Wireless Temperature Measurement in Lyo Process Development, Validation and Production
Originale
2. Lyo cycle development applying WTM
3. Applying WTM in critical positions during process validation or process performance qualification
4. The regulatory CTD
5. Current use of WTM in GMP production for market, as element of the CPV of the product
6. Conclusion
Key Words: Critical Formulation Temperature (CFT), Product Temperature (TP), Critical Product Parameter (CPP), Wireless Temperature Measurement (WTM), Process Performance Qualification (PPQ), Continuous Process Verification (CPV)
Correspondence:
Dr. Andrea Weiland-Waibel, Explicat Pharma GmbH, Georg-Knorr-Str. 4, 85662 Hohenbrunn, Germany; e-mail: a.weiland@explicat.com
Abstract
This article shows a new conceptual design to the development and modern validation of lyo cycles applying process control by determination of product temperature (TP) in critical positions („hot“ and „cold“ spots) with wireless temperature measurement (TEMPRIS®). The approach was implemented into the Common Technical Document (CTD) regulatory submission and successfully approved. Currently, WTM is applied during the manufacturing of the market (...)
