« MANUFACTURING
Figure 7, TOC results from 0 to 1 ppm were coded as 1 and results 1.1 to 100 ppm were coded as 2. The Minitab summary shown in Figure 7 illustrates that 2 populations are similar with 0.9103 (91.03%) signifi cance, thus proving their equivalence from 0 to 1 ppm, which was appropriate for examined ECP.
Stage 3: ECP Continued Process Verifi cation
The last and the longest stage of validation is Stage 3, which encompasses validation maintenance or in other words verifi cation that qualifi ed cleaning process continues to perform consistently. It is also called continued verifi cation process or CPV. Obviously, any changes to the process made since an initial qualifi cation should be evaluated to assess the impact of each individual change, as well as a cumulative impact of all changes. However, it is also important to evaluate not only changes but also to establish meaningful verifi cation program which would collect, evaluate, and trend data from each cleaning as well as conduct periodic cleaning verifi cations to assure that data attained during an original qualifi cation study are representative of the cleaning process performed.
Typically one should see process capability improve as manufacturing operation groups should become more profi cient in performing qualifi ed ECP. Figure 8 illustrates 3 years’ worth of continued verifi cation studies.
As shown in Figure 8, process capability indices of ECP improved from Ppk = 1.21 in Year 1 to Ppk = 2.17 in Year 2 and fi nally to Ppk = 2.43 in Year 3. One should notice that non-normal process capability analyses were used in these examples since the data sets were found to be non-normal.
It also should be noted that the goal of CPV should not only be confi rmation of qualifi ed cleaning methods but more important optimizations of ECP through learning and knowledge management. Because the cleaning of equipment is a critical offi cial process, it should be treated as such and therefore be validated, in the same way, as a manufacturing process would be.
MONITORING & TRACEABILITY of Temperatures and Other Physical Parameters
Certified Quality & Savings • Compliance with ISO EN 17025 and 15189 • 21 CFR 11 compliant software
Peace-of-Mind • 360-degree projected visual alarms • 24/7 real-time monitoring
Confidence During Transportation • Temperature and humidity traceability on-the-go
3,000+ Installations Worldwide
For more information, please visit:
www.bioMerieux-USA.com
www.americanpharmaceuticalreview.com | | 33 Conclusion
In conclusion, it is evident that a Process Validation lifecycle approach with its use of statistics is applicable to ECP validation. The risk and knowledge management methodology help us understand our
process (eg, ECP), the products of the processes (eg, a clean surface), our variables, and ultimately gives us confi dence during commercial production. Finally, utilization of statistics and statistical process controls are essential to eff ective and effi cient ECP post-performance qualifi cation monitoring
15+ YEARS EXPERIENCE IN ENVIRONMENTAL MONITORING
»
NEW
© 2015 BIOMÉRIEUX, INC. • BIOMÉRIEUX, THE BLUE LOGO AND LABGUARD 3D ARE USED PENDING AND/OR REGISTERED TRADEMARKS BELONGING TO BIOMÉRIEUX SA OR ONE OF ITS SUBSIDIARIES. • PSN-020-15
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