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Case Study | January 30, 1998

Validating and Testing a Fluid Bed System--Part 2

Source:
Don Rosendale,
V alidation Group Manager, V ector Corp.
Back to Part 1
Snags and Snafus
This installation presented sev eral challenges on v alidation and testing:
Pumping System
The solution was being batched using a <%=company %> flowmeter connected to a peristaltic pump. We were concerned about calibration for this
pump/meter combination because the pump was supposed to be installed at the lowest point in the piping sy stem, but in fact it had been installed at the
highest point, and because of its pulsing flow. As it turns out, we were able to measure deliv ery to +/- 1 percent. Another problem: Floor scales were being
calibrated around this new facility so sev eral scaling sy stems had to be freshly calibrated to obtain the necessary flowrate and totalizer data. The peristaltic
pump's hose blew on the last batch and had to be replaced, necessitating re-initiation of that test.
Personnel Availability
Training took place in segments, since not ev ery one was av ailable at any giv en time during the two weeks V ector was on site.
Data Handling
The sy stem uses a network LAN for communicating data to a central computer. Customer requests for re-configuration of this sy stem and additional
capabilities made our original test plans obsolete. Test plans had to be created and modified from the new configuration on the fly from specifications
generated only day s before. This resulted in some failed tests, misunderstandings, and general frustration as these tests needed to be done quickly due to
their production requirements.
Supervisory System
The superv isory sy stem prov iding the necessary batch reports had to be v alidated separately from the fluid bed sy stem as well as integrated with it. Since the
superv isor sy stem was in a separate part of the plant, we had to use walkie-talkies to confirm the accuracy of the superv isory station.
Other Obstacles
The customer's QA department had not had a chance to rev iew the documentation before conducting the tests. Two day s into the v alidation, we had to break
off and answer audit questions regarding the test plans. Also, deionized water for humidity control was not installed, and the humidifier sy stem was
ex tremely slow and had to be replaced by a "clean steam" unit. This unit was unav ailable during routine v alidation and had to be separately re-tested.
The Good New s
Factory testing the fluid bed using the prepared v alidation protocols reduced the number of problems we encountered. Calibration data on the equipment
was av ailable and current, so no re-calibrations were necessary . The room was presented in the same manner as it would be during regular processing. This
helped answer GMP questions, location, and operator training issues. The ex cellent condition of installation wiring and documentation (tagging, labels, etc.)
greatly assisted in identify ing and testing the indiv idual components and later troubleshooting.

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Conclusions
All problem issues were addressed to the customer's satisfaction, including their QA department. Because we performed a complete v alidation of the sy stem,
all problems encountered were caught before running actual product. This approach to fluid bed v alidation, while time-consuming and costly , prov ides
assurance that subsequent production runs on high-v alue material will proceed smoothly . In this instance the products to be run on the fluid bed cost, on a
per batch basis, almost as much as the entire cost of v alidation. Therefore processing of two successful batches more than compensates for the time, effort,
and cost of v alidating the fluid bed. By implementing v alidation procedures and structure protocols we can reduce warrantee costs by at least a third and
reduce startup times for installation of new fluid beds from six weeks to two. Thorough v alidation of process equipment prev ents damage to equipment and
loss of v aluable product, thereby sav ing manufacturers money .
For more information:
Don Rosendale, V alidation Group Manager,
Vector Corp.,
67 5 44th St., Marion, IA 52302.
Tel: 31 9-37 7 -8263, ex t. 322.

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