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Process for prefilling and terminally sterilizing syringes

  • US 5,597,530 A
  • Filed: 04/26/1996
  • Issued: 01/28/1997
  • Est. Priority Date: 08/18/1994
  • Status: Expired due to Term
First Claim
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1. A method of prefilling and terminally sterilizing a syringe, consisting of the sequential steps of:

  • a) providing an empty syringe barrel having first and second opposite ends, said first end having a port therethrough with a connector member formed about an exterior of said port and said second end being open;

    b) removing particulate matter from the interior of said syringe barrel;

    c) sterilizing a cap and a stopper, said stopper having first and second opposite longitudinal ends;

    d) prior to filling said empty syringe barrel, inserting said first end of said stopper into the second open end of said empty syringe barrel and moving said stopper toward said first end of said empty syringe barrel until said first end of said stopper reaches a position against said first end of said empty syringe barrel;

    e) prior to connecting the cap to the connector member to seal the port, filling said syringe barrel with a desired fluid medicament through said port of said first end of said syringe barrel wherein substantially no air enters said syringe barrel, said stopper moving from said first end to said second end of said syringe barrel by fluid pressure of said fluid medicament as the syringe barrel is filled;

    f) after filling the syringe barrel through the port, connecting said cap to said connector member of said first end of said filled syringe barrel to seal said port; and

    g) terminally sterilizing said prefilled and assembled syringe barrel, stopper and cap in an autoclave having a spray over-pressure cycle which maintains pressure about the exterior of said syringe barrel at least equal to the pressure within the interior of said syringe barrel.

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