TITLE

Microbial contamination of syringes during preparation: The direct influence of environmental cleanliness and risk manipulations on end-product quality

AUTHOR(S)
Stucki, Cyril; Sautter, Anna-Maria; Favet, Jocelyne; Bonnabry, Pascal
PUB. DATE
November 2009
SOURCE
American Journal of Health-System Pharmacy;11/15/2009, Vol. 66 Issue 22, p2032
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Purpose. The direct influence of environmental cleanliness and risk manipulations on prepared syringes was evaluated. 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. 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). 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.
ACCESSION #
47609417

 

Related Articles

  • Post-injection endophthalmitis sparks review of compounding procedures. Goldberg, Roger A. // Ocular Surgery News;4/25/2012, Vol. 30 Issue 8, special section p6 

    The article focuses on appropriate procedures for the use and compounding of sterile medications following endophthalmitis outbreaks linked to bevacizumab injection. Information on the outbreak of this condition in Florida are provided including treatment with vitreous tap and injection and...

  • Striving to Improve Intravitreal Injections. Kent, Christopher // Review of Ophthalmology;Jan2013, Vol. 20 Issue 1, p14 

    The article focuses on new techniques developed in instruments used for injections while operating on eyes. A guarded injection device which protects the needle form exposure to contaminants and keeps syringes sterilized has been developed by team led by Dr. Alexander M. Eaton at Fort Myers and...

  • Using medium-fill simulation to establish a benchmark microbiological contamination rate for low-risk-level compounding. Trissel, Iawrence A.; Ogundele, Abayomi B.; Ingram, Delshalonda S.; Saenz, Christopher A.; Gentempo, Joseph A. // American Journal of Health-System Pharmacy;9/15/2003, Vol. 60 Issue 18, p1853 

    A benchmark contamination rate for prefilled syringe compounding was determined by using a medium-fill-simulation method. One thousand thirty-five 1-mL tuberculin syringes were aseptically filled with 0.9 mL of sterile soybean-casein digest medium and capped. These syringes were placed into...

  • ISO 9000. Riswadkar, A.V. // Professional Safety;Apr95, Vol. 40 Issue 4, p30 

    Focuses on the use of the International Standards Organization's ISO 9000 as a global standard for quality in international trade. Structure of standards; Universal acceptance of ISO 9000; Requirements and benefits of certification; Processes involved in the successful ISO 9000 registration;...

  • Companies profit with ISO 9000 registration.  // Long Island Business News (7/1993 to 5/2009);2/13/95, Vol. 42 Issue 7, p11 

    Reports on the increasing number of companies in the United States who are moving in the direction of International Standard Organization (ISO) 9000 registration for marketing reasons. Benefits of the ISO 9000 registration; Increased competitiveness in the global marketplace.

  • International Standards--A Growth Business.  // Environmental Engineering;Autumn97, Vol. 10 Issue 3, p36 

    Focuses on the development of an international standard in product quality, industrial practices, legal requirements and other related issues. Discussion of the harmonization program of the British Standards Institution; Practices of the International Standards Organization; Regulations imposed...

  • Risk Mitigation and Microbial Control and Monitoring of Cleanrooms. Ginsbury, Karen S. // Pharmaceutical Technology;May2013 Supplement, ps20 

    The article presents a control strategy for maintaining and monitoring the level of particulates in cleanroom. It discusses various aspects related to the revised of the U.S. Pharmacopeia (USP) on microbiological control and risk mitigation of cleanrooms. It further mentions that ISO 14644-1 and...

  • The Role of Syringe Filters in Harm Reduction Among Injection Drug Users. Caflisch, Carlo; Wang, Jen; Zbinden, Reinhard // American Journal of Public Health;Aug1999, Vol. 89 Issue 8, p1252 

    Objectives. Three filters were tested for in situ efficacy in reducing bacterial contamination associated with injection drug use. Methods. In a self-matched control design with blinded laboratory testing, injection drug users were asked to use 3 filters in random succession when loading their...

  • Studies on Dental Aerobiology: IV. Bacterial Contamination of Water Delivered by Dental Units. ABEL, L. CABOT; MILLER, ROBERT L.; MICIK, RUDOLPH E.; RYGE, GUNNAR // Journal of Dental Research;Nov1971, Vol. 50 Issue 6, p1567 

    Water sprays from a dental handpiece and air-water syringe were evaluated for bacterial content. Bacterial concentrations that far exceeded limits permissible for public water supplies were observed. A simple method for reducing bacterial contamination in water lines for dental equipment is...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics