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Aseptic Pharmaceutical Manufacturing: The Design and Validation of Water for Injection Systems

In pharmaceutical manufacturing, water is an invaluable resource. It is used in the production, processing and formulation of drug products and is subject to review, monitoring and approval by government bodies. This article contains a conservative approach to evaluating and qualifying water systems used for aseptic pharmaceutical manufacturing as regulated by the US Food and Drug Administration (FDA).

Specification Requirements

As with all manufacturing processes, evaluation of a water system entails three distinct specifications: a user requirement, functional requirement and design requirement. The user requirement defines the quality of water required by the type of pharmaceutical production process. The functional requirements specification describes how the water system will operate. Functional requirements are identified with the goal of identifying system capacity and meeting chemical and microbial limits. Several references are available to aid in the design, development, installation and validation of WFI systems. Most notable are the US Pharmacopoeia Convention (USP) (1), Parenteral Drug Association (2) and ISPE (3). Design requirements detail how the system will be built including system components, construction materials and methods.


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By Hank Hicks, Validation Director, and David Bosch, Validation Manager, at Pharmaceutical Systems

Hank Hicks is Director of Validation at Pharmaceutical Systems Inc, USA. He has over 15 years' experience specialising in the areas of equipment, critical utilities and process validation. He has managed validation projects for installation of new process equipment, including facility construction/qualification, equipment installation/qualification, and process validation. He has had responsibilities to manage the interface with the FDA during inspections.


David J Bosch is Validation Manager at Pharmaceutical Systems Inc, USA. He has over 10 years' technical experience in equipment, process, and critical utilities validations. He also has experience in calibration of laboratory, manufacturing and data collection equipment, as well as commissioning, cycle development, IQ, OQ and PQ for autoclaves, depyrogenation equipment, washers, temperature controlled units, environmental chambers, laboratory, manufacturing equipment and critical utilities. He has also had direct interface with the FDA during inspections.


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Hank Hicks
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David J Bosch
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