Lack of latex allergen contamination of solutions withdrawn from vials with natural rubber stoppers.
The effect on latex allergen contamination and microbial growth of a latex-allergy precaution technique for preparing injectable products was studied. The study consisted of three parts: (1) preparation of 20 samples from vials with latex-containing stoppers in accordance with conventional guidelines, (2) preparation of 20 samples in accordance with latex-allergy precaution guidelines, and (3) preparation of 5 latex-free samples and 1 latex-contaminated sample as negative and positive controls, respectively. The conventional method involved swabbing a vial top with an alcohol prep pad, puncturing the dry natural rubber stopper with an 18-gauge needle attached to a latex-free syringe, and withdrawing the contents of the vial into the syringe. The latex-allergy precaution preparation technique was similar, except that the stopper was removed before the vial contents were withdrawn. There was essentially no difference in latex allergen concentrations between the two drug preparation methods. None of the samples prepared with the standard method supported any microbial growth. One sample prepared with the latex-allergy precaution method grew bacteria. Removal of the dry rubber stopper from vials did not yield solutions with less latex allergen than solutions prepared according to conventional guidelines.
Thomsen
D J
DJ
Department of Pharmaceutical Care, The University of Iowa Hospitals and Clinics, Iowa City 52240, USA. david-thomsen@uiowa.edu
Burke
T G
TG
D000485:Allergens / Q000032:analysis*; D004339:Drug Compounding; D004340:Drug Contamination; D004349:Drug Packaging; D007840:Latex / Q000032:analysis*; D020315:Latex Hypersensitivity / Q000517:prevention & control*; D019999:Pharmaceutical Solutions / Q000032:analysis*
D000485:Allergens; D007840:Latex; D019999:Pharmaceutical Solutions