Compliance & Certifications
AIPURE cleanroom environments are engineered to navigate the complex regulatory landscapes of the life sciences industry. We ensure your facility is “Audit-Ready” from day one. Most of our international projects are ISO Class 7–8 (EU GMP Grade C–D) OSD, nutraceutical and API facilities — the classification range where emerging-market plants are built and audited.
International Management Systems
Our quality, environmental and occupational health & safety management systems are certified to ISO 9001, ISO 14001 and ISO 45001, and audited annually by accredited third parties.
Engineering & Construction Licenses (China)
Specialized Medical & Industrial Expertise
Validation Documentation We Deliver
Every cleanroom we deliver comes with a complete, audit-ready validation package. Our documentation is prepared to satisfy WHO GMP, EU GMP Annex 1, US FDA, and PIC/S inspections — so your facility is qualified and defensible from day one.
Qualification Protocols & Reports
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DQ — Design Qualification
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IQ — Installation Qualification
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OQ — Operational Qualification
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PQ — Performance Qualification
Engineering & Compliance Documents
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URS — User Requirement Specification
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FAT / SAT records
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As-built drawings
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Cleanroom Classification Report per ISO 14644-1
All protocols are executed on-site and signed off before handover. Documentation can be prepared in English to support regulatory submission in your market.
Innovation & Intellectual Property（Selected Patents (19 shown)
A Decade of Patented Innovation (2015–2025), built on 20+ years of pharmaceutical engineering since 2004
Energy-Saving Control System and Method
Air Conditioning Equipment Management System and Method
Intelligent Room Differential Pressure Control System
Constant Temperature and Humidity Air Treatment
Material Transfer Facility and Method
Air Purifier
Fresh air system
Device with self-cleaning filter
Fully automated medical sterilization clean workbench
Cleanroom differential pressure balance control system
A constant humidity and oxygen purification fresh air system
An adjustable air outlet structure for cleanrooms
An air filter supply device for intensive care units
A laboratory emergency spray eyewash device
Condensate recycling device for double-effect evaporators
Clean operating room purification auxiliary equipment control software
Air filter APP control system
Cleanroom air handling system
Cleanroom air quality monitoring software
Audit-Ready & Verified:
“All certifications and engineering licenses are current and subject to annual third-party surveillance audits. Certificate copies, scopes and validity dates are available on request for client and regulatory inspections.”
Take Our Credentials to Your Boardroom
Download the complete, high-resolution portfolio of AIPURE’s international certifications, engineering licenses, and 10-year patent history for your internal audit.
Request the Compliance Portfolio
Secure Your Project’s Compliance Today
Don’t let regulatory hurdles delay your market entry. Partner with AIPURE for an “Audit-Ready” controlled environment that meets the world’s toughest standards.
Our documentation packages are prepared for review by Saudi FDA, Indonesian BPOM, WHO PQ and other national authorities in emerging markets.
