- Date:
-
- Webinar
GMP-gerechte Medientechnik (PT 24) - Live Online Seminar
- Event location:
- online
- Organizer:
- CONCEPT HEIDELBERG GmbH
Media in the GMP Environment: Regulations, Guidelines, and Inspection Practices
- Regulatory requirements related to media systems
- Quality and specifications (e.g., nitrogen, gases, steam)
- Risk focus points from an inspector's perspective
- Inspection of gases in bottles
"Non-GMP" Media in Pharmaceutical Production
- Drinking water - planning regarding stagnation prevention according to DIN 1988 / Pseudomonas & Legionella
- Wastewater (EU DIRECTIVES 2013/39/EU + 2000/60/EC and 2008/105/EC + German Wastewater Ordinance)
- Cooling water (BImSchV and microbiological measures for cooling circuits)
- Cost-effectiveness & operating costs
GMP for Pharmaceutical Water
- Overview of specifications according to pharmacopoeias
- Traditional pharmaceutical water treatment: PW and WFI
- WFI from membrane processes
- Storage and distribution: Design criteria and operation
- Sanitization concepts: Ozone and UV or hot water
- Common inspection deficiencies
Requirements for Steam in the Pharmaceutical Industry
- Black steam:
- Requirements for boiler feed water
- Quick steam generators vs. large water tank boilers: technology and construction
- Pure steam:
- Naturally circulating evaporators or falling film evaporators: technology and construction
- Requirements for degassing
- GMP requirements, constructive design, evaporator construction
- Sampling for conductivity, TOC, microbiological monitoring
- Non-condensable gases
- Room air humidification (with VE water, black steam, pure or sterilized steam)
Requirements for compressed air, nitrogen, and vacuum systems
- Design of compressed air networks
- GMP requirements & energetic aspects
- Pitfalls regarding exclusion requirements for 5μm particles according to ISO 8573-1:2010
- Nitrogen applications and supply systems
- Principles of different vacuum pumps
- Vacuum measurement technology & leak detection principles
- Interfaces in the generation and supply of gaseous media, sampling at incoming goods
Planning of Pharmaceutical Media Systems
- Design of quantities, nominal sizes, flow rates, pressure losses
- 3D models and routing
- Special RI symbols for pharmaceuticals
- Special components:
- Membrane valves
- DTS heat exchangers
- Sampling
- Detachable connections
- Interface between cleanroom construction and media technology
GMP Requirements and Inspection of Compressed Air Systems
- GMP guides & legal basics for compressed air
- Compressed air systems within GMP inspections
- Specifications
- Qualification and requalification
- Sterile filters
- Routine monitoring
- Examples of inspection deficiencies
Construction Supervision, Commissioning, and Safety
- Welding parameters and control
- Endoscopy, weld seams, and their quality criteria
- Requirements for execution, documentation, material certificates
- Pipe bending machines: when and why?
- Construction site regulations: storage, material and personnel flow during construction phase, separation of stainless steel and black steel work, etc.
- How to recognize nonsensical / exaggerated safety requirements (Lessons Learned, The Safety-First-Problem)?
Qualification of Media Systems
- Requirements of EU GMP Annex 15
- Qualification strategies
- Connection between URS, risk analyses, and qualification documents
- FAT and SAT / Avoidance of double inspections (GEP versus GMP)
- Test parameters DQ, IQ, OQ, PQ
- Typical deficiencies in the qualification of media systems
Special Features: Sampling, Rouging, Hoses, and Cleaning of Piping
- Formation of rouging & derouging
- Quantitative and qualitative risk assessment of rouging
- Sampling & sampling systems
- Use of hoses for pharmaceutical media
- Leach-out, labeling
- Testing (e.g., wipe, rinse, and/or leak test)
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Germany
Phone: +49 6221 844415
Fax: +49 6221 844464
email: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
