Isolator (Glovebox) offered by FABON Pharmatech Pvt Ltd (Nashik)

FABON Pharmatech Pvt Ltd – Company Profile

FABON Pharmatech Pvt Ltd, based in Nashik, Maharashtra, is a well‑established manufacturer of pharmaceutical and related industrial machinery. Founded in 1998 (or 2007 by some web references), the company has developed a wide product range including blenders, mills, coating lines, vacuum transfer systems, and notably, Isolator (Glovebox) systems . Operating with a compact but expert team, FABON emphasizes in‑house R&D, customization, and GMP‑compliant manufacturing for pharmaceutical clients locally and abroad.

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What Is an Isolator (Glovebox)?

A glovebox or isolator is a sealed enclosure that offers a controlled environment—either positive‐pressure for sterile/aseptic use (product protection), or negative‐pressure for operator and environmental protection while handling hazardous materials. Through built‑in gloves, operators manipulate materials inside without direct exposure or contamination risks. For pharmaceutical production involving highly potent APIs, sterile filled drugs, or toxic compounds, the isolator is a critical containment technology .

Key Technical Specifications – FABON’s Offering

Material & Construction

Constructed from stainless steel, typically SS‑316L for product‐contact areas and SS‑304 elsewhere to ensure corrosion resistance and cleaning ease.
Welded chambers with smooth interiors minimize particulate accumulation.
Viewing panels made of tempered glass or polycarbonate allow visibility without compromising sterile integrity .
External finish is polished silver stainless steel as offered by FABON.

Pressure & Containment Systems

Designed for both positive pressure (sterile processes) and negative pressure (handling hazardous powders/APIs), with manual auto control.
Operating pressure range typically spans from –200 Pa up to +200 Pa (case‑dependent).
The system can be configured with cascading zones for multiple containment levels if required.

Air Filtration & Airflow

Equipped with HEPA or ULPA filters achieving ≥ 99.997% efficiency at 0.3 µm.
Supports laminar airflow configurations (unidirectional or turbulent) for sterile grade A/B zones.
Bag‑in/bag‑out filter modules enable safe filter replacement while maintaining isolation.

Glove Ports & Operator Interface

Standard configurations typically offer 4–6 glove ports, though fully customizable.
Gloves are made of butyl rubber, neoprene, or Hypalon/CSM to resist chemical/biological exposure.
Glove port layout and spacing are tailored to client workflow patterns .

Sterilization & Cleaning Features

Optionally includes integrated VHP (Vaporized Hydrogen Peroxide) or Steam sterilization.
Some models support CIP/SIP for automated cleaning cycles compatible with GMP workflows.
Manual wipe-down with chemical disinfectants is also supported as needed.

Material Transfer Components

Rapid Transfer Ports (RTPs) or Airlocks/Pass‑Through Chambers secure the transfer of materials in/out without contaminating the main chamber.
Configurations can include Alpha‑Beta port systems for enhanced barrier integrity.

Monitoring & Control Systems

Basic units from FABON include automatic control mode, but are not computerized (i.e. no PLC/HMI interfaces).
Advanced systems (if customized) may incorporate pressure gauges, humidity and temperature sensors, and particle counters to maintain ISO Class 5 (Grade A) compliance.
Continuous monitoring or remote digital logging typically requires customization or third‑party integration.

Power & Frequency

Operates at standard 220 V, 50 Hz electrical supply—a match for Indian industrial standards.
Power consumption is efficient and controlled, suited for cleanroom-grade installations.

Supported Sizes & Configurations

The product is modular and customizable, supporting tabletop units to full standalone enclosures.
Chamber volumes range from ~100 L to 1,000 L or more, depending on project specifications.
Optional add‑ons: integrated balances for weighing, sample dispensers, leak test systems, robotic arms, etc.

Delivery, Pricing & Warranty

Base price: approx ₹3,00,000 per unit (~USD 3.6 K), MOQ: 1 unit, up to 10 units/month supply capability; delivery in ~45 days .
Warranty: 1 year standard inclusion.
Export‑ready: Delivered to Asia, Middle East, Africa, and domestic Indian market. Standard wooden packaging, FOB Mumbai terms.

