- Datum:
-
- Webinar
GMP-compliant Gases for Pharmaceutical Manufacturing - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
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
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
