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Microbial contamination of syringes during preparation: the direct influence of environmental cleanliness and risk manipulations on end-product quality.
- Source :
-
American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists [Am J Health Syst Pharm] 2009 Nov 15; Vol. 66 (22), pp. 2032-6. - Publication Year :
- 2009
-
Abstract
- Purpose: The direct influence of environmental cleanliness and risk manipulations on prepared syringes was evaluated.<br />Methods: Media-fill testing was used to estimate potential microbial contamination. Syringes were prepared in three different environments using four different uncontrolled high-risk manipulations. The three environments included an International Organization for Standardization (ISO) class 5 horizontal laminar-airflow hood in an ISO class 6 cleanroom (in accordance with United States Pharmacopeia [USP] chapter 797), an ISO class 7 drug preparation area of an operating room, and an uncontrolled decentralized pharmacy in a ward. For each combination of environment and manipulation, 100 syringes were filled by a single operator. The four high-risk manipulations used included simple filling of syringes with trypticase soy broth, three-second contact by the ungloved fingers of the operator with the hub of the syringe, three-second contact between an object and the hub of the syringe, and exposure of the filled syringes to ambient air for 10 minutes.<br />Results: Of the 1500 syringes prepared in three different environments, none produced within the cleanroom contained microorganisms, 6% were contaminated in the operating room, and 16% were contaminated in the ward (p < 0.0001). Certain high-risk manipulations were associated with a significant increase in the contamination of the surrogate syringes, including exposure to nonsterile ambient air and nonsterile objects or fingers (p < 0.0001).<br />Conclusion: High contamination rates were measured when the hub of syringes touched nonsterile environmental surfaces and fingers, whereas the drawn-air manipulation was associated with a lower risk of contamination. Working within a properly operating unidirectional airflow primary engineering control in an ISO class 5 cleanroom in accordance with USP chapter 797 requirements was demonstrated to be the best way to avoid bacterial or fungal contamination of injectable drugs directly resulting in patient infections.
- Subjects :
- Drug Compounding methods
Drug Storage
Environment, Controlled
Equipment Contamination
Humans
Injections standards
Pharmacopoeias as Topic
Pharmacy Service, Hospital standards
Quality Control
United States
Drug Compounding standards
Drug Contamination prevention & control
Syringes microbiology
Subjects
Details
- Language :
- English
- ISSN :
- 1535-2900
- Volume :
- 66
- Issue :
- 22
- Database :
- MEDLINE
- Journal :
- American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
- Publication Type :
- Academic Journal
- Accession number :
- 19890087
- Full Text :
- https://doi.org/10.2146/ajhp070681