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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 57 rate? With respect to the coffee grinder, how is the fineness of the grind determined and set? How re- producible are the settings? What is the uniformity of the grind? Does it contain a high proportion of "fines" or large particles? What are the capacities of the brewer and grinder and do they match the expected coffee shop volume? Finally, the process output must be examined and evaluated. Does the brewed coffee taste good? How will that be determined? Is it the same as the coffee chosen as a result of the taste testing? Are there any analytical methods that might provide confirmation? At what temperature should the cof- fee be held, and for how long? How should it be served, in a paper cup, foam cup, or china? Does the cup require insulation? Will take-out be avail- able? If reusable, how will the cups be washed? Are coffee stains or detergent residue issues? Once these variables have been defined, ex- amined, and evaluated, the validation study can begin. A single validation protocol can cover the entire process or, more usefully, the process can be broken down into several manageable steps with individual protocols for each. Validation protocols. Validation protocols should describe the intended process, define the accep- tance criteria, and set forth the procedures and tests that will be used to demonstrate that the process does what it is intended to do and results in an output that meets the predetermined ac- ceptance criteria. Ideally, the protocol should be written by those most familiar with the process to be validated, with input from other organizational units as necessary and appropriate. Development, process engineering, production, and regulatory affairs departments should almost always be in- volved. Other departments that might have input are purchasing, warehousing, and compliance. The quality assurance department must be involved at all phases of protocol development and must ap- prove the final protocol before validation begins. Protocols fit two broad categories. Qualification protocols are used for process equipment, such as tanks, mills, piping systems, autoclaves, ion exchange units, chromatography columns, and stopper washers. Validation protocols are used for processes that employ the qualified equipment and for processes related to the equipment, such as cleaning and sterilization. It is convenient to break down equipment quali- fication into several steps such as design, installa- tion, and operational as described below for the coffee brewing example. Tasting studies may have shown that custom- ers preferred coffee produced by pouring hot water through ground coffee supported on a fil- ter. The proportions of coffee and water as well as the coffee type and grind, filter type, the brewing time, and the temperature were known from the development studies used to support the tasting. Adequate design qualification used in equipment selection will ensure the commercial brewer and grinder will meet the process requirements estab- lished during development. Factors to be consid- ered include materials of construction, ease of use, space requirements, utilities, and process interac- tions (e.g., compatibility, adsorption, and leach- ables), and cleaning and maintenance. Once selected, the equipment is installed, ensur- ing that electrical and water supplies are available and adequate and that necessary operational and storage space for supplies is convenient and avail- able. The shop must be set up and arranged to op- timize workflow. Space and facilities for equipment