Laboratory design involves the process of creating engineering, technical, and technological design solutions for the construction of physicochemical, analytical and microbiology laboratories, as well as development laboratories for medicines, cosmetics, and medical devices.
Laboratory design is the search, approval and implementation of optimal design solutions, the creation of a quality control concept, and/or a development concept conforming to the requirements of GMP, GLP, and GCLP.
Laboratory design also includes such projects as:
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Microbiology laboratory design;
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Vivarium design;
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Virology Laboratory design;
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PCR laboratory design;
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Quality control laboratory design;
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Research laboratory design.
Laboratory design is accompanied by managing several essential tasks:
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Development of processes carried out in the laboratory, taking into account laboratory capability and capacity as well as all the requirements and restrictions;
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Ensuring process continuity, alignment of all stages and operations into one consecutive chain to avoid mix-ups or omissions;
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Meeting requirements for cleanrooms and protection zones of critical process operations as well as meeting cleanroom classification and pressure differential requirements;
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Implementation of architectural and structural solutions taking into account GMP requirements;
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Identification of measures to prevent cross-contamination;
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Development of utilities and systems for cleanrooms according to laboratory needs;
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Practical organization of personnel workplaces.
Laboratory design stages
First of all, laboratory design means the development of conceptual design, which must pass an expert evaluation (design qualification).
Laboratory conceptual design is the first stage of the design, the fundamental basis of any project.
Design qualification is a documented verification that the proposed laboratory design meets the requirements of the User Requirements Specification (URS) and GMP.
Based on the conceptual design that has passed qualification, laboratory design is carried out, and design and working documentation are developed.