AAF GMP Compliant Filters: Certified Filtration Solutions for Regulated Clean Environments
In industries governed by Good Manufacturing Practice (GMP), contamination control is not optional—it’s a critical requirement. Clean air plays a central role in ensuring product safety, regulatory compliance, and process integrity, especially in pharmaceutical manufacturing, biotechnology production, medical device assembly, and sterile environments.
AAF GMP Compliant Filters, developed by AAF International, are engineered and certified to meet the strictest global cleanroom standards—ensuring particle and microbial control that complies with EU GMP Annex 1, FDA cGMP, WHO guidelines, and ISO 14644 cleanroom classifications.
Whether you are designing a Grade A cleanroom, operating a sterile filling line, or managing an HVAC system for pharmaceutical packaging, AAF has a validated filtration solution to help you meet your compliance goals.
✅ What Are GMP Compliant Filters?
GMP Compliant Filters are air filters manufactured and tested to meet the performance, traceability, and documentation requirements of GMP-regulated facilities. These filters are used in HVAC systems, cleanrooms, laminar flow benches, terminal modules, and other controlled air systems to:
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Capture airborne particulates, bacteria, and viruses
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Prevent product cross-contamination
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Maintain ISO Class 5–8 cleanroom classifications
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Ensure environmental stability in critical processing zones
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Support regulatory audit readiness with full traceability
🌍 GMP Standards That AAF Filters Support
| Standard | Compliance Area |
|---|---|
| EU GMP Annex 1 | Sterile pharmaceutical manufacturing |
| FDA cGMP (21 CFR Part 210/211) | US pharmaceutical production & packaging |
| WHO TRS 961 Annex 6 | Global GMP guidelines for medicines |
| ISO 14644-1 | Cleanroom classification (ISO Class 1–9) |
| USP <797> / <800> | Compounding sterile preparations & hazardous drugs |
| GAMP 5 / VMP Integration | Validation Master Plans and filter traceability |
🛡️ Key Features of AAF GMP Compliant Filters
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✅ HEPA/ULPA Efficiency: Certified at ≥99.97% to ≥99.999995% for 0.3 to 0.12 microns
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✅ Individually Scan-Tested Filters: Compliant with EN1822 and ISO 29463 standards
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✅ FDA/Pharma-Grade Materials: Low-outgassing, non-shedding media; corrosion-resistant frames
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✅ Leak-Free Sealing: Gel-seal, knife-edge, or gasketed designs prevent bypass contamination
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✅ Documentation & Traceability: Filter serial numbers, factory test reports, COC, COA, and batch records
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✅ Compatible with GMP Air Handling Units (AHUs), Terminal HEPA Boxes, RABS, and FFUs
🔬 Applications of AAF GMP Compliant Filters
| GMP Area | Filter Use |
|---|---|
| 💉 Grade A (ISO 5) | Terminal HEPA filters in sterile filling, RABS, isolators |
| 🧪 Grade B (ISO 5/6) | Laminar flow, gowning rooms, background sterile support zones |
| ⚗️ Grade C (ISO 7) | Tablet production, formulation, granulation rooms |
| 💊 Grade D (ISO 8) | Weighing, packaging, dispensing areas |
| 🧬 QC / Micro Labs | HEPA filtration for sample analysis and product testing |
| 🏥 Pharmacy Compounding | ISO 5/7 clean hoods, BSCs, and sterile rooms |
🌟 AAF Filters That Meet GMP Compliance
🔹 AstroCel® II
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Mini-pleat HEPA/ULPA filter (H13–U17)
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Individually scan-tested
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Ideal for terminal modules, FFUs, and cleanroom ceilings
🔹 AstroCel® TM
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Terminal HEPA filter module
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Gel-seal and knife-edge options for 100% leak-proof sealing
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Used in Grade A/B ceiling applications
🔹 BioCel® V
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Rigid V-bank filter with ePM1 85% efficiency
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Excellent for HVAC pre-final stages in Grade C/D zones
🔹 DriPak® 2000
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Extended surface bag filter
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MERV 14–15 / ISO ePM2.5
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Intermediate filtration for GMP-compliant AHU systems
🔹 PerfectPleat®
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MERV 8–11 pre-filter
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Protects downstream HEPA filters, extending lifespan and efficiency
🧪 Technical Specifications Overview
| Specification | AAF GMP Filters |
|---|---|
| Filter Efficiency | H13–U17 (EN1822), ePM1 85–95%, MERV 14–16 |
| Testing Standards | EN1822, ISO 29463, ISO 16890, ASHRAE 52.2 |
| Filter Media | Micro-glass fiber, synthetic fiber, activated carbon (optional) |
| Frame Material | Galvanized steel, aluminum, stainless steel |
| Seal Types | Gel seal, knife-edge, gasketed |
| Service Life | 6–24 months depending on load |
| Cleanroom Class Support | ISO Class 1 to 8 |
| Traceability | Serial number, production batch, test certificate included |
💡 Benefits of AAF GMP Compliant Filters
✅ 1. Full Compliance with GMP and ISO Standards
AAF filters help you achieve and maintain regulatory readiness, supporting your VMP, SOPs, and QA documentation.
✅ 2. Reliable Contamination Control
High-efficiency filters prevent airborne particles and microorganisms from compromising cleanroom integrity.
✅ 3. Audit-Ready Documentation
Each filter is delivered with a certificate of conformance, test report, and full traceability for validation audits.
✅ 4. Compatible with All Cleanroom HVAC Systems
AAF filters are available in all standard sizes and can be customized for RABS, isolators, FFUs, and terminal modules.
✅ 5. Energy-Efficient and Long-Lasting
Optimized pleat design and low pressure drop reduce fan energy usage and extend filter replacement intervals.
📦 Why Choose AAF GMP Filters from VIETPHAT?
As the exclusive distributor of AAF International in Vietnam, CÔNG TY CỔ PHẦN KỸ THUẬT VIỆT PHÁT provides:
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🧠 GMP-certified filtration consulting for pharma, biotech, and medical cleanrooms
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📦 Large stock availability of HEPA, ULPA, and pre-filters in standard sizes
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🧪 On-site validation services: PAO testing, particle counting, ISO 14644 certification
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🔧 Installation support for terminal boxes, AHUs, FFUs, and more
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📋 GMP-ready documentation: COC, COA, test reports, SOP integration support
📞 Hotline: 0971 344 344
📧 Email: sales@vietphat.com
🌐 Website: www.vietphat.com
✅ Conclusion
In the world of GMP-regulated production, clean air is a vital part of product quality, patient safety, and regulatory compliance. AAF GMP Compliant Filters provide world-class air filtration performance, full certification, and trusted reliability—backed by one of the most experienced clean air brands in the industry.
🔒 Protect your cleanroom. Pass every audit. Choose AAF GMP Filters for certified contamination control.
