ISPE Webinar rCoP Water&Steam: Water for Injection Using Non-Distillative Methods – The ISPE D/A/CH Approach
This new series of ISPE Webinars kicks off on 29 April 2019 with the webinar Water for Injection Using Non-Distillative Methods – ISPE D/A/CH Approach.
Presenter Fritz Röder, Senior QA Manager Validation, Qualification and Engineering Merck KGaA, Darmstadt, will share collective insights from the ISPE D/A/CH Affiliate CoP for Water and Steam, and provide answers to questions like: What are suitable technologies for the final treatment step of a cold WFI system?
Water for Injection Using Non-Distillative Methods – the ISPE D/A/CH Approach
Since April 2017, the European Pharmacopeia has allowed pharmaceutical companies to produce Water for Injection using methods other than distillation. Meanwhile, the additional water quality standard for “Highly Purified Water”, currently found in the Ph. Eur., will be removed in April 2019.
This means huge changes in regulatory requirements for pharmaceutical companies, and although a new Q&A document had been launched by the EMA, some topics remain unclear to users. The ISPE D/A/CH Affiliate rCoP Water and Steam community has extensively discussed their questions and issues over the last 1.5 years to help clarify these topics for you.
This webinar will provide insights into the thoughts of the ISPE D/A/CH Affiliate experts and additionally addresses the following questions:
What are suitable technologies for the final treatment step of a cold Water for Injection system?
How can the final treatment step be validated?
How much control and oversight are needed for a cold Water for Injection system?
Why did we set up a new standard to determine the cut-off of an ultrafiltration module?
Help, High Purity Water does not exist anymore! Do I have to upgrade my existing HPW system now?
How could a requalification from High Purity Water to Water for Injection be carried out?
Meet the Presenter
Member rCoP Water & Steam ISPE D/A/CH
Senior QA Manager
Fritz Röder is a recognized expert in the pharmaceutical industry with broad knowledge in pharmaceutical media supply, GMP environments and the processing of solid, semisolid and liquid (sterile) dosage forms.
He is a member of the ISPE D/A/CH Affiliate rCoP for water and steam and in recent years has been involved in several audits and inspections and contributed to international standards. Since June 2017, Fritz has been working as the Senior Manager Validation, Qualification, and Engineering at Merck KGaA, Darmstadt (Germany).
Registration for the Webinar
The ISPE D/A/CH Water for Injection Handbook (german)
The Expert Team Water & Steam ISPE D/A/CH Community of Practice (rCoP) has created a guideline in the form of a manual. This provides an overview of the regulatory requirements, and open questions regarding the membrane-based production of WFI are answered from the perspective of the experts. Planners, operators, equipment manufacturers, drug manufacturers and government representatives are provided with the document a practical guide, which takes into account both the regulatory compliance and the technical and operational feasibility.