ABSTRACT

OVERVIEW It is inappropriate to discuss the design, installation, validation, operation, and maintenance of pharmaceutical water purification systems without providing examples of required specifications and associated documentation. Specifications are an extremely important item because they provide the vehicle that delineates design and performance requirements to the water purification equipment manufacturer or system integrator. Some water purification equipment suppliers focus their sales and marketing activities on “standard products.” Other manufacturers exhibit flexibility with regard to design and manufacturing criteria for individual components. The “ideal” specification should be prepared in a manner that clearly defines the unit operation specifics required for a project. “Standard equipment” manufacturers will either include “adders” for specified items that deviate from their standard product line or will take exception to specific sections of the specification in their proposal. The specification should, where possible, provide design details that are readily available from the majority of equipment manufacturers. Items that may be required for a specific component but would obviously increase the cost of the component disproportionately to the desired benefits should either be deleted or provided by “others” (mechanical contractor, installer, etc.). For example, an activated carbon removal port may be specified for an activated carbon unit. This is a critical item since it is required for the periodic replacement of activated carbon. It should be available from both standard equipment and “custom” manufacturers. On the other hand, it may be desirable to provide an exterior thermal insulation “package” for the unit, particularly if it is specified with hot water sanitization provisions. The insulation package is not an item readily available from most equipment manufacturers. Subsequently, it would be more costeffective to install the insulation package (using a mechanical contractor) after the equipment is positioned “in-place.” The insulation package is, for most installations, a necessary item, considering personnel protection. It should not be deleted. It should be included in the system specification by defining the “Scope of Supply.” A project manager or construction manager can provide valuable assistance to ensure that items that are not standard from water purification equipment suppliers be included as part of the installed system.