Project: Biopharmaceutical filtration automation (January 24, 2006)


January 24, 2006

Project Status Summary:
1. Control software development code complete 100%
2. HMI software code complete 100%
3. HMI external application configuration 100%
4. MF beta testing 100%
5. UF beta testing 100%

Factory Acceptance Testing
We started the factory acceptance test (FAT) this week at the skid vendor’s shop. The first goal of the testing is to prove communication between the software and control devices, which is generally documented with a loop check qualification. We began this task on Wednesday and completed it over the weekend. As mentioned previously, this is an important task that should not be overlooked in planning for an FAT, especially when the software and the instrumentation are supplied by different vendors, as was the case in our project. With the loop checks complete, more functional testing of the skid will continue this week. The functional testing is an engineering exercise to prove that the equipment supplied does in fact meet the design requirements and allows the client to accept the equipment as built. The difficult part of this analysis, however, is replicating process conditions at the vendor’s shop, which usually has limited utilities for use. For example, during this particular FAT, clean steam is not available for steam in place operations, so any testing of this functionality will be with simulated process variables.

After the point-to-point verification, we then test the hard-wired alarms and safety interlocks. It is important to first prove that safety interlocks are in place and functional before any further testing. After the safety tests, we will proceed to loop tuning and then the more integrated process testing. The equipment modules will be run individually for both normal and abnormal conditions (such as hold and abort) and also sequenced together in mock recipes.

Concurrent with our testing, the client’s process team will also be performing physical verifications and document reviews. Their tests will include a P&ID walk down, surface finish analysis, spray ball coverage tests on the vessels, slope verification, panel inspection and turnover package document review.

All of the tests performed are documented in a cGMP manner. We provided the FAT testing protocols for this project, which included the framework for our point-to-point test, alarm tests, and functional verifications. The documents are written with a more free form approach then a validation protocol such as an operational qualification. In FAT documents, the tests required and results are documented, but the instructions are less regimented then pre-approved protocols. The experienced process and automation engineer will need to determine the best method for each test, depending on available utilities and operating conditions. They will also need to determine whether results meet expected design criteria with or without equipment modifications. The completed FAT documents will become the basis of further testing during commissioning at the client site.

What's Next?
The factory acceptance test at the equipment vendor’s shop will continue this week.

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