STERILE FILLING AND SEALING PROCESS
Sterile Dosage form are the preparations free from pyrogens and micro-organism they are injected in the body. All the sterile dosage form are pyrogen free, bacteria free and perculate matter free. There should be no visible particle in the preparations.
Filling and sealing of Ampules in a approved sterile filling area .All filling and sealing process is carried out by trained or approved workers in Approved manufacturing industry.
Approval of manufacturing area is given by local or inter National Authorities.
After filling and sealing the ampules and vials are kept under sterilization process in Autoclave.
After sterilization ampules or vials are visually checked by trained workers and then they are sent to the packaging department, where they are packed by automated or semi-automated machines .
In some industries they are also packed by hand packing.
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