隔离器是洁净空气控制设备,可在无菌生产工艺(无论涉及危害物或非危害物)、技术操作人员及周围环境之间实现完全物理隔离。隔离器广泛应用于需要高等级防污染保护的场合,可作为复杂洁净室的替代选择。
隔离器内置高效空气过滤系统,能够显著降低密闭腔体内的微粒数量。隔离器相对紧凑的内部空间使其更易于采用气体或蒸汽灭菌剂进行彻底生物去污。根据工艺要求,隔离器可配置为相对于周围环境保持正压或负压。正压隔离器通过阻隔外部污染物实现产品保护并维持腔体无菌;而负压隔离器则通过将有害物或有毒物料严密控制在腔体内部,为操作人员和环境提供安全防护。
Aseptic Isolators are critical for providing an isolated ISO Class 5/Grade A environment required for manufacturing sterile products and carrying out aseptic processes. These isolators feature automated pressure hold tests, automated H2O2 bio-decontamination, and continuous environmental monitoring to ensure process sterility.
Applications
- Cell Therapy, Bioprocessing, and Cell Culture
- Pharmaceutical Manufacturing & Formulation
- Sterility Testing & QC Laboratories
- Electronics & Semiconductor Clean Processing
Containment Isolators utilize a negative pressure airflow system engineered for the safe handling of high-potency active pharmaceutical ingredients (HPAPIs) and toxic compounds. Built with breach compensation mechanisms and automated pressure testing, operator and environmental safety remains the top priority.
Applications
- HPAPI & Potent Powder Dispensing/Weighing
- Potent Compound Formulation & Milling
- Pharmaceutical R&D and QC Testing
Class III Biological Safety Cabinet-configured isolators provide maximum biosafety containment for handling Risk Group 3 and 4 biological agents. Featuring a leak-tight physical barrier with glove ports and negative pressure laminar flow, they protect operators from high-consequence pathogens.
Applications
- High-Containment BSL-3 / BSL-4 Laboratories
- Virology & Vaccine Research
- Diagnostic Biological Agent Handling
Designed for hospital and pharmacy compounding in accordance with USP <797> and USP <800> guidelines. Available in Compounding Aseptic Isolator (CAI) models for sterile IV preparation, and Compounding Aseptic Containment Isolator (CACI) models for cytotoxic and antineoplastic chemotherapy drug handling.
Applications
- Hospital Pharmacy Sterile Compounding (CAI)
- Chemotherapy & Cytotoxic Admixture Preparation (CACI)
- Total Parenteral Nutrition (TPN) Formulation
The Cell Processing Isolator (CPI) is an integrated cGMP isolation workstation designed for Advanced Therapy Medicinal Products (ATMP). Combining centrifuge, incubator, and bio-decontamination modules into one closed Grade A system, it optimizes cell therapy manufacturing while eliminating cleanroom overhead.
Applications
- Autologous & Allogeneic Cell Therapy
- Monoclonal Antibody Production & Cell Banking
- cGMP Clinical Trial & Commercial Cell Processing
Esco partners with filling line companies to create client-specific technology, utilizing cGMP compliant isolators and high-quality filling line accessories/technologies to ensure product safety and sterility throughout the entire manufacturing cycle. Enclosures range from Open/Closed Restricted Access Barrier Systems (o/cRABS) to leak-tight isolation technologies.
Applications
- Aseptic Liquid & Powder Vial Filling Lines
- Pre-filled Syringe & Packaging Containment
- Commercial Pharmaceutical & Biopharma Production