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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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. ...
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.
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...
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.
Cell and gene therapies (CGTs) is an emerging, high-growth area, but their manufacture is different from established small molecule and biologics platforms in many ways. These range from starter cell variability and traceability for patient safety, to the need for fast turnarounds, very dynamic scheduling and rapid deviation management. All of these, and more, profoundly affect the IT system requirements for CGT. As more CGTs are approved for...
There are many differences in manufacturing cell and gene therapies (CGTs) compared to established small molecule and biologics platforms and this profoundly affects the IT systems requirements. Some products are personalized so the process includes personal screening and sequencing data, with traceability and data privacy throughout. Starter cell variability adds complexity to a manufacturing process that must have a rapid turnaround, very dynamic scheduling and rapid deviation management. Outcomes must be tracked for the long term to improve patient outcomes as well as to support novel reimbursement models.Industrialization of CGTs therefore needs the support of advanced systems for manufacturing execution, orchestration, traceability, scheduling, patient data and outcome tracking. Some processes will be encapsulated in closed systems, and there may be analytical requirements for continuous process verification and dynamic adjustment. Operators distributed across the globe will be supported remotely by augmented and virtual reality technologies. This paper helps executives and IT professionals to understand the IT needed to support CGT manufacture, and stimulates collaboration across the industry to meet these challenges.
Dec 2019 | Technology Roadmapping
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.
Apr 2019 | Technology Roadmapping
Robotic systems first started making inroads in the biopharmaceutical industry through the implementation of high-throughput automated systems for drug discovery and analytical assays. Robotic systems now are making inroads in process development with the introduction of ambr and Tecan systems. In the next few years, our industry is likely to see more applications of robotic systems, particularly mobile and collaborative robots in warehouse and production floors of biomanufacturing facilities.
This paper introduces potential applications for robotics in biomanufacturing, outlines the current availability of robotic systems, and calls robotics suppliers to adapt existing systems or develop new solutions for the biomanufacturing industry. It also highlights key challenges to the adoption of mobile robotics in manufacturing with the aim of getting the industry to start to address them
Jan 2019 | Information Technology
The pressures to achieve more with less in the world of equipment and facilities maintenance has always been there, but what part can smart maintenance and the use of digital technologies do for us? What would an investment deliver in terms of lower costs and improved asset utilisation? This paper defines what ‘smart maintenance’ means to the biopharma industry and how to measure its maturity. It showcases a tool to assess ways of working and level of digital maturity, by mapping to BioPhorum’s ‘Digital Plant Maturity Model’. It will help you and your organisation make the case for investment and justify adopting higher levels of maintenance practice, better framing the contribution of maintenance with digital maturity transition – where to build and with which capabilities. The paper articulates the value and benefits of achieving the higher digital maturity levels for smart maintenance, such as improved asset utilization and management, cost reduction and elimination of unplanned activities. The paper includes a discussion on ‘next-generation’ analytics, describing how current and future analytics packages can integrate with data solutions and the benefits they can bring to the smart maintenance approach.