Project: Biopharmaceutical filtration automation-10/27/05


October 27, 2005

Project Status Summary:
1. MF (micro-filtration) software design 100%
2. MF software code complete 100%
3. UF (ultra-filtration) software design 100%
4. UF software code complete 95%
5. HMI software code complete 60%

Though we are making good progress in all areas of the project, with three of the phases complete, there still remains more work with the UF equipment modules. The customer has requested changes that require two additional CIP pressure-hold equipment modules for the TFF (tangential flow) skids. These are relatively simple equipment modules.

The HMI is set up and we now have a complete MF system with application software, process simulation, and graphic displays. We have not begun MF skid development testing, but project personnel continue moving forward to reach code completion for the project. The recent change in the design freeze (from October 15 to October 26) will move everything out another two weeks, including testing.

The simulation is relatively simple to write for this sort of process. See the August 9, 2005, entry for a discussion of how we perform the process simulation. What I find interesting about this custom simulation application is the short time required to develop the application. We have resources that are very capable at writing custom applications in VB6, VB.Net, ASP.Net, and XML/XSLT. The applications we write for our own internal purposes differ greatly from the applications we write for our customers. Any application that gets delivered to a customer site is developed against GAMP (good automated manufacturing practice; www/ ) guidelines. We always assume that customer-delivered applications must be bullet-proof and we work very hard to make them so. However, we don't code to the same standards for applications and tools developed for internal use only. Quick turnaround is normally a high priority for such tools in order to meet project schedule objectives. Nonetheless, these internally used applications still function as desired and help make project development and execution much more efficient than if we did not have such tools. Also, tools developed for internal purposes often become the seeds for customer-delivered applications that receive the full scrutiny and quality control outlined by GAMP. Our simulation application is one such tool.

What's Next?
We are coding the final UF equipment modules including and the UF graphic displays. These will likely extend beyond this week and be completed sometime next week. Of course, there may be a few more change requests from the customer this week. Next week we will likely be one week away from code completion and development testing.

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