manufacturing.
