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.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Introduction: What is cGMP-compliant Design?
- Overview: GMP rules & guides, interest groups and state of the art
- Proof of concept:
- URS, DQ, RA
- GMP design (PID, Layout, Component-list, FDS, SDS, HDS)
- GEP, SME, CQA & CPP: new keys for a successful commissioning & qualification process
Basic Aspects of hygienic Design and Material Selection
- Risk-based approach for the selection of suitable materials
- Equipment-specific definition of the hygiene-critical area
- Open & closed Equipment
- Construction aspects
- Pipe Connections
- Screw Joints
- Inner corners and angles
Process Contact Surfaces: Specifications and Surface Treatments
- Definitions of surface qualities
- Surface quality requirements
- Surface treatment Methods
- Mechanical Treatment
- Chemical Methods
- Electrochemical treatment
Pipework and Fittings, Connections, Welding & Seam Control
- Piping & Tubing Standards
- Cleanability & Dead Legs
- Detachable Connections
- Welding Technology & Welding Quality Criteria
Requirements for the Process Environment: the Clean Room
- Clean Room standards and classes
- Selection and procurement - factors influencing the selection of components
- Wall and ceiling Systems
- Acceptance tests for wall and ceiling
- Requirements for clean room doors
- Floor Systems
- Acceptance tests for Floors
- Critical clean room interfaces
- Application of components for different cleanliness classes
Electrical Engineering, Measurement and Control Technology in the GMP-regulated Environment
- Technical design of devices
- Selection of the appropriate measurement procedure
- Maintenance and calibration
Requirements for Automation and Control Systems
- Qualification or Validation
- Delimitation of the Subsystems
- Special feature - configuration Management
- Data Integrity
- Integration of FAT and SAT in the validation
Documentation in the Life Cycle of GMP Equipment
- Documentation in basic Engineering
- Documentation in detail engineering & implementation
- Important documents for qualification
- Operating documentation
- Material certificates
- Material certificates for metallic materials
- Material certificates for product or media-contacting Plastics
- Formal aspects
Requirements for the Quality Assurance System of Equipment Suppliers
- Quality management systems: DIN ISO 9001 as a Basis
- Quality management systems: overlap with GMP
- Qualification and validation at the equipment supplier
- Further supplier quality Systems
- Production conditions
- Differences between suppliers and Pharmaceutical manufacturers
Recording from 16/17 November 2022
Duration of the recording: about 7 h 50 min.