A risk-management approach to cleaning-assay validation
The authors evaluate the effect of roughness average, material of construction, acceptance limit, molecule properties, and method variability on the observed recovery of a compound during cleaning validation. The authors also recommend a strategy for classifying similar nonstainless-steel surfaces i...
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| Veröffentlicht in: | Pharmaceutical Technology 2010-06, Vol.34 (6), p.48 |
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| creator | Pack, Brian W Hofer, Jeffrey D |
| description | The authors evaluate the effect of roughness average, material of construction, acceptance limit, molecule properties, and method variability on the observed recovery of a compound during cleaning validation. The authors also recommend a strategy for classifying similar nonstainless-steel surfaces into three groups based upon the analytical recovery that was observed in this study. The strategy includes a way of classifying new or uncommon surfaces into the groups. The authors believe that their approach improves efficiency and compliance during the swabmethod validation of product-contact surfaces. [PUBLICATION ABSTRACT] |
| format | Magazinearticle |
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The authors also recommend a strategy for classifying similar nonstainless-steel surfaces into three groups based upon the analytical recovery that was observed in this study. The strategy includes a way of classifying new or uncommon surfaces into the groups. The authors believe that their approach improves efficiency and compliance during the swabmethod validation of product-contact surfaces. 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The authors believe that their approach improves efficiency and compliance during the swabmethod validation of product-contact surfaces. 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| fulltext | fulltext |
| identifier | ISSN: 1543-2521 |
| ispartof | Pharmaceutical Technology, 2010-06, Vol.34 (6), p.48 |
| issn | 1543-2521 2150-7376 |
| language | eng |
| recordid | cdi_proquest_reports_610484112 |
| source | Alma/SFX Local Collection; EBSCOhost Business Source Complete |
| subjects | Aluminum Cleaning Clinical trials Construction Design of experiments Laws, regulations and rules Manufacturing Methods Pharmaceutical industry Product safety R&D Research & development Risk management Safety and security measures Stainless steel |
| title | A risk-management approach to cleaning-assay validation |
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