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The cleaning validation process is a documented evidence process undertaken for <br /> <br /> cleaning procedure of a machine that isused for production process. Product <br /> <br /> manufacured in company W are solid product. The worst case method is used by <br /> &l...
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| Format: | Theses |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/31653 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | The cleaning validation process is a documented evidence process undertaken for <br />
<br />
cleaning procedure of a machine that isused for production process. Product <br />
<br />
manufacured in company W are solid product. The worst case method is used by <br />
<br />
clasifying some of the main machine used in production process against solid <br />
<br />
manufactured products. Assessmeny of selected product for cleaning validation <br />
<br />
process based on minimum daily dose, toxicity, solubility and degree of dificulty <br />
<br />
in the cleaning process. High value products will be used as the basis of testing <br />
<br />
the cleaning validation process. Acceptance criteria 10 ppm and 1/1000 Minimum <br />
<br />
Daily Dose compared. The selected acceptance criteriais the smallest between the <br />
<br />
10 ppm evaluation method and 1/1000 Minimum Daily Dose. The Duration of <br />
<br />
potable water use, the use of purified water and the volume of the cleaning <br />
<br />
solution is defined as the parameter of the cleaning procedure for production <br />
<br />
machine <br />
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