4,816 research outputs found
The measurement of air supply volumes and velocities in cleanrooms
Air supply volumes and velocities in cleanrooms are monitored by airflow measuring hoods and anemometers but these measuring methods can be inaccurate if used incorrectly. It is demonstrated in this article that measuring hoods are accurate if the air supply passes evenly out of the hood, as occurs when the air volume is measured from a four-way diffuser or no air supply diffuser. However, when a swirl diffuser was investigated, the measuring hood gave readings more than 50% greater than the true volume. The reasons for the inaccuracy, and methods to correct it were established. Vane anemometers give inaccurate readings at the face of high-efficiency air supply filters, and it was found that the most accurate reading was found about 15 cm from the filter face. The number of readings required across the filter face to obtain an accurate average velocity was investigated, as was a scanning method using overlapping passes
Removal of microbe-carrying particles by high efficiency air filters in cleanrooms
The removal efficiency of high efficiency air filters against microbe-carrying particles (MCPs) in the air supply of occupied rooms, such as cleanrooms, was determined. Knowing the size distribution of MCPs in the air to be filtered, and the removal efficiency of a filter against individual particle diameters, the overall removal efficiency was ascertained. A variety of filters were investigated, and it was found that a filter 90% efficient, when tested against sub-micrometre particles, used in standard classification methods such as EN 1822, was greater than 99.99% efficient in removing MCPs. The effect of filter efficiency on the quality of the air supply, and the concentration of MCPs in cleanroom air was also studied. No practical improvement in airborne concentrations was obtained by filters that had a removal efficiency greater than 99.99% against MCPs. Use of a filter suitable for removing MCPs, rather than sub-micrometre particles, would give a reduction of about 6 to 8-fold in the pressure drop over a filter, and a substantial reduction in the cost of running a cleanroom
Collection efficiency of microbial methods used to monitor cleanrooms
Microbiological sampling methods used in pharmaceutical cleanrooms should efficiently collect and
count microorganisms. Methods are described in this paper that allow collection efficiencies to be
determined and maximised, and comparisons to be made between sampling methods
Assessing microbial risk to patients from aseptically manufactured pharmaceuticals
The microbial risk to patients from aseptically manufactured pharmaceuticals is dependent on the
chance that a product contains sufficient microbes to initiate an infection. This possibility is
dependent on risk factors associated with the method of production and product formulation, and
can be calculated. An analysis of these risk factors can be used to minimise patient risk and assist in
determining the appropriate level of contamination control required for manufacturing
Removal efficiency of high efficiency air filters against microbe-carrying particles (MCPs) in cleanrooms
The removal efficiency of high efficiency air filters was determined against microbe-carrying particles (MCPs) in the air supply to cleanrooms. Knowing the size distribution of MCPs in the air to be filtered, and the filter's removal efficiency against individual particle diameters, the overall removal efficiency was ascertained. The removal efficiency of individual species of microbes with a known size was also obtained. A variety of filters were investigated, and it was found that a filter 90% efficient against the most penetrating particle size (as classified by EN 1822) was greater than 99.99% efficient in removing a MCPs. The effect of filter efficiency on the microbial concentration in both the air supply and the cleanroom air was studied, and no practical improvement in the air quality was obtained by filters that had a removal efficiency greater than 99.99% against MCPs. Use of a filter suitable for removing MCPs, rather than sub-micrometre particles, would give a reduction of about 6 to 8-fold in the pressure differential across the filter, and a substantial reduction in the energy costs of running a cleanroom
The application of the ventilation equations to cleanrooms - Part 2: Decay of contamination
This article is the second of a three-part
series that investigates the application of
the ventilation equations to designing
and testing cleanrooms. This part is
concerned with the decay equation. The
recovery test, described in ISO 14644-3
(2005) is discussed, and improvements
recommended. The application of
the decay equation to the ‘clean up’
requirement given in the EU GGMP
(2008) is also discussed. Finally, a method
is considered that calculates the time
needed for airborne contamination in
cleanroom areas to decay to acceptable
concentrations
Decay of airborne contamination and ventilation effectiveness of cleanrooms
This article reports an investigation into the ability of the air supply in non-unidirectional cleanrooms to aid recovery from episodes of airborne contamination, and minimise airborne contamination at important locations. The ISO 14644-3 (2005) recovery test, which measures the rate of decay of test particles, was assessed and a reinterpretation of the test results suggested. This allowed air change effectiveness indexes to be calculated and used to evaluate the ventilation effectiveness of the cleanroom’s air supply. Air change effectiveness indexes were measured in various designs of cleanrooms, and reasons for deviations in the value of the indexes investigated
Experimental and CFD airflow studies of a cleanroom with special respect to air supply inlets
Investigations were carried out into the airflow in a non-unidirectional airflow cleanroom and its affect on the local airborne particle cleanliness The main influence was the method of air supply A supply inlet with no diffuser gave a pronounced downward jet flow and low levels of contamination below it, but poorer than average conditions in much of the rest of the room A 4-way diffuser gave much better air mixing and a more even airborne particle concentration throughout the cleanroom Other variables such as air inlet supply velocity, temperature difference between air supply and the room, and the release position of contamination also influenced the local airborne cleanliness
A CFD analysis of airflow fields in a cleanroom was compared with measured values It was considered that a turbulent intensity of 6%, and a hydraulic diameter based on the actual size of the air inlet, should be used for the inlet boundary conditions and, when combined with a k-epsilon standard turbulence model, a reasonable prediction of the airflow and airborne particle concentration was obtained
Dispersion of microbes from floors when walking in ventilated rooms
The redispersion factor of microbe-carrying particles, which is the ratio of the concentration of floor-derived microbes in room air to those on a floor surface, was determined, as was the percentage of floor-derived microbes in room air. These relationships were shown to vary according to conditions in the room. Equations were derived that allow these relationships to be calculated for a variety of room conditions, including air supply rates, levels of personnel activity, and the effect of gravitational deposition on microbe-carrying particles.<p></p>
The redispersion factor in ventilated rooms, such as cleanrooms and operating rooms, when the floor surface concentration was measured by nutrient agar contact dishes, was found to vary from about 1.5 x 10-4 to 7.4 x 10-6, and the percentage of floor-derived microbes in room air from about 0.004% to 10.5%. In a typical cleanroom, the redispersion factor is likely to be about 1.0 x 10-4, and the percentage of floor-derived microbes, 0.7. In a typical operating room, the redispersion factor is likely to be about 5.2 x 10-6 and the percentage of floor-derived microbes, 2.<p></p>
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