RAVONA Aseptic Isolators:
At RAVONA, we specialize in the design and manufacturing of Aseptic isolators that provide the highest level of protection for your aseptic products and processes. RAVONA isolators are engineered to create a controlled, aseptic environment, ensuring an Aseptic environment and conditions. RAVONA’s aseptic isolators are critical in industries like pharmaceuticals, biotechnology, and healthcare, where aseptic conditions are essential.
What are Aseptic Isolators?
An aseptic isolator is a sealed, controlled environment designed to protect aseptic products from contamination while maintaining aseptic conditions. The RAVONA aseptic isolators are used in environments where aseptic conditions are required, such as Fill and Finish, Sterility Testing, Cell & Gene Therapy, or any other conditions requiring a high level of product protection. The industries that require aseptic isolators are pharmaceuticals, biologics, or medical devices. The aseptic isolators create an isolated barrier to prevent exposure to contaminants from the outside environment while ensuring that the internal conditions remain free from microbial or particulate contamination. RAVONA Aseptic Isolators are specifically designed to meet the most demanding standards, ensuring the creation of Grade A environments and Class 100 conditions.
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Why Choose RAVONA Aseptic Isolators?
RAVONA’s aseptic isolators are designed with the highest standards of safety, aseptic conditions, and efficiency. Here’s why our solutions are trusted across industries
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Protection of Product and Environment
Our isolators provide a controlled environment that prevents contamination from microorganisms, particulate matter, and other external contaminants, ensuring that the aseptic quality of your product is maintained.
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Grade A & Class 100 Environments
RAVONA Aseptic Isolators are engineered to maintain Grade A environments (equivalent to ISO 5 air cleanliness) and Class 100 conditions (as per US Federal Standard 209E), ensuring that your aseptic processes are conducted in an environment with minimal particulate contamination. This level of control is crucial in the manufacture of aseptic products.
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Safe Handling of Aseptic Materials
Whether you are handling aseptic APIs, biologics, or other sensitive materials, RAVONA’s aseptic isolators provide a secure, aseptic environment, ensuring that products remain uncontaminated throughout the process.
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Improved Operational Efficiency
RAVONA isolators are designed for safe, remote handling of aseptic materials, reducing the need for direct contact and minimizing the risk of contamination. This enhances workflow and reduces downtime, all while maintaining the highest levels of aseptic conditions.
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Regulatory Compliance
RAVONA’s aseptic isolators meet global regulatory standards, including FDA, cGMP, and ISO certifications for aseptic processing and aseptic product handling.
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Equipped with:
RAVONA aseptic isolators are equipped with the following features:
- H2O2 RDS – RAVONA Biodecontamination System – ensuring a robust decontamination process.
- HEPA H-14 Filtration system.
- An Integrated air sampler and particle counter.
- Integration for any filling machine supplier.
- Laminar airflow system.
- Reports generation system, with an industrial PC.
- HP-API Aseptic solution.
- Integrated Glove Tester IGT-400 model.
We Comply with the Following Standards and Guidelines
Benefit from optimal glove integrity, and maximum peace of mind.
RAVONA Aseptic Isolators
Key Features of RAVONA Aseptic Isolators:
Positive or Negative Pressure Control: To ensure that no external contaminants enter the isolator, our systems use positive pressure to keep airborne particles out, creating an aseptic barrier around the work area. In Cytotoxic Aseptic handling, a Negative pressure Isolator can be offered as well.
HEPA Filtration: HEPA H-14 filters provide highly efficient filtration, removing particulate contaminants from the air and maintaining aseptic conditions inside the isolator.
RAVONA RDS – H₂O₂ Decontamination System: RAVONA’s H₂O₂ (Hydrogen Peroxide) Decontamination System ensures effective decontamination of the internal environment of the isolator between cycles. This system uses vaporized hydrogen peroxide to eliminate any residual microbial contamination, providing an additional layer of aseptic assurance before and after each use. This system is critical for ensuring that the isolator is free from contaminants and maintaining the highest aseptic standards for sensitive processes.
Continuous Environmental Monitoring: Our isolators come equipped with real-time monitoring systems to track critical conditions such as temperature, humidity, and particulate levels, ensuring compliance with strict aseptic standards.
Ergonomic Glove Ports: The glove ports in RAVONA isolators allow for safe, glove-assisted handling of aseptic materials without breaking the isolator’s aseptic barrier.
Automated Systems for Efficiency: For processes that require automation, our isolators can be equipped with automated material handling systems, reducing human intervention and improving workflow efficiency.
Customizable Designs: Every process is unique. RAVONA offers fully customizable aseptic isolators tailored to your specific requirements, whether you’re handling biologics, aseptic APIs, or regular Aseptic products.
Applications of RAVONA Aseptic Isolators:
Why Choose RAVONA for Aseptic Isolation Technology?
At RAVONA, we understand the critical importance of maintaining aseptic conditions in the handling of sensitive materials and products. Our aseptic isolators are built to the highest standards of safety, efficiency, and regulatory compliance. Here’s why RAVONA is the trusted partner for your aseptic containment needs:
Aseptic Assurance: Our isolators provide a fully controlled, aseptic environment, ensuring that products remain uncontaminated during processing and handling.
Regulatory Compliance: All of our isolators meet the highest global standards, including FDA, cGMP, ISO, and other industry certifications, ensuring compliance with the latest regulatory requirements for aseptic processing.
Custom Solutions: We work closely with our clients to design and manufacture fully customizable aseptic isolators that meet the specific needs of your processes, from biopharmaceutical production to medical device manufacturing.
Contact RAVONA Today
Enhance the aseptic quality, safety, and efficiency of your operations with RAVONA’s aseptic isolators. Contact us today to discuss how we can provide the ideal containment solution for your aseptic processing needs.
