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. 2023 Dec 12;5(12):000494.v3.
doi: 10.1099/acmi.0.000494.v3. eCollection 2023.

Assessment of microbial contamination in laser materials processing laboratories used for prototyping of biomedical devices

Yinka M Somorin  1   2 , Gerard M O'Connor  1
Affiliations

Assessment of microbial contamination in laser materials processing laboratories used for prototyping of biomedical devices

Yinka M Somorin et al. Access Microbiol. .

Abstract

Microbial contamination of medical devices during pilot production can be a significant barrier as the laboratory environment is a source of contamination. There is limited information on microbial contaminants in laser laboratories and environments involved in the pilot production of medical devices. This study aimed to determine the bioburden and microbial contaminants present in three laser laboratories - an ISO class 7 clean room, a pilot line facility and a standard laser laboratory. Microbiological air sampling was by passive air sampling using settle plates and the identity of isolates was confirmed by DNA sequencing. Particulate matter was analysed using a portable optical particle counter. Twenty bacterial and 16 fungal genera were isolated, with the genera Staphylococcus and Micrococcus being predominant. Most isolates are associated with skin, mouth, or upper respiratory tract. There was no significant correlation between microbial count and PM2.5 concentration in the three laboratories. There were low levels but diverse microbial population in the laser-processing environments. Pathogenic bacteria such as Acinetobacter baumannii and Candida parapsilosis were isolated in those environments. These results provide data that will be useful for developing a contamination control plan for controlling microbial contamination and facilitating advanced manufacturing of laser-based pilot production of medical devices.

Keywords: bioburden; clean room; laser; medical devices; microbial contamination; particle count; pilot line.

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Conflict of interest statement

The authors declare that there are no conflicts of interest.

Figures

Fig. 1.
Fig. 1.
Trend of microbial contaminants in different laser materials processing laboratories. Bacterial count at rest (a) and during operation (b) as well as fungal count at rest (c) and during operation (d), with four replicates at each location. Error bars represent 95 % confidence interval (CI) of median.
Fig. 2.
Fig. 2.
Trend of microbial contaminants within workstations in a pilot manufacturing line: Bacterial count at rest (a) and during operation (b) as well as fungal count at rest (c) and during operation (d), with four replicates at each location. Error bars represent 95 % confidence interval (CI) of median.
Fig. 3.
Fig. 3.
Micro-organisms isolated in different laser materials processing laboratories.
Fig. 4.
Fig. 4.
Distribution of isolates in the pilot manufacturing line workstations located within the pilot line facility.
See this image and copyright information in PMC

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