title: Proposal for a new categorization of aseptic processing facilities based on risk assessment scores.
abstract: Risk assessment of aseptic processing facilities was performed using two published risk assessment tools. Calculated risk scores were compared with experimental test results, including environmental monitoring and media fill run results, in three different types of facilities. The two risk assessment tools used gave a generally similar outcome. However, depending on the tool used, variations were observed in the relative scores between the facilities. For the facility yielding the lowest risk scores, the corresponding experimental test results showed no contamination, indicating that these ordinal testing methods are insufficient to evaluate this kind of facility. A conventional facility having acceptable aseptic processing lines gave relatively high risk scores. The facility showing a rather high risk score demonstrated the usefulness of conventional microbiological test methods. Considering the significant gaps observed in calculated risk scores and in the ordinal microbiological test results between advanced and conventional facilities, we propose a facility categorization based on risk assessment. The most important risk factor in aseptic processing is human intervention. When human intervention is eliminated from the process by advanced hardware design, the aseptic processing facility can be classified into a new risk category that is better suited for assuring sterility based on a new set of criteria rather than on currently used microbiological analysis. To fully benefit from advanced technologies, we propose three risk categories for these aseptic facilities.
authors.affiliation: Pharmaceutical Research & Technology Laboratories, Astellas Pharmaceutical Inc., Shizuoka, Japan. hirohito.katayama@jp.astellas.com
authors.forename: Hirohito
authors.initials: H
authors.lastname: Katayama
authors.forename: Atsushi
authors.initials: A
authors.lastname: Toda
authors.forename: Yuji
authors.initials: Y
authors.lastname: Tokunaga
authors.forename: Shigeo
authors.initials: S
authors.lastname: Katoh
mesh_terms: D001207:Asepsis / Q000379:methods*; D004340:Drug Contamination / Q000517:prevention & control; D004345:Drug Industry / Q000379:methods / Q000592:standards; D004783:Environmental Microbiology / Q000592:standards; D005160:Facility Design and Construction / Q000592:standards*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards; D012107:Research Design / Q000592:standards*; D018570:Risk Assessment / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D012307:Risk Factors; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations