| Aseptic Filling Machine Isolator | | | | filtration and a self contained unidirectional airflow |
| Process Description: | | | | system. |
| This isolator allows for the entry of presterilized | | | | - One RTP alpha port used for introduction of trayed |
| stoppers and caps through a Rapid Transfer Port | | | | empty vials. |
| (RTP). Powder is also presented into the Isolator via | | | | - One RTP alpha port used for introduction of |
| the RTP. Glassware is transferred to the isolator in | | | | stoppers, capsand product. |
| separate transfer isolators. The Transfer Isolator | | | | - Several spooled sanitary fittings (various sizes) for |
| "docks" to the filling isolator via a RTP and the trays of | | | | vacuum, liquids, nitrogen, etc. |
| glassware are manually positioned on the accumulator | | | | - Several compression fittings (various sizes) for |
| of the filling machine. The vials are automatically | | | | electrical wire pass-through. |
| moved by the filling machines through the filling, | | | | - Special "mouse hole" protected by unidirectional |
| stoppering and capping stations and exit through a | | | | airflow for exit of filled vials. |
| "mouse hole" in the end wall of the isolator. A | | | | - Cam-lock connections for inlet and outlet of gas |
| conveyor carries the vials from the Isolator under an | | | | sterilant. |
| externalunidirectional airflow module and into the | | | | - Temperature control to maintain the Isolator at |
| adjoining packaging room. | | | | ambient temperature with high/low set points. |
| Design Advantages of water filling machines isolator | | | | - Several spooled sanitary fittings (various sizes) for |
| - Ergonomically designed oval gloveports are specified | | | | vacuum, liquids, nitrogen, etc. |
| as standard, with Hypalon gloves. | | | | - Several compression fittings (various sizes) for |
| - Fully welded 7 gauge 316L stainless steel | | | | electrical wire pass-through. |
| construction, with laminated safety glass, and 5/8 inch | | | | - Special "mouse hole" protected by unidirectional |
| corner radiuses. | | | | airflow for exit of filled vials. |
| - The digital pressure controller allows the Isolator to | | | | - Cam-lock connections for inlet and outlet of gas |
| maintain a constant pressure within high and low set | | | | sterilant. |
| points, with a visual alarm back-up. | | | | - Temperature control to maintain the Isolator at |
| - Positive pressure ventilation system with HEPA | | | | ambient temperature with high/low set points. |