Pharmacy isolator performance testing.
Aseptic containment isolator.
Aseptic compounding of hazardous chemotherapy and other harmful agents.
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.
Barrier isolation system provides inherently superior sterility compared to open front clean air devices such as laminar flow clean benches and class ii biological safety cabinets.
How baker s pharmacy isolators meet usp 797 performance criteria.
We can either offer modifications to the core product range or a full bespoke design process.
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.
Isolators continuously provide an iso class 5 environment hence housing filling machines inside it not only protects the final products but the personnel and the surrounding environment as well.
5 and 6 models.
Usually the certifier will conduct particle tests and airflow studies while a technician is compounding and transferring materials.
Chemoshield compounding aseptic containment isolator.
But solo s range of single use isolators solves that problem by doing away with cleaning validation altogether.
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.
Specialised containment for toxin linker compounding.
The system is equipped with inflatable and static seals to guarantee air tightness class ii iso 10648 2.
Increasing drug potency has major implications for manufacturing especially with cleaning between batches.
The potential time and cost savings are huge.
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.
The aseptic containment isolator system assures very stringent containment levels thanks to a perfect combination of design and manufacturing strategies.
Welcome to the solo range of containment and aseptic isolator operating platforms.
Isolation technology guarantees ultimate containment control against cross contamination during aseptic and or potent pharmaceutical manufacturing.