What Makes a Good Single Use Process Component Vendor?

January 7, 2014
Holland Provides a Broad Range of Single Use Components for the Biopharmaceutical Industry

Holland Provides a Broad Range of Single Use Components for the Biopharmaceutical Industry

At Holland, we’ve been providing stainless steel process solutions for over 60 years. So when we started to see many of our pharmaceutical and biopharmaceutical customers switching to plastic disposables, it was a little scary. Instead of running from these alternatives, we have embraced them. Holland now offers a full portfolio of single use options including components like tubing and fittings, all the way to single use pumps, valves, and manifolds. As we entered this rapidly maturing market, we learned that the needs of our single use customers are not exactly the same as our stainless customers. This post will focus on what makes a good single use solutions provider.

As with stainless, success with single use systems requires a team effort from procurement, planning, supply chain management, and process engineering. While many times we find ourselves reacting to a customer who has a problem with reusable pump or valve failure, this just is not possible with our single use customers. Single use products have a “predictive failure”- they are discarded after each use.

In reusable systems, equipment availability can be controlled with through maintenance and engineering efforts. This isn’t the case with disposables. While some single use components are considered “stock” items, most do have shelf life limitations. This makes both manufacturers and distributors reluctant to keep an excess of inventory on the shelf.

Single use products like filling manifolds or custom bags generally have lead times in excess of 3 weeks. All single use systems much also be highly characterized and validated, there is no such thing as a simple drop in replacement.

For this reason, it is incumbent upon both the manufacturer, distributor, and end user to ensure responsible supply chain management and planning. When viewed in this light, single use system suppliers become operational partners. Activities such as equipment qualification, controlled document management (such as validation guides), and sterilization validation are generally handled by the vendor, not the end user.

Good single use vendors are able to help process engineers switch from reusable systems with which they are comfortable to newer single use systems. This not only means providing product knowledge and information, but also letting justifying to end users when the change makes good business sense, and also when it doesn’t.

As in stainless systems, good vendors should have extensive product and process knowledge. This helps us follow simple heuristics and shorts cuts when designing new systems. Simplifying design allows us to employ a “design once- use many” strategy. This allows for simplification of inventory management and fully leverage of the benefits of single use offerings. By following this strategy, we won’t have to reinvent the wheel, or better yet, requalify the wheel for each new process application.

Changes also tend to pose a bigger problem in single use systems than in reusables and need to be addressed differently. Stainless steel has been around for 100 years and hasn’t changed a whole lot. Silicone tubing resins change all the time. Whether process changes are requested by the user, suggested by the vendor, or imposed on both parties by regulators or OEM’s, well thought out quality, regulatory, and business decisions need to be made. Managing these changes facilitates continual internal improvement for both end users and vendors.

To conclude, the challenges and responsibilities of single use vendors have few parallels and many differences. It’s important for vendors to be proactive and responsibly lead, instead of reacting to customer needs by providing information and product knowledge. Vendors become operational partners and must work diligently to ensure successful single use deployment.

While this hopefully serves as a high level overview of things to look for in a good vendor, it’s also a shameless plug. At Holland, we understand the challenges facing the rapidly maturing single use market. Contact us today with any of your single use questions.