THE INDUSTRY IS MOVING IN THE RIGHT DIRECTION
Until now, biopharma companies have responded to inconsistent valve and diaphragm reliability performance by adopting a strategy
of excessive preventative maintenance, but this strategy carries unacceptable cost and has limited effectiveness.
Today, the situation is changing, and the winning suppliers will be those who are able to demonstrate and guarantee the reliable
performance of their products. Customers increasingly want to see products rigorously rig-tested using test cycles that mimic
the full-scale plant, especially for valves and diaphragms installed onto crucial installations.
Barnoon sums it up:
"It would be good to have more testing that is indicative of performance. There's testing right now that examines critical
characteristics of a diaphragm, there's testing that gives you chemical compatibility, but some of the manufacturers are starting
to look at testing that is more predictive of performance over multiple cycles. It would be good if this were something the
whole industry could move toward."
To this end, the end-user community has rallied together to establish a common test cycle to be used by suppliers for reliability
testing. These requirements are now being absorbed into technical standards through partnerships with organizations such as
the American Society of Mechanical Engineering, BioProcessing Equipment (ASME BPE). This is simply following the lead of other
industries, such as nuclear, aerospace, and automotive, which have gone through similar transitions in the past.
It should be recognized that the necessary investment in time, skills, energy, and utility systems to carry out this testing
can be considerable, even if representative accelerated tests can be developed. The question is, who is going to pay?
The answer is that the costs of early and uncontrolled failure on full-scale plants are already being paid by the end user.
These costs are so huge that end-users are increasingly prepared to do business only with those suppliers that are able to
demonstrate reliability and can show the test data to prove it. In short, testing will become a cost of doing business in
the biopharmaceutical industry. This is not to say that end-users are unwilling to pay; it's only reasonable to expect to
pay a premium inline with an increase in performance.
Bayer's Amin states:
"Currently, we are paying much more in terms of failure that affects our process rather than paying more for a reliable diaphragm
backed up with solid test data. Not only Bayer, but every manufacturer in the industry because they also know the cost of
lost batches. The industry is more than willing to pay for reliability. When fully cycle tested diaphragms are available in
the marketplace, I'll be at the front of the queue."
Users, then, are willing to pay a premium for products that areproven to be more reliable. Users expect to pay more for product
longevity, reliability, and test data. They will increasingly be expecting to see these features and costs wrapped into their
commercial agreements with suppliers.
Trends in Soft Parts
Change, of course, is never easy, and there will be growing pains for both suppliers and customers as the industry moves through
this much needed transition. As always, with industry-wide change, there will be those organizations that recognize the opportunity
quickly and become the early movers to gain market share. There will then be the fast followers that realize that they risk
losing market share, which will quickly spur them into action. There are then the followers who will change only when industry
standards and expectations have changed. Lastly, there will be those that will not change: they will either have such a superior
product that they can ignore the new service features offered by their competitors or they have to exit the market.
Steve Jones is a director at the BioPhorum Operations Group, firstname.lastname@example.org