Efficacy of Three Commercial Disinfectants in Reducing Microbial Surfaces’ Contaminations of Pharmaceuticals Hospital Facilities
Abstract
:1. Introduction
2. Materials and Methods
2.1. Microbial Species Required by USP 35 <1072> and In-House GMP Facility Strains
2.2. Microorganism Suspension Preparation and Titer Determination
2.3. Disinfectants
2.4. Preparation of Coupons
2.5. Analytical Method and Experimental Protocol to Evaluate Disinfectants’ Efficacy
2.6. Log10 Reduction Index and Acceptance Criteria
- -
- Na(Msusp) = Na × DF × V
- -
- Nv(Msusp) = Nv × DF × V
2.7. Microorganisms Identification
2.8. Robustness
2.9. Cleaning and Disinfection Standard Operating Procedure
- (1)
- Saturation of the wipes by immersion in the first disinfectant solution
- (2)
- Squeezing the wipes to remove excess liquid;
- (3)
- Passing the wipe over the surface, proceeding from top to bottom and from left to right, overlapping the passes and making sure that there were no areas where the wipe has not been passed;
- (4)
- Contact time of action of disinfectant was 10 min;
- (5)
- For the surfaces described above, repetition of the first 4 points with the Dec-ahol.
2.10. Validation of Cleaning and Disinfection Procedure
3. Results
3.1. Microorganisms Identification and Purity
3.2. Disinfectants’ Efficacy and Log10 Reduction Index
3.3. Validation of Cleaning and Disinfection Procedure
3.4. Robustness
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Reference Strains | In-House GMP Facility Strains |
---|---|
Candida albicans ATCC 10231 | Kocuria rosea |
Aspergillus brasiliensis ATCC 16404 | Staphyloccus epidermidis |
Staphylococcus aureus ATCC 6538 | Micrococcus luteus |
Pseudomonas aeruginosa ATCC 15442 | |
Escherichia coli ATCC 8739 | |
Bacillus subtilis ATCC 6633 | |
Bacillus subtilis spore ATCC 6633 |
6 Hydrogen Peroxide | Microorganisms | ||||||
---|---|---|---|---|---|---|---|
Surface | Log10 ± St. Dev. | ||||||
B. subtilis | S. aureus | Spores B. subtilis | P. aeruginosa | E. coli | C. albicans | A. brasiliensis | |
Glass | 4.46 ± 0.01 | 4.52 ± 0.01 | 2.64 ± 0.08 | 4.59 ± 0.01 | 4.64 ± 0.01 | 4.47 ± 0.01 | 4.11 ± 0.01 |
AISI 307 Steel | 4.49 ± 0.01 | 4.41 ± 0.01 | 2.66 ± 0.06 | 4.51 ± 0.01 | 4.58 ± 0.01 | 4.50 ± 0.01 | 4.09 ± 0.03 |
PVC | 4.50 ± 0.01 | 4.44 ± 0.01 | 2.62 ± 0.07 | 4.66 ± 0.01 | 4.58 ± 0.01 | 4.50 ± 0.01 | 4.07 ± 0.03 |
Melamine | 4.49 ± 0.01 | 4.44 ± 0.01 | 2.68 ± 0.05 | 4.58 ± 0.01 | 4.63 ± 0.01 | 4.49 ± 0.01 | 4.20 ± 0.02 |
Compact Policarbonate | 4.47 ± 0.01 | 4.44 ± 0.01 | 2.64 ± 0.04 | 4.63 ± 0.01 | 4.59 ± 0.01 | 4.45 ± 0.01 | 4.18 ± 0.02 |
Quaternary ammonium | Microorganisms | ||||||
Surface | Log10 ± St. Dev. | ||||||
B. subtilis | S. aureus | Spores B. subtilis | P. aeruginosa | E. coli | C. albicans | A. brasiliensis | |
Glass | 4.24 ± 0.02 | 4.38 ± 0.02 | - | 4.50 ± 0.01 | 4.50 ± 0.01 | 4.24 ± 0.02 | 3.87 ± 0.03 |
