Sara Pharmaceuticals    
 
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    The plant has been established and constructed keeping in mind the broad outlines and principles of USFDA.

    Accordingly, separate sections are designed for the production of different therapeutic groups. Totally separate entries for workmen & materials as well as independent Air handling systems have been provided to rule out any possibility of cross contamination.


    Production process - an overview Washing

    All containers and closures are washed under aseptic controlled environment. Total Area maintained under terminal Hepa filters to avoid any foreign particles and fibres entering this area. Special gowning procedure is laid down for workmen entering this area. Vials are washed by hot distilled water by fully automatic machine


    Sterilisation

    Rubber plugs are washed and processed in a special bung processor which is a totally closed chamber, starting from distilled water wash unto steam sterilization and vacuum drying.


    Manufacturing

    The manufacturing areas are totally segregated with independent air handling systems to maintain the desired room conditions. Terminal Hepa filters are provided in all areas including the sterile corridors. Differential pressure gradients are maintained for each and every room with continuous monitoring. High speed, automatic machines are installed from filling. Human contact is avoided in the manufacturing operations until it leaves the sterile areas.

    Constant in-process quality control measures like fill volume, bulk solution assay, sealing of ampoules and visual inspection is carried out at regular intervals. Quality assurance department ensures full compliance to cGMP at all stages.


    Ampoules

    Stage I

    Approved raw material are weighed in the stores by Junior Chemist/Technician in presence of the Manufacturing Chemist in the dispensing room. Such materials will bear labels indicating the name of the material, Quantity and raw material control numbers.


    Stage II

    Weighed raw materials are counter checked by another chemist.


    Stage III

    All the materials in solid form are dissolved in the vehicle as mention in the SOP of individual product.


    Stage IV

    The materials are transferred to the mixing tank in the order specified in SOP an agitated by means of SS stirrer provided for that purpose.

    Stage V

    The bulk is filtered using filter press having a porosity of 0.5 micron. A sample from Bulk is drawn for analysis by Quality Assurance Chemist.

    Stage VI

    The solution after getting clearance by QA Chemist is filled in ampoules according to SOP of individual product and sealed in oxygen flame before sealing nitrogen is passed in the ampoules.


    Stage VII

    Then the ampoules are subjected to sterilization in the autoclave at 118 C 14 LBS for 30 minutes.


    Stage VIII

    Then after unloading from the autoclave they are subjected to visual inspection by trained personnel.


    Stage IX

    Then the ampoules are send to the labeling department for labeling and packing. A Sample is collected by QC for analysis.


    Stage X

    After getting clearance from QA Department the product is transferred to finished product warehouse for sale. Affixing approved status labels.
     
     
     
     
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