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Modular , Certified ISO Cleanroom for Biomedical Projects GCC Southeast Asia

Product Details:

Place of Origin:	Guangdong,China
Brand Name:	GCC
Certification:	ISO/GMP/CE

Detail Information

Place of Origin:

Guangdong,China

Brand Name:

GCC

Certification:

ISO/GMP/CE

Intsall Report:

Provided

Characteristic:

Control The Air Cleanliness

Using Field:

Workshop

Advantage:

Auto Control

Feature:

Advanced Design And Engineering

Airflow Control:

Positive Pressure

Fire Rating:

Class A

Item Name:

Medical Cleanroom

Key Word:

Modular Clean Room

Project:

Medical Cleanroom Engineering

Warranty:

1 Year

Power Supply:

220V, 50Hz

Highlight:

High Light

Highlight:

GMP cleanroom modular solution

prefab cleanroom biomedical project

ISO modular cleanroom physical chemical

Trading Information

Minimum Order Quantity:

Price:

Negotiation

Packaging Details:

Wooden Box

Delivery Time:

14Days

Payment Terms:

T/T

Supply Ability:

5000Sets/Month

Product Description

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

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.
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.

Ratings & Review

Overall Rating

5.0

Based on 50 reviews for this supplier

Rating Snapshot

The following is the distribution of all ratings

5 stars

4 stars

3 stars

2 stars

1 stars

All Reviews

Convenient And Safe Ordinary Pass Box For Cleanroom Material Transfer

Indonesia Jan 4.2026

Helpful (1200)

The pass box performs reliably during material transfer in food cleanroom environments, effectively controlling contamination risks between areas of different cleanliness classes. Its easy-to-clean structure and food-grade materials comply with HACCP and GMP requirements, providing a reliable safeguard for food safety production.

Low Noise & Energy-Saving High-Efficiency Fan Filter Unit (FFU) for Cleanroom Applications

United States Dec 24.2025

Helpful (200)

We have used the FFU in our project, and the performance is excellent! It is energy-efficient, low-noise, and delivers uniform airflow, making it an essential unit for high-standard clean production lines.

A*m

Nigeria Dec 2.2025

Helpful (1)

The grossing station features a well-designed downdraft exhaust system with uniform airflow. It effectively controls formalin fumes, even during long operating hours, significantly improving laboratory safety.

Tags:

Modular , Certified ISO Cleanroom for Biomedical Projects GCC Southeast Asia

High Light

Highlight:

GMP cleanroom modular solution

prefab cleanroom biomedical project

ISO modular cleanroom physical chemical

Overall Rating

Rating Snapshot

All Reviews

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