This is a dosage form used where the products for injection is unstable when made into a liquid preparation. Products to be manufactured in this category are purchased as sterile bulk drug. They are first tested for sterility and endotoxin and than they are used to make the dosage form.

The process includes washing of vials which are then subject to drying and sterilization in a DHS. this machine is programmed first to dry the vials and than to sterile them. Working area is divided into four segments D, C, B & A class areas. Class A area is the area under the laminar flow under which the machine is installed and most of the operations are carried in this area. Class B is the area surrounding the machine which is controlled by AHU. Two AHU of 2000 CFM and 125mm static pressure are installed in this area to manage the air circulation. Chilled water is being circulated in these AHUs to give cooling to the area. Temperature and humidity are maintained in this area.

Dried vials are than take over to a machine where they are inverted, filled, plugged, and are sealed. The capacity of the machine is to fill 120 vials per minute with an average of 40,000 vials in 8 hours

 
 
 
 
 
 
 
 

 

   
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