title: Self-sealing capacity of vial stoppers after multiple needle punctures.
abstract: OBJECTIVE
  To evaluate the self-sealing capacity of vial stoppers in two common radiopharmaceuticals after more than 10 needle punctures.
  
  
  METHODS
  Assessment of self-sealing capacity was performed according to the self-sealing capacity test described in United States Pharmacopeial Convention (USP) General Chapter <381>. Groups of 10 vials of technetium (Tc)-99m sulfur colloid and Tc-99m tetrofosmin were tested for maintenance of self-sealing capacity following 10 punctures with 22-, 20-, and 18-gauge needles. Each vial was sequentially retested after additional sets of 10 punctures until failure of self-sealing capacity or until a total of 100 punctures, whichever came first.
  
  
  RESULTS
  The median number of needle punctures with maintenance of self-sealing ability before failure for 22-, 20-, and 18-gauge needles was >100 (range all >100), >100 (all >100), and 60 (30-90), respectively, for sulfur colloid and >100 (all >100), >100 (50 to >100), and 50 (20-70), respectively, for tetrofosmin. Incidentally, coring particles were observed frequently in vials after many punctures with 18-gauge needles, but infrequently with 20-gauge and rarely with 22-gauge needles.
  
  
  CONCLUSIONS
  Vial stoppers in two radiopharmaceutical products demonstrated robust self-sealing capacity, substantially exceeding the USP standard of 10 punctures with a 21-gauge needle. Coring particles were frequently observed after many punctures when using larger-bore needles but rarely when using smaller-bore needles. Under conditions commonly used, failure of self-sealing capacity and generation of coring particles are not anticipated to be problems encountered when puncturing vial stoppers of these two products substantially more than 10 times.
authors: University of Iowa Hospitals and Clinics, Iowa City, IA 52242, USA. james-ponto@uiowa.edu
authors: James A
authors: JA
authors: Ponto
mesh_terms: D004349:Drug Packaging / Q000592:standards*; D009339:Needles; D009943:Organophosphorus Compounds / Q000032:analysis; D015609:Organotechnetium Compounds / Q000032:analysis; D010602:Pharmacopoeias as Topic; D019275:Radiopharmaceuticals / Q000032:analysis; D012408:Rubber / Q000737:chemistry*; D013671:Technetium Tc 99m Sulfur Colloid / Q000032:analysis; D014481:United States
chemical_list: D009943:Organophosphorus Compounds; D015609:Organotechnetium Compounds; D019275:Radiopharmaceuticals; C078700:technetium tc-99m tetrofosmin; D013671:Technetium Tc 99m Sulfur Colloid; D012408:Rubber