Introduction to Precision Aseptic Isolation

When your laboratory needs to conduct sterility testing or aseptic processing, contamination control is not negotiable. Standard clean benches and open workstations leave samples exposed to operator-borne particles and environmental contaminants, compromising test validity, invalidating sterility assurance data, and putting your GMP compliance at risk.

The Sterility Test Isolator is engineered to eliminate these risks. As a cornerstone of the Sterility Test Isolator series, this system is built for pharmaceutical QC laboratories, biotechnology facilities, and research institutes that require uncompromising aseptic containment for sterility testing, aseptic transfer, and contamination-sensitive operations. This Sterility Test Isolator provides a fully enclosed, validated aseptic environment for your most critical sterility assurance work. We understand that in your line of work, a closed barrier is not just a feature—it is a necessity.

Technical Specifications

Here is a detailed breakdown of the technical capabilities for the Sterility Test Isolator. Our models are designed to meet rigorous GMP and pharmacopoeia standards.

• Model/Part Number: IsoFACT 2T

• Number of Gloves in Main Chamber: 2

• Number of Operators: 1

• Overall Dimensions (W×H×D): 2270×850×2430 mm

• Main Chamber Internal Dimensions (W×H×D): 1200×630×700 mm

• Transfer Chamber Internal Dimensions (W×H×D): 595×515×700 mm

• Model/Part Number: IsoFACT 3T

• Number of Gloves in Main Chamber: 2

• Number of Operators: 1

• Overall Dimensions (W×H×D): 2217×1160×2170 mm

• Main Chamber Internal Dimensions (W×H×D): 1595×650×700 mm

• Transfer Chamber Internal Dimensions (W×H×D): 595×515×700 mm

• Model/Part Number: IsoFACT 4T

• Number of Gloves in Main Chamber: 4

• Number of Operators: 2

• Overall Dimensions (W×H×D): 2417×1160×2170 mm

• Main Chamber Internal Dimensions (W×H×D): 1795×650×700 mm

• Transfer Chamber Internal Dimensions (W×H×D): 595×515×700 mm

• Chamber Type: Rigid Wall Isolator

• Material of Construction: SUS304, SUS316L

• Chamber Cleanliness Classification: Dynamic Grade A (as required)

• Isolator Airflow Pattern: Laminar Flow

• Main Chamber Supply/Return Air Filter: HEPA H14

• Transfer Chamber Supply/Return Air Filter: HEPA H14

• Hydrogen Peroxide Concentration During Decontamination: 400 to 500 PPM

• Sterilant Solution: 30% Hydrogen Peroxide Solution

• VHP Decontamination Cycle Time: Transfer Chamber ≤35 min, Main Chamber ≤70 min

• Decontamination Efficiency: SLR > 6

• Chamber Pressure Control Range: -80 to 80 Pa

• Leakage Rate: ≤0.5% vol/h

• Chamber Temperature Rise: 1°C to 3°C

• Noise Level: ≤75 dB(A)

• Illumination: >300 LX

• Control System: Siemens PLC with touchscreen HMI

• Power Supply: AC 220V ±22V

• Frequency: 50Hz ±1Hz

• Power Consumption: 3500W

• Standard Features: 21 CFR Part 11 Audit Trail, SCADA Software Architecture, Automatic Leak Testing, Positive Pressure, PAO/DOP Test Port, Compressed Air Dehumidification, Desiccant Dehumidification, Differential Pressure Gauge, Temperature & Humidity Sensor

Standard Accessories included:

• Isolator base unit with rigid wall chamber

• Siemens PLC control system with touchscreen HMI

• H14 HEPA filters (supply and return, main and transfer chambers)

• VHP bio-decontamination system

• Differential pressure gauge

• Temperature and humidity sensor

• PAO/DOP test port

• Operation manual with validation documentation

Items Excluded:

• On-site installation and commissioning (available at additional cost)

• Calibration certificate (available upon request)

• Extended warranty (available for purchase)

• Additional glove ports or custom configurations

• Consumable sterilant solution

Pre-installation requirement:

• A stable, level floor with sufficient load-bearing capacity

• A dedicated power outlet matching the unit's specifications (AC 220V)

• Adequate clearance around the unit for access and maintenance

• Compressed air supply for dehumidification

• 30% hydrogen peroxide sterilant solution for VHP cycles

• Site layout and utility planning before installation

• Operator training on standard safety procedures for aseptic isolators is recommended

Key Benefits: Precision, Efficiency, and Safety for Your Lab

Our Sterility Test Isolator is more than just a piece of equipment; it is a solution designed to address the real-world challenges you face daily. We have focused on core features that deliver tangible benefits, enhancing your lab's productivity and the reliability of your outcomes.

• Integrated VHP Bio-Decontamination: Advanced aVHP technology delivers rapid and effective bio-decontamination with validated >6-log microbial reduction. This directly solves the common pain point of contamination risk, giving you confidence in your sterility assurance data. For more information on our range of precision lab equipment, visit our website at https://os4u.com.bd/.

• Grade A Unidirectional Airflow: H14 HEPA filtration delivers stable Grade A airflow conditions for reliable aseptic protection. This engineering excellence reflects the manufacturer's commitment to pharmaceutical-grade containment. You can see their full capabilities at https://www.antechscientific.com/.

• Fast Decontamination Cycle: Optimized sterilization and aeration processes enable fast turnaround within 2.5 hours, with transfer chamber cycles under 35 minutes and main chamber cycles under 70 minutes, streamlining your workflow.

• Low-Temperature Sterilization: Minimal chamber temperature rise of just 1°C to 3°C during VHP cycles protects temperature-sensitive biological products and sterile materials.

• Fully Sealed Hard-Wall Chamber: Robust hard-wall structure with inflatable sealing technology ensures excellent containment with leakage rate ≤0.5% vol/h, protecting both operators and samples.

• Data Integrity Compliance: Supports electronic records, audit trails, batch management, and FDA 21 CFR Part 11 compliance, making reporting, troubleshooting, and audits easier.

• Intelligent PLC Control System: Touchscreen HMI with automatic/manual operation, parameter management, and multi-level user access control allows for precise process control and unattended operation.

Solving the Problems That Slow Lab Work Down

We know the frustrations that come with routine sterility testing. The Sterility Test Isolator is built to eliminate them.

• Struggling with contamination risks in open workstations? The fully enclosed hard-wall chamber with Grade A unidirectional airflow and integrated VHP bio-decontamination eliminates operator-borne and environmental contamination, ensuring reliable sterility assurance.

• Concerned about GMP compliance and data integrity? The system supports 21 CFR Part 11 audit trails, electronic records, and batch management, helping you meet regulatory requirements with confidence.

• Tired of time-consuming decontamination cycles? Optimized VHP cycles complete in under 2.5 hours, with fast aeration for rapid turnaround between batches.

• Need to protect temperature-sensitive products? Low-temperature sterilization with minimal chamber temperature rise of 1°C to 3°C protects biological products and sterile materials during decontamination.

By choosing this Sterility Test Isolator, you are investing in a dependable partner for your lab's daily operations, designed to deliver aseptic containment and reliability where it matters most.

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Warranty & Support

We provide a 1-year manufacturer’s warranty covering parts and labor. Technical support, installation assistance, and operational training are also available. Replacement parts and consumables are available throughout the product’s service life.

Call to Action

Request a Quotation or Technical Datasheet: Contact us for more information, customized configurations, and solutions tailored to your specific requirements.