Medical Cleanroom Engineering
We specialize in providing integrated cleanroom design, construction, and validation services that meet international standards (ISO/GMP) for the pharmaceutical, medical device, biotechnology, and research institute sectors. From gene therapy to sterile manufacturing, from lab R&D to large-scale production, we leverage cutting-edge technology, rigorous quality control, and full life-cycle services to build safe, reliable, and compliant clean environments for you. We ensure product purity, process integrity, and operational efficiency.
Features
1.Compliance First
Strict adherence to China GMP (2010 Revision), EU GMP Annex 1, US FDA cGMP, and ISO 14644 international standards.
Compliance is built into the design from the outset, ensuring smooth audits and certifications by domestic and international regulatory authorities.
2.Modular & Flexible
High-performance metal wall panel modular systems offer robust structure, excellent airtightness, enable rapid installation, and facilitate future modifications, expansions, or relocations.
Flexible layouts tailored to process flows (personnel, material, waste) support various production modes and future technological upgrades.
Parameter
| Parameter |
ISO Class 5 (Class 100) |
ISO Class 7 (Class 10,000) |
ISO Class 8 (Class 100,000) |
Notes |
| Classification Standard |
ISO 14644-1 Class 5 |
ISO 14644-1 Class 7 |
ISO 14644-1 Class 8 |
Corresponds to old US FED STD 209E names |
| Max. Allowable Particles/m³ |
≥0.5μm: 3,520 |
≥0.5μm: 352,000 |
≥0.5μm: 3,520,000 |
Calculated per ISO standard |
| |
≥5.0μm: 29 |
≥5.0μm: 2,930 |
≥5.0μm: 29,300 |
|
| Airflow Type |
Unidirectional (Vertical/Horizontal) |
Non-Unidirectional |
Non-Unidirectional |
Unidirectional flow ensures high cleanliness |
| Air Changes per Hour (ACH) |
(Air velocity: 0.45±0.1 m/s) |
40-60 |
20-40 |
Adjusted based on room function and heat load |
| Temperature Control |
20-24°C (±2°C) |
20-24°C (±2°C) |
20-24°C (±2°C) |
Typical setting, customizable |
| Relative Humidity Control |
45%-65% (±5% RH) |
45%-65% (±5% RH) |
45%-65% (±5% RH) |
Special processes may have specific requirements |
| Differential Pressure (Pa) |
≥ +10-15 to adjacent areas |
≥ +10-15 to adjacent areas |
≥ +10-15 to adjacent areas |
Maintains gradient to prevent cross-contamination |
| Illuminance (Lux) |
≥300 |
≥300 |
≥300 |
Work surfaces can have enhanced local lighting |
| Noise Level (dB(A)) |
≤65 |
≤65 |
≤65 |
Measured at rest |
| Typical Applications |
Aseptic filling, sterility testing, cell therapy |
Buffer preparation, weighing, non-sterile manufacturing, device assembly |
|
|
Integrated Engineering Service Advantages
* Phase 1: Consulting & Design
* In-Depth Needs Analysis: Work closely with your production, quality, and R&D teams to thoroughly understand process requirements.
* Concept & Preliminary Design: Provide Process Flow Diagrams (PFDs), room layouts, and people/material flow diagrams.
* Detailed Design: Deliver full construction drawings (HVAC, electrical, plumbing, controls) and 3D BIM models for clash detection to avoid construction conflicts.
* Phase 2: Construction & Management
* EPC (Engineering, Procurement, Construction) Model: Single-point responsibility avoids multi-party disputes and ensures overall control of project schedule, cost, and quality.
* Strict Quality Management System: Full auditing and documentation of materials, workmanship, and milestones.
* Experienced Team: Project managers, engineers, and construction personnel have extensive experience in biopharmaceutical projects.
* Phase 3: Testing & Certification
* IQ/OQ/PQ Services: Provide complete Installation, Operational, and Performance Qualification documentation packages ensuring compliance with GEP and GMP.
* Third-Party Certification: Assist in liaising with accredited third-party testing agencies for authoritative certification and reports.
* Phase 4: Operation & Support
* Training Services: Provide systematic training for your operation and maintenance staff.
* Maintenance: Offer efficient preventive maintenance plans and spare parts support.
* Upgrades & Retrofits: Provide future technology upgrade and facility modification plans based on existing systems.
FAQ
Q1: What is the approximate total investment for building a biopharmaceutical cleanroom?
A: Costs vary significantly based on cleanliness class, area, control precision (temp/RH/pressure), equipment selection (local/imported), and automation level. Typically, an ISO Class 5 (Grade A) area costs much more per square meter than an ISO Class 8 area. We recommend providing initial process requirements for a budgetary estimate.
Q2: How long does the entire project take from design to certification?
A: A mid-size project (500-1000㎡) typically takes 6-12 months. The exact timeline depends on design complexity, approval processes, equipment lead times, and site conditions. We develop a detailed Master Plan and share it with you for full transparency at every step.
Q3: Can your control system integrate data with my existing production equipment (e.g., fillers, lyophilizers)?
A: Absolutely. Our EMS/BMS systems use open protocols (e.g., OPC, Modbus) and have strong integration capabilities to communicate and integrate data with mainstream production equipment, SCADA, and MES systems, enabling a true "Smart Factory."
Q4: How is ongoing compliance ensured during operation?
A: Ongoing compliance relies on three pillars: 1) Reliable Hardware: We provide high-quality, stable infrastructure. 2) Robust Software: The EMS system enables continuous monitoring and data logging. 3) Scientific Management: We help you establish Standard Operating Procedures (SOPs) for gowning, cleaning/disinfection, environmental monitoring, preventive maintenance, and provide relevant training.
Q5: Do you provide validation (IQ/OQ/PQ) documentation services?
A: Yes, this is a core part of our service. We have a dedicated validation team that prepares and executes full validation documentation packages according to GAMP 5 guidelines, ensuring all documents meet GMP regulations and efficiently support your audits.
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