Podcast: Water for Injection Using Non-Distillative Methods Webinar Q&A
Since April 2017, the European Pharmacopeia allows to produce Water for Injection (WFI) using other methods than distillation. Meanwhile, the additional water quality "Highly Purified Water" (HPW) could be found in the Ph. Eur. but will be removed in April 2019. This means a huge change in the regulatory situation for the pharmaceutical companies. A new Q&A document had been launched by the EMA, but some topics remain unclear. Therefore, the ISPE D/A/CH CoP water and steam has discussed all questions extensively for 1.5 years and written down their position.
This webinar provided insight into the thoughts of the ISPE D/A/CH experts and additionally addresses the following questions:
What are suitable technologies for the final treatment step of a cold WFI system?
How can the final treatment step be validated?
How much control and oversight is needed for a cold WFI system?
Why did we set up a new standard to determine the cut-off of an ultrafiltration module?
Help, HPW does not exist anymore! What can I do? Do I have to upgrade my existing HPW system now?
How could a requalification from HPW to WFI be carried out?
Listen to Fritz Röder and a team of panelist as they discuss ten of the most asked or most interesting questions from the webinar in April 2019.
Fritz Roeder of Merck is based in Darmstadt, Germany and is an experienced project manager and engineer with broad knowledge in the pharmaceutical industry. He is an experienced speaker and author on a variety of pharmaceutical water topics.
Michael Clever of Roche is based in Penzberg, Germany and is an expert in the field of clean media operations with a strong engineering background in utility plants. He did a lot of research in the field of ultrafiltration and rouging.
Jochen Schmidt based in Basel, Switzerland, is the Process Utilities Lead at CRB. He has been working in the pharmaceutical water sector for more than 20 years with his main focus on the conception, process selection and dimensioning of complete water systems for the generation, storage and distribution of PW, WFI and pure steam.
By the ISPE Regulatory Team
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