Is Your Derouging and Passivation Strategy Based on Real Data?
Rouge development due to the usage of high temperature water in piping and vessels is a continuing issue in the pharmaceutical industry. Many SOPs and directives are developed and instituted at individual biopharmaceutical and traditional pharmaceutical companies to combat rouge development. These practices, procedures, and directives are nominally prophylactic and rarely based on empirical data. How can we institute a frequency for derouging and passivation based on science and need and not a prophylactic time interval?
To answer these questions, I recently authored a Knowledge Brief that offers concrete methods to determine rouge development over time and the relationship between online monitoring and independent testing. This allows for accurate determination of frequency viability to derouge and passivate based on real data and not supposition. Using real data to justify a derouging and passivation procedure can enhance the longevity of the piping and vessels as the procedure is administered only when needed.
This may decrease the frequency for derouging and passivation saving the individual company money, downtime, and maintenance. Although no monitoring system is perfect for all applications, having a corroborating independent laboratory measurement to an online measurement can substantiate and validate the online measurement while providing additional confidence in the online data. How does your company determine its derouging and passivation strategy? What are your reactions to the points I’ve laid out in the Knowledge Brief? I look forward to your feedback in the comments.
The topic of continuous manufacturing has drawn considerable interest across all modalities of pharmaceutical manufacturing. Thus far much of the progress has been seen in small molecule drug product manufacturing platforms where multiple products have...
The design, construction, commissioning, qualification, and continued performance of water and steam systems for the pharmaceutical industry present significant challenges. These systems need to meet Good Manufacturing Practice (GMP) regulations...