Analyze
Figure 5
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This phase examines the data gained during the previous experiments. Operators can perform the analysis for the first experiment
(i.e., monitoring the process under UV light) through close viewing of the recorded video. If personnel modify the mixing
process later, they can evaluate the improvements afterward using the same method. The video sometimes reveals minor details
that went unnoticed during the operation. The analysis of the second experiment (i.e., settling plates) can be performed either
by observing the plates under a microscope or, if the appropriate material was used, by a technique such as high-performance
liquid chromatography, gas chromatography, or ultrahigh-performance liquid chromatography for assay. In the latter case, the
plates should be rinsed thoroughly with a solvent, and samples should be prepared carefully. The third experiment (i.e., the
particle counter) generates data directly, and operators can analyze the digital recording on the counter.
Improve
Figure 6
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When the flaws in the process have been identified, the method for improving the process should be chosen. One method of improving
the process is to train the operators to improve their material-handling techniques. Operators can watch the video and review
the analysis data generated during the previous phase. Clear visual perception of the material is critical when handling an
active ingredient or hazardous chemical that cannot be seen with the naked eye. The operators should have proper safety equipment
while they perform critical processes.
An alternative is to improve the equipment design to reduce or eliminate spillage. Most often, a cross-functional team with
representatives from the equipment vendor is useful in developing conceptual designs. Once the design is complete, it can
be tested with simulation software from companies such as COMSOL (Stockholm) and AspenTech (Cambridge, MA), which will reveal
flaws. The airflow monitoring pattern developed during video analysis can be a helpful tool for simulation development (4,
5).
Controls
The final stage after implementation of the changes is to monitor the operation continuously for improvement. Minor improvement
is always possible. If possible, process changes should be recorded in the company's continuous-improvement program, which
will enable the effectiveness of the changes to be evaluated quarterly or semiannually.
Conclusion
Spillage and dusting is a major challenge in the biopharmaceutical industry when an operation involves micrometer-sized particles.
Through continuous improvement and techniques such as Six Sigma, the challenges can be associated with critical process points.
This approach enables personnel to pinpoint the problem and provide direction for solutions. The DMAIC model provides an excellent
directional approach for solving these problems.
Piyush Viradia is a process engineer at Genzyme, 1125 Pleasant View Tr., Ridgefield, NJ 07663, tel. 201.993.1577, piyush.viradia@genzyme.com
.
References
1. IBM, "Aligning Lean Six Sigma in Managing Process Development," white paper (IBM, Armonk, NY, August 2002).
2. IKA, Labor Pilot2000/4 mill, MHD module specifications,
http://www.ikausa.com/labmixersinline.htm, accessed Apr. 7, 2010.
3. Space Environment Technologies, "ISO 21348 Process for Determining Solar Irradiances Compliance,"
http://www.spacewx.com/ISO_solar_standard.html, accessed Apr. 7, 2010.
4. P. Jeffries, Chem. Eng. J. 24 (2), 36-41 (2005).
5. A. Agrawal, Chem. Eng. J. 24 (2), 42-49 (2005).
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