Introducing Ravona's next-level Aseptic solutions.
Ravona’s Aseptic isolators allow operators to handle products that demand an Aseptic environment. Specifically designed to protect the sterility of various substances and processes, our Aseptic isolators can also safeguard operators from cytotoxic materials.
Our Aseptic isolators are integrated with advanced valid H2O2 bio-decontamination systems (RDS®). Designed and manufactured in-house by Ravona, the system decontaminates the isolator’s internal surfaces quickly and efficiency.
OUR WIDE VARIETY OF ASEPTIC SOLUTIONS
Key Features & Advantages
A complete separation between product and possible sources of contamination.
Increased Sterility Assurance
Reduces false result, re-testing and recall frequency. Saves time and a multitude of costs.
Less Product Waste
The separation of internal and external environments allows for lower-classification operation of the surrounding areas, which reduces overall costs.
Save valuable working space and optimize the working process.
Customized Ergonomic Solutions
EU GMP Class A (ISO 5/US Class 100) working chamber provides the highest product protection.
At minimum, the application requires an EU-GMP Class D (ISO 8/US Class 300) environment.
End-to-end documentation and validation coverage that meets the highest standards.
Extensive Validation Package
Automation complies with FDA CFR 21 Part 11 and Audit trail.
CFR 21 Part 11 Compliance
We can provide a controlling solution for RH and temp challenges within specific working environments.
Temp & RH Controlling
Ravona’s IGT-400 is implemented as an option into its Aseptic solution systems.
Glove Integrity Tester
H2O2 catalyzation in single pass to less than 0.5n PPM – providing short cycle time.