Nikolaus Ferstl, University Hospital of Regensburg
Dr Markus Keller, Fraunhofer Institute for Manufacturing Engineering and Automation (IPA)
Markus Multhauf, Senior Consultant GMP-Engineering
Tim Ohlrich, gempex
Dr Jan Rau, Dockweiler
Dr Georg Schwarz, gempex
Dr Georg Sindelar, msg industry advisors
The goal of this event is to understand how to translate GMP requirements of process or product into an adequate Equipment design. Wherever possible, concrete materials, values, Parameters that have proven themselves - or are required by authorities - are mentioned.
What does “GMP-compliant equipment design” mean? Why is there no authority approval of GMP equipment? These questions are asked quite often, both by plant engineers and by employees of the pharmaceutical industry itself.
This is relatively easy to answer. There is not ONE plant or equipment design that can be compliant for all pharma manufacturing plants or processes.
There are numerous pharmaceutical manufacturing processes, ranging from dry granulation and tableting to fermentation or sterile filling. Adding manufacturing processes from the classical (chemical) production of active pharmaceutical ingredients increases their number considerably. To some extent, however, pharmaceutical requirements are also observed when producing medical devices such as implants. The equipment used for these processes is as varied as the processes themselves. The product itself can place multiple requirements on the production equipment, too. For the design of equipment, it makes a big difference whether the product to be produced needs to be sterile or not, or whether it is a highly effective product. In the latter case, not only do GMP design criteria have to be observed, but also requirements for personal protection. A product or intermediate may, however, also be sensitive to oxygen or moisture. Obviously, all this affects the design of equipment.
Consequently, this no course or guidance document illustrating the requirements for every possible type of production equipment.
Back to the question: What is GMP-compliant equipment design? In principle, this vague requirement can be broken down to four very obvious requirements for pharmaceutical manufacturing equipment:
- the equipment must not have a negative impact on product Quality
- the equipment must be easy to clean
- the equipment must comply with the applicable technical regulations
- the equipment must be suitable for its purpose.
These four points can also be found in different wording in numerous guidelines of GMP-relevant authorities, but are still so little concrete that they require a more detailed explanation. For that is important to understand the principle of “GMP design” - how the requirements of a process or equipment can be translated into a plant design. Many points play a role here, such as
- Material selection
- Surface qualities
- Hygienic design
- Quality assurance in plant construction
How this can look in detail is part of this event. Values, details or materials considered as standard will be mentioned and this will be shown by means of examples.
The speakers of the event are the authors of the new ECA Guide on GMP-compliant Equipment Design. They will walk you through the individual chapters and give further explanations.
This event will be of interest to anyone involved in equipment design, evaluation and qualification. Addressed are executives and employees of equipment suppliers, engineering service providers, engineering technology and quality assurance of pharmaceutical companies.