The Abstracts of the paper carried by the Journal of JACA
Traditional method for measuring airborne microbes is based on two procedures called sampling and incubation. Sampling normally involves drawing a sampler from an air stream or room by means of instruments based on 3 type’s collecting-method, which named impaction, liquid impingement and filtration. Incubation of agar plates typically requires several days. Though the traditional methods can identify the species of microorganisms, they can’t obtain any information about suspended viable particles in real time. Recently, introduction of HACCP (Hazard Analysis and Critical Control Point) and measures of bioterrorism have been the subject of social attention. This paper describes the actual state of rapid microbiological methods, and future subjects.
Rapid microbiological method by ATP method
New approach for setting management criterion in microbiological monitoring using ATPZERO1 method
This paper describes the case study of adopting rapid microbiological method technology to the environmental minitoring and microbiological testing of WFI mainly as in-process control of pharmaceutical and tissue engineering manufacturing. The research includes the case example of operation model based on the trend monitoring of microbial ATP amount measured by ATPZERO1 method (the registered trademark of Hitachi Plant Services Co., Ltd.) with improved reaction protocol that enables one hundred-fold more sensitive than the conventional ATP method.
Variety of rapid microbial methodologies have been introduced and investigated for applications. Official guidelines have been specified for validating those methodologies in the US, such as USP<1223>. One of challenges is to validate the real time based microbial detection technology with specific reference microbes from supplier’s perspectives with compliance to the USP<1223>. It is appropriate for evaluating the fundamental performance, however this process with actual microbes may not be productive for calibration and certification of detection system in production and services. Another challenge which is introduced by this article as well is that detection performance calibration and certification process with mimic microbes through production and services of detection system may represent actual performance.
The BioTrak Real-Time Viable Particle Counter is a full featured instrument that detects the total number of particles in the air as well as determining which of those particles are viable in nature. The BioTrak falls into a class of instruments known as Rapid Microbiology Methods (RMM). BioTrak have garnered significant interest due to the potential benefits they offer to the manufacturing space where environmental microbiological contamination is of concern. The ability to detect the presence of viable particles in real time is a key differentiator offered by the BioTrak.
In recent years, cost reduction and energy saving have gained importance in the design of clean rooms against the background of global environmental concerns, energy problems, and product price competition. Under these circumstances, the overall approach to clean room design is shifting to one where limited areas of a building have high cleanliness standards while the overall level of cleanliness is more relaxed. A conventional clean booth that provides local high cleanliness is partitioned by a vinyl curtain or similar, but this reduces work efficiency when staff enter and leave. As an alternative, we have developed a new clean booth technology, T-Clean® Air Wall, that frees the clean area of physical screens such as vinyl curtains through the use of air curtains. This paper reports on the characteristics of the new clean booth technology and the results of full-size experiments.
In this article, an inverse simulation is introduced to obtain nonparametric sensitivities for heat transfer and fluid flow design under general expressions of objective functional. Then it is shown that the sensitivities on whole boundary can be obtained by a couple of numerical computations of the forward and corresponding inverse problems whether or not the design parameters are defined, which enables us to decide the design parameters after the sensitivity analysis. Two illustrative examples are presented for optimization of natural and mixed convection heat transfer.