ASEPTIC PROCESSING ISOLATORS
Robotics & Isolator Systems
Robotics & Isolator Systems is The best Combination for Advanced Aseptic Processing.
Ravona Isolator technology is ready for adaptation with robotics and some of the manipulator's arms on the market that is already electronically and mechanically controlled.
The systems require custom fittings and covers to protect the moving parts and the products inside these chambers.
Many of these Isolators/Glove boxes are widely used in advanced electronics and pharmaceutical facilities.
In the Pharmaceutical industry, there are over 200 aseptic filling lines using isolators and industry leaders and manufacturing engineers continue to embrace enclosures.
Potent Aseptic Environment
Ravona design Aseptic Isolators allow easy working with Potent Biological substances that demand an aseptic environment. The system is designed for use in biological potent laboratories mainly for the manipulation of potent biological substances.
The system allows an easy working environment for researchers eliminating the need for pressure suits and other awkward solutions.
Ravona’s Aseptic Isolators are focused on protecting the user. The chamber works under negative pressure conditions to ensure full containment. The system is designed to ensure internal laminar flow to aid in preventing contamination and cross-contamination.
Ravona positive pressure compounding Aseptic Sterile Isolator.
is designed to provide a sterile positive pressure work environment for the compounding weighting and packing of non-hazardous drugs. HEPA filtered flow supply at 20 air changes per minute within both the work zone ISO Class 5 conditions. Laminar airflow assures a continuous stream of HEPA filtered air across the work zone and interchange areas assuring sterility and minimizing cross-contamination.
Ravona Aseptic Isolator.
An aseptic isolator protects the product from contaminants in the surrounding environment.
Positive pressure is maintained in the isolator in order to ensure that particles from room will not enter the isolator and contaminate the product in the case of a very minimal leak.
Mainly used in the pharmaceutical manufacturing industry, a barrier isolator creates an aseptic environment for compounding injectable, ophthalmic, and inhaled medications.
Due to the significant risk posed by microbiological contamination, the critical area where the compounding /filling takes place requires protection beyond that of a typical laboratory isolator.
According to the draft revision of USP 797, compounding aseptic isolators will be divided into two classifications: Restricted Access Barrier Systems (RABS) and Isolators.
An isolator is defined as an ISO 5 enclosure that meets the following criteria:
Uses rapid transfer ports or another type of decontaminated, high-integrity interface to transfer compounding materials into the isolator.
Uses an automatic sporicidal decontamination system such as VHP (Vapor Hydrogen Peroxide).
Constantly maintains a significant overpressure relative to the surrounding environment.
Manufacturer provides documentation verifying that the isolator can maintain ISO 5 at all times.
RABS Restricted Area Barier System
RABS is a type of barrier system for aseptic processing of pharmaceutical products that reduces or eliminates interventions into the critical zone.
In practice, its level of contamination control lies somewhere on the spectrum between a conventional cleanroom aseptic processing and an isolator.
The ISPE has decided that in order to be classified as a RABS, a system
must include the following elements:
• Properly designed equipment
• Management oversight
• A quality system in place
• Proper surrounding room design to maintain ISO 5 in the critical zone
• Proper gowning practice
• Proper training
• Initial high-level disinfection with a sporicidal agent
• Proper SOP's for rare interventions
• Appropriate line clearance
• Documentation of event.