Abstract:
OBJECTIVE In order to provide technical support for the real-time monitoring and early warning of pharmacy intravenous admixture services(PIVAS) to the planktonic bacteria and dust particles, the feasibility of substituted method of real-time monitoring technology was verified, and the comparison of the application of this technology versus traditional planktonic bacteria and dust particle testing methods was carried out, in accordance with the requirements of the U.S. Pharmacopeia(USP) for the feasibility verification of substitution methods.
METHODS First of all, the feasibility of the substituted method was verified through the comparison of key parameters data such as linear correlation, accuracy, precision, specificity, quantitative limit, reproducibility and durability between a biological aerosol real-time monitoring system(BAMS) and the traditional air plankton sampler. Secondly, the actual application effects of the BAMS, plankton-sampler and dust particle counter were compared and evaluated in the PIVAS clean room.
RESULTS The BAMS had a significant sensitivity advantage over the traditional plankton-sampling apparatus, and its verification indexes, such as recovery, precision, specificity, linearity, reproducibility and durability, all met the relevant requirements under USP<1223>. There was no significant difference in the dust particle counting efficiency of BAMS in PIVAS clean area compared with the traditional method.
CONCLUSION The BAMS is not different from the traditional environmental monitoring method in clean area, and has higher detection sensitivity and timeliness than the traditional planktonic bacteria sampler. The BAMS can be applied to the real-time monitoring of environmental microbial pollution in hospital PIVAS clean room.