« MANUFACTURING
Figure 5. Diff erence in population tail examination between a regular t-test and TOST.
Figure 6. Equivalence test results.
TOSTs may be used to evaluate the manufacturing process residual removal time for 2 cleaning validation runs or cleaning runs for 2 products using the same ECP. The swab tests’ TOC results for 2 data sets may be analyzed using Minitab software. The prerequisite for this kind of test is an equivalent sample size for both populations and normality of both populations. Provided these prerequisites are met, Figure 6 shows the outcome of this analysis for 2 products.
In the case of a cleaning evaluation (as seen in Figure 6), this statistical approach has been applied to determine the relative cleanability of 2 products.
The TOST compares 2 group means and their confi dence intervals by comparing them to a predefi ned equivalence limit (90% in
One Detection Technology. Three Applications. One Automated Platform.
— Automated Microbial Enumeration and Reporting
— Non-Destructive Test Uses No Reagents — Positive Results in Hours — Single or Concurrent Testing
The Growth DirectTM System revolutionizes microbial testing.
By providing a single technology to perform all key microbial quality control tests, the Growth DirectTM System automates and accelerates testing with positive results in hours and final CFU counts in about half the time of traditional methods, eliminating error-prone manual steps and saving labor.
To learn more about automating your microbial QC lab, visit
www.rapidmicrobio.com
www.americanpharmaceuticalreview.com |
| 31
»
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76