title: Importance of good manufacturing practices in microbiological monitoring in processing human tissues for transplant.
abstract: Skin allografts represent an important therapeutic resource in the treatment of severe skin loss. The risk associated with application of processed tissues in humans is very low, however, human material always carries the risk of disease transmission. To minimise the risk of contamination of grafts, processing is carried out in clean rooms where air quality is monitored. Procedures and quality control tests are performed to standardise the production process and to guarantee the final product for human use. Since we only validate and distribute aseptic tissues, we conducted a study to determine what type of quality controls for skin processing are the most suitable for detecting processing errors and intercurrent contamination, and for faithfully mapping the process without unduly increasing production costs. Two different methods for quality control were statistically compared using the Fisher exact test. On the basis of the current study we selected our quality control procedure based on pre- and post-processing tissue controls, operator and environmental controls. Evaluation of the predictability of our control methods showed that tissue control was the most reliable method of revealing microbial contamination of grafts. We obtained 100 % sensitivity by doubling tissue controls, while maintaining high specificity (77 %).
authors.affiliation: Siena Skin Bank, Policlinico S.M. alle Scotte, Viale Bracci, 53100, Siena, Italy, e.pianigiani@ao-siena.toscana.it.
authors.forename: Elisa
authors.initials: E
authors.lastname: Pianigiani
authors.forename: Francesca
authors.initials: F
authors.lastname: Ierardi
authors.forename: Michele
authors.initials: M
authors.lastname: Fimiani
mesh_terms: D006801:Humans; D008829:Microbiology / Q000592:standards*; D011786:Quality Control; D014019:Tissue Donors; D016378:Tissue Transplantation / Q000592:standards*; D020858:Tissue and Organ Harvesting / Q000379:methods* / Q000592:standards*