|
The design of pharmaceutical facilities involves multiple disciplines like pharmaceutics, architectonics, heating, ventilation and air conditioning, mechanics, electrics, etc. It makes it very difficult for a pharmaceutical engineer to comprehensively evaluate the various kinds of industrial standards and propose complete and scientific requirements that are conforming to the cGMP requirements for the designing, the construction and the validation of pharmaceutical facilities. This has been widely recognized as a major problem facing pharmaceutical engineers. Another problem for the pharmaceutical engineers is how they can face the challenges from the ever developing technological advancements and regulatory changes.With references from domestic and international literatures concerning the designing, the construction and the validation of facilities for solid pharmaceutical preparations, this paper introduces the present conditions and the development trends related to facilities for solid pharmaceutical preparations. It describes in detail the general principles on the process designing, the architectural designing, the layout planning, the design details, the material selection and the utility system designing of oral solid dosage forms facilities. Referencing the relevant standards and guidelines of the EMEA of the European Union, the FDA of the US, the ICH, the ISPE and some multinational corporations, it introduces the NCPC Development Zone company construction process of facilities for oral solid workshop, including the proposal of user requirement specifications, the layout designing of the workshop, the designing of the personnel and material flow within the facilities, the general layout of the plant, the architectural designing, the compilation of the process flows, the calculation concerning the material balance, the assessment of the capacities of the machines, and the designing of such utility systems as the air conditioning system, the water system and the compressed air system. It describes the processes concerning the civil engineering, the clean decoration, the equipment installation, the process pipeline construction standards, and the construction management and control. And the standards, the methods and the relevant data concerning the validation of such utility systems as the air conditioning system, the water system and the compressed air system and the equipment after the trial run are systematically and comprehensively elaborated.
|