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-via

SUBMITTER: Raval JS 

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

REPOSITORIES: biostudies-literature