Dr. Andreas Schieweck
Landesamt für Gesundheit und Soziales M-V Arzneimittelüberwachungs- und prüfstelle
Referent:innen
Markus Multhauf
Consultant Pharmaceutical Engineering
Fabian Foerster
Westfalen
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.
Hintergrund
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?
- Which quality parameters of gases must be tested, which can be taken from the certificate?
Zielgruppe
The target group are employees from technology, production and quality assurance in pharmaceutical and active ingredient production who are entrusted with the planning,
Date & Technical Requirements
Date
Tuesday, 25 November 2025, 10.00 to approx. 16.30 h CET
Wednesday, 26 November 2025, 10.00 to approx. 12.30 h CET
Wednesday, 26 November 2025, 10.00 to approx. 12.30 h CET
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the Information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
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
Quality and Production from the Perspective of a Gas Manufacturer
- Quality assurance for air separation units, filling stations, tank vehicles, storage containers, cylinders for gases
- Necessary and unnecessary tests for incoming goods inspection of supplied gases
- Frequency and procedure for checking the inside of containers (bottles and truck tanks) for corrosion and contamination
- Training and training certificates for manufacturers and tank-truck drivers of gases
- Special technical features and developments in Distribution systems and points of use for cold compressed gases
- Innovations in the quality assurance of gases (Information on planned changes to Pharm.Eur. e.g. for monitoring oil content in compressed air)
- Individual production of specialty gases / reference standards
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)
| ECA-Member*: | € 1590,- |
| Non ECA Member*: | € 1790,- |
| EU/GMP Inspectorates*: | € 895,- |
| APIC Member Discount*: | € 1690,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung 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
Teilnehmerstimmen
Seminarprogramm als PDF
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