Field test of pharmaceutical cleanroom cleanliness subject to multiple disturbance factors

Yang, Zixu; Hao, Yunfeng; Shi, Wenxing; Shao, Xueming; Dong, Xiufang; Cheng, Xuanrui; Li, Xianting; Ma, Xiaojun

doi:10.1016/j.jobe.2021.103083

Cited by 12 publications

(6 citation statements)

References 18 publications

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“…A study by (Yang et al, 2021) [14] was carried out in a biopharmaceutical production line. This study contained the description of HVAC, layout, and other equipment in more detail.…”

Section: Discussionmentioning

confidence: 99%

“…First of all, these are structural and technical adaptations that can be made to laboratory rooms. The laboratory should be equipped with a buffer room and an airlock (see Yang et al, 2021) [14]. Further, Feng et al (2019) mention ensuring appropriate air distribution in the room [17].…”

Section: Discussionmentioning

confidence: 99%

“…In the pharmaceutical industry, this can lead to the contamination of drugs; in healthcare, it can increase the likelihood of the infection of patients in the operating room; and in laboratories, it can falsify experimental results (Kamar et al, 2015) [13]. Indoor environmental quality research has been conducted into, for example, pharmaceutical laboratories (Yang et al, 2021;Yau et al, 2012) [14,15], assisted reproduction laboratories (Boone et al, 1999) [16], and biosafety laboratories (Feng et al, 2019) [17]. Elevated aerosol concentrations in microbiology laboratories that do not use biological agents of concern do not pose an immediate threat to laboratory personnel but can directly affect experimental results.…”

Section: Introductionmentioning

confidence: 99%

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Particle Number of Aerosol in Specific Conditions of Biotechnology Laboratory Cleanroom

Junga,

Trávníček,

Vítěz

et al. 2023

Applied Sciences

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This paper presents the results of experimental measurements of the number of aerosol particles in cleanroom air of a biotechnology laboratory for DNA analysis. The aerosol content in the air can harm the accuracy of any analysis performed. The experimental measurements demonstrate compliance with the ISO cleanroom requirements for class 7. The indoor environment of the investigated biotechnology laboratory cleanroom can be classified as ISO cleanroom class 8. The particle count values depend on the month in which the measurement is made. The location of the measurement site, on the other hand, does not have too much influence. Our results showed that the values of particle number in the laboratory ranged from 325,965 to 2,740,877 pc/m3 for particles of 0.5 μm and more. From these measurements, it can be concluded that the biotechnology laboratory premises were not very suitable locations to perform for the intended DNA tests since microbiological contamination had the capacity to distort the results of these tests. As such, the authors propose several strategies to improve the current situation. These strategies are based on changing the laboratory work organization and cleaning methodology. In addition, the monitoring of particles with a size of 5 µm or more is recommended.

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“…A study by (Yang et al, 2021) [14] was carried out in a biopharmaceutical production line. This study contained the description of HVAC, layout, and other equipment in more detail.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Particle Number of Aerosol in Specific Conditions of Biotechnology Laboratory Cleanroom

Junga,

Trávníček,

Vítěz

et al. 2023

Applied Sciences

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“…Perhaps most common in the semiconductor and materials industry, cleanrooms are used in a range of sectors where small airborne particles can lead to adverse effects on the manufacturing process and quality of engineered materials [1,2]. In addition to particles, cleanroom facilities are specifically designed to control and maintain specific air quality, including temperature, pressure and flow rate.…”

Section: Introductionmentioning

confidence: 99%

“…In addition to particles, cleanroom facilities are specifically designed to control and maintain specific air quality, including temperature, pressure and flow rate. Currently, cleanrooms are categorized into classes based on the level of particle contamination [1], but there is significant requirement for the control of chemical hazards. Personnel who work in cleanroom must practice contamination control measures through use of attire to trap contaminants being released from the body (gown, masks, coverall etc) and via exposure to special rooms with airlocks and air showers.…”

Section: Introductionmentioning

confidence: 99%

High selectivity and sensitivity through nanoparticle sensors for cleanroom CO₂ detection

Channegowda,

Verma,

Arabia

et al. 2024

Nanotechnology

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Clean room facilities are becoming more popular in both academic and industry settings, including low-and middle-income countries. This has led to an increased demand for cost-eﬀective gas sensors to monitor air quality. Here we have developed a gas sensor using CoNiO2 nanoparticles through a cost-eﬀective combustion method. The sensitivity and selectivity of the sensor towards CO2 were inﬂuenced by the structure of the nanoparticles, which were aﬀected by the reducing agent (biofuels) used during synthesis. Among all reducing agents, urea found to yield highly crystalline and uniformly distributed CoNiO2 nanoparticles, which when developed into sensors showed high sensitivity (limit of detection: 200 ppm) and selectivity for the detection of CO2 gas in the presence of common interfering volatile organic compounds observed in cleanroom facilities including ammonia, formaldehyde, acetone, toluene, ethanol, isopropanol and methanol. In addition, the urea-mediated nanoparticle-based sensors exhibited room temperature operation, high stability, prompt response and recovery rates, and excellent reproducibility. Consequently, the synthesis approach to nanoparticle-based, energy eﬃcient and aﬀordable sensors represent a benchmark for CO2 sensing in cleanroom settings.

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Dynamic identification and seismic capacity of an innovative cleanroom with walkable ceiling system

Magliulo,

Zito,

D’Angela

2024

Bull Earthquake Eng

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Past earthquakes highlighted the vulnerability of cleanrooms, especially in earthquake-prone countries like Italy; the post-earthquake reconnaissance showed that damage to cleanrooms led to immeasurable economic losses. This study investigates the seismic performance of an innovative cleanroom, seismically designed and provided with innovative components. Full-scale shake table tests were performed on the cleanroom according to ICC-ES AC156 protocol; the cleanroom was tested under operating conditions. Both dynamic properties and seismic behavior of the specimen were assessed. The tests showed the excellent seismic behavior of the cleanroom, confirming that simple devices can significantly improve the seismic performance of nonstructural elements.

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Field test of pharmaceutical cleanroom cleanliness subject to multiple disturbance factors

Cited by 12 publications

References 18 publications

Particle Number of Aerosol in Specific Conditions of Biotechnology Laboratory Cleanroom

Particle Number of Aerosol in Specific Conditions of Biotechnology Laboratory Cleanroom

High selectivity and sensitivity through nanoparticle sensors for cleanroom CO₂ detection

Dynamic identification and seismic capacity of an innovative cleanroom with walkable ceiling system

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Field test of pharmaceutical cleanroom cleanliness subject to multiple disturbance factors

Cited by 12 publications

References 18 publications

Particle Number of Aerosol in Specific Conditions of Biotechnology Laboratory Cleanroom

Particle Number of Aerosol in Specific Conditions of Biotechnology Laboratory Cleanroom

High selectivity and sensitivity through nanoparticle sensors for cleanroom CO2 detection

Dynamic identification and seismic capacity of an innovative cleanroom with walkable ceiling system

Contact Info

Product

Resources

About

High selectivity and sensitivity through nanoparticle sensors for cleanroom CO₂ detection