Cleanroom Glossary

A room with controlled airborne particle concentration, constructed and operated to minimise particle introduction, generation and retention.

Core standard for classifying air cleanliness by airborne particle concentration.

Monitoring requirements used to demonstrate cleanroom performance related to particle concentration.

Defines test methods for cleanrooms and associated controlled environments.

Guidance for cleanroom design, construction and start-up.

Covers cleanroom operations, including operational programmes, garments, cleaning and behaviour.

Requirements for separative devices such as clean-air hoods, gloveboxes and isolators.

Classification of air cleanliness by chemical concentration, also known as AMC.

Extremely particle-controlled zones, mainly in critical semiconductor and nanotechnology processes.

High-cleanliness environment often used for critical aseptic zones and sensitive production steps.

Controlled production environment often used as background or for less critical process steps.

Base controlled environment for support, packaging or less critical activities.

EU guidance for sterile medicinal product manufacture, with strong focus on contamination control strategy, barriers, monitoring and aseptic processing.

Site-wide documented strategy to prevent and control microbial, particulate and pyrogen contamination.

Critical zone for high-risk operations such as aseptic filling and exposed primary packaging.

Background environment for Grade A zones in aseptic preparation and filling unless an alternative barrier rationale applies.

Clean areas for less critical sterile-manufacturing steps; exact use is determined by risk assessment.

Manufacture and handling of sterile products without terminal sterilisation in the sealed final container.

Barrier between operator and critical process that restricts direct access.

Closed barrier system providing a high degree of separation between process and environment.

High-efficiency filter for airborne particles; selection and testing must match the application.

Filter with higher removal efficiency, often used in highly demanding microelectronics applications.

Air-handling system controlling temperature, humidity, pressure, air changes and filtration.

Theoretical number of air changes per hour. Not sufficient on its own to demonstrate cleanroom performance.

Unidirectional airflow with near-uniform velocity used to sweep contamination away from critical zones.

Programme for monitoring microbial and particulate conditions during operation and qualification.

Colony-forming unit used as a measure of viable microorganisms in a sample.

Microbial load on a product, material, surface or environment before sterilisation.

Component of Gram-negative bacteria that may trigger pyrogenic reactions and can remain relevant after cells are killed.

Vaporised hydrogen peroxide used for bio-decontamination of enclosed spaces or barrier systems.

Alcohol-based cleaning and disinfection agent; concentration, contact time and limitations must be process-defined.

Disinfectant with demonstrated efficacy against bacterial spores.

Defined process for donning cleanroom garments to limit personnel-borne contamination.

Electrostatic discharge; especially relevant to semiconductors, electronics, materials and personnel grounding.

Airborne molecular contamination capable of chemically affecting processes, optics or wafers.

Advanced therapy medicinal product, including gene therapy, cell therapy and tissue-engineered products.

Testing whether a container-closure system maintains its required barrier throughout shelf life.

Media-fill simulation used to assess whether an aseptic process remains controlled under representative conditions.

Systematic corrective and preventive actions used to remove causes and prevent recurrence.

Structured demonstration that facilities and processes are designed, installed, operated and performing as intended.