Disposable Technologies Implementation: Understanding and Managing Risks - In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to ma
As disposable technologies supplant stainless steel in our biomanufacturing facilities, there are some important implications
over and above the design and cost issues. The key difference is that as we move to disposable technologies, we become more
dependent on suppliers. The more customized and unique the product, the more dependent we are. One might argue that this situation
is no different from that of sterilizing filters, but this ignores the differences in the maturity of the technologies and
the extent of their usage within manufacturing. With sterile filters, we are dealing with a mature technology and established
suppliers who have been working with users for more than 20 years, all of which has led to the development of procurement
strategies that minimize dependencies and establish a robust supply chain. In contrast, in the disposable technologies arena
we have relatively new technologies that are making significant inroads into manufacturing, replacing large swathes of reusable
equipment. The key features of the current disposable market are:
Miriam Monge
a large number of suppliers offering a wide range of technologies
rapid and changing development of technologies
no clear market leaders with offerings in all areas of disposable technologies
no standardization across the range of products between suppliers.
Table 1. Risk management for disposables implementation
As a result, the challenges we face as an industry are first to understand the risks, then to critically evaluate them and
develop coherent risk mitigation strategies. At Biopharm Services, through years working on a variety of projects we have
developed a formal approach to risk identification and management (Table 1). This article focuses primarily on supply chain
issues, because these concerns are often ignored at the beginning of a project. It is important to take supply chain issues
into account early, however, because decisions made in the engineering phase of a project can have major impact on the facility's
future operations. Some common examples of bad practice include:
Specifying a technology from a specific supplier and writing that into all the specifications and validation documentation,
which makes future change difficult.
Not developing design practices that minimize the number of unique items and not basing designs on common components. This
leads to a lot of stock items and causes problems in supply, warehousing, and cost management.
Not evaluating the suppliers of the disposable technologies on the basis of their ability to provide long-term service, support,
and quality operations for the consumables.
This list is not exhaustive; it is intended to illustrate the need for a more integrated approach between engineering, procurement,
and operations, focusing on both hardware and the consumables. We would argue that this is vital for new investments integrating
disposables.
Vice President of marketing and disposables implementation at Biopharm Services. She is also the European chair of ISPE's Community of Practice for Disposable Technologies.
Articles by Miriam Monge
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