Overview

Containment Isolator

A containment isolator is fully enclosed system designed to provide a high level of protection when handling hazardous, toxic, potent, or sensitive materials.

A containment isolator creates a physical barrier between the operator and the process area. Operators handle materials through glove ports, while the internal environment is controlled through airflow, filtration, pressure control, and validated cleaning.

Core Advantages

High Containment

It achieves Occupational Exposure Limits (OEL) <1 µg/m³, meeting OEB 4/5 requirements. Negative-pressure control, HEPA filtration and airtight design ensure zero cross-contamination.

Process Integration

Modular glove-box sections, pass boxes, RTP ports integrate seamlessly with milling, dispensing, or filling equipment to form a complete contained line.

GMP Compliance

Designed to meet GMP requirements, our isolators offer smooth internal surfaces, easy cleaning, sterilization, pressure monitoring, and documentation controls.

<1 µg/m³

OEB 5 Containment

OEB 1-5

Potency Band Range

SS 316L

GMP-Grade Steel

Containment Reference

OEB / OEL Occupational Exposure Levels

OEB 1
1,000 - 5,000 μg/m³
Very Low Toxicity
OEB 2
100 - 1,000 μg/m³
Low Toxicity
OEB 3
10 - 100 μg/m³
Medium Toxicity
OEB 4
1 - 10 μg/m³
High Toxicity
OEB 5
0.1 - 1 μg/m³
Very High Toxicity
OEB 6
< 0.1 μg/m³
Extreme Hazard
Higher OEL (Less Hazardous)
Lower OEL (More Hazardous)

OEB 1-2 Containment

Open Processing

Standard ventilation, local exhaust, basic dust control.

OEB 3 Containment

Partial containment

Dust-tight equipment, negative-pressure booths, HEPA exhaust.

OEB 4-5 Containment

High Containment

Containment isolators, Split valves, WIP/CIP capability, HEPA filtration.

OEB 6 Containment

Very HIgh Containment

High-integrity isolators, closed automated systems and Highest-level PPE.

OEL values represent 8-hour TWA airborne concentration limits. Band classification per ISPE Risk-MaPP & SMEPAC guidelines. OEB 6 denotes extreme-hazard compounds (< 0.1 μg/m³) requiring absolute containment engineering controls.

Solutions

By creating a sealed physical barrier combined with controlled airflow, HEPA filtration, and glove-port access, these isolators prevent cross-contamination and ensure safe manipulation of high-potency ingredients.

Dispensing Weighing Isolator

Dispensing & Weighing Isolator

Used for accurate weighing and dispensing of high-potency powders or hazardous materials. It helps reduce dust emission and operator exposure during manual powder handling.

Sampling Isolator

Sampling Isolator

Safe in-process sampling of hazardous, toxic, or high-potency materials. Suitable for QC lab interfaces and inline process monitoring with full audit trail capability.

Milling & Micronization Containment Isolator

Milling Containment Isolator

Designed to contain dust generated during particle size reduction processes. It can be integrated with jet mill, pin mill, hammer mills to ensure safe processing.

Charging & Discharging Isolator

Charging/Discharging Isolator

Contained drum charging and discharging station for bulk powder transfer. It features continuous liner bag-in/bag-out system to prevent operator exposure during high-volume material handling.

Filter Dryer Discharge Isolator

Filter Dryer Discharge Isolator

Used for the contained discharge of dried pharmaceutical or chemical products from filter dryers or vacuum dryers. It helps prevent exposure to dry powder, which can generate airborne dust.

Flexible isolator

Flexible Isolator

A flexible film isolator with a larger interior volume and safety options. It offers a lightweight, modular, and cost-effective containment solution for handling hazardous materials.

Features

Engineered for Safety and Process Integrity.

High Containment Performance

Achieves OEB 4/5 containment levels with airborne particulate concentration below 1 μg/m³. Designed for potent active pharmaceutical ingredients and highly toxic compounds.

Airflow & Filtration System

Equipped with dual-stage HEPA filtration and a Bag-In/Bag-Out safe-change system, allowing operators to replace contaminated filters safely without breaking the containment barrier.

cGMP Compliance

Engineered to meet ISO 14644-7 standards for isolators, providing a validated Class A/ISO 5 environment where required. It comes with comprehensive IQ/OQ validation support.

Ergonomic Design

Multiple glove ports are positioned for comfortable and intuitive operator access. Gloves are available in various materials to match chemical compatibility and durability requirements.

Easy Cleaning

Constructed from premium stainless steel with a mirror-polished finish for efficient cleaning. Compatible with VHP, chemical disinfectants, and CIP/WIP systems.

Robust Monitoring & Control

Real-time pressure, airflow, and filter status monitoring with audible/visual alarms. Touchscreen HMI for easy control of ventilation, lighting, and auxiliary systems.

Specification

Containment Isolator Data Sheet

Containment Performance

  • OEL Rating 0.1-10 μg/m³ (OEB 4/5)
  • Pressure Differential −25 to −70 Pa
  • HEPA Filtration H14 (EN 1822)
  • Air Changes ≥ 20 ACH

Construction & Materials

  • Chamber Material 316L Stainless Steel
  • Surface Finish (Ra) ≤ 0.4 μm inside
  • Glove Ports configurable
  • Transfer System RTP / Bag-in-Bag-out

Compliance & Utilities

  • Standards GMP / CE / ATEX
  • CIP / WIP Optional
  • Control System PLC + HMI (21 CFR Pt.11)
  • Power Supply 400 V / 50 Hz (custom)

Download Full Technical Datasheet

Get the complete specifications, and performance data in one document. PDF · ~2MB

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Applications

Safeguarding Operators and Environments.

HPAPI Processing
Pharmaceutical

API Handling

Used during the chemical synthesis of cytotoxic drugs, hormones, and oncology compounds where protecting the operator from toxic dust and vapors is the highest priority.

Fine Chemical
Chemicals

Highly Toxic Chemicals

Equipped with solvent-resistant components, containment isolators are suitable for contained charging, sampling, weighing, and transfer of hazardous powders and liquids.

Veterinary Manufacturing
Veterinary

Antibiotics & Hormones

Containment isolators provide a safe and compliant working environment for operators while ensuring product integrity and preventing cross-contamination between different veterinary drug products.

Food & Flavors
Food

Flavors & Additives

Containment isolators are suitable for handling concentrated flavors, additives, enzymes, and fine powders in the food industry, helping improve operator safety and product hygiene.

FAQ

Answers to the most common technical and commercial questions from procurement managers and process engineers evaluating containment solutions.

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What is the maximum containment level this isolator can achieve?
Our containment isolators are engineered to handle hazardous, potent, or sensitive materials up to OEB 5. They consistently maintain occupational exposure limits (OEL) below 1µg/m³.
What applications are containment isolators used for?
They are commonly used for weighing, dispensing, sampling, transfer, mixing, filling, and handling of potent powders, toxic chemicals, biological materials, and sensitive products.
What materials are used to construct containment isolators?
The standard construction material is 316L stainless steel, chosen for its chemical resistance and cleanability. Viewing panels are typically made of laminated safety glass or polycarbonate.
How are containment isolators cleaned or decontaminated?
They can be cleaned manually through glove ports or equipped with automated cleaning and decontamination systems, such as CIP nozzles or VHP sterilization.
Can containment isolators be customized?
Yes. They can be customized with different chamber sizes, glove configurations, transfer systems, filtration units, and integration with process equipment.