AISI 307 Steel | 4.28 ± 0.02 | 4.36 ± 0.02 | - | 4.49 ± 0.00 | 4.48 ± 0.01 | 4.36 ± 0.02 | 3.90 ± 0.01 |
PVC | 4.30 ± 0.02 | 4.41 ± 0.01 | - | 4.58 ± 0.01 | 4.49 ± 0.01 | 4.28 ± 0.02 | 3.97 ± 0.02 |
Melamine | 4.38 ± 0.02 | 4.40 ± 0.02 | - | 4.46 ± 0.01 | 4.49 ± 0.01 | 4.34 ± 0.02 | 3.91 ± 0.04 |
Compact Policarbonate | 4.23 ± 0.02 | 4.42 ± 0.00 | - | 4.60 ± 0.01 | 4.47 ± 0.01 | 4.36 ± 0.02 | 3.99 ± 0.04 |
70 Isopropanol | Microorganisms | ||||||
Surface | Log10 ± St. Dev. | ||||||
B. subtilis | S. aureus | Spores B. subtilis | P. aeruginosa | E. coli | C. albicans | A. brasiliensis | |
Glass | 4.18 ± 0.02 | 4.26 ± 0.01 | - | 4.35 ± 0.02 | 4.31 ± 0.02 | 4.20 ± 0.02 | 3.84 ± 0.05 |
AISI 307 Steel | 4.24 ± 0.02 | 4.33 ± 0.02 | - | 4.37 ± 0.02 | 4.36 ± 0.02 | 4.19 ± 0.02 | 3.82 ± 0.03 |
PVC | 4.25 ± 0.01 | 4.30 ± 0.02 | - | 4.52 ± 0.01 | 4.35 ± 0.02 | 4.20 ± 0.01 | 3.92 ± 0.04 |
Melamine | 4.36 ± 0.02 | 4.25 ± 0.02 | - | 4.40 ± 0.00 | 4.38 ± 0.02 | 4.25 ± 0.01 | 3.84 ± 0.05 |
Compact Policarbonate | 4.19 ± 0.03 | 4.39 ± 0.01 | - | 4.49 ± 0.01 | 4.45 ± 0.01 | 4.21 ± 0.02 | 3.83 ± 0.05 |
6% Hydrogen peroxide IPA 70% | Microorganisms | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Surface | Log10 ± St. Dev. | |||||||||
B. subtilis | S. aureus | Spores B. subtilis | P. aeruginosa | E. coli | C. albicans | A. brasiliensis | K. rosea | S. epidermidis | M. luteus | |
Glass | 7.40 ± 0.16 | 7.40 ± 0.22 | 6.74 ± 0.09 | 7.40 ± 0.13 | 7.40 ± 0.16 | 7.40 ± 0.16 | 7.70 ± 0.26 | 7.22 ± 0.11 | 7.22 ± 0.12 | 7.40 ± 0.15 |
AISI 307 Steel | 7.22 ± 0.19 | 7.70 ± 0.30 | 6.66 ± 0.08 | 7.40 ± 0.20 | 7.70 ± 0.32 | 7.70 ± 0.34 | 7.40 ± 0.13 | 7.40 ± 0.10 | 7.40 ± 0.15 | 7.22 ± 0.16 |
PVC | 7.40 ± 0.27 | 7.40 ± 0.23 | 6.70 ± 0.08 | 7.70 ± 0.30 | 7.70 ± 0.23 | 7.70 ± 0.30 | 7.70 ± 0.30 | 7.22 ± 0.09 | 7.40 ± 0.18 | 7.40 ± 0.20 |
Melamine | 7.22 ± 0.21 | 7.40 ± 0.20 | 6.66 ± 0.07 | 7.40 ± 0.26 | 7.70 ± 0.28 | 7.70 ± 0.20 | 7.70 ± 0.26 | 7.40 ± 0.10 | 7.22 ± 0.12 | 7.22 ± 0.16 |
Compact Policarbonate | 7.70 ± 0.30 | 7.22 ± 0.21 | 6.66 ± 0.07 | 7.70 ± 0.23 | 7.70 ± 0.28 | 7.70 ± 0.30 | 7.40 ± 0.15 | 7.22 ± 0.12 | 7.10 ± 0.11 | 7.40 ± 0.15 |
Quaternary ammonium IPA 70% | Microorganisms | |||||||||
Surface | Log10 ± St. Dev. | |||||||||
B. subtilis | S. aureus | Spores B. subtilis | P. aeruginosa | E. coli | C. albicans | A. brasiliensis | K. rosea | S. epidermidis | M. luteus | |
Glass | 6.80 ± 0.13 | 6.74 ± 0.14 | 6.52 ± 0.10 | 6.70 ± 0.16 | 6.70 ± 0.09 | 6.74 ± 0.11 | 6.74 ± 0.11 | 6.70 ± 0.10 | 6.70 ± 0.11 | 6.66 ± 0.08 |
AISI 307 Steel | 6.66 ± 0.09 | 6.74 ± 0.12 | 6.66 ± 0.09 | 7.22 ± 0.16 | 6.74 ± 0.10 | 6.80 ± 0.16 | 6.74 ± 0.11 | 6.70 ± 0.09 | 6.66 ± 0.07 | 6.70 ± 0.09 |
PVC | 6.80 ± 0.14 | 6.80 ± 0.16 | 6.49 ± 0.07 | 6.74 ± 0.07 | 6.80 ± 0.12 | 6.92 ± 0.17 | 6.80 ± 0.12 | 6.74 ± 0.12 | 6.74 ± 0.09 | 6.70 ± 0.08 |
Melamine | 6.74 ± 0.12 | 6.80 ± 0.14 | 6.62 ± 0.11 | 6.74 ± 0.09 | 6.74 ± 0.11 | 6.74 ± 0.14 | 6.74 ± 0.09 | 6.74 ± 0.10 | 6.74 ± 0.08 | 6.70 ± 0.07 |
