Cleanroom
A controlled environment designed to minimize airborne particles, microbial contamination, and other pollutants.
HEPA Filter
High-Efficiency Particulate Air filter; removes 99.97% of particles ≥0.3 micrometers.
ULPA Filter
Ultra-Low Particulate Air filter; removes 99.999% of particles ≥0.12 micrometers.
Gowning Procedure
The systematic process of donning specialized protective garments to prevent contamination from personnel.
Laminar Flow
Unidirectional airflow in parallel streams, minimizing turbulence and particle dispersion.
Differential Pressure
Pressure difference maintained between cleanroom zones to control airflow and prevent contamination ingress.
Air Changes Per Hour (ACPH)
The number of times the total air volume in a room is replaced within one hour.
ISO Classification
International standards (ISO 14644) defining cleanroom particulate cleanliness levels.
EU GMP Annex 1
European regulatory guideline specifically for the manufacture of sterile medicinal products.
Viable Particles
Living microorganisms (bacteria, fungi, spores) that can cause contamination.
Non-Viable Particles
Inanimate airborne particles (dust, skin flakes) that are not living organisms.
Environmental Monitoring
A program to regularly assess air, surface, and personnel cleanliness in a cleanroom.
Aseptic Processing
Manufacturing process conducted in a sterile environment to prevent microbial contamination of sterile products.
Pass Box
A sealed chamber used to transfer materials between cleanroom zones while maintaining pressure differentials.
Cleanroom Grades (A, B, C, D)
EU GMP classifications indicating different levels of cleanliness for sterile manufacturing areas.
Rest State
The cleanroom condition where all equipment is installed and operating, but no personnel are present.
Operational State
The cleanroom condition during routine production with the specified number of personnel working.
Sanitization
A process that reduces the number of microorganisms to a safe level, typically using disinfectants.
Bioburden
The total number of viable microorganisms present on a surface, in a product, or in an environment before sterilization.
Air Shower
A chamber that uses high-velocity HEPA-filtered air jets to remove surface particles from personnel entering a cleanroom.