PHARMACEUTICAL PROCESSING | OCTOBER 2014 23 ■
■ SOLID DOSAGE
sive “training set” – has been around for about 20 years. Some
modified release polymers present false negatives with respect
to classic tablet hardness and its impact on friability. In this connection, materials scientists can provide the appropriate test for
a tablet made with “non-conventional” excipients.
How important is the after-sale service to maintaining test-
ing equipment in precise operating condition?
Dr. Gold: It is important to be able to count on stateside
availability of replacement and maintenance parts for testing
equipment. There are examples of testing equipment manufacturers who have multiple warehouses in strategic areas
that mitigate any downtime associated with needed repair.
On the other hand, there are examples where parts are only
sourced outside the United States. This adds at least two
days on to critical / rate-limiting test equipment that in some
cases may not have a spare at the manufacturing site.
Dr. van den Dries: The after-sale service to maintain testing equipment is essential. Much of the equipment is quite
sensitive and complex, so it must be calibrated regularly to
avoid technical issues. Training of the workforce is also essential when implementing new technologies, as conventional
technologies like HPLC are well-established and people know
what to do when there are issues with it, and ultimately the
same standards are expected for new analytical technologies.
Dr. Kettler: Failure to provide after the sale support
should eliminate a vendor from consideration for any future
instrument RFP/RFQ opportunities.
What do you see as the future for tablet testing equipment?
Dr. Gold: We see the coordination of test equipment with
tablet press manufacturers. Some tablet manufacturers already utilize online test equipment (hardness/thickness/
weight) and offer this option as a package to their customers.
Dr. Kettler: Fast, accurate and inexpensive is what everybody wants and every instrument manufacturer desires to
provide. Unfortunately, for most test methods a purchaser
only gets to pick two of those attributes. The future will
likely involve companies endeavoring to deliver all three
Dr. van den Dries: I expect more and more implementation of in-process testing for the future of tablet testing
equipment. Regulatory authorities are also putting increased
emphasis on this; for example, the FDA has withdrawn guidance “Powder Blends and Finished Dosage Units--Stratified
In-Process Dosage Unit Sampling and Assessment” as it is
reconsidering its position regarding in-process testing leading to increased quality assurance. I foresee this process
continuing to grow and being implemented in the industry,
and believe the number of tests should increase. ■
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