Comparison between MEA and DG18-agar impaction for <i>A</i>. <i>niger</i>.

<p>Comparison between MEA and DG18-agar impaction for <i>A</i>. <i>niger</i>.</p

Correlation coefficient (r) of impaction and sedimentation for <i>A</i>. <i>niger</i> and <i>S</i>. <i>aureus</i>.

<p>Correlation coefficient (r) of impaction and sedimentation for <i>A</i>. <i>niger</i> and <i>S</i>. <i>aureus</i>.</p

Comparative study of impaction and sedimentation in an aerosol chamber using defined fungal spore and bacterial concentrations

<div><p>Biocontamination control is a very significant part of the manufacturing process of sterile drugs. Sterility is frequently monitored by active or passive air sampling measurements, but there are no specific rules as to how this is to be done. This study tested air sampling methods of active impaction and passive sedimentation under standardized conditions. <i>Aspergillus niger</i> (<i>A</i>. <i>niger</i>) and <i>Staphylococcus aureus</i> (<i>S</i>. <i>aureus</i>) were selected in this experiment to examine parallels, correlations and differences between the two methods. The results show that the number of colony forming units per plate (CFU/plate) was higher for <i>A</i>. <i>niger</i> in the active method, whereas for <i>S</i>. <i>aureus</i> it was higher in the sedimentation method. A high correlation coefficient was found between the impaction and sedimentation methods for <i>A</i>. <i>niger</i>. For <i>S</i>. <i>aureus</i>, depending on the culture media used and the time for passive air sampling, a larger number of CFU/plate was found than in active air sampling. This study concludes that active and passive air sampling can be used for monitoring the air in clean rooms. For fungal spore detection, the impaction is more efficient, as it is possible to sample a higher volume of air in a shorter period of time, whereas the optimal measurement methods for <i>S</i>. <i>aureus</i> depend on a number of factors.</p></div

Impaction measurements (n = 30) of <i>A</i>. <i>niger</i> and <i>S</i>. <i>aureus</i> with mean values in CFU/ml (test suspension) and CFU/plate.

<p>Impaction measurements (n = 30) of <i>A</i>. <i>niger</i> and <i>S</i>. <i>aureus</i> with mean values in CFU/ml (test suspension) and CFU/plate.</p

Recovery of <i>S</i>. <i>aureus</i> concentration on CNA-agar.

<p>Recovery of <i>S</i>. <i>aureus</i> concentration on CNA-agar.</p

Design of ISO-PRO-under pressure isolator (MECALAB/MBraun® AG).

<p>Design of ISO-PRO-under pressure isolator (MECALAB/MBraun® AG).</p

Comparison between CASO- and CNA-agar impaction for <i>S</i>. <i>aureus</i>.

<p>Comparison between CASO- and CNA-agar impaction for <i>S</i>. <i>aureus</i>.</p

Recovery of <i>A</i>. <i>niger</i> concentration on MEA.

<p>Recovery of <i>A</i>. <i>niger</i> concentration on MEA.</p

Recovery of <i>S</i>. <i>aureus</i> concentration on CASO-agar.

<p>Recovery of <i>S</i>. <i>aureus</i> concentration on CASO-agar.</p

Air circulation in the aerosol chamber.

<p>Air circulation in the aerosol chamber.</p