| Autor: |
Johnson DH; Department of Biomedical Engineering, University of Alabama at Birmingham, 1530 3rd Avenue South, Birmingham, AL 35294, USA. dhj@uab.edu, Bidez MW, Delucas LJ |
| Jazyk: |
angličtina |
| Zdroj: |
Annals of biomedical engineering [Ann Biomed Eng] 2012 Apr; Vol. 40 (4), pp. 898-906. Date of Electronic Publication: 2011 Nov 09. |
| DOI: |
10.1007/s10439-011-0451-x |
| Abstrakt: |
Hazard analysis and risk assessment techniques are utilized within many private sector industries and government agencies, including the medical device and pharmaceutical industry, within a structured process to control human injuries and environmental and property damage. In the U.S. the Federal Drug Administration (FDA) requires a hazard analysis be performed on all medical devices. While there are biomedical engineering applications reported which deal with human hazards in clinical, patient care environment, no previous studies extend these traditional techniques to a university-based, research environment. This study applies a tiered approach to hazard analysis and risk assessment to a biomedical, university-based, research environment in the design of a high throughput platform that screens chemical excipients (additives) for their ability to increase protein solubility. Each design stage (conceptual, preliminary, system, and detailed) requires a unique hazard analysis technique based on available information. The analysis techniques applied here are evaluated for their use in a biomedical research environment where experiment accuracy is a primary concern. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
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