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GMP Series - Downloads

Applying the Principles of Hygienic Design to Solid Dosage Forms
€ 117.00
€ 139.23
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pdf download
Excerpt from the GMP Compliance Adviser
Edition: first edition, 12/2015
43 Pages
ISBN: 978-3-95807-025-7
Delivery: immediately after receipt of payment
Excerpt from the GMP Compliance Adviser

Hygienic design refers to the easy-to-clean design of parts, components and production machinery. It results in machines with a closed design that have little dead space and are easy to clean. Hygienic design is particularly important when handling solids because solids, unlike liquids, can be distributed throughout the entire building by the ventilation system, from surface to surface and from person to person if the solids are not handled properly or are handled open. At the same time, there is a risk of product cross-contamination, which in accordance with the EU GMP Guidelines must always be avoided. The design of the machinery to be used is extremely important in this context and should be taken into account at an early stage of planning.

Applying the Principles of Hygienic Design to Solid Dosage Forms explains all important design characteristics for hygienic design, using the example of different types of connections, feeding and dosing systems, and cleanroom installations.

You will learn all you need to know about:
  • Regulatory requirements
  • General design principles
  • Selection of materials
  • Surfaces
  • Connections
  • Hoists
  • Roller conveyors
  • Pneumatic conveyor system
  • Dosing systems
  • Platforms and stands
  • Cleanroom installations
Don’t fail to order your copy of Applying the Principles of Hygienic Design to Solid Dosage Forms!

Technical Requirements

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  • Engineering
  • Production
  • Quality Assurance
Denk, Richard

Richard Denk has been working in the areas of hygienic design, containment and the production of highly active substances for over 20 years. He has been head of the containment group for the production of highly active substances since 2014. He developed the Containment Pyramid and founded the Containment Expert Group of the ISPE.

Brandes, Ruven

Ruven Brandes became Head of Technology and Compliance Support for technical QA in 2006. He combines technological expertise with a strong quality awareness and possesses a broad range of professional experience. Mr Brandes is involved in a number of different associations and committees and also works as an author and speaker.

Technical Solutions for Personnel Protection in Solid Drug Manufacturing
GMP Fundamentals – A Step-by-Step Guide (download)
GMP Compliance Adviser
Single User Licence (monthly subscription)