Q&A with
Steve Sirabian, executive vice-president of Glatt Air Techniques
Steve Sirabian
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PharmTech:
What is the biggest industry challenge you're now facing?
Sirabian:
One challenge that has received relatively little publicity is the difficulty for innovations to gain traction. Traditionally,
innovation has been a hallmark of the pharmaceutical industry, but pressures such as plant closings, generic competition,
and reduced pipelines have made it difficult to introduce new technologies for pharmaceutical processing. Innovations often
are met with genuine interest at first, but hurdles later arise that frequently result in the somewhat reluctant abandonment
of the new concept.
The difficulties begin with limited research budgets and reduced staffs, but the problems go deeper. The inherent risk of
anything new means that it is difficult if not impossible to predict the return on investment (ROI) precisely. In fact, the
more innovation attempted, the greater the number of failures, and a company must be willing to accept that failure rate.
The industry once had the margins to absorb failures, but the current economic environment discourages such an approach.
Regulatory concerns play an equal role in suppressing innovation. One of the first questions asked about a new technology
is how many validated installations are currently in operation.
In the end, the only realistic opportunity for new technologies seems to lie with new drugs. The time and cost of most manufacturing
changes preclude any consideration of new processes from a practical perspective. But even here, the difficulty in forecasting
the ROI may trump the processing benefits available.
PharmTech:
Do you see a new industry trend emerging?
Sirabian:
More and more projects are executed using high-level washing in place (WIP) with full cleaning in place (CIP) reserved for
only the most demanding applications. CIP entails fully automated cleaning, but WIP cleans at a level greater than 90% and
then relies on a manual cleaning phase. On a different note, automated machine-level controls have long been a manufacturing
standard, but now I see a move toward networked applications and central servers with local slave controls.
