BioPhorum Drug Substance Closed Systems in Controlled Non-Classified Workstream has recently published its room...
Plug-and-play validation – how much testing do you really need to do?
A plug-and-play approach has the potential to make a significant impact on the way we design, build and use biopharmaceutical facilities. One of the many benefits is the ability to buy standard, off-the-shelf items that can significantly reduce the qualification workload and testing required to bring a piece of equipment on-stream.
Unfortunately, the traditional way of validating new equipment requires lots of testing in great detail by an end-user – even if a supplier has already done this.
The new Plug-and-play computerized systems validation strategy paper aims to drastically reduce the amount of testing needed to be performed on a new piece of equipment and, significantly, give users the confidence that this is a valid thing to do. This will help maximize the benefits of adopting BioPhorum’s approach to using interoperable, modular equipment assemblies (‘skids’).
The benefits of plug-and-play
The paper provides guidance for end-users and suppliers of process orchestration layers (POLs) and process equipment assemblies (PEAs) to successfully demonstrate that their equipment complies with the interface specifications created by the BioPhorum Plug and Play team. Users can then realize the benefits of using the plug-and-play interface specifications.
The paper does not provide general or complete guidance on equipment qualification or process validation of POLs or PEAs, it only gives advice on validating the interface between them.
The idea is similar to off-site construction in housebuilding, where everything is delivered to the site and is ready to be used. In this scenario, plug-and-play testing does not happen at the end-user but earlier in the process at the supplier and away from the manufacturing site. The supplier builds, tests and certifies units so that end-users do not have to repeat it every time.
“The paper supports what we’ve said about the potential savings of using plug-and-play,” said Keith Morris, Smart Manufacturing SME at PM Group. “It makes suggestions about how to treat equipment so you can have confidence that it performs correctly without you having to do all that testing for yourself.”
As the paper is only guidance, not a prescriptive list of everything that needs action, it will help you decide what level of testing you need to do on equipment. It will also give you confidence that your suppliers have operated correctly and given you equipment you can rely on. Finally, it will help you understand what they have done so you can safely reduce your testing.
This validation strategy paper is part of BioPhorum’s overall plug-and-play drive to educate industry that there is a better way of doing things. This is not just for regulatory bodies and QA departments but also for equipment manufacturers who have traditionally built custom solutions.
We need to convince them that they can design a piece of equipment once and sell it many times to customers who might pay a premium for it. As industry volumes increase, suppliers are unlikely to have the capacity to make bespoke equipment. A plug-and-play approach for suppliers should mean equipment is cheaper to manufacture while they earn more revenue and is more sustainable.
If end-users, suppliers and regulators can realize the benefits of reduced testing, then everybody wins.