Isolator adalah perangkat udara bersih yang memberikan pemisahan lengkap antara proses aseptik (berbahaya/tidak berbahaya), personel teknis, dan lingkungan kerja sekitar. Isolator umumnya digunakan dalam aplikasi yang membutuhkan tingkat perlindungan tinggi dari elemen luar atau kontaminan, dan dapat berfungsi sebagai alternatif untuk cleanroom canggih.
Isolator biasanya dilengkapi sistem filtrasi udara terintegrasi yang mampu menurunkan jumlah partikel secara signifikan di area tertutup. Ukuran interior isolator yang relatif ringkas membuatnya lebih mudah dibersihkan dengan agen sterilisasi gas atau uap. Isolator dapat dikonfigurasi untuk memiliki tekanan positif atau negatif relatif terhadap lingkungan sekitar tergantung pada aplikasinya. Isolator tekanan positif memberikan perlindungan produk terhadap kontaminan, sehingga menjaga sterilitas; sedangkan isolator tekanan negatif, di sisi lain, memberikan perlindungan personel dan/atau lingkungan dengan menahan bahan berbahaya atau beracun di dalam isolator.
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