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Дом > продукты > Будочка чистой комнаты > GMP Pharmaceutical Clean Room Dispensing Booth Laminar Flow Weighing Station with H14 HEPA Filtration ISO 5

GMP Pharmaceutical Clean Room Dispensing Booth Laminar Flow Weighing Station with H14 HEPA Filtration ISO 5

Детали продукта

Место происхождения: Гуандун, Китай

Фирменное наименование: ECER

Сертификация: CE, ISO 9001, GMP

Номер модели: CB-ФАРМА-ISO5

Условия оплаты & доставки

Количество мин заказа: 1 комплект

Цена: USD 5000-50000 / Set

Упаковывая детали: Деревянный ящик с противоударной пеной, герметичный отсек HEPA-фильтра, влагозащитный барьер экспорт

Время доставки: 15-30 рабочих дней

Условия оплаты: Т/Т,Л/К,Вестерн Юнион

Поставка способности: 50 комплектов в месяц

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Детали продукта
Выделить:

Pharma Grade Dispensing Booth

,

GMP Sterile Weighing Station

,

Aseptic Laminar Flow Cleanroom

Класс чистоты:
Класс ISO 5 (Класс 100)
Эффективность HEPA-фильтра:
H14, 99,995% при 0,3 мкм
Скорость воздушного потока:
0,36–0,54 м/с (регулируемая)
Уровень шума:
≤ 65 дБ(А)
Освещение:
≥ 300 люкс (светодиод класса очистки)
Материал рабочей поверхности:
Нержавеющая сталь SUS304, зеркальная полировка
Класс чистоты:
Класс ISO 5 (Класс 100)
Эффективность HEPA-фильтра:
H14, 99,995% при 0,3 мкм
Скорость воздушного потока:
0,36–0,54 м/с (регулируемая)
Уровень шума:
≤ 65 дБ(А)
Освещение:
≥ 300 люкс (светодиод класса очистки)
Материал рабочей поверхности:
Нержавеющая сталь SUS304, зеркальная полировка
Описание продукта
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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