Genetic Engineering & Biotechnology News

NOV1 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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GENengnews.com | SEPTEMBER 1, 2018 | 11 and restricted. Preferred components have been subjected to extensive evaluation and have comprehen- sive validation packages. Typically, junctions with many other components have also been tested. Use of preferred components, which are held in stock, in an assembly design there- fore accelerates lead times. Nonpreferred components have valida- tion packages that are sufficient to satisfy regulatory and customer requirements, but they are not as exhaustive as those for pre- ferred components. In addition, stocks are not maintained, and thus result in longer lead times. Restricted components are typically specialized components used once for a cus- tomized assembly. The use of preferred components drives the use of components with the highest level of quality and certifications. All the informa- tion on these components is readily accessible in the ACMS system should the customer be subjected to a regulatory compliance audit. Project Evaluation All Pall, SU assembly projects benefit from use of the ACMS, beginning with the initial customer request. The enquiry module houses customer responses provided in URS documents. Information on the customer, the desired system, the project specifications, the specific application and operating conditions (upstream, downstream, fluids, process pa- rameters, etc.), and other project details, such as delivery times, testing requirements, and need for prototypes, are also included in the ACMS. This information is first used in the initial review process to determine if the project en- quiry can be approved. Once a project moves forward, it is used to ensure that the materi- als are compatible, that the assembly design is "fit for purpose," and that the required com- ponents are or can be qualified and sourced. The information is also considered during technical and manufacturing reviews. Over- all, use of the ACMS provides traceability of the approval process for all stakeholders. Design Phase The design phase takes place within the ACMS as well. The drawing module, or con- figurator, allows generation of system draw- ings. It provides automatic junction verifica- tion and automatically creates a bill of mate- rials (BOM) for each SU system design. Numerous autochecks and workflows have been incorporated to ensure that proj- ects do not move forward unless all require- ments/specifications are met. No components can be used that haven't been through Pall's strict approval process. Only components that can operate safely under the specific process conditions can be selected. Drawings cannot be finalized and sent for customer ap- proval until all component junctions have been confirmed to be validated. Test results for components, including pre- and poststerilization, are included. The junction test module contains all data gener- ated during junction testing, and information is kept in one place, making it fully traceable and readily accessible. The ACMS also provides information on lead time and pricing based on the different components selected for an assembly. Access to this information allows for informative conversations with users, particularly if there is a request for specific components. Using the ACMS, it is possible to suggest other alternatives based on preferred components that meet the overall requirements but with a reduced lead time and potentially cost. Powerful Searching Functionality The ACMS is designed with advanced search features to better facilitate the SU as- sembly design process for customers from many perspectives and with many end uses. In some cases, design of a new system may not even be necessary or advisable. Many biopharmaceutical manufacturers today are looking to reduce costs through equipment rationalization. With the ACMS, it is possible to search all previous designs stored in the system. Such searches can be conducted using many different criteria, en- abling the identification of assemblies similar to the one currently being requested. This can streamline the design process and result in savings. This searching functionality can also be used to identify any previously designed sys- tems or parts of systems that were initially intended for different applications but may Single-Use Technologies for Bioprocessing Allegro single-use system incorporating a 50L mixer, sterile connectors, filters, and a sampling port.

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