Potential for airborne contamination in turbulent- and unidirectional-airflow compounding aseptic isolators.
PURPOSE: The ability of turbulent- and unidirectional-airflow compounding aseptic isolators (CAIs) to control airborne contamination during aseptic compounding of compounded sterile preparations (CSPs) was studied. METHODS: A three-phase challenge of the comparative airborne-contamination management...
| Publicado en: | American Journal of Health-System Pharmacy Vol. 64; no. 6; pp. 622 - 632 |
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| Autores principales: | , , |
| Formato: | glossary pictorial research tables/charts Journal Article |
| Publicado: |
Oxford University Press / USA
3/15/2007
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=106108146&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 106108146 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10792082 1X3 jtl: American Journal of Health-System Pharmacy issn: 10792082 maglogo: N pubinfo: dt: 3/15/2007 vid: 64 iid: 6 pid: 622 pub: Oxford University Press / USA artinfo: ui: 106108146 2009542299 10.2146/ajhp060067 NLM17353571 106108146 ppf: 622 ppct: 10 formats: fmt: @attributes: type: P tig: atl: Potential for airborne contamination in turbulent- and unidirectional-airflow compounding aseptic isolators. aug: au: Peters GF McKeon MR Weiss WT affil: Lab Safety Corporation, Cumberland, WI. sug: subj: Asepsis Methods Drug Compounding Methods Drug Compounding Standards Drug Contamination Prevention and Control Air Pollution, Indoor Asepsis Equipment and Supplies Comparative Studies Drug Compounding Equipment and Supplies Environment, Controlled Quality Control (Technology) United States Human ab: PURPOSE: The ability of turbulent- and unidirectional-airflow compounding aseptic isolators (CAIs) to control airborne contamination during aseptic compounding of compounded sterile preparations (CSPs) was studied. METHODS: A three-phase challenge of the comparative airborne-contamination management capabilities of five CAIs was conducted using augmented, industry-standard visual tracer and discrete particle counting methods. In phase 1, a visual smoke tracer was used to conduct a standardized, comparative challenge. In phase 2, CAI operational contamination-control capabilities were measured in accordance with the International Organization for Standardization (ISO) class 5 air cleanliness conditions using a standardized CSP process qualification procedure. Alcohol drying times were also compared. In phase 3, the gross contamination clearance interval required to achieve the ISO class 5 condition after a gross contamination event was measured for each CAI. RESULTS: All four unidirectional-airflow CAIs met ISO class 5 cleanliness requirements throughout all testing phases and areas of the work zone and demonstrated alcohol drying times of 16 seconds or less. The turbulent-airflow CAI tested failed to achieve the ISO class 5 operating condition at any time during the testing and required alcohol drying times of six minutes. The unidirectional-airflow CAIs tested met the laminar-airflow workstation-equivalency requirements of chapter 797 of the United States Pharmacopeia, pharmaceutical aseptic processing standards, the industry-standard definition of a closed isolator, and the rigorous demands of pharmacy and nursing sterile compounding. CONCLUSION: The performance of four unidirectional-flow CAIs supports their use in pharmacy and nursing CSP operations, whereas the performance of one turbulent-flow CAI does not. pubtype: Academic Journal doctype: glossary pictorial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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