User Viewpoints on Disposables Implementation - What end users think about single-use systems. - BioPharm International


User Viewpoints on Disposables Implementation
What end users think about single-use systems.

BioPharm International
Volume 22, Issue 6


The preceding section on challenges and opportunities leads us to the evaluation process. All users have to evaluate new technologies, and disposables are no different. So what are the specific considerations? As expected, this is not a simple process and many factors must be considered. It is also important to develop a close collaboration with the supplier during the evaluation process.

Quality. The goal is to to ensure a supply of material with totally reproducible, consistent quality. How can this be achieved? End users indicated that there is still a way to go before such reproducibility is achieved. One end user indicated that during audits, his team looks carefully at the training programs put in place for the staff that manufacture the disposables systems. The level of staff turnover is also noted. "The manufacturing and assembly of disposable systems is rarely highly automated, so consistent quality can only be obtained by highly experienced manufacturing operators at the disposables manufacturing end," he (she) also explained. Of course, quality controls, over incoming raw materials and in-process, and on finished products plays an important role in ensuring reproducible quality.

Economic evaluation. Are there savings to be had at the time of implementation and over the whole product lifecycle? A business case and comparison with existing systems typically will be made. Many companies assess the total cost of ownership, and some use net present value models that integrate costs from each process step. According to one user, when looking at costs, "we integrate waste costs but we don't integrate the relative waste costs for traditional manufacturing technologies." In this instance, although the user is evaluating the increase in the solid waste costs of disposables, they do not evaluate the reductions seen in liquid wastes when moving from disposables.

Technology assessment. What is the level of maturity of the technology and the potential of risk to product?

Supply chain. As discussed above, companies place enormous emphasis on the robustness of the disposables supply chain. One interviewee from a major vaccine manufacturing company reinforced this point. "We consider [that] we are taking considerable risk [when] outsourcing many activities for our manufacturing requirements that we would have previously carried out internally," he said. As a result, his team asks many questions, such as: Is this an experienced mature supplier who has been supplying disposable technologies to the market for several years, or a total newcomer? Is there an alternative supplier for a given technology? "Certainly, our aim is to have dual sourcing for all our disposable technologies," he continues. "For existing applications, this is not always the case, because validating a second supplier represents a lot of work, so the resources need to be made available to carry out the necessary validation work." If there is only one supplier of a technology, then the end user clearly needs to carry out a very detailed supply chain evaluation.

As with any supplier, there must be regular audits and controls, and strong relationships must be built up to create trust. In terms of risk, the fact that there has been considerable consolidation among the filter and bag suppliers limits choice. Ideally, for every technology there would be the option to work with material from an alternative vendor, but that may not be possible.

Another interviewee from a major monoclonal antibody manufacturing company explained increased supply chain risk involved in disposables and how his company handled it. "In contrast to traditional reusable systems, where we have full control in terms of ongoing maintenance and so on, with disposables we are changing the scenario and have far less control," he (she) stated. "We have developed a full deviation and investigational methodology for identified defects in the disposables supply chain as this could potentially affect a large number of our products."

Evaluation process. The evaluation process typically involves a feasibility study, testing, and comparison to the traditional set-up. Depending on the complexity of the technology, the evaluation can last from a few months or up to two years. Generally, the technology will initially be implemented at pilot-scale, occasionally with the need to work with the supplier to fine-tune certain technology features and to ensure the robustness of the supplier's manufacturing, quality, and supply chain for the given technology.

There were several common issues that were experienced during this evaluation process.

First, end users often have technical questions relating to specific features of the technology (such as the agitator not working correctly, or difficulty with the aeration systems, filters, and other systems).

End users also often have questions about validation, and validation inevitably takes longer than anticipated. Users are often told that validating disposable systems is simpler than validating traditional systems, but this is not the experience of many of the end users we talked to. "The different studies that we need to carry out in terms of chemical resistance and interaction studies often take considerably longer than the equivalent studies required for traditional systems," commented one.

So what are the important criteria that must be met before any disposable technology can be adopted? They are performance, cost, and supply chain security.

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