Sterility Test Isolator AT-IS-4: The Ultimate Solution for Contamination-Free Sterility Testing

Introduction

Ensure absolute sterility assurance with the Sterility Test Isolator AT-IS-4—a state-of-the-art, enclosed aseptic system designed for pharmaceutical, biotechnology, and medical device industries. Engineered with high-efficiency HEPA filtration, automated decontamination, and Siemens PLC control, this isolator eliminates contamination risks and enhances regulatory compliance while reducing operational costs.

Key Benefits at a Glance

✅ 100% Contamination-Free Testing – Fully enclosed, sterile workspace with HEPA H14 filters (99.995% efficiency).
✅ Regulatory Compliance – Meets cGMP, EU GMP Annex 1, USP <797>, and ISO 14644-1 Class 5 standards.
✅ Automated Hydrogen Peroxide (H₂O₂) Sterilization – Kills 99.9999% of pathogens (6-log reduction).
✅ Siemens PLC-Controlled System – Ensures precision, traceability, and real-time monitoring.
✅ Lower Cleanroom Costs – Operates independently of large cleanroom facilities, reducing maintenance and compliance costs.
✅ Optimized Workflow & Efficiency – Faster sterilization cycles (~2 hours) and real-time data logging for seamless validation.

Sterility Test Isolator Overview

Key Features & Components

1. Advanced Contamination Control & Sterilization System

? HEPA Filtration (H14, 99.995% efficiency) – Provides a Grade A (ISO 5) cleanroom environment.
? Automated Hydrogen Peroxide (H₂O₂) Sterilization –
✔ Broad-spectrum sterilization (6-log reduction).
✔ Non-corrosive to equipment & materials.
✔ Vaporization temp: ≤130°C, Dehumidification: ≤35% RH.
✔ H₂O₂ Dosage: ~50ml, Sterilization Cycle: ~2 hours.

2. Smart Design & Ergonomics

? User-Friendly Touchscreen Interface – Siemens 7.0-inch touchscreen for intuitive control.
? 15° Tilted Operation Panel – Enhanced operator comfort & visibility.
? Mirror-Polished Chamber Interior – Easy-to-clean, seamless surface minimizes microbial buildup.
? Brushed Stainless Steel Exterior – Durable and resistant to contamination.
? Universal Wheels for Mobility – Quick and easy repositioning.

3. Precision Airflow & Ventilation System

? Airflow System:
✔ Top Inlet & Top Outlet Design – Optimal airflow control.
✔ PLC-Controlled Automatic Airflow Adjustment.

? Air Intake:
✔ Primary Filter → HEPA H14 Filtration.
✔ Dwyer Differential Pressure Meters monitor filter efficiency.
✔ German EBM Fans (1400 m³/h Max Airflow) – Reliable and high-performance.

? Exhaust System:
✔ Filtered through HEPA before outdoor release.
✔ Dwyer Pressure Meters for blockage detection.
✔ German EBM Fans (620 m³/h Max Airflow).

4. Cutting-Edge Control System

? Siemens PLC-Controlled Automation for precision and repeatability.
? Three-Level Password Protection – Secure access for Operators, Technicians, and Managers.
? Real-Time Monitoring & Alerts –
✔ Pressure loss
✔ Double-door interlock alarms
✔ Sterilization parameters tracking
? USB Data Export & Printing – Ensures compliance with FDA, EMA, and GMP regulations.
? Optional Video Traceability System – Record and review all sterility testing operations.

Why Choose the AT-IS-4 Sterility Test Isolator?

? Unmatched Performance & Efficiency

✅ Achieve 100% sterility assurance with 6-log microbial reduction.
✅ Automated PLC-controlled operations reduce human error & manual handling.
✅ Faster decontamination cycle (~2 hours) minimizes downtime.

? Cost Savings & ROI

✅ Eliminates the need for costly cleanroom facilities.
✅ Minimizes compliance costs with real-time monitoring & automated reporting.
✅ Low maintenance requirements reduce operational expenses.

? Precision Engineering for Compliance & Safety

✅ HEPA H14 filtration (99.995% efficiency) ensures Grade A cleanroom conditions.
✅ Siemens PLC System provides consistent, repeatable sterility testing.
✅ Meets international regulatory standards (cGMP, ISO 14644-1 Class 5, USP <797>).

Applications of Sterility Test Isolator

? Pharmaceutical Industry – Sterility testing of injectables, vaccines, biologics, and sterile drugs.
? Biotech Labs – Ensuring contamination-free biological sample testing.
? Medical Device Industry – Testing implantable medical devices, catheters, and surgical tools.
? Hospitals & Clinical Labs – Quality control testing for IV fluids, blood products, and sterile preparations.
? Food & Beverage Industry – Sterile packaging and aseptic food processing testing.

Common Challenges & Our Solutions

? Get Your Customized Sterility Test Isolator Today!

? Optimize sterility testing efficiency while reducing operational costs.
? Ensure 100% contamination-free results with cutting-edge technology.
? Meet all regulatory requirements with automated compliance tracking.