Markus Multhauf
Consultant Pharmaceutical Engineering
Referent:innen
Dr. Andreas Schieweck
Landesamt für Gesundheit und Soziales M-V Arzneimittelüberwachungs- und prüfstelle
Zielgruppe
The target group are employees from technology, production and quality assurance in pharmaceutical and active ingredient production who are entrusted with the planning,
Zielsetzung
The aim of the seminar is to provide practical information on the key GMP, quality and engineering aspects in the planning and operation of systems for gaseous media such as nitrogen, compressed air, steam, medical gases, etc.
Background
From a GMP perspective, far too little attention is often paid to the media – they ‘just come out of the wall’. Media, especially gaseous media, are usually brought to the place of use in a hidden manner, sometimes even disregarding the zoning. However, this grey area is not limited to the technology, but also affects the responsibilities and procedures for maintenance, sampling, testing, certificate acceptance and approval. Practical experience has shown that questions repeatedly arise during the planning, qualification and operation of media systems that cannot be answered clearly. This can lead to drastic quality problems, which is why media technology has increasingly become the Focus of inspections in recent years.
In this seminar, we want to provide answers to practical Questions, such as
- What do the regulatory requirements for gaseous media actually look like?
- Where can I find a valid specification?
- What does a GMP-compliant design of media Systems look like?
- Which technologies are state-of-the-art?
- What needs to be considered when building and commissioning media systems?
- How often do filters need to be checked or replaced?
- Which components need to be Qualified?
Programm
Gases in the GMP Environment: Regulations, Guidelines & Inspection Practice
- Regulatory requirements in connection with media Systems
- Quality and specifications (e.g. nitrogen, compressed air, steam)
- Risk priorities from an inspector’s perspective
- Supplier audits
Design of Compressed Air, Nitrogen and Vacuum Systems
- Compressed air generation & Distribution
- Design of quantities, nominal diameters, flow rate, pressure losses
- URS for compressed air
- Pitfalls regarding the 5μm particle requirement in ISO 8573
- Nitrogen applications and supply Systems
- Design principles vacuum-systems
Planning of GMP Media Systems
- PID symbols for GMP-piping Systems
- Special components:
- Valves
- Detachable Connections
- Filter
- Interface cleanroom
Construction, Commissioning & Qualification
- Requirements for execution, documentation, material certificates
- Welding, Bending, pressed connections: When and why?
- Construction site: Storage, material and personnel flow, separation of stainless steel and black steel work
- Remark on excessive requirements regarding construction site safety (lessons learned)
- SAT / Avoidance of double testing (GEP versus GMP)
- Qualification strategies: CPP’s, CQA’s, IQ, OQ, PQ
Requirements for Pure Steam
- Difference Pure & Clean steam
- Natural circulation or falling film evaporator: Technology and design
- Feed water degassing & Non-condensable gases
- Control for dryness and superheat
- Sampling for conductivity, TOC
- Example CAPA: Wet materials found in Autoclave after completion of cycle
- Remark: Room air humidification (with deionised water, black steam, clean or pure steam)
Weitere Informationen
Technical Details
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.
Contacts
Questions regarding content:
Dr Robert Eicher (Operations Director), +49 6221 84 44 12, eicher@concept-heidelberg.de
Questions regarding Organisation:
Ms Nicole Bach (Organisation Manager), +49 6221 84 44 22, nicole.bach@concept-heidelberg.de
Dr Robert Eicher (Operations Director), +49 6221 84 44 12, eicher@concept-heidelberg.de
Questions regarding Organisation:
Ms Nicole Bach (Organisation Manager), +49 6221 84 44 22, nicole.bach@concept-heidelberg.de
Recording from 25/26 November 2025
Duration of Recording: appprox 4 h 50 min
Teilnahmegebühr
| ECA-Member*: | € 1190,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1250,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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