Isolators zijn apparaten voor zuivere lucht die een volledige scheiding bieden tussen een aseptisch proces (gevaarlijk/ongevaarlijk), het technische personeel en de omringende werkomgeving. Isolators worden over het algemeen gebruikt bij toepassingen die een hoge mate van bescherming vereisen tegen externe invloeden of verontreinigingen, en kunnen dienen als alternatief voor geavanceerde cleanrooms.
Isolators beschikken doorgaans over ingebouwde luchtfiltratiesystemen die het aantal deeltjes in een gesloten ruimte aanzienlijk kunnen verlagen. Door de relatief compacte binnenruimte van de isolator is deze eenvoudiger te reinigen met gas- of dampvormige sterilisatiemiddelen. Isolators kunnen, afhankelijk van de toepassing, worden geconfigureerd met overdruk of onderdruk ten opzichte van de omringende omgeving. Overdrukisolators bieden productbescherming tegen verontreinigingen en behouden zo de steriliteit; terwijl onderdrukisolators daarentegen personeels- en/of milieubescherming bieden door gevaarlijke of giftige stoffen binnen de isolator te houden.
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