The pharmaceutical isolator is a bacteriologically sealed enclosure used in the medical and pharmaceutical environment for toxic processes and aseptic filling process. It is made Of a perfectly sterile main isolator where the products are handled. stored Or packaged using shoulder-high gloves placed on one of the walls. It also includes transfer systems that allow the entry and exit of the products and the elimination of waste Without breaking aseptic conditions.
Features
• Fast-track design process; modeling
• 316Lall stainless steel construction
• Radiused corners and seamless surfaces allow for ease Of cleaning and decontamination
• Advanced ergonomics for the individualized requirements ofyour workflow
• Integrated aseptic material transfer systems
• On-board
• Controlleci environments forspecifed set points including temperature and RH
• System for continuous monitoring Of critical conditions
• 10/00; complete documentation and validation package
• Factory Acceptance Testing
• Units meet or exceed all cGMPand0ther relevant standards and guidelines including: ISO classes, USP, GAMP 5. and 210 & 211