plug and play


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On the plug-and-play audit trail to connect intelligent pieces of equipment

An audit trail is a secure, computer-generated, time-stamped electronic record that allows the reconstruction of events around the creation, modification, or deletion of an electronic record. It should be in a clear and specific format and capture key data, including when (date and time), by whom (identity), where (location, terminal or device identification), and what (detail about the change). However, many end-users have significant issues...

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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

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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BioPhorum’s Plugfest showcases its plug-and-play momentum

BioPhorum’s recent three-day Plugfest event performed a series of tests designed to help its Plug and Play Workstream build towards proof-of-concept testing and the commercial launch of plug and play capability.  Bill Lydon – author, analyst and consultant for the automation and controls industry – wrote an observer report for Automation.com about the event. He discussed BioPhorum’s plug-and-play vision, the innovative use of remote...

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Fostering a step change in automated equipment interfaces

Equipment skids usually need to be treated as bespoke units when they are connected to control systems, which places automation on the critical path for facility design, build and reconfiguration. Any problems can clearly have major implications for a facility project – builds and reconfigurations would be much easier and quicker if equipment interfaces were standardized and offered interoperability. BioPhorum’s new Stirred tank unit: interface...

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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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Plug and play: The value of plug-and-play automation in single-use technology

Automation can improve efficiency, track performance, adjust operations, and liberate operators from mundane routines. Automation requires a flexible set of tools that align well with the inherent flexibility of single-use technology (SUT). Although SUT flexibility enhances a biomanufacturer’s ability to modify operations to meet the needs of today’s dynamic industry, it also increases timelines and costs related to customizing and validating automated additions. This paper presents the findings of a team of industry automation experts who are sharing their experiences and testing new automation methods, with a vision to a reusable, standardized approach that enables rapid integration of intelligent process skids.

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How plug-and-play will help you glide through the biomanufacturing dance

​​It is pretty clear that automation can improve efficiency, track performance and liberate operators from mundane routines. But with it comes cost and time factors around customization, communication and validation. So, the challenge is not just how to automate, but how to do it well. Using a ‘plug-and-play’ approach can greatly enhance the benefits of automation. By standardizing the communication framework, it can substantially cut the time...

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Plug and play workshop

A lack of equipment and automation standardization can cause a whole host of problems in the setup and reconfiguration of mAb drug substance manufacturing systems. For example, automation is often on the critical path for a facility build and the bespoke nature of interfaces means timelines can be long and uncertain. And once a facility is built it can be very difficult to switch technologies, meaning new processes are hard to adopt. It is also...

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