What is an isolator in manufacturing?
In production sites, an isolator allows the containment of pharmaceutical processes. They require a protected environment, free of viable microorganisms. The isolator ensures the production area and the personnel/environment are separate. Its role is to prevent contamination from one area spreading to the other.
What is the difference between CAI and CACI?
When working with non-hazardous material, a compounding aseptic isolator (CAI) is used to create a positive pressure controlled environment. When handling hazardous material, a compounding aseptic containment isolator (CACI) is used to create a negative pressure controlled environment.
What is a sterility isolator?
The isolator for sterile conditioning is a bacteriologically sealed enclosure used to isolate an area. It is specially designed to prevent human or environmental contamination of the internal area. Its atmosphere can be controlled.
What is the difference between RABS and isolators?
The main difference between closed RABS and isolators is that closed RABS have no automated bio-decontamination cycle using H2O2 vapour or another sanitant. The interior of the closed RABS unit is bio-decontaminated manually using cleaning solutions.
What is an Aseptic Isolator?
Extract Technology Compounding aseptic isolators are specifically designed for compounding pharmaceutical ingredients or preparations. They are manufactured to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes.
What is a lab isolator?
Laboratory isolators are used to provide aseptic processing and accelerate microbiological control in the laboratory and other healthcare facilities. The range of use of lab isolators can be diversified through clinics, pharmaceutical industries, and other minority usage scopes.
What is a compounding Aseptic Isolator?
Compounding Aseptic Containment Isolator (CACI) provides a safe and clean environment for compounding of hazardous, sterile drug preparations in compliance with USP 797 and 800 criteria. It is suitable for work involving hazardous materials, antineoplastic, or cytotoxic compounding applications.
What is a MSTI test?
MSTI is a Modular Sterility Testing Isolator System conceived for Lab professionals who require aseptic conditions for sterility testing of pharmaceutical products.
What is a 3 phase isolator?
3 phase isolator switches are a type of fused switch disconnector mechanism. As the name suggests, these switch devices help to ensure that electrical systems and circuits are completely and safely powered down. They do so by isolating (i.e. cutting off the power supply to) a particular part of the circuit in question.