Compact Policarbonate | 6.74 ± 0.09 | 6.74 ± 0.15 | 6.49 ± 0.11 | 6.74 ± 0.10 | 6.74 ± 0.11 | 6.80 ± 0.13 | 6.80 ± 0.09 | 6.70 ± 0.13 | 6.66 ± 0.07 | 6.70 ± 0.10 |
6% Hydrogen peroxide + IPA 70% | Microorganisms a | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Surface | B. subtilis | S. aureus | Spores B. subtilis | P. aeruginosa | E. coli | C. albicans | A. brasiliensis | K. rosea | S. epidermidis | M. luteus |
Glass | 2 ± 0.9 | 2 ± 1.3 | 9 ± 2.2 | 2 ± 0.7 | 2 ± 0.9 | 2 ± 0.9 | 1 ± 0.8 | 3 ± 0.9 | 3 ± 1 | 2 ± 0.8 |
AISI 307 Steel | 3 ± 1.6 | 1 ± 1 | 11 ± 2.1 | 2 ± 1.2 | 1 ± 1.1 | 1 ± 1.2 | 2 ± 0.7 | 2 ± 0.5 | 2 ± 0.8 | 3 ± 1.3 |
PVC | 2 ± 1.7 | 2 ± 1.4 | 10 ± 1.9 | 1 ± 1 | 1 ± 0.7 | 1 ± 1 | 1 ± 1 | 3 ± 0.7 | 2.4 ± 1 | 2 ± 1.2 |
Melamine | 3 ± 1.9 | 2 ± 1.2 | 11 ± 1.9 | 2 ± 1.6 | 1 ± 0.9 | 1 ± 0.6 | 1 ± 0.8 | 2 ± 0.5 | 2.7 ± 1 | 3 ± 1.3 |
Compact Policarbonate | 1 ± 1 | 3 ± 1.9 | 11 ± 2 | 1 ± 0.7 | 1 ± 0.9 | 1 ± 1 | 2 ± 0.8 | 3 ± 1 | 4 ± 1.2 | 2 ± 0.8 |
Quaternary ammonium + IPA 70% | Microorganisms a | |||||||||
Surface | B. subtilis | S. aureus | Spores B. subtilis | P. aeruginosa | E. coli | C. albicans | A. brasiliensis | K. rosea | S. epidermidis | M. luteus |
Glass | 8 ± 2.7 | 9 ± 3.4 | 15 ± 4 | 10 ± 4.5 | 10 ± 2.2 | 9 ± 2.5 | 9 ± 2.6 | 10 ± 2.6 | 10 ± 2.8 | 11 ± 2.2 |
AISI 307 Steel | 11 ± 2.5 | 9 ± 2.9 | 11 ± 2.5 | 3 ± 1.3 | 9 ± 2.3 | 8 ± 3.5 | 9 ± 2.6 | 10 ± 2.3 | 11 ± 2 | 10 ± 2.3 |
PVC | 8 ± 3.1 | 8 ± 3.6 | 16 ± 3 | 9 ± 1.6 | 8 ± 2.6 | 6 ± 2.8 | 8 ± 2.5 | 9 ± 3 | 9 ± 2.2 | 10 ± 2 |
Melamine | 9 ± 3 | 8 ± 3 | 12 ± 3.5 | 9 ± 2.1 | 9 ± 2.6 | 9 ± 3.4 | 9 ± 2.2 | 9 ± 2.3 | 9 ± 1.8 | 10 ± 1.7 |
Compact Policarbonate | 9 ± 2.1 | 9 ± 3.7 | 16 ± 4.5 | 9 ± 2.4 | 8 ± 2.5 | 8 ± 2.9 | 8 ± 1.8 | 10 ± 3.5 | 11 ± 2 | 10 ± 2.7 |
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Di Martino, G.; Pasqua, S.; Douradinha, B.; Monaco, F.; Di Bartolo, C.; Conaldi, P.G.; D’Apolito, D. Efficacy of Three Commercial Disinfectants in Reducing Microbial Surfaces’ Contaminations of Pharmaceuticals Hospital Facilities. Int. J. Environ. Res. Public Health 2021, 18, 779. https://doi.org/10.3390/ijerph18020779
Di Martino G, Pasqua S, Douradinha B, Monaco F, Di Bartolo C, Conaldi PG, D’Apolito D. Efficacy of Three Commercial Disinfectants in Reducing Microbial Surfaces’ Contaminations of Pharmaceuticals Hospital Facilities. International Journal of Environmental Research and Public Health. 2021; 18(2):779. https://doi.org/10.3390/ijerph18020779
Chicago/Turabian StyleDi Martino, Giuseppina, Salvatore Pasqua, Bruno Douradinha, Francesco Monaco, Chiara Di Bartolo, Pier Giulio Conaldi, and Danilo D’Apolito. 2021. "Efficacy of Three Commercial Disinfectants in Reducing Microbial Surfaces’ Contaminations of Pharmaceuticals Hospital Facilities" International Journal of Environmental Research and Public Health 18, no. 2: 779. https://doi.org/10.3390/ijerph18020779