Plug and Play

The Plug-and-play computerized systems validation strategy is a guidance document aimed at maximizing the benefits of adopting the BioPhorum approach to interoperable, modular equipment assemblies (commonly referred to as ‘skids’). The approach is based on NAMUR´s Module Type Package (MTP) standard1
and a series of interface specifications which the BioPhorum Plug and Play team is creating.

Typically, equipment skids (MTP process equipment assemblies (PEAs)) need to be treated as bespoke units when they are connected to control systems (MTP process orchestration layers (POLs)). This places automation on the critical path for facility design, build and reconfiguration. This document presents a stirred tank unit (STU) interface specification. The STU class of equipment includes single-use bioreactors (SUBs) which are central to the manufacturing operations of many companies producing biopharmaceuticals using a batch process at intermediate scales. By combining this specification with MTP, equipment and control systems, providers can enhance interoperability and reduce the equipment installation time from months to weeks or even days, depending on the installation scenario. And by providing good documentation to their customers’ quality systems, they can enable customers to reduce their internal validation effort.