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Isolators

Ravona Pharma's Sterility Test Isolator

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Ravona Pharma's Sterility Test Isolator

  • Overview
  • Key features
  • Benefits
  • Industry

Overview

The Ravona Pharma Sterility Test Isolator is a state-of-the-art, highly specialized piece of equipment, designed to meet the rigorous demands of pharmaceutical and biopharmaceutical industries. It ensures that sterility testing is carried out in a controlled, contaminant-free environment, thereby safeguarding the quality and safety of drugs and biologics. This isolator is engineered to the highest standards, offering exceptional reliability and regulatory compliance, making it a trusted solution for pharmaceutical manufacturers, researchers, and quality control labs.

Key Features

Advanced Non-Heating Element Technology:

The Ravona Sterility Test Isolator comes equipped with a completely automated and integrated H2 Decontamination system that is controlled by the main Programmable Logic Controller (PLC). This advanced system generates Hydrogen Peroxide (H2O2) aerosol for rapid decontamination and aeration cycles, ensuring a sterile environment inside the isolator while minimizing operator intervention and maximizing efficiency. This technology is a critical feature that enhances sterility assurance for pharmaceutical and biopharmaceutical facilities, where high levels of cleanliness and contamination control are essential.

Customized accessories as per requirements:

The Ravona Sterility Test Isolator is equipped with a range of cutting-edge monitoring and testing tools designed to enhance the sterility assurance and environmental control within the isolator. These advanced features provide critical insights into the air quality, sterility, and integrity of the isolator, ensuring that every test is performed under optimal, contamination-free conditions.

Benefits

GAMP Certification

GAMP certified automation system provided with the isolator

Advanced Filtration

HEPA filter H14 with electronic differential pressure monitoring

Reliable Performance

Maintenance-free exhaust fan, pressure controlled with a pressure transmitter.

Industry

Pharmaceuticals

Pharmaceuticals

FAQs

The Ravona Pharma Sterility Test Isolator is designed to meet Class 2 ISO 10648-2 standards and is Siemens CFR 21 Part 11 compliant, ensuring it adheres to the highest regulatory and safety requirements in pharma and bio-pharmaceutical facilities.

The isolator features an advanced non-heating element technology with a completely automated H2O2 decontamination system, controlled by the main PLC. It produces H2O2 aerosol for faster decontamination and aeration cycles, improving efficiency.

The isolator comes with customized accessories such as viable and non-viable particle counters, H2O2 concentration sensors, Millipore steritest symbio pump, glove port integrity tester, and a GAMP-certified automation system for optimal performance and compliance.