Isolator (Glovebox)

Product Details

Isolator (Glovebox) for Pharmaceutical Industry: Technical Specification & Application

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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)

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

Company Details

Fabon Pharmatech is a Nashik‑based manufacturer of pharma‑grade equipment, with roots going back to 1998. We are  specialize in stainless‑steel machines designed for pharmaceutical, chemical, and food applications, meeting GMP/FDA standards

• Mixing & Blending Equipment: Double-cone blenders, V-blenders, octagonal blenders, Conta blenders, pillar-type blenders
• Granulation & Milling Tools: Multi-mill machines, cone mills, wet mills, rapid mixer granulators
• Coating & Processing Lines: Auto-coaters, fluid-bed processors, pasté kettles, CIP/WIP systems
• Screening & Conveyance: Vibro sifters (SS 316L), vacuum transfer systems, lifters, scrubbers, dedusters, air-handling units
• Containment & Hygienic Tools: Isolators/gloveboxes, intermediate process containers (IPC), solution tanks