Los aisladores son equipos de aire limpio que proporcionan una separación completa entre un proceso aséptico (peligroso/no peligroso), el personal técnico y el entorno de trabajo circundante. Los aisladores se utilizan generalmente en aplicaciones que requieren un alto grado de protección frente a elementos externos o contaminantes, y pueden servir como alternativas a salas limpias complejas.
Los aisladores suelen contar con sistemas integrados de filtración de aire capaces de reducir significativamente el recuento de partículas en un área cerrada. El tamaño relativamente compacto del interior del aislador facilita su limpieza con agentes esterilizantes de gas o vapor. Los aisladores se pueden configurar para tener presión positiva o negativa con respecto al entorno circundante según la aplicación. Los aisladores de presión positiva proporcionan protección del producto contra contaminantes, manteniendo así la esterilidad; mientras que los aisladores de presión negativa, por otro lado, proporcionan protección del personal y/o del medio ambiente al contener los materiales peligrosos o tóxicos dentro del aislador.
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