Australia Pharmaceutical R&D Laboratory Modular Cleanroom Project
Project Overview
Airkey successfully delivered a modular cleanroom solution for a pharmaceutical R&D laboratory in Melbourne, Australia. Designed to meet strict GMP requirements while providing flexibility for future expansion, the cleanroom offers a highly controlled environment for pharmaceutical research and product development.
Project Information
| Item | Details |
|---|---|
| Project Name | Australia Pharma R&D Clean Lab |
| Industry | Pharmaceutical R&D |
| Location | Melbourne, Australia |
| Cleanroom Class | ISO 8 (Class 100,000) |
| Cleanroom Area | 37.6 m² |
| Internal Height | 3.0 m |
| Product Model | Light Series (FAG-I9N-A63 (9×7)-F) |
About the Client
Established in 2011, Oak Laboratories Pty Ltd. is an Australian company specializing in product development services for the pharmaceutical, veterinary, cosmeceutical, and food industries.
With extensive expertise in formulation development and manufacturing, the company required a cleanroom environment that could support diverse R&D activities while complying with stringent pharmaceutical regulations.
Project Challenges
The client required a cleanroom solution capable of:
- Meeting pharmaceutical-grade GMP requirements.
- Supporting multiple product development projects with flexible layouts.
- Accommodating future expansion needs.
- Ensuring high cleanliness standards for sensitive R&D processes.
- Completing installation quickly without modifying the existing facility floor.
Airkey Modular Cleanroom Solution
To address the client's requirements, Airkey designed and supplied a modular ISO 8 cleanroom featuring:
GMP-Compliant Design
The cleanroom was designed, manufactured, and validated in accordance with pharmaceutical GMP standards, ensuring compliance with stringent regulations applicable to pharmaceutical, veterinary, cosmetic, and food industries.
Flexible Modular Structure
Considering the client's evolving R&D needs, the cleanroom adopts a modular design that allows easy reconfiguration and future expansion, minimizing downtime and investment costs.
Hygienic Construction Materials
All wall panels, structural frames, and interior materials are resistant to disinfectants and chemical corrosion. Smooth, non-porous surfaces and rounded joints help prevent particle accumulation and facilitate easy cleaning.
High-Efficiency Air Filtration
The cleanroom utilizes H14 HEPA filtration combined with EC FFUs to provide stable airflow and effective particle control, ensuring ISO 8 cleanliness performance.
Fast Installation
Factory prefabrication combined with on-site assembly significantly reduced installation time by approximately 40–60% compared with conventional cleanroom construction methods.
Project Highlights
1. Raised Floor System for Uneven Site Conditions
To preserve the existing facility floor while overcoming uneven ground conditions, Airkey implemented an adjustable raised floor system. This solution ensured excellent floor flatness and precise leveling without any modification to the original floor.
Additionally, door heights were customized to align perfectly with the raised floor structure.
2. Energy-Efficient Air Handling System
The cleanroom was equipped with EC motor FFUs featuring both individual and centralized speed control functions.
Benefits include:
- Energy savings
- Low noise operation
- Stable airflow performance
- Precise cleanliness control
Together with H14 HEPA filters, the system consistently maintains ISO 8 cleanroom standards.
3. Comfortable Temperature Control
A split-type air conditioning system was installed to maintain stable indoor temperatures and provide a comfortable working environment for laboratory personnel.
4. Compliance with Australian Electrical Standards
All electrical components, including power outlets, are certified to Australian SAA standards, ensuring full compliance with local electrical safety regulations.
5. Factory Testing and One-Time Validation Success
Prior to shipment, all cleanroom components underwent comprehensive factory testing.
The customer visited Airkey's manufacturing facility to observe product testing and assembly procedures firsthand.
Critical parameters including:
- Cleanliness level
- Air velocity
- Illuminance
all passed validation successfully during the first performance test, resulting in high customer satisfaction.
Project Results
By implementing Airkey's modular cleanroom solution, the client achieved:
ISO 8 cleanroom compliance for pharmaceutical R&D
Faster installation with minimal site disruption
Flexible space for future expansion
Enhanced operational efficiency
Full compliance with Australian safety standards
