SPACE / PLANNING
Zoning, Clean Level, Layout
Cell culture processing facilities in the field of regenerative medicine are required to comply with cleanliness classifications based on GCTP ministerial ordinances and ISO 14644.
We consistently design and propose standard equipment layouts that meet the requirements for each class, including Grade A to D zone configurations, from the planning stage.
● Zoning
We adopt zone configurations tailored to the grade.
A configuration that ensures positive pressure, differential pressure, and air change rates in the center, while accommodating the flow of people, goods, and materials on the outside.
Each class ensures independence through anterooms, pass-throughs, and differential pressure control.
*Compliance Standards: GCTP Ministerial Ordinance, ISO 14644, Three Principles of GMP
● Clean Level
Grade
A
B
C
D
Area Classification
Critical Operation Area
Inside BSC/Isolator
Direct Support Area
Culture Room
Other Support Areas
Preparation Room / Main Work Area
Other support areas
Sterilizer/Machine room
Japanese Pharmacopoeia
A
B
C
D
ISO 14644-1
Class 5
Class 7
Class 8
-
Non-working hours
3,520
3,520
352,000
3,520,000
During operation
3,520
352,000
3,520,000
-
【Grade A】
Area Classification: Critical Operation Area BSC
Inside Isolator
Japanese Pharmacopoeia: A
ISO 14644-1: Class 5
At Rest: 3,520
In Operation: 3,520
【Grade B】
Area Classification: Direct Support Area
Culture Room
Japanese Pharmacopoeia: B
ISO 14644-1: Class 7
At Rest: 3,520
In Operation: 352,000
*Unit: Maximum allowable particle count (particles/m³) / Particle size 0.5 μm or larger
[Grade C]
Area classification: Other support areas
Preparation room / Main work area
Japanese Pharmacopoeia: C
ISO 14644-1: Class 8
At rest: 352,000
In operation: 3,520,000
*Compliance Standards: The 15th Edition of the Japanese Pharmacopoeia / ISO 14644-1
[Grade D]
Area Classification: Other support areas
Sterilizer/Machine room
Japanese Pharmacopoeia: D
ISO 14644-1: -
At rest: 3,520,000
In operation: -
Keep heat, moisture, and noise outside the culture room
The cell manipulation area (A) is inside the culture room (B), and the culture room is inside the support area (C, D).
We maintain a nested structure where the center has higher cleanliness, preventing direct access from outside air or corridors.
Nesting sterile spaces
Separate equipment with high environmental impact, such as sterilizers, freezers, and refrigerators, into zones C and D.
Do not disturb the temperature, humidity, airflow, or particle control within the culture room, and do not transmit vibrations during long-term operation.
Separate the flow lines for people, materials, and waste.
Separate the flow lines for cell manipulation from those for pretreatment, sterilization, and waste disposal using an anteroom/pass-through to suppress contamination risk at the source.
Separate the work flow lines for the biosafety cabinet unit and the centrifuge, even within the same culture room.
● Principles of Layout