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Manufacture of prefilled syringes

  • US 6,189,195 B1
  • Filed: 08/22/1995
  • Issued: 02/20/2001
  • Est. Priority Date: 08/22/1995
  • Status: Expired due to Fees
First Claim
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1. A process of manufacturing a syringe, the process comprising:

  • molding a barrel and a plunger substrate within at least a class 100 environment, without subsequently washing the barrel and the plunger substrate;

    packaging the barrel and plunger substrate within at least a class 100 environment, thereby maintaining the barrel and the plunger substrate substantially free of contaminants;

    molding a plunger cover and a tip seal within an environment less clean than a class 100 environment;

    packaging the plunger cover and the tip seal within at least a class 100 environment, thereby maintaining the plunger cover and the tip seal substantially free of contaminants;

    transporting the packaged barrel and the packaged tip seal to a first assembly site having at least a class 100 environment;

    unpackaging the barrel and the tip seal within the at least class 100 environment at the first assembly site;

    assembling the unpackaged tip seal to the unpackaged barrel within the at least class 100 environment at the first assembly site, thereby providing a barrel/tip seal combination;

    transporting the packaged plunger substrate and the packaged plunger cover to a second assembly site having at least a class 100 environment;

    unpackaging the plunger substrate and the plunger cover within the at least class 100 environment at the second assembly site;

    assembling the unpackaged plunger cover to the unpackaged plunger substrate within the at least class 100 environment at the second assembly site, thereby providing a plunger assembly;

    packaging the barrel/tip seal combination within at least a class 100 environment, thereby maintaining the barrel/tip seal combination substantially free of contaminants;

    packaging the plunger assembly within at least a class 100 environment, thereby maintaining the plunger assembly substantially free of contaminants;

    transporting the packaged barrel/tip seal combination and the packaged plunger assembly to a final assembly site having least a class 100 environment;

    unpackaging the barrel/tip seal combination and the plunger assembly within the at least class 100 environment at the final assembly site; and

    assembling the unpackaged plunger assembly to the unpackaged barrel/tip seal combination within the at least class 100 environment at the final assembly site.

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