Introduction 
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  The term parenteral is derived from 
  The Greek word 
                           Para (outside) 
                           Enteron(intestine)
  It denotes the route of administration other than oral 
    route.
  o Because this route of administration bypasses the 
    normal body defense  mechanisms it is essential 
    that these products are prepared with a higher 
    degree of care and skills than utilized in preparing 
    conventional oral or topical products. 
  o The finished product must be sterile, non-
    pyrogenic and free from extraneous insoluble 
    materials. 
                 Quality Control tests for Parenterals
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        Quality control is a concept which strives to produce a perfect product by a series of 
              measures designed to prevent and eliminate errors at different stages of production.
        There are mainly  four  Quality control tests performed. They are 
        i.     leakage test
        ii.   Pyrogen test
        iii. Sterility test
        iv. Particulate evaluation (clarity test)
                Leakage test 
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  This test is performed only for ampoules which have been sealed by fusion 
    to ensure that there should not be any leakage in them.
  Vials & bottles not subjected to this test because of flexibility of rubber.
  There are two methods for the identification  of leaks in parenterals they are
  1. Methylene blue  dye test
  2.  spark test
           Methylene blue dye test
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   The ampoules are immersed in vacuum chamber consisting of 1% 
    methylene blue solution
   A vacuum of about 27 inch Hg is created for about 15 to 30 min.
   This causes the solution to enter the ampoules with defective sealing.
   The vacuum is released and ampoules are observed.
   If a leakage is present, the solution in the ampoules appear blue color.
                  Spark test
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    The machine uses high precision electrodes to inspect the full 
     circumference of the containers, including the closure zone.
     All containers are presented individually to the electrodes. 
     Any moisture that has penetrated through capillary forces in a crack, 
     pinhole or just weak glass is registered as a change in resistance. 
    Appearance of blue color confirms the presence of leakage.