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Demystifying Cleanroom Terminology: A Comprehensive Guide

Updated: Jan 31


Sinergix Cleanrooms and Contractors Blog Post Cleanroom Terms and Conditions.

Cleanrooms, with their controlled environments and meticulous standards, are integral to industries such as pharmaceuticals, biotechnology, electronics, and healthcare. Navigating the terminology associated with cleanrooms can be challenging, especially for those new to the field. In this comprehensive guide, we will demystify the key terms and concepts related to cleanrooms, providing a clear understanding of the language used in these critical environments.


Cleanroom:


A controlled environment with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. Cleanrooms are designed to maintain specific cleanliness levels to ensure the integrity of sensitive processes.


Cleanroom Classification:


Cleanrooms are classified based on the maximum allowable particulate contamination levels. Common classification standards include ISO 14644-1 for particles and ISO 14644-2 for biocontamination.


ISO Class:


A numerical designation that signifies the cleanliness level of a cleanroom according to the ISO 14644-1 standard. Lower ISO classes indicate cleaner environments.


HEPA Filter:


High-Efficiency Particulate Air (HEPA) filters are used in cleanrooms to remove airborne particles. They are designed to achieve high particle removal efficiency.


ULPA Filter:


Ultra-Low Penetration Air (ULPA) filters are more efficient than HEPA filters, removing a higher percentage of particles from the air.


Air Changes Per Hour (ACH):


The number of times the air within a cleanroom is replaced with fresh air in one hour. ACH is a critical parameter for maintaining cleanliness levels.


Velocity:


Refers to the speed of air movement within a cleanroom, usually measured in feet per minute (FPM). Proper air velocity is crucial for controlling particulate contamination.


Laminar Flow:


A controlled airflow in which air moves with uniform velocity in a single direction, usually from a filter ceiling to the floor. Laminar flow helps minimize particle accumulation.


Gowning:


The process of donning specialized garments, including cleanroom suits, gloves, and other protective gear, to prevent human contamination in cleanrooms.


Pass-Through Chamber:


An enclosed chamber with interlocking doors designed to facilitate the transfer of materials between different cleanroom areas without compromising cleanliness.


ISO Cleanliness Code:


A system for expressing the cleanliness of hydraulic fluids. It defines the maximum allowable particle count at various size ranges.


Particulate Contamination:


Microscopic particles present in the air that can compromise the cleanliness of a cleanroom. Controlled through air filtration and other preventive measures.


Biocontamination:


The presence of living organisms such as bacteria, viruses, and fungi that can compromise the sterility of a cleanroom. Controlled through stringent cleaning and disinfection protocols.


Air Shower:


A chamber through which personnel must pass before entering a cleanroom. Air showers remove contaminants from clothing and ensure a cleaner transition into the controlled environment.


Temperature and Humidity Control:


Critical factors in cleanroom environments, controlled to meet specific process requirements. Maintaining consistent temperature and humidity levels is crucial for certain processes.


Decontamination:


The process of reducing or eliminating contamination in a cleanroom. Methods include cleaning, disinfection, and sterilization.


HVAC (Heating, Ventilation, and Air Conditioning):


Systems designed to control temperature, humidity, and air quality in a cleanroom. Proper HVAC systems are essential for maintaining cleanliness levels.


Risk Assessment:


A systematic process of evaluating potential sources of contamination and assessing the associated risks. Used to implement preventive measures in cleanroom design and operation.


Conclusion:

Understanding cleanroom terminology is fundamental to ensuring the success of operations within these highly controlled environments. Whether you are a seasoned professional or new to the field, familiarity with the language of cleanrooms is key to effective communication and adherence to industry standards. This guide provides a foundation for navigating the terminology associated with cleanrooms,

fostering a clearer understanding of the principles and practices that contribute to the success of critical processes conducted within these specialized environments.

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