Any liquid or Powder Filling Machine needs the interior environment to be aseptic or sterile so that no contamination takes place. While the filling process takes place, at regular intervals, the machine needs the ducts to be capped, the flow to be stopped and the filling to be enclosed. In these situations, an Aseptic Filling Isolator helps in maintaining the sterilised environment of the machine while performing the above tasks. These isolators ensure unidirectional airflow, hinged window panels with easy lift process for user efficiency and the signature “mouse hole” attached on the end wall for easy exit of the vials filled with liquid or powder to the packaging room adjacent to the isolator.
Features of an Aseptic Filling Isolator
In order to ensure that the products, both liquid and powder are manufactured and controlled while maintaining the quality standards, the isolators help in filling the materials and processing them under Good Manufacturing Practice (GMP). Within the application, the Aseptic Filling Isolator maintains a safe and sterile environment in the all over the system. The features are –
Easy and Safe transfer
While transferring the materials inside or outside the isolator, the safe transfer system ensures that the containment does not undergo any harm such as breaking or tampering. Therefore, the operator of the process has a safe task and the whole process runs smoothly without any hazard of stopping the process in middle.
Unidirectional Airflow
While transferring the vials filled with the production material, the unidirectional and reticulated airflow of the Aseptic Filling Isolator helps in maintaining the aseptic atmosphere inside the machine, thereby, preventing any contamination.
Safe Changing of HEPA Filters
HEPA or High-Efficiency Particulate Air filters act as mechanical absorbers to force air through the fine mesh wall where foreign particles are arrested. The isolators help in safe changing and clearing of these filters so that the air flow runs through purification.
Barriers
For aseptic filling, some barriers are strategically used to safeguard the operators from getting in contact with the drugs, acidic materials or other toxic materials. The barriers also prevent contamination of the products by keeping out foreign particles.
Other features
Air velocity measurement procedures, temperature regulation, proper control of Programmable Logic Controller (PLC) and providing protection to the operators, especially during transferring of toxic materials or drugs are some of the additional features of Aseptic Filling Isolator.
Application of Filling Isolators –Safe for operation and operator
The Aseptic isolators are used in safe component processing and safe handling of toxic materials, both liquid and powder.
Pharmaceutical product processing
The Aseptic Filling Isolator ensures thorough and repeated sterilisation and cleaning of the delicate pharmaceutical products such as the injectable drugs. While formulating, filling and finishing the operations, the vessels, vials and other machine parts undergo validated sterilisation to prevent cross-contamination.
Safeguard from Potent Chemical
The operators of the machine are safeguarded while handling the toxic chemicals or active pharmaceutical drugs. The isolation technology helps in the safe handling of these products while formulating, filling, handling, finishing and cleaning them.
While handling any pharmaceutically vulnerable or toxic materials or drugs, the products (both powder and liquid) passes through formulation, filling, handling and cleaning. The aseptic isolators help in safeguarding the products and the operators.
