Isolator (Glovebox)
A Pharmaceutical Isolator (Glovebox) is necessary for product sterility, operator protection, and regulatory compliance in pharmaceutical production. It offers a controlled, contamination-free environment for the handling of potent or sterile materials, and it is a key element in sterile and containment applications.
Description
Isolator (Glovebox) for Pharmaceutical Industry: Technical Specification & Application
Introduction
A Pharmaceutical Isolator (Glovebox) is a containment system that provides a controlled environment to handle sensitive material, such as highly potent APIs (HPAPIs), sterile products, and dangerous compounds. It protects against contamination while securing the safety of the operator by ensuring a physical barrier between the operator and the product.
Technical Specifications of Isolator (Glovebox)
- Material of Construction
Stainless Steel (SS 316L for contact surfaces, SS 304 for non-contact surfaces) – resistant to corrosion, GMP standards.
Transparent Glass Windows or Polycarbonate – ensure visibility and maintain a sterile condition.
Smooth Welded Chamber Construction – ensures dust-free collection and easy cleaning.
- Containment Levels & Pressure Control
Positive Pressure Isolator – applied to sterile/aseptic use in order to bar the entry of contamination.
Negative Pressure Isolator – applied for working with hazardous or powerful compounds to save the operator.
Pressure range: -200 Pa to +200 Pa, application-dependent.
- Filtration & Airflow System
HEPA/ULPA Filters (≥99.997% efficiency, 0.3 microns) – allows clean air circulation within the isolator.
Laminar Airflow (Unidirectional or Turbulent Flow) – preserves aseptic conditions.
Exhaust Filtration with Bag-in/Bag-out System – safe disposal of harmful substances.
- Glove Ports & Sleeves
Butyl, Neoprene, or Hypalon Gloves – offer chemical resistance and flexibility.
Customizable Glove Ports – usually 4 to 6 ports, depending on the size of the isolator.
- Decontamination & Sterilization System
Integrated VHP (Vaporized Hydrogen Peroxide) or Steam Sterilization – provides sterilization prior to and after use.
CIP/SIP (Clean-in-Place/Sterilize-in-Place) System – automated cleaning and sterilization for GMP compatibility.
- Loading & Material Transfer System
Rapid Transfer Port (RTP) – enables safe material entry and exit.
Alpha-Beta Port Mechanism – avoids cross-contamination.
Integrated Pass-Through Chamber – minimizes exposure risks.
- Monitoring & Control System
PLC-Based Touchscreen HMI Control – instantaneous monitoring of airflow, pressure, and decontamination cycles.
Temperature, Humidity, and Particle Monitoring Sensors – maintains compliance with ISO Class 5 (Grade A) cleanroom standards.
- Customization & Accessories
Size & Configuration Customization – tabletop or standalone versions available.
Weighing & Dispensing Isolators – built-in balance for accurate powder handling.
Integrated Glove Leak Tester – guarantees airtight integrity.
Applications of Isolator (Glovebox) in the Pharmaceutical Industry
Sterile Drug Manufacturing
Applied in aseptic filling, compounding, and sterile filtration to avoid microbial contamination.
Handling of Highly Potent Compounds (HPAPIs)
Prevents operators when handling toxic or potent active ingredients.
Weighing & Dispensing of Hazardous Powders
Prevents dust-free handling of cytotoxic or hormonal drugs.
Cell & Gene Therapy and Biotechnology Applications
Applied in cell culture, tissue processing, and vaccine production.
Quality Control & Microbiological Testing
Offers an ISO Class 5 clean space for sterility testing in QC laboratories.
Radioactive & Nuclear Medicine Applications
Utilized for the safe handling of radiopharmaceuticals.
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