IBC: FOCUS ON STANDARDIZATION
At the IBC Single-Use Applications meeting, held in Boston on Jun. 6–9, 2011, I gave a talk entitled "Standardization of Single-Use...Pros,
Cons and Possibilities." The topic of standardization has appeared in many surveys as one of the top 10 needs for expanding
single-use implementation. However, there is little definition of what is meant by "standardization," which could be applied
to many areas.
One particular area of discussion is the interchangeability of sterile connectors to enable single-use unit systems with sterile
connectors from different suppliers to be linked. In preparing my talk, I also discovered that there is already an interchangeable
"standard sterile connector" recognized by industry. If you search for this phrase in Google Images, you'll find a photo of
a traditional two-way hosebarb fitting.
In my talk, I discussed how standardization of advanced sterile connectors must begin with the end-user's company. Different
systems' assemblers and integrators can generally source whatever advanced sterile connector is specified, so the first effort
must be for the end-user's company to decide what its preferred sterile connector will be. Since the introduction of the first
advanced sterile connector (Pall's Kleenpak), there are now five additional designs on the market from other suppliers, but
there is still no industry consensus on which design might become the "standard" of the future. Unlike the easily copied tri-clamp
style hygienic flange connector, which is commonly used in stainless-steel and some single-use systems, or the aforementioned
hosebarb fitting, many advanced single-use sterile connectors incorporate patented technology and designs. Users calling for
the standardization of sterile connectors have yet to address which design should dominate or why the patent-holder should
license their design to competitive suppliers. Once bioprocessers agree on a preferred design within their own facilities
or companies, once there is consensus on an industry-preferred design (such as happened with tri-clamp style connectors),
and once patents expire, options will appear to either "standardize" one of the original sterile connector designs. The alternative
is that users will prefer an innovative proprietary design that is superior to current designs, but has yet to be seen. Until
then, care has to be taken to avoid inhibiting innovation and it may not be realistic to expect meaningful voluntary standardization
from the bioprocessing supply industry.
One area where there is an industry initiative underway to standardize connectors, however, is for polymeric tri-clamp style
hygienic flange seal connectors. In response to stimulus letter from the Bio-Process Systems Alliance (BPSA), the American
Society of Mechanical Engineers bioprocessing equipment standards group (ASME–BPE) has formed a task force to review the requirements
for single-use polymeric tri-clamp style connectors and how the ASME–BPE Standard for stainless steel hygienic flange seal
connectors can be modified in response to accomodate their use. Unlike their stainless steel counterparts, single-use polymeric
tri-clamp connectors do not require cleanable finishes, crevice-free cleanable seals, or thermal resistance and mechanical
strength suitable for steaming in place. They also do not require tolerances that are readily achieved with stainless steel
on a lathe, but are difficult to achieve with plastic molding, thus incurring unnecessary mold costs. Expansion and relaxation
of the ASME–BPE standard to cover the specific requirements for single-use polymeric tri-clamp style connectors will be a
benefit to both suppliers and users.