New toolkit to accelerate single-use design and specification
The single-use user requirements toolkit is now live and available for free download on the BioPhorum website The toolkit streamlines the design and specification process between end user and supplier, ensuring both parties speak the same language, when capturing requirements in a single suite of documents. Enabling suppliers to service the needs of end user while aligning to the requirements of the ASTM E3051 standard.
The toolkit consisting of three templates, supporting documents, presentations and videos, is the culmination of two years’ work of representatives from over 40 member companies. It is a significant body of work, that if used industry-wide will have a significant impact on the growing single-use technology market.
“We found [the toolkit] incredibly helpful with the organization of all the requirements necessary to design and implement the single-use system,” explains Daniele Werner, Single-Use Engineer, Merck & co, who used the system to set up a project that needed 25 new single-use components. Allowing them to communicate their requirements to the suppliers in such a way that all the systems were built right the first time.
Simon Himsworth, BioPhorum facilitator, believes that “the real benefit of the toolkit is the way it creates a common language between the end-user and supplier. This in turn will force thinking around single-use requirements at an early stage and keep all documentation in one place.”
Suppliers are also benefiting from the implementation of these templates. “Across the board, the experience from our Application Engineering team has been overwhelmingly positive,” said Christian Julien, Meissner Filtration Products. “It captures the essential information for single use implementation and more importantly this is captured in one document. The toolkit gives us a great opportunity to streamline the process.”
The streamlining of information gathering is critical as the single-use systems become more complex. By following the templates within the toolkit, the requirements of the end-user can be validated at the outset by the supplier. As this increases the efficiency of the design and specification process it in turn leads to benefits for all involved.
Three templates are available to download as a pack: the single-use user requirement template enables the end user to communicate their requirements to the suppliers and in turn it enables the suppliers to explain how they can meet these needs; the technical diligence template can be pre-populated with end-user requests for detailed information on how the supplier may fulfill their specific requirements, and will allow both parties to make informed choices; and the supply chain template allows the end-user to request supply chain-related information.
Companies who apply these templates within their businesses will be at a distinct advantage in terms of time and efficiency as well as ensuring consistent communication with their suppliers or end-users.
Working alongside members of the BioProcessing Systems Alliance (BPSA), the team has put together a wealth of content that will support companies to implement this toolkit. There are videos explaining the benefits and ease of implementation as well as presentations on the multiple business benefits.