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Research ArticleRESEARCH

Proposal for a New Categorization of Aseptic Processing Facilities Based on Risk Assessment Scores

Hirohito Katayama, Atsushi Toda, Yuji Tokunaga and Shigeo Katoh
PDA Journal of Pharmaceutical Science and Technology July 2008, 62 (4) 235-243;
Hirohito Katayama
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  • For correspondence: hirohito.katayama@jp.astellas.com
Atsushi Toda
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Yuji Tokunaga
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Shigeo Katoh
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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.

  • Risk assessment
  • Aseptic processing
  • Risk categories
  • Advanced technology
  • Conventional facility
  • Media fill
  • Microbiological monitoring

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PDA Journal of Pharmaceutical Science and Technology
Vol. 62, Issue 4
July/August 2008
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Proposal for a New Categorization of Aseptic Processing Facilities Based on Risk Assessment Scores
Hirohito Katayama, Atsushi Toda, Yuji Tokunaga, Shigeo Katoh
PDA Journal of Pharmaceutical Science and Technology Jul 2008, 62 (4) 235-243;

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Proposal for a New Categorization of Aseptic Processing Facilities Based on Risk Assessment Scores
Hirohito Katayama, Atsushi Toda, Yuji Tokunaga, Shigeo Katoh
PDA Journal of Pharmaceutical Science and Technology Jul 2008, 62 (4) 235-243;
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