Advanced Cleanroom Solutions
From Compliance to Commissioning
Cleanroom Solutions
Looking for high-precision cleanroom solutions? Explore our range of GxP-compliant controlled environments designed to safeguard your production safety and scientific purity. Whether you are setting up a biopharma facility, a medical device facility, or a high-containment laboratory, we deliver validated cleanroom systems — with the IQ/OQ/PQ documentation your regulator will ask for.
Biopharma Cleanroom Solutions
High-containment environments for Biologics, Chemical Drugs, and OSD, ensuring strict compliance with FDA and EU GMP standards.
Medical Device Cleanroom Solutions
Controlled environments engineered to protect device sterility, validated to ISO 13485 & ISO 14644-1 for reliable regulatory compliance.
Laboratory Controlled Environments
Laboratory-grade contamination control for R&D and clinical testing facilities, no reportable biosafety incidents across many projects delivered since 2004.
Why Choose AIPURE?
Engineering Built on Standards, Delivered as Validated Systems
AIPURE utilizes a “modular, factory-prefabricated construction (80% off-site prefabrication)” concept to drive rapid, high-quality deployment. We provide comprehensive compliance services for pharmaceutical, medical, and laboratory sectors to meet global regulatory guidelines.
Proven Engineering Excellence Across Industries
Delivering pre-validated GMP cleanrooms to emerging markets —
audit-ready for WHO, EU GMP Annex 1, and FDA inspection.
Full-Chain Small Molecule Pharma Base
An integrated R&D and manufacturing facility with a strict quality management system aligned with international standards for high-quality drug production.
Intelligent OSD Manufacturing Hub
Integrating high-precision engineering for standardized OSD processing, from research labs to large-scale extract, ensuring GxP compliance &environmental control.
National Vaccine Production Landmark
A specialized biopharma facility with 10 vaccine lines, maintaining a 60-year legacy as a national designated production unit for critical biological products.
Publicly Listed IVD Manufacturing Hub
A specialized facility for POCT and molecular diagnostics, strictly aligned with ISO 13485:2016 and CE marking requirements under EU IVDR (2017/746).
Specialized ELISA Diagnostic Center
A high-tech R&D and manufacturing hub utilizing advanced biocontainment and precision environmental control to support high-throughput diagnostics and clinical research.
National Designated Bio-Medical Facility
A high-tech enterprise with military medical roots, 3,000 m² of ISO Class 7 cleanrooms for state-designated production of large-volume injectables and blood separation devices.
Regional Center for Disease Control (CDC)
A specialized public health facility featuring high-containment biosafety labs, no reportable biosafety incidents across many projects delivered since 2004.
Global Antibody R&D & Manufacturing Hub
Supporting the “Human Antibody Project” for a global biotech leader, featuring ISO 9001 & 13485 certified laboratories optimized for high-throughput antibody development and protein research.
Precision Biotech Research & Logistics Center
Delivering science-grade controlled environments for proteomics and life science research, ensuring global compliance and environmental stability for international inventory management.
Full-Chain Small Molecule Pharma Base
An integrated R&D and manufacturing facility with a strict quality management system aligned with international standards for high-quality drug production.
Intelligent OSD Manufacturing Hub
Integrating high-precision engineering for standardized OSD processing, from research labs to large-scale extract, ensuring GxP compliance &environmental control.
National Vaccine Production Landmark
A specialized biopharma facility with 10 vaccine lines, maintaining a 60-year legacy as a national designated production unit for critical biological products.
Publicly Listed IVD Manufacturing Hub
A specialized facility for POCT and molecular diagnostics, strictly aligned with ISO 13485:2016 and CE marking requirements under EU IVDR (2017/746).
Specialized ELISA Diagnostic Center
A high-tech R&D and manufacturing hub utilizing advanced biocontainment and precision environmental control to support high-throughput diagnostics and clinical research.
National Designated Bio-Medical Facility
A high-tech enterprise with military medical roots, 3,000 m² of ISO Class 7 cleanrooms for state-designated production of large-volume injectables and blood separation devices.
Regional Center for Disease Control (CDC)
A specialized public health facility featuring high-containment biosafety labs, no reportable biosafety incidents across many projects delivered since 2004.
Global Antibody R&D & Manufacturing Hub
Supporting the “Human Antibody Project” for a global biotech leader, featuring ISO 9001 & 13485 certified laboratories optimized for high-throughput antibody development and protein research.
Precision Biotech Research & Logistics Center
Delivering science-grade controlled environments for proteomics and life science research, ensuring global compliance and environmental stability for international inventory management.
Verified Compliance Services meeting International Regulatory Standards.
We analyze your GxP compliance needs (FDA/EU/WHO) and process requirements to provide expert feasibility studies and cost-optimization strategies.
Description: Our engineers create detailed 3D layouts, focusing on precision climate control, airflow patterns, and contamination prevention protocols.
Description: Executing the build with our “Productized Engineering” concept to ensure standardized quality, rapid deployment, and structural integrity.
We manufacture high-quality cleanroom components—including AHUs, modular panels, and FFU systems—specifically tailored to your facility’s needs.
Description: Providing 24/7 monitoring, long-term environmental stability tuning, and preventive maintenance to protect your “no reportable biosafety incidents” record.
Description: Rigorous testing and validation to ensure the environment meets specified ISO classes and biosafety standards before operational handover.
Six-Phase Delivery Process
Phase 4 Commissioning — 3 weeks — IQ/OQ protocols executed, deviation log closed.
Yes. We have a proven track record in specialized sectors. Our expertise covers Biopharmaceuticals (Vaccines/MABs), Medical Devices (IVD/Implants), and High-containment Laboratories (BSL-1 to BSL-3), ensuring industry-specific contamination control.
It is our unique approach to modular construction. By standardizing components and pre-fabricating key elements, we achieve 30% faster deployment and higher structural precision compared to traditional on-site construction, significantly reducing your time-to-market.
Yes. On-site installation supervision, commissioning and remote monitoring are included in our standard international scope of supply, including overseas on-site installation guidance, system commissioning, and technical inquiries: 24h · Contracted clients, critical alarms: 4h · remote monitoring: 24/7. We have delivered projects across the Middle East, Central Asia, Southeast Asia and Africa.
We implement multi-layered safety protocols, including redundant high-precision pressure differential control, advanced HEPA/ULPA filtration, and real-time environmental monitoring systems to eliminate any risk of leakage or cross-contamination.
From initial consulting to 24/7 maintenance, let our experts design a cleanroom solution that grows with your business.
