Airkey, a trusted modular cleanroom manufacturer in China, recently partnered with a leading softgel manufacturer to design, build, and validate a state-of-the-art 485 square meter GMP cleanroom, featuring super low humidity control (35% ±10%) for critical processes and full GMP validation. This project highlights our expertise in creating environments with precision environmental control for complex oral solid dosage production.
This custom-built facility was engineered to meet stringent local GMP regulations, with a core focus on stringent temperature and humidity control to ensure the quality and stability of the softgel products throughout the manufacturing process.
Project overview: A tailored solution for softgel manufacturing
- Project Scope: A complete 485 sqm modular cleanroom.
- Cleanroom Classification: ISO 8 (Class D) throughout.
- Key Achievement: Successful passage of official GMP validation.
- Critical Design Focus: Segregation of personnel and material flow to prevent cross-contamination.
Precision engineering for critical manufacturing processes
The client's production required exceptionally low humidity control for several core areas. Airkey's engineering team designed a specialised HVAC system capable of meeting these demanding conditions:
For critical process rooms (blister, encapsulation, sorting/polishing, printing):
- Stringent Humidity Control: 35% ±10% RH (Super Low Humidity)
- Precise Temperature Control: 18°C ±3°C
- Cleanroom Class: Class D (ISO 8)
- Air Changes Per Hour (ACPH): 25
This stable temperature and humidity environment is critical for preventing moisture absorption by hygroscopic softgel shells, ensuring product integrity, and maximising production yield.
Supporting area environmental control
For ancillary rooms that support the core manufacturing workflow, a separate environmental regime was established to ensure both comfort and compliance:
For support Rooms (Airlock, Dispensing, Gowning, WIP, etc.):
- Temperature Control: 22°C ±3°C
- Humidity Control: 50% ±10% RH
- Cleanroom Class: Class D (ISO 8)
- ACPH: 25
Key design features & GMP compliance solutions
- Customised HVAC system: The heart of the project was a bespoke HVAC system for cleanroom capable of achieving and maintaining the challenging super low humidity levels required in the process rooms, a critical factor for GMP certification.
- Optimised cleanroom layout: The modular cleanroom design expertly separated personnel flow from material flow. This design is a cornerstone of contamination control in pharmaceutical cleanrooms, minimising the risk of cross-contamination.
- Flexible structure for equipment: With ceiling heights of 2.7 meters in most areas and 4 meters in rooms housing large equipment like tumbling dryers, the cleanroom was customised to accommodate the client's specific machinery, showcasing the adaptability of prefabricated cleanrooms.
- Scalable modular Cconstruction: Utilising modular cleanroom panels allowed for a fast installation with minimal disruption, enabling the client to quickly achieve operational readiness and pass their GMP audit.
- Proven results: Successful GMP validation
The ultimate measure of success for any pharmaceutical cleanroom is passing the official GMP validation process. This Air-key designed facility did so successfully, a testament to our rigorous cleanroom design standards, quality construction, and deep understanding of regulatory compliance.
Why choose Airkey for your GMP cleanroom?
- Expertise in cGMP Compliance: We build to GMP standards from the ground up.
- Precision Environmental Control: Specialists in humidity and temperature control for demanding applications.
- Turnkey Cleanroom Solutions: From design and cleanroom installation to support for validation.
- Proven Track Record: Successful projects in softgel manufacturing, biopharma, and more.
Contact us today for a custom GMP cleanroom quote.
If you are planning a pharmaceutical manufacturing facility that demands rigorous environmental control and GMP compliance, partner with Airkey. Let us engineer a cleanroom solution that ensures your product quality and operational success.
Website: www.airkeyx.com
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