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Wireless Temperature Measurement in Lyo Process Development, Validation and Production

May 2019
Die Pharmazeutische Industrie 81(5):719

Authors:

Andrea Weiland-Waibel

Explicat Pharma

Wireless temperature measurement during lyo process development, validation and production with the aim to apply process control. This is performed by the determination of product temperature Tp in critical positions ("hot" and "cold" spots). Also it is explained how this approach was implemented into the Common Technical Document (CTD) regulatory submission and that it was successfully approved. How to use the Tp measurement as a key element of the continuous process verification is also demonstrated.

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Risk Assessment Tables in der pharmazeutischen Entwicklung

May 2014

Andrea Weiland-Waibel

Summary Use of Risk Assessment Tables during Development Stage The paper addresses the importance of analysis of the critical pharmaceutical process parameters during development stage. Practical recommendations are given as to how to apply this approach to manage the pharmaceutical development process and utilize the data package. The approach is in line with the FDA initiative for the cGMP ... [Show full abstract] regulations for the 21st century, ICH Q8, ICH Q9, the 2011 FDA-Guidance on Process Validation as well as the EMA- Guideline on process validation for finished products – information and data to be provided in regulatory submissions, published in February 2014 and co- ming into effect as of August 2014. It is shown that in relation to PAT (Process Analytical Technology) justified process parameter ranges and specifications may be developed, that the development report may be made compliant for the CTD (Common Technical Document) and how further activities for pro- duct/process can be assessed. Key words cGMP for the 21st Century · Design Space · Pharmazeutische Entwicklung · Risk Assessment Tables · Modern Process Validation

Article

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Modern Lyo Cycle Optimization " Hot " and " Cold " Spot Determination by Wireless Real-Time Temperat...

March 2015

Andrea Weiland-Waibel

Traditional lyo cycle development leads to a predetermined program that usually is subject of process validation. As a consequence this cycle needs to be applied for the fabrication of the product under all circumstances. If for any reasons e. g. only a part of a total batch size can be manufactured, no adaptations are possible, i. e. the shortening of the cycle is not allowed due to regulatory ... [Show full abstract] compliance. This article demonstrates a new conceptual design to the development and modern validation of lyo cycles applying process control by determination of Product Temperature (T P) in critical positions (" hot " and " cold " spots) which allows for adaptation of the lyo cycle. Furthermore usage of these positions in development scales during scale-up and routine production is shown.

Conference Paper

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Hot and Cold Spot Determination to allow for Process Control by Use of Product Temperature Tp PAT De...

April 2015

Andrea Weiland-Waibel

PAT-Tools as real-time process control, dynamic qualification of "Hot and Cold Spots", case study

Presentation

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Recent Experiences with Continued Process Verification of a Lyocycle-Implementation of Product Tempe...

December 2018

Andrea Weiland-Waibel

Process control using Product Temperature and results applying continued process verification of a lyocycle