Validation
Construction
Control
Air Conditioning
Construction
Design
Building the future of cutting-edge medicine with reliable technology.
One-stop solutions for CPC (Cell Processing Centers) essential for regenerative medicine and immune cell therapy.
Consistent support for all processes. We propose the optimal solution.
ABOUT CPC
What is a CPC (Cell Processing Center)?
A CPC (Cell Processing Center) is a highly advanced cleanroom facility designed for the safe culture and processing of cells and tissues used in regenerative medicine and cell therapy.
Because these facilities handle cells that will be returned to a patient's body, they are required to maintain an extremely strict sanitary and clean environment in compliance with various laws and regulations, such as the "Act on the Safety of Regenerative Medicine" and "GMP/GCTP ministerial ordinances."
Three Essential Requirements for CPC Construction
Air Pressure and Differential Pressure Control (Contamination Prevention)
To prevent the entry of foreign matter and bacteria from the outside and maintain indoor cleanliness, precise air pressure (positive/negative pressure) balance control tailored to the application is required.
Room Layout and Flow Separation by Function
Strict operational flow planning is required to prevent contamination caused by the movement of people and materials, along with the separation of air conditioning systems for each purpose, such as culture rooms, preparation rooms, and formulation rooms.
Performance Qualification (Validation) and Space Decontamination
Qualification evaluation (DQ/IQ/OQ) to verify and prove that the cleanliness is as designed, and periodic space sanitation using hydrogen peroxide, etc., are essential.
Even after operation, we maintain on-site quality standards through regular inspections and validation updates.
● Facility/Equipment Validation
● Sanitation
3. バリデーション・サニテーション
We implement quality standards without compromise, from design compliant with the Japanese Pharmacopoeia to construction management.
● HVAC design (differential pressure cascade) ● HEPA layout design
● Air volume/air change rate calculation ● Instrumentation design (differential pressure/air velocity monitor)
2. Design and Construction
We minimize pre-installation uncertainty, from initial consultation and regulatory compliance checks to facility planning.
● Zoning design ● Cleanliness design compliant with the Japanese Pharmacopoeia
● Flow line design (people, materials, products, waste) ● Phased expansion planning
1. Planning and Design
We provide total support for decision-making during implementation and reliability after operation, based on regenerative medicine standards.
From planning, design, and construction
to validation and sanitation, without fragmentation,
we provide total support for integrated CPC construction.
Our Strengths
1. Planning and Programming
We minimize pre-installation uncertainty, from initial hearings and regulatory confirmation to facility planning.
● Zoning design ● Cleanliness design compliant with the Japanese Pharmacopoeia
● Flow line design (people, materials, products, waste)
● Phased expansion planning
2. Design & Construction
We implement quality standards without compromise, from design compliant with the Japanese Pharmacopoeia to construction management.
● HVAC Design (Differential Pressure Cascade)
● HEPA Layout Design
● Airflow and Air Change Rate Calculation
● Instrumentation Design (Differential Pressure/Air Velocity Monitor)
3. Validation and Sanitation
Even after operation begins, we continue to maintain on-site quality standards through regular inspections and validation updates.
● Facility and Equipment Validation
● Sanitation
SPACE / PLANNING
Zoning, Cleanliness Levels, and 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 zone configurations from Grade A to D and standard equipment layouts that meet the requirements for each class, starting from the planning stage.
AIR / ENGINEERING
VALIDATION / SANITATION
Validation and Sanitation
The long-term operational quality of CPC is guaranteed by conducting periodic validation and on-site verification work. We carry out everything from validation to sanitation in accordance with standardized procedures.
Measurement and confirmation results from the site are recorded and support quality control as reports.
PROJECTS
Recent Construction Projects
At BioStyleClinic Osaka, we planned the air conditioning equipment to be integrated according to the usage of the culture room, preparation room, and processing room.
This is a CPC construction case that implements cleanliness management and differential pressure control, including equipment within the ceiling.
Safety Design
Continuous Operation
Based on a design philosophy that includes people, materials, air, and documentation, we establish quality on-site.
We reduce the burden after startup through operational design that anticipates quality maintenance and improvement.
We prepare for gradual facility expansion and specification changes with a flexible configuration.
Future Expansion
For regenerative medicine sites,
clean rooms with reliable quality
Our philosophy is to realize a safe and sustainable cell processing environment by holistically addressing the human flow, airflow, material transport routes, cleanliness maintenance, and GCTP-compliant document management required for CPC construction.
With a view from the planning stage through to operation and expansion,
we provide integrated CPC construction that balances the precision and continuity required in the field of regenerative medicine.
