Session Abstracts

Why Use Electrolytic Ozonation (Micro-Ozonation) Versus Standard Ozonation through Practical Case Study - Robert Neri, Sanofi

This session will compare two types of Ozone Sanitisation for water installations - one based on periodically sanitising the water with high concentrations of ozone; the other on sanitising continuously with micro quantities of ozone. This comparison case study is based on feedback from several different installations.

Rapid Microbiological Methods – Chances and Risks - Dr. Frank Panofen, Merck

Alternative Microbiological Methods offer a wide range of applications. They are considered to revolutionise the way microbiological parameters will be assessed and the associated data interpreted. Nonetheless the implementation of these methods in the pharmaceutical industry show slow adoption of the market. 

From this session, participants will gain clear understanding of the potential of Rapid Microbiological Methods and the risks of implementing such a method.

Sampling of water, Steam & Gasses. How to fit sampling seamlessly into an overall control strategy - Michael Vestermark, Novo Nordisk

Often utility sampling is either overdone or performed too sparsely. No regulatory consensus exists on frequency and extent of sampling. Process understanding and addressing the threats to the process is a helpful tool to tailor a sampling policy supporting an overall process control strategy.

From this session, participants will learn how to put sampling into a context with other means of control strategy and will also get tips on how to reduce the amount of sampling.

Process Gases: User Requirements and Application of Risk Assessment Techniques  - Frank van der Steen, Frank Validation & Consultancy Services

This session focuses on the generation of an User Requirement for a utility system, and specifically to a process gas system from inception through system release. The UR is considered an integral part of the system lifecycle documentation, and should address the identified detection and mitigation mechanisms required to be included within the design of a process gas system to adequately minimize the risk to the quality attributes established for the process gasses.

The sessions discusses the various stages in UR generation and the hazards to be considered during the risk assessment process. The principles described within the Good Practice Guide on Process Gasses are included within this session.

Rouge: the Intrinsic Phenomenon in 316L Stainless Steel, a Key Material for Biopharmaceutical Facilities - Michelle Gonzalez, BioPharm Engineering Consultant

This presentation will try to demystify the presence of rouge in 316L stainless steel; its unavoidable link with iron; regulatory opinions, rules or mandates; rouge detection and monitoring and the resulting practical dilemma, rouge removal from, or analytical management of process systems.

With this presentation, participants will learn that the preeminent concern of the biopharmaceutical industry regarding the rational solution to rouge should be to adopt sensible management processes of this unavoidable phenomenon, rather than to continue with the indiscriminate application of remediation treatments that may utilise subjective and sometimes confusing procedures with less than uniform and reassuring results.



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