Clean Zone Analysis

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: 

The 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 purpose of this Operation Qualification (OQ) phase is to confirm through verification that cleanroom, as installed, achieves the operational parameters specified..

PHASE 4 – Performance qualification:

The purpose of this Performance Qualification (PQ) phase is to confirm through verification that equipment and structure are performing together in an operational state – All measurement are performed “in operation”

PHASE 5 – Cleanroom Monitoring: 

Once certified to a particular class the cleanroom factors are regularly monitored to ensure that parameters have not drifted, or changed, and that the environment is under control. Requirements for compliance are found in ISO 14644-2.

Environmental monitoring is a range of test methods used to identify and understand the environment that exists within the manufacturing process. It involves the analysis of surfaces, air, water and chemicals used within the manufacturing space.

Specification for class or grade of clean rooms are based on environmental monitoring as detailed in ISO 14644 or within the rules and guidance for pharmaceutical manufacturers and distributors (USP or EP).

Environmental monitoring tests available

Air samples: viable quantitative and qualitative, non-viable
Microbial surfaces: contact and swabs
Water testing: microbiological and chemical
Compressed air monitoring: viable
Disinfectant qualification
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