Conceptual design

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We offer our clients general design of cleanrooms, from conceptual design to working documentation.

A carefully developed conceptual design provides a clear basis for making further decisions.

During preparation of conceptual project, the initial data and their analysis play a key function. Inadequacy of primary data can lead to incorrect decisions.

When developing conceptual design, all technological solutions will be adopted in accordance with GMP, the requirements of local regulations, as well as Customer’s data and recommendations.

Basic principles of clean room design:

  • Strict compliance with all regulatory documents, including GOST R ISO 14644 part 4, Order of the Ministry of Industry and Trade of Russia of 14.06.2013 No. 916 (GOST R 52249-2009)
  • Ensuring safety: compliance with the principle of “safety first”, fire safety requirements, environmental safety, etc.
  • Economic justification of capital costs for the creation of clean rooms.
  • Energy efficiency – lower operating costs.

 

Conceptual (technological) design is a technical task for an architectural and construction project and includes:

 

  • Architectural and construction concept of the facility, including the layout of premises, indicating the grade of cleanliness, description of production facilities;
  • The concept of the production process, including equipment layout plans, technological block diagram, list and characteristics of the main process equipment;
  • Storage areas concept;
  • Quality control;
  • Personnel movement concept, materials, products and wastes;
  • Ventilation and air conditioning (HVAC);
  • Technological environments;
  • Energy supply;
  • Instrumentation and automation;
  • GMP concept, including risk analysis;
  • Safety concept (occupational health and industrial sanitation).

Technological (conceptual) project consists of drawings and an explanatory note.

Main drawings include:

  1. Premises and equipment layout.
  2. Dimensions of premises (task for architectural and construction part).
  3. Points of connection of communications (task for designing electrical part).
  4. Points of connection of communications (task water supply and sewerage).
  5. Classes of purity and indoor air pressure (task for ventilation and air conditioning).
  6. Streams of personnel, raw materials, products, wastes.

 

Key sections of the Explanatory Note:

 

  • Description of production, flows of raw materials, materials, products, personnel.
  • Basic technological solutions.
  • Work technology.
  • Requirements for the construction and installation of clean rooms.
  • Proposals for the organization of basic engineering systems.
  • Preliminary calculation of the required power capacities.
  • The need for staff.
  • Environmental protection measures.
  • Measures on safety precautions, industrial sanitation, labour protection, fire prevention measures.
  • Technological task for design of electric lighting.
  • Technological task for power electrical equipment.
  • Technological task for the design of ventilation and air conditioning.
  • Technological task for water supply and sewerage.
  • List of production wastes and methods of utilization.

 

Data performed in conceptual design is not only the basis for the subsequent design stages, but also very important information in obtaining a production license, and certification of production for compliance with the requirements of good manufacturing practices (GMP).

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