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This shortcut is designed for production & engineering professionals in pharmaceutical and biotech manufacturing, as well as for Quality assurance personnel who is dealing with particles in water and gas. It may also be useful for employees in plant construction and planning, who are concerned with the GMP-compliant construction or conversion of clean utility systems.
Objectives
The requirements for particles in pharmaceutical water and pure gases are sometimes contradictory, sometimes even technically difficult to realize. There is also a gray area between visible and nonvisible particles. Uncertainty also exists with regard to filters: whether they can be used in critical utility systems and how they should be validated.
Particles in Parenteralia continue to be an “issue”, leading to product recalls. In addition to the 100% visual inspection of final products, the fundamental reduction of the particle load in the manufacturing processes is an important aspect of the Quality Life Cycle. In this context, clean utilities play an essential role.
Programme
This shortcut will help you gain a practical understanding of the design and operation of media systems in terms of particle content. You will gain knowledge to differentiate important and correct GMP requirements from outdated or incorrect requirements. Based on the specifications of pharmacopoeias and standards, participants will learn about the state of the art for the different media and particle size ranges. Technical solutions are presented.
The following points, among others, are subject of this shortcut:
Differentiation between visible and “non-visible” particles
Available measurement technology for particles
Filter technology for media Systems
Relationship between particles and microbiology
Particle problems in practice
Pharmacopoeial statements: USP <788> and Ph.Eur. 2.9.19
Relationship between rouging and particles
Is there particle-free WFI?
Requirements of DIN 58950-7 and EN 285 for pure steam
Further Information
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register.
Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of Copyright.
Presentation and certificate: Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
Please note: When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
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