title: Development and assessment of sterility of a closed-system pediatric peritoneal dialysis.
abstract: OBJECTIVE
  To develop an easy-handling totally closed pediatric peritoneal dialysis system and assess the sterility assurance level.
  
  
  METHODS
  From February to December 2008 was designed and developed a closed-system pediatric peritoneal dialysis at the Bioengineering Division of Braile Biomédica Indústria, Comércio e Representações S/A. Twenty systems were manufactured and submitted to sterility assurance level testing, and were divided into Group A (10)--using the sterility test--and B (10)--ethylene oxide gas penetration.
  
  
  RESULTS
  In Group A, the sterility test was negative for bacteria and fungi proliferation within 14 days in all systems. In Group B, the gas penetration test showed that there was gas penetration in all points assessed.
  
  
  CONCLUSIONS
  It was possible to develop a new easy-handling closed-system pediatric peritoneal dialysis and ensure its sterility.
authors.affiliation: São José do Rio Preto Pediatric Cardiovascular Surgery Service -Hospital de Base - São José do Rio Preto Medical School, SP, Brazil. anapabi@hotmail.com
authors.forename: Ana Paula Pereira
authors.initials: AP
authors.lastname: Biazi
authors.forename: Ulisses Alexandre
authors.initials: UA
authors.lastname: Croti
authors.forename: Domingo Marcolino
authors.initials: DM
authors.lastname: Braile
authors.forename: Marcos Aurélio Barboza de
authors.initials: MA
authors.lastname: Oliveira
authors.forename: Jane Gonçalves Soares
authors.initials: JG
authors.lastname: Costa
authors.forename: Lucas Monteiro
authors.initials: LM
authors.lastname: Cardoso
mesh_terms: D001419:Bacteria / Q000254:growth & development; D002648:Child; D005027:Ethylene Oxide / Q000032:analysis; D005658:Fungi / Q000254:growth & development; D005740:Gases / Q000032:analysis; D006801:Humans; D008567:Membranes, Artificial; D010530:Peritoneal Dialysis / Q000295:instrumentation*; D013242:Sterilization / Q000379:methods / Q000592:standards*
chemical_list: D005740:Gases; D008567:Membranes, Artificial; D005027:Ethylene Oxide