Education Details
Critical Utilities are an essential part of GMP development and manufacturing of active ingredients and pharmaceuticals. It is one of the very few areas where the systems are working continuously and are therefore unique from an engineering viewpoint. The generation, storage and distribution of critical utilities are fundamental to the success of your facility management. The design, installation, optimisation and validation of clean steam, WFI, purified water, process gases and compressed air systems therefore present unique challenges that this conference will position you to solve.
This two-day must-attend conference will use case studies to explore current technologies, regulatory requirements and risk-based approaches in Critical Utilities for pharmaceutical and biopharmaceutical manufacturing. In-depth discussion will focus on the control and management of these critical processes in order to optimise product quality, cost effectiveness and minimise your carbon footprint. The programme will include seminars, workshops, case studies and Q&A sessions. You will also have the opportunity to visit some contemporary facilities.
Topics will cover:
- Risk-based Approaches
Design options and optimisation alternatives for critical utilities as well as understanding of risk-based approaches (ICH Q9 and ASTM E2500-07) and regulatory requirements for Pharmaceutical Water Systems, Ozone Sanitisation of Pharmaceutical Water, Steam and Process Gases including Compressed Air.
- Water Systems and Ozone
The absence of non-biased industry guidance has prevented many companies from using Ozone Systems:
How to better understand what Ozone Systems are, why it can be a safer, more efficient and more
cost-effective way to sanitise pharmaceutical water, and how they can be incorporated into both new and
retro-fitted facilities.
- Process Gases - including Compressed Air
Understand how to trace, sample and monitor the components ordered and delivered at your plant as well as components produced on-site.
- Clean Steam
Aspects related to sterility and cleanability, dimensions and tolerances, surface finish, material joining, and seals from for example the ASME BioProcessing (BPE) standard.
- Life Cycle Cost Optimisation and Management
Best practice sharing, workshops AND knowledge share on implementation of cost-optimisation strategies throughout the life cycle; from design through installation, testing, turnover and maintenance.
View the Conference Agenda (
258 KB)
Leaders
Anders Vidov, Managing Director, Deltatec Pharma
Katrin Åkerlindh, Business Operations Manager, Linde Healthcare, Region Europe North
Who should attend?
This conference is directed to water system designers, facility maintenance staff, facility/utility engineers, QA, QC, microbiologists, process engineers, quality assurance engineers, regulatory affairs specialists, project managers and operations managers.
Plant Tours
In the afternoon of day one, delegates will have the opportunity to visit one of three state-of-the
art sites to see in action the concepts presented during the different sessions.
(Places are limited for each site and will be allocated on a first-come, first-served basis)
Networking Evening
Social Networking Event at the Carlsberg Brewery: Tuesday 12 March, 2013
ISPE invites you to attend our social networking event at the Carlsberg Brewery. Join your peers for an
informative discussion about the “Micro Bio Control Process”. The session will be followed by a three-course
meal and a drink at the Carlsberg Brewery. Register now for only €90.
Thank you to our Top Tier Sponsors
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