Compounding Parenteral Products in Pediatric Wards—Effect of Environment and Aseptic Technique on Product Sterility
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. Compounding of Parenteral Product Samples
2.3. Study Methods
2.4. Sterility Test and Identification of Contaminants
2.5. Analysis of Data
2.6. Study Ethics
3. Results
3.1. Observation during Compunding
3.2. Environmental Monitoring during Compounding
3.3. Monitoring of Personnel after Compounding
3.4. Sterility Test for Compounded Samples
3.5. Contaminants
4. Discussion
Limitations of the Study
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Aseptic Working Techniques Used While Compounding: | PR, Step Followed (%) | MR, Step Followed (%) | BSC, Step Followed (%) |
---|---|---|---|
Participant does not have infectious disease | 100 | 100 | 100 |
Participant is not wearing jewellery or watches on his/her hands or wrists | 100 | 100 | 100 |
Participant cleans the table with an alkaline cleanser | 56 | 72 | - |
Participant cleans the table with 80% denaturized ethanol | 78 | 75 | - |
BSC is kept on for 15 min before starting the compounding | - | - | 92 |
Airflow of the BSC is at maximum speed | - | - | 100 |
Participant washes hands with soap before compounding | 44 | 56 | 67 |
Participant disinfects hands before compounding | 100 | 100 | 100 |
Participant uses a disposable non-sterile protective gown | - | - | 50 |
Participant uses a hair cover | - | - | 0 |
Participant puts on a surgical face mask | 11 | 11 | 0 |
Participant puts on non-sterile gloves before disinfecting the equipment to be used in the compounding and cleaning the compounding area | 36 | 31 | 67 |
Participant cleans the cabinet with an alcoholic disinfectant | - | - | 100 |
Participant places a sterile drape cover onto the benchtop in the BSC | - | - | 50 |
Participant disinfects the equipment to be used in the compounding prior to use or when transferring it into the BSC | 11 | 14 | 47 |
Participant disinfects his/her hands before changing the gloves | - | - | 100 |
Participant changes the gloves before starting the compounding | 100 | 100 | 100 |
Participant disinfects the septum of the vial | 100 | 100 | 100 |
Front glass of the BSC is kept in working position | - | - | 100 |
Participant opens sterile packages inside the BSC | - | - | 92 |
Participant does not touch the connecting part of the syringe or the needle | 100 | 100 | 97 |
Participant disinfects the septum of the vial before piercing it again | 63 (n = 19) | 20 (n = 14) | 13 (n = 14) |
Participant mixes the product by turning back and forth, not shaking | 97 | 97 | 94 |
No spatters | - | - | 69 |
Participant wipes possible spatters from the BSC immediately (if outside the drape cover) | - | - | 0 (n = 11) |
Participant cleans the BSC with an alcoholic disinfectant after compounding | - | - | 50 |
Participant leaves the BSC on maximum or half speed after finishing the compounding and cleaning | - | - | 83 |
Ward 1 | Plate | PR1 | PR2 | PR3 | MR1 | MR2 | MR3 | BSC1 | BSC2 | BSC3 |
Participant 1 | TSA | 24 | 11.4 | 24 | 42.4 | 14.1 | 0 | 0 | 0 | 0 |
SDA | 0 | 24.9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Participant 2 | TSA | 80 | 68.6 | 40 | 0 | 0 | 0 | 0 | 0 | 0 |
SDA | 0 | 34.3 | 80 | 0 | 0 | 0 | 0 | 0 | 0 | |
Participant 3 | TSA | 60 | 0 | 30 | 180 | 26.7 | 0 | 0 | 0 | 0 |
SDA | 0 | 0 | 0 | 90 | 0 | 0 | 0 | 0 | 0 | |
Participant 4 | TSA | 26.7 | 26.7 | 0 | 0 | 21.8 | 30 | 0 | 0 | 0 |
SDA | 26.7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Participant 5 | TSA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
SDA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Participant 6 | TSA | 186.7 | 48 | 40 | 64.5 | 20 | 0 | 0 | 0 | 0 |
