CHALLENGES AND OPPORTUNITIES
When we discussed the challenges and opportunities posed by disposable technologies, we asked a number of questions. Do disposables really change the way end users look at and manage operations? Do disposables technologies change the way they view and operate the factory? How can the opportunities be maximized, and the downsides be minimized?Challenges. From these conversations, several key challenges emerged.
Quality and reliability. By moving to disposables, the end user is effectively outsourcing a major part of manufacturing and quality management. As a result, the user must work very closely with the supplier to ensure that robust quality throughout the manufacturing process is maintained.
Supply chain. Supply chain risk is a common sourse of complaints related to dual sourcing and consistency of supply. One user commented that his (her) company's zero change policy requires careful planning. "We ask our disposable suppliers contractually for a guarantee of supply without change for a 5–10 year period," he (she) said. Such a policy means that the user has to consider the supply chain in most minute detail in terms of component and film suppliers and ensure that all the necessary contracts are in place.
Ergonomics. One user noted the operator's role in terms of handling of large-scale containers and the manipulation of tubing sets. "When working with disposables, there is a much greater dependence on the operators themselves. If they make a manipulation error, this could contaminate the whole process," he said. "We work with our suppliers in designing disposable systems that are as intuitive as possible, are idiot-proof, and so minimize the risk of operator error."
Opportunities. The opportunities presented by single-use technologies for manufacturing tend to relate to flexibility of operation, ease of product changeover, and the removal of wasted activities in terms of preparation and cleaning. "The great opportunity with disposables is that we can spend more time concentrating on manufacturing steps, the productive steps, and get rid of preparation work," said one interviewee. Users also see significant benefit from disposables when applied to process development, where fast turnaround in pilot and clinical supply facilities are extremely important.