Process engineering opportunities/risks

Our failure risk analysis and opportunity method and iterative software tool, as part of our New Product Process Innovation (NPPI) Tool Library, promotes systematic collaboration and team-oriented engineering thinking when a new pharmaceutical manufacturing system process and/or product are developed. (We call it opportunity method too, since most risks, if not all, offer new opportunities for innovation.) It is based on our generic process failure risk analysis method that could be apphed to literally any process that involves risk—and innovation is a very risky process. 

Following this mainly engineering view point, the first volume Polymers -Opportunities and Risks I is dedicated to the basics of the engineering of polymers (materials, processing, design, surface, use phase, recycling, depositing) - but always in view of the environmental impact. 

The development of a VMP requires several decisions. If the facility is new, due consideration is given to determine, on time, the target dates for routine production to ensure completion of validation for facility approval otherwise manufacturing at risk is the alternative choice. The deadline determination provides ample opportunity to perform validation of utilities, critical equipment installation, and qualification prior to construction work. In addition, it provides a sufficient time frame to identify the critical processes and steps involved. The parameters critical for each step shall be established. The critical equipment required shall be determined. Critical processes, steps involved, parameters, and equipment are identified. For existing facilities, establish the criteria for revalidation based on known vulnerabilities and engineering projects in progress. 

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