GMP Pharmaceutical Clean Room Dispensing Booth Laminar Flow Weighing Station with H14 HEPA Filtration ISO 5
Price:
USD 5000-50000 / Set
MOQ:
1 Set
Delivery Time:
15-30 working days
Brand:
ECER
Product Description
Pharmaceutical GMP Dispensing Booth & Laminar Flow Weighing Station
The ECER CB-PHARMA-ISO5 is a GMP-compliant pharmaceutical clean room dispensing booth engineered for sterile medicine compounding, powder weighing, and aseptic material handling. Achieving ISO Class 5 (Class 100) cleanliness with vertical unidirectional laminar airflow and H14 HEPA filtration at 99.995% @ 0.3μm, it creates a contamination-free workspace essential for pharmaceutical manufacturing, hospital pharmacy compounding, and biotech laboratory applications.
Key Features
- GMP & ISO 5 Compliance: Fully compliant with EU GMP Annex 1, FDA cGMP, and ISO 14644-1 Class 5 standards for pharmaceutical cleanroom operations.
- H14 HEPA Filtration: High-efficiency H14 HEPA filter provides 99.995% particle removal efficiency at 0.3μm, ensuring ultra-clean working environment for sterile compounding.
- Vertical Laminar Airflow: Precision-engineered unidirectional downflow design delivers uniform clean air across the entire work surface, preventing cross-contamination.
- SUS304 Stainless Steel Construction: Full stainless steel interior and work surface with mirror-polished finish for easy cleaning, sterilization, and long-term corrosion resistance.
- Operator Protection: Negative pressure plenum with HEPA-filtered exhaust protects operators from hazardous powder exposure during dispensing operations.
- Low Noise Operation: Optimized fan and airflow design maintains noise levels ≤ 65 dB, ensuring operator comfort during extended use.
- LED Illumination: Built-in purification-grade LED lighting ≥ 300 Lux for clear visibility during precision weighing and compounding tasks.
- Differential Pressure Monitoring: Integrated pressure gauge monitors filter loading status for proactive maintenance scheduling.
Technical Specifications
| Cleanliness Class | ISO Class 5 (Class 100, Grade A) |
| HEPA Filter Efficiency | H14, 99.995% @ 0.3μm |
| Airflow Velocity | 0.36–0.54 m/s (adjustable) |
| Airflow Type | Vertical Unidirectional Laminar Downflow |
| Noise Level | ≤ 65 dB(A) |
| Illumination | ≥ 300 Lux (purification-grade LED) |
| Work Surface Material | SUS304 Stainless Steel, Mirror Polish |
| Wall Panel Material | SUS304 Stainless Steel / Anti-Static PVC Curtain |
| Power Supply | 220V / 380V, 50Hz / 60Hz |
| Vibration Level | ≤ 0.5μm (suitable for precision balances) |
Pharmaceutical & Healthcare Applications
- Sterile medicine compounding and IV admixture preparation
- API powder weighing, dispensing, and sampling
- Aseptic filling and packaging operations
- Quality control laboratory sample handling
- Cytotoxic and hazardous medicine preparation
- Microbiology media preparation and sterility testing
- Hospital pharmacy cleanroom workstation
- Biotech R&D sterile processing
Quality Assurance & Certifications
- ISO 9001:2015 Quality Management System Certified
- CE Marked (EU Compliance)
- GMP Compliant Design (EU GMP Annex 1 / FDA cGMP)
- Factory Acceptance Test (FAT) & Site Acceptance Test (SAT) documentation provided
- DQ/IQ/OQ/PQ validation support available
Turnkey Service & Support
ECER provides comprehensive one-stop pharmaceutical clean room solutions, including:
- Custom design and layout engineering based on user requirement specifications (URS)
- On-site installation and commissioning by certified engineers
- HEPA filter integrity testing (DOP/PAO test) and airflow validation
- User training and operation manual in English
- 12-month warranty with lifetime technical support
- Spare parts supply and after-sales service worldwide
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Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.
Company
Hongkong Yaning Purification industrial Co.,Limited
Location
No. 6, Sanhuan Rd, Chiling Industrial Zone , Houjie Town, Dongguan City, Guangdong Province, China
Contact Person
Viola