SDA | 53.3 | 0 | 0 | 0 | 20 | 0 | 0 | 0 | 0 | |
Mean | TSA | 37 CFU/4 h | 22.25 CFU/4 h | 0 CFU/4 h | ||||||
SDA | 12.17 CFU/4 h | 6.11 CFU/4 h | 0 CFU/4 h | |||||||
Combined | 49.17 CFU/4 h | 28.36 CFU/4 h | 0 CFU/4 h | |||||||
Ward 2 | Plate | PR1 | PR2 | PR3 | MR1 | MR2 | MR3 | BSC1 | BSC2 | BSC3 |
Participant 7 | TSA | 0 | 0 | 72 | 0 | 30 | 0 | 0 | 0 | 0 |
SDA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Participant 8 | TSA | 0 | 0 | 13.3 | 30.9 | 17.1 | 0 | 0 | 0 | 0 |
SDA | 0 | 0 | 0 | 15.5 | 0 | 0 | 0 | 0 | 0 | |
Participant 9 | TSA | 0 | 0 | 0 | 72 | 0 | 0 | 0 | 0 | 0 |
SDA | 0 | 0 | 0 | 0 | 48 | 40 | 0 | 0 | 0 | |
Participant 10 | TSA | 0 | 30 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
SDA | 16 | 0 | 0 | 24 | 0 | 0 | 20 | 0 | 0 | |
Participant 11 | TSA | 45.7 * | 0 | 68.6 | 0 | 0 | 0 | 0 | 0 | 0 |
SDA | 11.4 * | 0 | 0 | 40 | 0 | 0 | 0 | 0 | 0 | |
Participant 12 | TSA | 34.3 | 48 | 96 | 0 | 0 | 68.6 | 21.8 | 0 | 0 |
SDA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Mean | TSA | 22.66 CFU/4 h | 12.15 CFU/4 h | 1.12 CFU/4 h | ||||||
SDA | 1.52 CFU/4 h | 9.30 CFU/4 h | 1.11 CFU/4 h | |||||||
Combined | 24.18 CFU/4 h | 21.45 CFU/4 h | 2.23 CFU/4 h |
Ward 1 | Plate | PR1 | PR2 | PR3 | MR1 | MR2 | MR3 | BSC1 | BSC2 | BSC3 |
Participant 1 | Right | 0 | 0 | 1 | 7 | 1 | 0 | 0 | 0 | 1 |
Left | 0 | 0 | 1 | 3 | 0 | 0 | 0 | 0 | 0 | |
Participant 2 | Right | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
Left | 1 | 3 | 0 | 0 | 0 | 1 | 7 | 0 | 1 | |
Participant 3 | Right | 2 | 3 | 2 | 16 | 2 | 0 | 0 | 5 | 0 |
Left | 8 | 1 | 6 | 12 | 1 | 1 | 0 | 2 | 0 | |
Participant 4 | Right | 0 | 0 | 1 | 1 | 0 | 3 | 2 | 0 | 0 |
Left | 1 | 2 | 2 | 3 | 0 | 2 | 0 | 0 | 0 | |
Participant 5 | Right | 1 | 0 | 4 | 4 | 0 | 4 | 3 | 0 | 2 |
Left | 1 | 1 | 23 | 13 | 0 | 8 | 5 | 1 | 0 | |
Participant 6 | Right | 1 | 0 | 0 | 0 | 1 | 5 | 0 | 2 | 0 |
Left | 2 | 1 | 2 | 5 | 3 | 1 | 0 | 2 | 0 | |
Mean | Right | 0.9 | 2.4 | 0.9 | ||||||
Left | 3.1 | 2.9 | 1.0 | |||||||
Ward 2 | Plate | PR1 | PR2 | PR3 | MR1 | MR2 | MR3 | BSC1 | BSC2 | BSC3 |
Participant 7 | Right | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Left | 0 | 1 | 3 | 0 | 1 | 0 | 1 | 0 | 1 | |
Participant 8 | Right | 0 | 0 | 4 | 13 | 0 | 3 | 1 | 0 | 0 |
Left | 0 | 0 | 1 | 0 | 2 | 2 | 0 | 2 | 0 | |
Participant 9 | Right | 1 | 0 | 0 | 1 | 3 | 2 | 0 | 0 | 3 |
Left | 1 | 0 | 1 | 0 | 1 | 4 | 0 | 0 | 1 | |
Participant 10 | Right | 0 | 0 | 0 | 6 | 9 | 4 | 1 | 1 | 2 |
Left | 0 | 1 | 1 | 6 | 10 | 0 | 2 | 0 | 0 | |
Participant 11 | Right | 2 * | 1 | 0 | 11 | 0 | 1 | 0 | 10 | 10 |
Left | 0 * | 3 | 6 | 2 | 0 | 0 | 0 | 8 | 24 | |
Participant 12 | Right | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Left | 4 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | |
Mean | Right | 0.6 | 2.9 | 1.6 | ||||||
Left | 1.3 | 1.7 | 2.2 |
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Virtanen, S.; Kapp, K.; Rautamo, M.; Schepel, L.; Lindén-Lahti, C.; Cruz, C.D.; Tammela, P. Compounding Parenteral Products in Pediatric Wards—Effect of Environment and Aseptic Technique on Product Sterility. Healthcare 2021, 9, 1025. https://doi.org/10.3390/healthcare9081025
Virtanen S, Kapp K, Rautamo M, Schepel L, Lindén-Lahti C, Cruz CD, Tammela P. Compounding Parenteral Products in Pediatric Wards—Effect of Environment and Aseptic Technique on Product Sterility. Healthcare. 2021; 9(8):1025. https://doi.org/10.3390/healthcare9081025
Chicago/Turabian StyleVirtanen, Sonja, Karmen Kapp, Maria Rautamo, Lotta Schepel, Carita Lindén-Lahti, Cristina D. Cruz, and Päivi Tammela. 2021. "Compounding Parenteral Products in Pediatric Wards—Effect of Environment and Aseptic Technique on Product Sterility" Healthcare 9, no. 8: 1025. https://doi.org/10.3390/healthcare9081025