Automated bioburden measurements in Purified Water for Pharma
Implementation and validation of online water bioburden analyzers (OWBA) in Pharma is a huge step in automating Purified Water production with patient safety as our main priority.
When producing Purified Water for use in production of API, a lot of samples are taken to ensure clean and purified water with minimized bioburden. The current control strategy is to measure all parameters with either online or inline equipment for conductivity, TOC, etc. except for bioburden, which is measured by CFU. To reduce the load of CFU plates in laboratory and to take the first step to releasing safe purified water faster, Novo Nordisk is implementing Online Water Bioburden Analyzers (OWBA). This system measures viable bacteria through their enzymatic activity to give a near real-time picture of the bioburden in water. This presentation will highlight the thoughts behind the chosen system, the challenges of the implementation phase, and give insights into the current phase of validation through a long-term study. To finalize the presentation our next steps for getting to use this system for release will be discussed with the audience.
Speaker
Sebastian Strandberg Rutell (USRZ) is from Novo Nordisk and are the engineering and operations responsible for one of the new green field factories.
He has the goal of implementing process analytically technology (PAT) and has been working at Novo Nordisk in almost 3 years.
He is one of three persons working with OWBA (Online Water Bioburden Analyzers) in the purified water production.
Agenda
17:20 - Registration
17:20 - Registration
17:30 - Introduction
17:40 - Presentation - part 1
18:30 - break
18:45 - Presentation - part 2
19:25 - Wrap up
19:30 - Networking & sandwiches
This event will be conducted in english.
Make sure to unregister in case you can't participate. Otherwise you will be charged a no-show fee of 250 kr.
Sign up: Not a member? In order to sign up, you must create a user profile. Note, when creating a user profile, you will be able to access IDA's online services - you will not become a member of IDA.
Important information regarding personal data on participant lists: Your name, title and company will appear on the attendance list for this event. The participant list is available to the organizer and the other participants on the event itself, in the form of an online attendance list. In addition, at some events, name tags are provided, where your name, title and company appear. If you unsubscribe from the event, your information will not appear in the attendance list.
When you are registered as a participant at this event, you will also automatically receive info about the next event within the same subject area.
This event is closed for registration.
Information