Airkey, a premier modular cleanroom manufacturer based in China, recently partnered with a forward-thinking Canadian animal drug company to overcome this exact challenge.
The client was constrained by a 100-square-meter, static stick-built cleanroom with most areas at Class D. Their expansion and upgrade plans—requiring new Class B and Class C environments—were nearly impossible with traditional construction. The need to add HEPA filters and air return columns promised extensive, disruptive, and costly modifications.
Recognising the inefficiency, the client adopted Airkey's innovative modular cleanroom renovation strategy — a hybrid approach that blended existing infrastructure with state-of-the-art prefabricated cleanroom technology for a superior, compliant, and future-proof facility.
The Stick-Built Challenge: Why Traditional Renovation Was Not Viable
The limitations of the existing stick-built cleanroom were significant:
- Inflexible Structure: Could not support efficient upgrades to higher cleanroom classifications like Class B.
- High Labor Intensity: Cutting into solid ceilings for HEPA filter installation would be slow, messy, and expensive.
- Long Downtime: Traditional renovation would have severely disrupted ongoing pharmaceutical production.
- Difficult Compliance: Achieving the precise GMP cleanroom requirements for cross-contamination control was a major concern.
The Airkey Solution: A Strategic Hybrid Modular Renovation
Our engineered approach maximised value and minimised disruption through a smart, three-phase plan:
- Strategic Asset Reuse: We retained and integrated all suitable existing walls, minimising waste and cost.
- Old Ceiling Removal: The outdated ceiling structure was cleared to make way for a modern, functional system.
- Precision Modular Integration: New modular cleanroom panels and ceilings were installed in areas requiring upgrade or reconfiguration.
Key Design Upgrades for Enhanced GMP Compliance
- Critical Process Separation: To strictly adhere to GMP regulations and prevent cross-contamination, we designed separate Class B rooms for the high-risk filling room and mixing room. Each was equipped with its own personnel airlock room and dynamic pass box to control material and personnel flow.
- Efficient Area Upgrades: The washing room and weighing room were cost-effectively upgraded from CNC to Class D by preserving the original walls and installing new ceiling grids with HEPA filters.
- Seamless HVAC Integration: All new HEPA filters were fitted with custom dust collars for a perfect seal to the existing AHU system. Our engineering team pre-validated that the current system could supply the required cleanroom airflow for the new design, ensuring optimal performance.
The Modular Advantage: Speed, Precision, and Less Disruption
The shift to a prefabricated cleanroom system was the key to success:
- Faster Installation: All components were precision-manufactured in our factory, including pre-drilled installation holes, slashing on-site labor and construction time.
- Minimal Production Downtime: The streamlined process got the client's veterinary drug manufacturing back online faster.
- Future Flexibility: The modular cleanroom design allows for easy reconfiguration or future expansion, protecting the client's long-term investment.
Conclusion: A Smart Investment in Compliant Manufacturing
This project demonstrates that a cleanroom renovation does not require a total tear-down. Airkey's hybrid modular cleanroom approach delivered a custom, GMP-compliant manufacturing environment for animal health products on an accelerated timeline and within budget.
