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Installation procedure of a Cleanroom

This document describes the general rules and behaviour all operators must follow when setting up and installing a Clean Room, from site organisation to certification tests, with the purpose of guaranteeing a good constructive quality, repeatable performances when using the Clean Room, short commissioning times and low pre-startup cleaning costs.

Cleaning before and after the installation of a Clean Room

Clean Rooms are environments where the concentration of airborne particles is controlled, which are built and used to minimise the introduction, generation and retention of particles and where other significant parameters such as temperature, humidity and pressure are monitored as needed. Building such a refined environment within an area that is dirty with uncontrolled access means jeopardising its performance right from the start and incurring in sizeable costs due to the need of performing repeated cleaning cycles before starting it up, stabilizing and validating it. These risks and costs can be minimised or even reduced to zero with a suitable installation procedure.

Clean Process Protocol

The Clean Concept defines the general rules operators must follow when installing a Cleanroom and all related systems. A specific protocol must be drafted for each Clean Room that envisages analyses of all installation phases as well as the definition of protection / access levels operators must comply with. Below is an example of the levels:

  • Building works and finishes – Level 1: This level applies to the start of finishing work on the building to the delivery of the area.
  • Cleanroom setup – Level 2: This level applies to the installation of Clean Room components and ends when the suspended ceiling, floor and walls are finished.
  • Preliminary ventilation – Level 3: During this level, the plant is activated to verify its correct functioning and to direct residual dust to pre-filtration systems.
  • Cleaning – Level 4: Level reserved to the cleaning of Clean Rooms by specialized operators (floor cleaning and waxing).
  • Installation of HEPA filters – Level 5: Level reserved to the installation of the most important components, i.e. HEPA/ULPA filters;
  • Certification test– Level 6: This level envisages the validation of the Clean Room in compliance with standard ISO 14644.

For example, the following must be defined within each level:

  • all the activities that may or may not be carried out inside the areas
  • the activities that must be performed before proceeding to the next level
  • access /exit routes for operators and materials
  • tidiness and cleanliness requirements
  • cleaning rules
  • type of packaging to be introduced to the area
  • clothing operators must wear

Installation of a Clean Room

Building high-quality Clean Rooms means curating every detail from start to finish – it is better to be safe than sorry.