Plug and Play

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Plug-and-Play audit trail requirements

Plug-and-Play audit trail requirements

This document is one of a series, written to address the problems associated with automating equipment that lacks interoperability in the biopharmaceutical industry. It relates to the BioPhorum Stirred Tank Unit Interface Specification referenced in Appendix A, which was the first of its kind and as such, contains a number of introductory sections describing the principles upon which it, and an accompanying series of documents, are based. In turn, these principles relate back to the established standards of S88, S95 and OPC-UA, and the developing ‘plug-and-play’ approach of NAMUR (User Association of Automation Technology in Process Industries), with its module type package (MTP) equipment definition.

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Plug-and-play computerized systems validation strategy

Plug-and-play computerized systems validation strategy

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.

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Automated Facility: Stirred tank unit interface specification

Automated Facility: Stirred tank unit interface specification

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.

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