Decontamination System (Isolator) for Aseptic Barriers

Product Specifications

Technical details and manufacturing context for Decontamination System (Isolator)

Definition

The Decontamination System (Isolator) is a critical component of an Aseptic Barrier (Isolator/RABS) designed to achieve and maintain a sterile or aseptic internal environment. Its primary role is to decontaminate the isolator's interior, including all internal surfaces, tools, and materials, before and during aseptic processing operations. It functions as the core sterilization or sanitization mechanism that enables the isolator to act as a physical barrier, protecting the product from external contaminants and the operator from hazardous substances. The system is typically integrated into the isolator's design, with controls and monitoring interfaces accessible to the operator. It is selected based on the isolator's chamber volume, which typically ranges from 0.5 to 5.0 m³, and the required decontamination cycle time, which can vary from 30 to 120 minutes depending on the agent and load. The system operates within a temperature range of 15–40 °C and a relative humidity range of 30–80% RH to ensure effective decontamination. It requires a clean, dry air supply at 0.5–0.8 MPa for pneumatic valves and actuators, and a single-phase power supply of 220–240 V AC, with power consumption between 1.5 and 3.0 kW. The system is constructed with corrosion-resistant stainless steel (316L) for contact surfaces, PTFE seals and gaskets, and high-grade plastics for specific components. It is designed to meet ingress protection ratings of IP54–IP65 (IEC 60529) and operates with a noise level not exceeding 70 dB(A) at 1 meter. The weight of the system depends on chamber size and configuration, typically ranging from 500 to 1500 kg. All product-specific values are directory reference ranges and must be confirmed with the legal manufacturer for the actual model and application.

Working Principle

The system typically operates by generating and circulating a decontaminating agent (e.g., vaporized hydrogen peroxide - VHP, peracetic acid, or chlorine dioxide) throughout the sealed isolator chamber. A controlled cycle involves phases of conditioning (preparing the environment), gassing (introducing and maintaining the agent at a specified concentration), and aeration (removing the agent to safe levels). The process is automated and validated to ensure a defined log reduction of biological indicators. For VHP systems, the concentration is typically maintained between 200 and 1000 ppm, with optimal humidity in the range of 30–80% RH. The cycle time, including all phases, is typically 30–120 minutes, depending on chamber volume and load. The system uses sensors and controls to monitor and adjust parameters, ensuring consistent and reproducible decontamination.

Common Materials

Stainless Steel (316L), PTFE (Seals/Gaskets), Quartz (for UV-C systems), High-grade Plastics (for specific components)

Technical Parameters

Parameter	Typical range	Notes & selection driver
Chamber Volume	0.5–5.0 m³	Select based on isolator size and workload
Decontamination Cycle Time	30–120 min	Includes conditioning, gassing, and aeration phases
Vaporized Hydrogen Peroxide Concentration	200–1000 ppm	Typical range for effective sterilization
Temperature Range	15–40 °C	Operating temperature for decontamination process
Relative Humidity Range	30–80 % RH	Optimal humidity for VHP efficacy
Air Supply Pressure	0.5–0.8 MPa	Required for pneumatic valves and actuators
Power Supply	220–240 V AC	Single phase, 50/60 Hz
Power Consumption	1.5–3.0 kW	Depends on chamber size and heating requirements
Noise Level	≤70 dB(A)	At 1 meter distance
Ingress Protection Rating	IP54–IP65	Protection against dust and water jetsIEC 60529
Material of Construction	316L SS	Corrosion-resistant stainless steel for contact surfacesASTM A240
Weight	500–1500 kg	Depends on chamber size and configuration

Ranges are indicative industry figures for RFQ preparation, not a supplier commitment. Confirm every value and standard with the legal manufacturer before ordering.

Components / BOM

Vaporizer/Generator
Converts the liquid decontaminant (e.g., hydrogen peroxide solution) into a vapor or aerosol for distribution.

Material: Stainless Steel, PTFE
Distribution System (Nozzles/Ducts) Part
Ensures even distribution and circulation of the decontaminating agent throughout the entire isolator chamber.

Material: Stainless Steel
Concentration Sensor
Monitors and controls the real-time concentration of the decontaminating agent during the cycle.

Material: Stainless Steel, Sensor-specific materials
Aeration Unit (Blower/Filter)
Provides high-efficiency particulate air (HEPA) filtered air exchange to remove the decontaminant after the gassing phase.

Material: Stainless Steel, HEPA filter media

Industry Taxonomies & Aliases

Commonly used trade names and technical identifiers for Decontamination System (Isolator).

Applied To / Applications

This component is essential for the following industrial systems and equipment:

Aseptic Barrier (Isolator/RABS)

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Manufacturers of Decontamination System (Isolator)

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Frequently Asked Questions

What is the typical chamber volume range for this decontamination system?

The chamber volume typically ranges from 0.5 to 5.0 m³, depending on the isolator size and workload. The actual volume must be matched to the isolator's internal dimensions and the required decontamination load.

What decontaminating agents can be used with this system?

The system can operate with agents such as vaporized hydrogen peroxide (VHP), peracetic acid, or chlorine dioxide. The specific agent and its concentration must be validated for the intended application and biological indicators.

What are the typical cycle times for decontamination?

The decontamination cycle time, including conditioning, gassing, and aeration phases, typically ranges from 30 to 120 minutes. The exact duration depends on chamber volume, agent concentration, and the required log reduction.

What are the utility requirements for this system?

The system requires a clean, dry air supply at 0.5–0.8 MPa for pneumatic valves and actuators, and a single-phase power supply of 220–240 V AC, 50/60 Hz. Power consumption is typically 1.5–3.0 kW. These values are reference ranges and must be confirmed for the specific model.

Data Basis

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pressure:	Up to 2.5 bar (typical), with pressure differential control ±0.05 bar
flow rate:	10-100 m³/h (adjustable based on chamber volume)
cycle time:	30-120 minutes (including dwell and aeration phases)
temperature:	Ambient to 80°C (operational), up to 121°C for sterilization cycles
slurry concentration:	Not applicable (typically uses vaporized or aerosolized agents)

Decontamination System (Isolator)

Product Specifications

Industry Taxonomies & Aliases

Applied To / Applications

Industrial Ecosystem & Supply Chain Structure

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