Sterilization process for iodine-containing antimicrobial topical solutions

Abstract

The invention herein provides an improved manufacturing process for sterile containers pre-filled with topical antimicrobial solutions that reduces or avoids undesirable by-products as a result of the ethylene oxide gas sterilization technique. The process of the invention produces containers pre-filled with antimicrobial solution that are sterilized in accordance with the ethylene oxide technique, while at the same time have a toxic residue content within acceptable limits. The invention is particularly useful in the manufacture of plastic containers pre-filled with iodine-based antimicrobial solutions.

1 . A process for assembling and packaging a container containing a liquid antimicrobial solution comprising the steps of: 
 a) providing a formed empty container;    b) subjecting said container to fluorination;    c) filling said fluorinated container with liquid antimicrobial solution;    d) sealing the filled container; and    e) subjecting said filled container to ethylene oxide sterilization.    
   
   
       2 . The process according to  claim 1 , wherein the container is composed of plastic.  
   
   
       3 . The process according to  claim 2 , wherein the plastic container is in the form of a a bottle.  
   
   
       4 . The process according to  claim 2 , wherein the plastic container is composed of polyethylene.  
   
   
       5 . The process according to  claim 1 , wherein the liquid antimicrobial solution comprises a broad-spectrum antimicrobial agent.  
   
   
       6 . The process according to  claim 4 , wherein the broad-spectrum antimicrobial agent comprises iodine.  
   
   
       7 . The process according to  claim 5  wherein the broad spectrum antimicrobial agent is povidone-iodine.  
   
   
       8 . A sealed and sterilized plastic container filled with antimicrobial solution being substantially free of contaminants from the interaction of ethylene oxide gas and iodine-containing antimicrobial solution, said filled container prepared by the process according to  claim 1 .  
   
   
       9 . A method of reducing contaminants produced by the interaction of ethylene oxide gas sterilization and iodine-containing antimicrobial solutions comprising: 
 selecting a fluorinated plastic container;    filling said container with iodine-containing antimicrobial solution;    sealing said filled container; and    subjecting said filled container to ethylene oxide sterilization.