Design of cleanrooms

Whether design drafting, manufacturing, delivery, installation, and validation of cleanroom solutions, the MFME can act as the both prime contractor and subcontractor using own hardware components as below:

  • air sterilization systems:
    • inlet and exhaust air conditioning systems;
    • inside air cleaning systems;
    • air distributing and exhausting units;
    • integrated control of engineering systems;
  • equipment for creating of local clean zones:
    • biosafety boxes;
    • biosafety cabinets;
    • dressing-free treatment units for burn patients;
    • process equipment;
    • bactericidal lamps ceiling or wall mounted;
    • intensive care equipment (ceiling pendants and bed head units).

The amount of work completed considers the validation of cleanrooms at following stages:

  • project validation – DQ;
  • cleanroom installation validation – IQ (except process equipment);
  • cleanroom in-operating validation – OQ (except process equipment).

Design of cleanrooms

The following liaison protocol between MFME and prime design contractor at several stages of design drafting is applicable:

1. Investment feasibility study

When drafting of project documentation , the prime design contractor shall consider:

  • a room (by centralized systems) or an area (by stand-alone systems) for installation of inlet and exhaust air system components of a cleanroom;
  • basic rooms for enclosing structures and process equipment for each cleanroom.

The prime design contractor shall also include in the project documentation the reference pictures of existing cleanrooms realized by MFME as well as the pictures and technical data of hardware components produced by MFME for healthcare and industry.

Following documents shall be provided by the prime design contractor to MFME:

  • assignment for an investment feasibility study of a construction or reconstruction;
  • construction drawings of the areas reserved for cleanrooms;
  • project and as-built documentation (floor planes, sectional elevations, constructions, engineering system planes);
  • cleanroom operating procedure;
  • equipment placing planes;
  • technical data of process equipment (dimensions, energy consumption, delivered media, service areas etc.);
  • heat radiation and gas-dust emission parameters of the equipment by operating;
  • number of personnel in each room.

The MFME shall provide to the prime design contractor the following information, as hard or soft copy:

  • list of cleanroom equipment;
  • cleanroom costs calculation;
  • energy consumption data.

2. Detailed engineering

Further to the documents mentioned, the prime design contractor shall provide to MFME also the following:

  • architectural planning assignment of a construction or reconstruction;
  • information about utility systems;
  • equipment placing planes incl. specifications with dimensions, connection types, installed capacities, heat radiation and gas-dust emission parameters by operating, utility system routing, position and number of electric outlets;
  • information about initial state of air conditioning systems;
  • position of solid and window walls of cleanroom.

In turn, the MFME shall forward to the prime design contractor the documents as follows:

  • explanatory note regarding the project sections mentioned below;
  • process solutions (with regard to rooms);
  • architectural and building section (enclosing structures);
  • heating and air conditioning (built-in heating panels incl. heaters of Kermi type, air inlet, distributing and exhaust systems, air cleaning and sterilizing systems, air cross-flow control units);
  • water supply system and sanitary piping (washstands for surgery, washers, hand-driers, eye showers, mirrors);
  • electrical equipment (bactericidal lamps mounted into ceiling void respectively air dispenser, electrical outlets of intensive care units for process equipment connection, air cleaning and sterilizing system fans);
  • electrical equipment (bactericidal lamps for cleanrooms, general and emergency lights, illuminated signs);
  • heating and air conditioning automatic control (cleanroom automatic control);
  • medical gas supply (intensive care and bed head units);
  • weak-current equipment (clocks in intensive care rooms and OP-theatres);
  • estimate documentation;
  • preliminary construction work order for cleanroom installation.