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Validation of the Radiation Sterilization of Pharmaceuticals
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
A process specification for each product should be prepared and documented. Details of such a process specification for gamma, electron beam and X-ray irradiation can also be found in ISO 11137–1 (Section 9.4) (ISO, 2006) and include: A description of the packaged product, including the dimensions, density and orientation of the product within the package, and acceptable variationsThe loading pattern of the product within the irradiation containerThe conveyor path to be usedThe maximum acceptable doseThe sterilization doseFor products that support microbial growth, the maximal interval of time between manufacture and completion of irradiationThe routine dosimeter monitoring positionThe relationships between the dose at the monitoring position and the minimum and maximum dosesFor products that have to be given multiple exposures to the radiation field, any required reorientation between exposures. Specifically, for electron beam and X-ray irradiation, the process specification should also include the irradiator operating conditions and limits, that is, beam characteristics and conveyor speed.
Specification Control
Published in John A. Burgess, Design Assurance for Engineers and Managers, 2020
From a design assurance point of view, the process specification is a means of achieving a portion of the design intent. The process specification directs the supplier or manufacturer along an established path toward fulfilling the design requirements. As such, it is in the best interests of the engineering department to be actively involved in the process specification system.
Dynamic design method of digital twin process model driven by knowledge-evolution machining features
Published in International Journal of Production Research, 2022
Jinfeng Liu, Peng Zhao, Xuwen Jing, Xuwu Cao, Sushan Sheng, Honggen Zhou, Xiaojun Liu, Feng Feng
Digital twin is one of the most promising enabling technologies for realising intelligent manufacturing and Industry 4.0 (Tao et al. 2019). Digital twin can integrate the physical and virtual data throughout a product lifecycle, and the advanced analytics of process data can be used to improve the process performance in the physical space. In order to realise the monitoring, simulation, prediction and control of the physical space, the digital twin technology is used to guide the process design. Process specification is a technical document for the manufacturing process and operation method of the product. It is not only a disciplinary document that all production personnel should enforce strictly and implement conscientiously, but also the basis for product preparation, production scheduling, worker operation and processing inspection.