Case Study-Cleanroom YEE Malaysia
Enclosure System: Built with high-performance rockwool sandwich panels. The wall layout seamlessly incorporates professional cleanroom wall panel technology.
I. Project Overview
The cleanroom YEE Malaysia project is a high-precision purification facility spanning a total area of 600 square meters. Professionally engineered for the biopharmaceutical and medical device sectors, this facility is custom-tailored to support specialized PE bag layout production lines. As an experienced cleanroom manufacturer and a trusted global cleanroom supplier, Wonclean provided the complete turn-key engineering setup, ensuring all structural, mechanical, and safety components are fully unified for international regulatory compliance.
II. Design Standards & Parameters
The technical parameters of this project are strictly designed to satisfy ISO 7 (Class 10,000) and global GMP certification mandates:
- Cleanliness Level: ISO 7 (Class 10,000) inside the core cleanroom zone.
- Temperature Control: 20℃ - 24℃ continuous constant control.
- Relative Humidity: 40% - 70% RH regulated environment.
- Ceiling Differentiation: Designed with a structural double-ceiling system for the core cleanroom zone, and a standard single-ceiling configuration for the controlled rooms and material storage areas.
III. Core System Configuration
Every structural component and mechanical entity has been selected to meet premium pharmaceutical grade engineering threshold limits:
- Enclosure System: Built with high-performance rockwool sandwich panels. The wall layout seamlessly incorporates professional cleanroom wall panel technology. The overhead structure is constructed using a heavy-duty, walkable cleanroom ceiling panel system, allowing maintenance personnel to walk above the ceiling safely without disturbing the sterile environment below.
- Air Purification & HVAC: Powered by a network of Fan Filter Units (FFU) equipped with energy-efficient EC motors and linked to a centralized control panel. The system integrates precise differential pressure gauges and return air grilles with built-in volume control dampers (OBD) to regulate internal pressure gradients.
- Logistics & Access Control:
- Material Air Shower: A heavy-duty material air shower unit measuring 2400mm (W) × 2400mm (H) is positioned at the main material entry.
- High-Speed Roll-Up Door: A 2400mm (H) × 2400mm (W) rapid roll-up door is integrated into the material room for optimal logistics separation.
- Pass Boxes: Equipped with 3 sets of 800mm × 800mm internal dimension pass boxes made of premium 304 stainless steel, each featuring integrated UV germicidal lamps.
- Doors & Vision Panels: Includes standard flat swing doors, double-layer tempered glass cleanroom windows, and a dedicated emergency exit door equipped with a panic push bar.
IV. Construction Highlights & Advantages
- Equipment Access Optimization: To accommodate future machinery updates, a specialized removable wall panel system measuring 5000mm (H) × 4500mm (W) has been engineered into the perimeter wall, enabling large equipment entry without damaging the main structure.
- Integrated Utility Sleeves: The walkable double ceiling comes pre-fabricated with dedicated sleeves and structural frames for the fire sprinkler system. This allows local vendors to install fire pipes seamlessly without compromising the cleanroom airtightness.
- Sterile Engineering: Smooth internal junctions, flush window mountings, and automatic down-bottom seals on all major swing doors work together to eliminate air turbulence and dust accumulation dead zones, ensuring an uninterrupted clean environment.
