Markus Multhauf, Senior Consultant GMP-Engineering
Facilities in the pharmaceutical and biotechnological production are comprised to a large extent of pipelines. The costs for construction - but also for modifications - vary widely. The volume of requirements for these projects can vary widely as well - from a few sentences to more than thousand pages.
Many specifications are outdated or can only be understood “historically”, e.g. the delta-ferrite specification according to the Basel Standard 2, or the requirements for pipe dimensions according to ISO 1127.
In many pharmaceutical companies, the central engineering department has been thinned out in recent years, so that some factory standards on pharmaceutical piping classes are outdated or no longer exist.
For suppliers and plant engineering companies without the necessary expertise it is difficult to distinguish important and correct customer requirements from incorrect specifications - which can lead to massive calculation and handling errors, including delays and additional costs. In quality assurance there are often time-consuming discussions as well. And above all, the question is: what are the real GMP requirements for pharmaceutical piping?
This webinar aims at suppliers, plant construction and engineering companies as well as pharmaceutical users of piping systems but also quality assurance and persons responsible for the qualification of theses systems.
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As a participant of this webinar you will gain an insight into the state of the art and current developments in piping construction for pharmaceutical and biotechnological applications. A number of details will be presented, including
- Standards for pipes and components
- When is the 3D rule required, when the 1.5D rule?
- Insulation of pipes in the clean room
- Which material certificates are required and for what?
- In which cases can passivation be omitted?
- What should be taken into account when checking the welding?
- Is the definition of a maximum roughness of Ra 1.6µm for the weld reasonable?