Isolators for potent chemical handling

5000 INR

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Product Details:

Power Source Electric
Feature High containment (OEB 4/5), ergonomic design, pressure monitoring, integrated decontamination cycle
Automation Grade Semi-automatic / Fully automated options
Model No PCI-ISO-2024
Voltage 230 V AC
Capacity Designed for batch and continuous operations; customizable based on application requirements
Frequency 50 Hz / 60 Hz
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Isolators for potent chemical handling Price And Quantity

Minimum Order Quantity 1 Piece
Price 5000 INR

Isolators for potent chemical handling Product Specifications

Accuracy 0.1% for pressure and airflow monitoring
Core Components Glove ports, Air filtration unit (HEPA/ULPA), decontamination system, pass box, control panel
Frequency 50 Hz / 60 Hz
Dimension (L*W*H) Customizable; Standard module: 2500 mm x 1200 mm x 2200 mm
Model No PCI-ISO-2024
Voltage 230 V AC
Capacity Designed for batch and continuous operations; customizable based on application requirements
Power Source Electric
Usage Safe handling of potent chemicals and active pharmaceutical ingredients (APIs)
Type Closed Barrier Isolator System
Automation Grade Semi-automatic / Fully automated options
Feature High containment (OEB 4/5), ergonomic design, pressure monitoring, integrated decontamination cycle
Equipment Materials 316L Stainless Steel, Toughened Glass, Pharma-grade Polycarbonate
Weight 1000 Kg to 1800 Kg (Typical, varies with size and configuration)
Measurement Range Pressure range: -100 Pa to +100 Pa
Temperature Range Ambient to 40C
Display Type Digital Touchscreen HMI

Isolators for potent chemical handling Trade Information

Supply Ability 5-10 Piece piece Per Month
Delivery Time 6-8 Week

Product Description

Cytotoxic drugs and many NCEs (new chemical entities) have an OEL (operator exposure level) below 1 µg/m3, thus requiring processing that isolates the operator from any exposure. All components in Getinge's airtight isolator systems are pre-tested to assure the highest level of reliability and to facilitate validation of the equipment. Operators have a safe, ergonomic workplace, with the choice of AD or DPTE gloves for maximum protection and comfort. The isolators, which fulfill process requirements as per ISO 10648-2, are made of easy-to-clean stainless steel and glass.

High-quality 316L stainless steel construction
Coved corners for easy cleaning
Laminated glass window for safety and process protection
Safe, ergonomic workplace
Full compliance with ISO 10648-2

High Containment and Safety Features

Designed for Operator Exposure Band (OEB) Level 4/5 compliance, the isolator safeguards personnel during potent chemical and API handling. Integrated features such as auto-pressure decay leak testing, electromechanical interlocks, VHP decontamination, HEPA/ULPA filters, and rapid emergency purge systems deliver a comprehensive contamination barrier and minimize occupational exposure risks.

User-friendly Operation and Ergonomics

With a large, scratch-resistant viewing panel, 195 mm glove ports, smooth, crevice-free interiors, and LED cleanroom illumination, the isolator prioritizes operator comfort and visibility. The digital touchscreen HMI offers intuitive control, while its modular, floor-mounted design allows for flexible installation across various production environments.

Smart Connectivity and Automation

Seamlessly integrate with SCADA or BMS systems via Ethernet, USB, or Modbus interfaces to enable real-time monitoring and remote operation. Automation is enhanced with semi-automatic or fully automated options, along with digital monitoring of pressure and airflow for rigorous process control, accuracy 0.1%. Optional accessories expand functionality to meet diverse process needs.

FAQs of Isolators for potent chemical handling:

Q: How does the isolator ensure operator protection during potent chemical handling?

A: The isolator achieves OEB Level 4/5 containment with a complete closed barrier system, including 195 mm glove ports, HEPA H14 filtration (99.995% efficiency), optional ULPA filters, integrated VHP decontamination, and electromechanical door interlocks. These elements work together to prevent personnel exposure to hazardous substances during operations.

Q: What processes can be performed inside the isolator, and how is cleaning maintained?

A: The isolator is designed for both batch and continuous handling of potent chemicals and APIs. Its seamless surfaces, crevice-free construction, and integrated VHP system make cleaning and sterilization efficient, supporting safe change-overs and compliance with cGMP requirements.

Q: When and why should leak testing be performed on the isolator system?

A: Leak testing, using an automatic pressure decay method, should be conducted prior to operations, after maintenance, or when changing processes. It ensures the isolator remains airtight, maintaining containment integrity and safeguarding both product and operator.

Q: Where can the isolator be installed, and is it customizable for different facility requirements?

A: The isolator uses a modular, floor-mounted design, making it suitable for installation in pharmaceutical, biotech, and chemical manufacturing facilities. Dimensions and features, such as glove port size, filter type, and accessories, can be tailored to specific application needs.

Q: What is the benefit of the integrated remote monitoring and connectivity features?

A: With Ethernet, USB, and Modbus interfaces, plus compatibility with SCADA/BMS, operators gain real-time access to process data, remote diagnostics, and control, ensuring enhanced safety, regulatory documentation, and efficient workflow management.

Q: How does the isolator maintain air quality and control environmental conditions?

A: The system maintains 0.45 m/s laminar airflow and uses HEPA H14 (optionally ULPA) filters for high efficiency particulate removal. Dedicated ducted exhaust (with scrubber option) and continuous pressure monitoring maintain clean, controlled conditions, while integrated LED lighting maximizes visibility.

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