Applications in Pharmaceutical & Biotech Industries

Sterile Drug Manufacturing

Used in aseptic filling, sterile compounding, microbiological testing, and other ISO Class 5 processing operations requiring contamination control.

Handling HPAPIs and Hazardous Powders

Ensures operator safety while handling potent APIs, cytotoxic drugs, hormones, and toxic powders. Negative pressure isolators prevent leaks during weigh/dispense operations.

QC and Microbiology Labs

Provides a sterile micro‐environment for sample preparation, QC tests, sterility assurance, and microbial testing consistent with GMP norms.

Cell & Gene Therapy and Biotech Applications

Ideal for cell culture handling, vaccine formulation, gene therapy production requiring aseptic and contamination‑free conditions Fabon Pharma.

Radiopharmaceutical & Nuclear Medicine Units

When properly filtered and shielded, gloveboxes allow safe handling of low‑level radiopharmaceuticals for diagnostic or therapeutic use.

Competitive & Market Context

Indian Market Trends

Indian isolator/glovebox market is expanding rapidly due to increased biotech, sterile manufacturing and CRO/CMO activity.
Government PLI and Make in India schemes are supporting domestic manufacturing of high-end pharma equipment, reducing reliance on imports and improving affordability and support infrastructure .
Innovations now include IoT sensors, remote monitoring, robotic integrations, and deeper automation—areas where FABON may evolve from basic units toward higher-spec systems.

FABON’s Competitive Strengths

Local manufacture (Nashik) enables quick response, quicker lead times, and lower costs.
Customization ability—units tailored to client size, throughput, and contamination risk management.
Cost-effectiveness—priced lower than many branded global alternatives, while providing regulatory compliance and after‑sales support.
Adjacent machinery portfolio—clients benefit from integration with FABON’s other pharma equipment like vacuum transfer systems, CIP/WIP lines, blenders, etc., for full-process capabilities Fabon Pharma.

Strengths & Limitations

✅ Key Advantages

Affordable baseline price (₹3 Lakh), suitable for budget-conscious installations.
Rapid lead time (approx. 45 days) for domestic delivery.
Basic automatic control and stainless steel housing ideal for entry‑level containment.
GMP compliant build and export-ready certifications.
Service proximity—Nashik/ Maharashtra location ensures easy installation, validation support, spare parts delivery, and maintenance.

⚠️ Considerations / Limitations

Lacks built-in PLC/HMI or computerized controls—advanced automation may require customization or after-market add-ons.
Filter exchange, decon cycles or monitoring may be manual or semi-automated in default configuration.
Standard glove ports and component layouts; extensive customization may increase pricing and lead times.
1-year warranty only; clients aiming for longer service commitments may need custom support contracts.

Ideal Use Cases & Buyer’s Checklist

Best-suited for

Small to mid-sized pharma manufacturers engaged in aseptic filling, QC lab sterility testing, or handling moderately potent compounds.
Facilities establishing sterile production lines with budget constraints and needing locally supported equipment.
R&D and biotech labs needing flexible, cost‑effective contamination control for non-radioactive or non‑robotic workflows.

Buyer’s Evaluation Checklist

Pressure mode requirement: positive, negative, or hybrid?
Sterility class target: Is ISO 5 (Grade A) sufficient?
Glove port configuration: number/spacing to match operator workflow.
Need for computerized control, data logging, automation, or SCADA integration?
Sterilization method: VHP vs CIP/SIP vs manual.
Transfer port needs: RTP, pass‑through, antechamber.
Filter maintenance: bag‑in/bag‑out preferred for hazardous materials.
Validation support: IQ/OQ/PQ, documentation needed.
After‑sales support: availability of spare parts, service contracts.
Space & load logistics: verify installation delivery approach, footprint, and utilities.

FABON Pharmatech’s Isolator (Glovebox) is a cost-effective, GMP‑compliant, and locally supported containment solution designed for the Indian pharmaceutical and biotech market. It is well suited for aseptic operations, potent material handling, QC labs, and small‑ to mid‑scale production lines. While it lacks built‑in automation and digital controls by default, its adaptability allows customization to meet evolving requirements—offering an ideal entry point for organizations seeking safe, compliant containment systems with strong local serviceability.