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The author discusses issues related to the supply of soft parts in the biopharma industry.
The biopharmaceutical industry has for a long time suffered inconsistent reliability performance of valves and diaphragms. The cost of a single batch failure can run into the millions of dollars while unplanned production stoppage and contamination investigations consume vast amounts of resources. One cause can be poor maintenance practices by the user, but as lessons are learned and practices improved, the spotlight is shifted. End users increasingly expect valve and diaphragms to deliver more consistent reliability performance through better product design, reliability testing, and improved change control. To enable this much needed transition, the time is right for the bio/pharmaceutical industry and valve and diaphragm suppliers to change the way they do business with each other.
In the past, it has been impossible to predict the life of a diaphragm until tested in the user's full-size commercial system. Although expensive and risky, this has also meant that suppliers are often distanced from the end user's real-world application and reliability experiences. Meanwhile, replacement parts are often supplied through distributors, further distancing suppliers from end-user's performance issues.
Case Study, Bayer HealthCare, San Francisco
Divakar Amin, engineering manager, final product manufacturing at Bayer HealthCare, described the implications of inconsistent diaphragm valve performace to the BioPhorum Operations Group:
"I have experienced two recent incidents involving valve failure during the fill-finish process, causing leakage into a final processing operation. The cost of the lost batch each time was measured in millions of dollars. When we opened each valve up, we found that the diaphragm material had deformed because the material was not suitable for the thermal cycling of the valve.
"We need to ensure that valve manufacturers match the process application to the capabilities of their products. Bulk tanks are exposed to high temperatures during sterilization, peaking at 130 °C. Valve manufacturers tell us that their diaphragm material can withstand 150 °C, but what they don't tell us is how many thermal cycles their material can withstand, especially if the cycle includes low temperature processing. If the polymer is not tested against the full thermal cycle, we have no level of confidence that it's not going to fail and leak.
"It's very important that suppliers perform the reliability testing in the lab and tell us how many thermal cycles the diaphragms will sustain. Without this information I'm left having to change-out my diaphragms every three months because I simply cannot risk losing another batch."
Barak Barnoon, director of process engineering and analytics at Pfizer, raised another example of inconsistent diaphragm valve performance in real-world applications to the BioPhorum Operations Group:
"What is missing currently, is control on their part of their suppliers and their diaphragm raw materials. We have seen impaired performance due both to changes in their sourcing and also in the manufacturing processes of their diaphragm suppliers. There's a big opportunity to increase the level of control and good manufacturing practices."
Divakar cites a further example of inadequate change control:
"If very small changes are made to the diaphragm material, then they can have a big impact on performance. We have experienced a situation where an autoclave valve was replaced with an 'identical' product. Subsequently, the heat-up time of the autoclave went out of its validated range. After extensive investigations we discovered a very minor, undisclosed change to the valve that impacted the process."
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.