Pharmaceuticals

How Can the Consequences of Poor Activated Carbon Operation Impact System Validation?

By William V. Collentro

ACTIVATED CARBON BACTERIA EDI ION EXCHANGE MAINTENANCE OPERATIONS ORGANICS PHARMACEUTICALS PURIFIED WATER REVERSE OS- MOSIS SYSTEM DESIGN TROU- BLESHOOTING WFI

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Abstract

Facilities producing Water for Injection (WFI) without the use of distillation should consider items that could impact individual component operation. A Failure Mode and Effect Analysis (FMEA) of each unit operation in the system can identify potential risk factors that should be addressed throughout the design process, preparation of standard operating procedures, analytical monitoring program, and proactive maintenance program.

A responsive FMEA should present a list of items that could impact the performance of each unit operation and explain the consequences of the change in performance. The FMEA should be prepared such that the potential, detection, and impact of each condition that could result, or is associated with unacceptable component performance is addressed and assigned a risk factor

Subsequently, responsive system design, operation, monitoring, and maintenance considerations can be established to mitigate risk factors for both an individual component and the WFI system.

Overview

The maintenance program for a WFI system without distillation was presented in the April edition of Ultrapure Water (1). Figures 1 and 2 in the previous article demonstrate the pretreatment section and “RO/CEDI” section of the system. These figures may be seen in the previous article, which is accessible here.

Conditions/events associated with development of a FMEA for the activated carbon adsorption unit (ACAU) in the pretreatment section will be presented in this article to demonstrate evaluation of a selected component in the system. The consequences/results of each condition/ event for the ACAU will be discussed.

A tabulated summary of the potential, detection, and impact for the ACAU is presented using “generalized risk indication” in lieu of numeric values.

 

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