Dataset Information

Real-time monitoring of non-viable airborne particles correlates with airborne colonies and represents an acceptable surrogate for daily assessment of cell-processing cleanroom performance.

ABSTRACT: BACKGROUND AIMS:Airborne particulate monitoring is mandated as a component of good manufacturing practice. We present a procedure developed to monitor and interpret airborne particulates in an International Organization for Standardization (ISO) class 7 cleanroom used for the cell processing of Section 351 and Section 361 products. METHODS:We collected paired viable and non-viable airborne particle data over a period of 1 year in locations chosen to provide a range of air quality. We used receiver operator characteristic (ROC) analysis to determine empirically the relationship between non-viable and viable airborne particle counts. RESULTS:Viable and non-viable particles were well-correlated (r(2) =?0.78), with outlier observations at the low end of the scale (non-viable particles without detectable airborne colonies). ROC analysis predicted viable counts ??0.5/feet(3) (a limit set by the United States Pharmacopeia) at an action limit of ??32 000 particles (??0.5 µ)/feet(3), with 95.6% sensitivity and 50% specificity. This limit was exceeded 2.6 times during 18 months of retrospective daily cleanroom data (an expected false alarm rate of 1.3 times/year). After implementing this action limit, we were alerted in real time to an air-handling failure undetected by our hospital facilities management. CONCLUSIONS:A rational action limit for non-viable particles was determined based on the correlation with airborne colonies. Reaching or exceeding the action limit of 32 000 non-viable particles/feet(3) triggers suspension of cleanroom cell-processing activities, deep cleaning, investigation of air handling, and a deviation management process. Our full procedure for particle monitoring is available as an online supplement.

SUBMITTER: Raval JS

PROVIDER: S-EPMC4165074 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature

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Real-time monitoring of non-viable airborne particles correlates with airborne colonies and represents an acceptable surrogate for daily assessment of cell-processing cleanroom performance.

Raval Jay S JS Koch Eileen E Donnenberg Albert D AD

Cytotherapy 20120702 9

<h4>Background aims</h4>Airborne particulate monitoring is mandated as a component of good manufacturing practice. We present a procedure developed to monitor and interpret airborne particulates in an International Organization for Standardization (ISO) class 7 cleanroom used for the cell processing of Section 351 and Section 361 products.<h4>Methods</h4>We collected paired viable and non-viable airborne particle data over a period of 1 year in locations chosen to provide a range of air quality. ...[more]

PMID: 22746538

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Dataset Information

Real-time monitoring of non-viable airborne particles correlates with airborne colonies and represents an acceptable surrogate for daily assessment of cell-processing cleanroom performance.

Publications

Real-time monitoring of non-viable airborne particles correlates with airborne colonies and represents an acceptable surrogate for daily assessment of cell-processing cleanroom performance.

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