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Steam Sterilization in Autoclaves
| Content Provider | Scilit |
|---|---|
| Author | DeSantis, Phil |
| Copyright Year | 2021 |
| Description | The validation of steam sterilization in autoclaves constitutes perhaps the most-studied validation problem faced by the pharmaceutical industry. Indeed, it was failure to sterilize certain large-volume parenteral solutions that resulted in several patient deaths in the early 1970s, prompting the United States Food and Drug Administration (FDA) to call for the “validation” of sterilization processes. Because of this, autoclave sterilization was the first validation program undertaken by the industry. This requirement soon spread to other pharmaceutical processes. Sterilization in autoclaves remains a universal issue in nearly all facilities where sterile operations occur and continues to be of paramount concern to both the industry and the various international drug regulatory agencies. Book Name: Handbook of Validation in Pharmaceutical Processes |
| Related Links | https://api.taylorfrancis.com/content/chapters/edit/download?identifierName=doi&identifierValue=10.1201/9781003163138-13&type=chapterpdf |
| Ending Page | 230 |
| Page Count | 14 |
| Starting Page | 217 |
| DOI | 10.1201/9781003163138-13 |
| Language | English |
| Publisher | Informa UK Limited |
| Publisher Date | 2021-08-30 |
| Access Restriction | Open |
| Subject Keyword | Book Name: Handbook of Validation in Pharmaceutical Processes Sterilization in Autoclaves Steam Undertaken Constitutes Fda Administration Paramount |
| Content Type | Text |
| Resource Type | Chapter |
