Historically, pharmaceutical products have been produced in a traditional ‘batch’ system, in which every operation is executed separately using a defined quantity of materials. In batch manufacturing ...
Drug firms looking to ramp-up production with continuous processes must think beyond the reactor and ensure the technologies used downstream can also manage sustained 24/7 manufacturing. Continuous ...
Continued process verification (CPV) is the third stage of the product lifecycle of any medicine either within the small or large molecule arena. The CPV is the subsequent step to process design ...
Due to their rodent origins, CHO cell lines can harbor endogenous retroviruses or retrovirus-like particles. Additional virus safety risks arise from the potentiality that the cell culture could be ...
ANSI/ISA-106.00.01, Procedure Automation for Continuous Process Operations, has been published by ISA. The standard sets forth models, styles, strategies, philosophies, and life cycle for the ...
The ANSI/ISA-106 standard and its supporting technical reports offer a structured approach to automating procedures in continuous process industries. Designed to reduce risk, improve consistency and ...
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