Cleanroom and Clean Zones

A cleanroom is a modular environment in which the following environmental factors are kept under control; temperature, airborne particulates, microbes, relative humidity, differential pressure, and air flow.Cleanroom Validation is performed to ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meets User Requirement Specifications (URS); to ensure that the facility, equipment, and environment meet defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system to meet defined standards.

The validation of a new cleanroom follows a specified lifecycle. The life cycle comprises five phases:

PHASE 1 – Design qualification

Cleanroom validation starts with Design Qualification (DQ). The purpose of this phase is to prove through objective evidence that the design is fit for its intended purpose. Design Qualification is a verification exercise against requirements defined in the acceptance criteria of your DQ protocol.

PHASE 2 – Installation qualification

TheĀ purpose of this Installation Qualification (IQ) phase is to confirm through verification that equipment, as installed, confirms to user requirements and design requirements.

PHASE 3 – Operation qualification

The objective for this Operational Qualification (OQ) phase is to show through objective evidence that the cleanroom operates in conformance with design requirements and user defined requirements, and that it consistently operates within a defined range of conditions.

PHASE 4 – Performance qualification

The purpose of Performance Qualification (PQ) of the cleanroom is to demonstrate with objective evidence that the cleanroom consistently operates within defined parameters to produce the defined, desired environmental outcome.

PHASE 5 – Cleanroom certification

The objective for this Operational Qualification (OQ) phase is to show through objective evidence that the cleanroom operates in conformance with design requirements and user defined requirements, and that it consistently operates within a defined range of conditions.

ENVISIONEER MAGNETIC SYNERGIES