Under the current usp 797 guidelines a compounding aseptic isolator may be used as a substitute for a cleanroom if it is certified to meet iso 5 under dynamic conditions.
Aseptic containment isolator.
Solo s aseptic isolators are designed for batch fill finish type applications where complete sterility is required.
Welcome to the solo range of containment and aseptic isolator operating platforms.
Chemoshield compounding aseptic containment isolator.
The aseptic containment isolator system assures very stringent containment levels thanks to a perfect combination of design and manufacturing strategies.
5 and 6 models.
We can either offer modifications to the core product range or a full bespoke design process.
The potential time and cost savings are huge.
Specialised containment for toxin linker compounding.
Usually the certifier will conduct particle tests and airflow studies while a technician is compounding and transferring materials.
Increasing drug potency has major implications for manufacturing especially with cleaning between batches.
The pharmagard es nr800 compounding containment pharmacy isolator is a restricted access barrier systems rabs that creates negative pressure recirculating iso class 5 clean air environment for aseptic compounding of hazardous drugs and minute quantities of chemotherapy drugs to meet usp 800 requirements.
Esco streamline pharmacy compounding aseptic containment isolator provides a safe and clean environment for compounding of hazardous sterile drug preparations in compliance with usp 797 criteria.
A compounding aseptic containment isolator caci designed for the containment of hazardous chemotherapy and other agents and iv admixtures chemoshield negative pressure compounding aseptic containment isolators offer a contained leak tight tested to ags standard negative pressure work area suitable.
The isolator is therefore the perfect solution for sterile processing of high potent.
Aseptic compounding of hazardous chemotherapy and other harmful agents.
But solo s range of single use isolators solves that problem by doing away with cleaning validation altogether.
The system is equipped with inflatable and static seals to guarantee air tightness class ii iso 10648 2.
Isolation technology guarantees ultimate containment control against cross contamination during aseptic and or potent pharmaceutical manufacturing.
How baker s pharmacy isolators meet usp 797 performance criteria.
A closed containment cabinet such as an aseptic containment isolator cai compounding aseptic containment isolator caci and biological safety cabinet class iii are safe options to use in research laboratories limiting exposure of lab personnel providing a clean work environment avoid pathogenic microorganisms to exit or enter the cabinet and prevent cross contamination.