Life Science Cleanroom Terms

AIR CHANGES PER HOUR (ACPH): 
Air changes per hour or the air change rate (ACR) is the amount of times a cleanroom can completely replace its air volume within an hour. The higher the air changes per hour, the more effective it will be at removing contamination, therefore achieving a higher classification.

AIRLOCK:
An airlock is a small room that separates two spaces of different environmental classification.  These rooms are equipped with interlocked doors to prevent the opening of more than one door at a time.  This ensures that the differential air pressure between the two spaces is maintained and that airflow is therefore controlled.
Airlocks control airflow critical to GMP manufacturing to prevent the ingress of aerosol particulate that could contaminate critical processes and to contain the egress of microorganisms that could present a danger to operators or other processes.

ASEPTIC:
Free from contamination by harmful bacteria, viruses, or other microorganisms.

ASEPTIC FILLING:
The process of transferring sterile drug products into sterile containers and sealing them in a controlled, sterile environment. It is a critical step in sterile manufacturing that prevents contamination during final packaging.

BIOBURDEN:
A bioburden is the total number of microorganisms associated with a specific item such as personnel, manufacturing environments (air and surfaces), equipment, product packaging, raw materials (including water), in-process materials, or finished products.

BIOSAFETY CABINET (BSC):
An enclosed workspace that protects operators, samples, and the environment.

CGMP:
Current Good Manufacturing Practices; regulations for pharmaceuticals and biologics.

CLEANROOM:
A cleanroom is defined by ISO 14644-1:2015 as “a room within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the room.”

CLEANROOM CLASSIFICATION:
A method of assessing level of cleanliness against a specification for a cleanroom or clean zone. method of assessing level of cleanliness against a specification for a cleanroom or clean zone. Levels should be expressed in terms of an ISO Class (1 to 9) or EU GMP Grade (A to D), which represents maximum allowable concentrations of particles in a unit volume of air.

CLEANROOM FURNITURE:
Specialized furniture designed to minimize particle generation.

COLD CHAIN:
A temperature-controlled supply chain for preserving sensitive materials.

CONTAMINATION:
The presence of unwanted particles, microbes, or substances in a cleanroom environment.

CROSS-CONTAMINATION:
Unintended transfer of contaminants between products or environments.

CRYOPRESERVATION:
Freezing biological materials for long-term storage.

DECONTAMINATION:
The removal or neutralization of contaminants.

DIFFERENTIAL PRESSURE:
Pressure differences between cleanroom areas to prevent contamination.

DOOR INTERLOCK:
Door interlocks prevent potential contamination between two clean rooms which may happen when two doors are accidentally opened at the same time. Interlocked doors support good cleanroom entry and exit practices by only allowing one door to open at a time, preserving integrity of the higher-grade cleanroom.

ENVIRONMENTAL MONITORING (EM):
The process of testing cleanroom air and surfaces for particles and microbial contaminants.

EU GMP ANNEX 1:
European guideline for sterile product manufacturing

FDA:
U.S. Food and Drug Administration, which enforces cGMP regulations.

FORMULATION:
The process of combining ingredients to create a final product.

FUME HOOD:
A ventilated workspace commonly used in laboratories to safely handle hazardous fumes, vapors, or dusts. In the life sciences, it helps protect personnel and prevent contamination during chemical procedures.

GOWNING:
The process of donning protective clothing to reduce contamination risk.

HEPA FILTER:
A High-Efficiency Particulate Air filter that captures at least 99.97% of airborne particles ≥0.3 microns. It is essential in maintaining contamination control in cleanrooms and biosafety cabinets.

ISO 14644:
International standard for cleanroom classification and testing.

LAMINAR AIRFLOW (LAF):
A unidirectional airflow system that minimizes cross-contamination.

MATERIAL TRANSFER HATCH:
A controlled pass-through chamber used for transferring materials into and out of cleanrooms. It minimizes contamination by maintaining pressure differentials and limiting personnel movement.

NON-VIABLE PARTICLE:
A particle that does not contain living microorganisms but may carry contaminants.

PARTICLE COUNTER:
A device that measures airborne particle concentration.

PREFILTERS:
Filters placed upstream of HEPA or ULPA filters to capture larger particles and extend the life of high-efficiency filters. They are commonly used in HVAC and cleanroom air handling systems.

SETTLE PLATE:
A method for monitoring microbial contamination by exposing agar plates in the cleanroom.

STERILIZATION:
The complete destruction or removal of all forms of microbial life, including spores. Common methods in the life sciences include autoclaving, irradiation, and chemical sterilants.

ULPA FILTER:
Ultra-Low Penetration Air filter with even higher efficiency for smaller particles.

VALIDATION:
A documented, evidence-based process that confirms systems, processes, and equipment consistently operate within defined parameters to meet regulatory and quality requirements.

VIABLE PARTICLE:
A particle that contains or is a living microorganism.

VIRAL VECTOR PRODUCTION:
Creating viral carriers for delivering genetic material in gene therapies.