GMP-Compliant Flat Door Pass Box | 304 Stainless Steel |Pharma Grade
Pharma-Grade UV: Programmable 254nm UV-C cycles (0-60min) with motion-sensing safety cutoff for GMP environments.
Diagnostic Lighting: 500 Lux medical-grade LEDs with color temperature adjustment (3000K-6500K) support visual inspections.
Electronics Mode: Faraday cage grounding option neutralizes static during wafer transfers (＜10V residual charge).
Biotech Ready: Radiused corners (R≥3mm) and seamless welds pass EMA Annex 1 swab validation.
| Parameter Name | parameter |
| Material | 304 sanded stainless steel |
| Window Design | Double doors with tempered glass observation windows |
| Interlock System | Mechanical interlock to prevent simultaneous door opening |
| Lighting | UV sterilization lamp and embedded clean lighting lamp |
| Internal Design | Rounded corners to eliminate dead angles |
| Door Handle | SUS304 stainless steel for durability |
| External Dimensions | W760 × D670× H720 (mm) |
| Internal Dimensions | W600 × D600 × H600 (mm) |
| Certifications | ISO,GMP,CE |
Key Features
1. 304 Sanded Stainless Steel Construction: Durable and corrosion-resistant for cleanroom compatibility.
2. Double Door Design: Features tempered glass observation windows for visibility and aesthetics.
3. Mechanical Interlock System: Ensures both doors cannot be opened simultaneously, preventing cross-contamination.
4. UV Sterilization and Clean Lighting: UV lamp for sterilization and embedded lighting for illumination during transfers.
5. Rounded Interior Corners: Eliminates dead angles for easier cleaning and compliance with hygiene standards.
6. Durable Door Handle: Made of SUS304 stainless steel for long-lasting use.
7. Optimized Dimensions: Compact yet spacious design for efficient use in cleanroom environments.
8. Safety & Visibility: Tempered glass ensures clear visibility and enhanced safety.
Application Scenarios
Material transfer in pharmaceutical cleanrooms.
Sterile sample handling in biomedical laboratories.
Contamination-sensitive component transfer in electronics manufacturing.
Q1: How does this GMP-Compliant Flat Door Pass Box ensure sterile material transfer while adhering to strict pharmaceutical regulations?
This pass box is specifically engineered to meet GMP Annex 1 and ISO 14644-1 Class 5 cleanliness requirements, critical for pharmaceutical manufacturing. The 304 stainless steel construction provides a smooth, non-porous surface that resists particle buildup and simplifies sanitization, ensuring compliance with FDA and EU guidelines. The flat door design minimizes recessed areas where contaminants could accumulate, while a mechanical interlock system prevents cross-contamination by ensuring only one door opens at a time. Equipped with HEPA H14 filters (≥99.995% efficiency at 0.3μm), it maintains a particle-free environment, making it ideal for transferring sensitive materials like APIs or sterile vials in regulated cleanrooms.
Q2: Can the 304 stainless steel construction of this pass box withstand frequent sanitization and chemical exposure in pharmaceutical cleanrooms?
Yes. The 304 stainless steel build offers superior corrosion resistance, making it suitable for environments where daily cleaning with aggressive disinfectants is standard. Its smooth, durable surface resists scratches and particle adhesion, reducing maintenance efforts and contamination risks. The pass box is designed with welded seams and airtight seals to maintain structural integrity even in high-humidity or chemically intensive settings. Routine maintenance, such as filter replacements (HEPA filters every 12–18 months) and gasket inspections, ensures long-term reliability. For highly corrosive applications, optional upgrades to 316L stainless steel are available, further enhancing chemical resistance.
Q3: How does the flat door design of this GMP-Compliant Pass Box optimize space and operational efficiency in pharmaceutical workflows?
The flat door design is tailored to save space in compact cleanrooms, as it eliminates protruding handles or mechanisms, reducing the unit’s footprint while maintaining a functional interior for material transfer. The seamless, flush-mounted door not only conserves valuable floor or wall space but also supports easy sanitization and reduces the risk of particle entrapment, aligning with GMP cleanliness standards. The mechanical interlock system streamlines operations by ensuring safe, sequential door movements, minimizing downtime in high-traffic environments. The ergonomic layout allows for quick, intuitive access, enhancing operator efficiency in time-sensitive pharmaceutical processes where precision and speed are critical.
