Haşim Solmaz
- Sterile Production: From Cleanroom Design to Final Product
- What is NOT a Cleanroom Monitoring: EMS and BMS
AGENDA Day 1Day 2
09:00 - 09:45
Cleanroom Design & Construction
Sterile Production: From Cleanroom Design to Final Product
Haşim Solmaz, LWS
Sterile Production: From Cleanroom Design to Final Product
Haşim Solmaz, LWS
09:45 - 10:30
Cleanroom Design & Construction
Developments in Cleanroom Design with the Latest ISO14644-4
Frans Saurwalt, Kropman
Developments in Cleanroom Design with the Latest ISO14644-4
Frans Saurwalt, Kropman
10:30 - 11:00
Coffee Break
11:00 - 11:45
Fill & Finish Processes
Current Regulatory Requirements and Trends on Aseptic Fill & Finish Equipment
Marcel Menhorn, Bausch + Ströbel
Current Regulatory Requirements and Trends on Aseptic Fill & Finish Equipment
Marcel Menhorn, Bausch + Ströbel
11:45 - 12:30
Fill & Finish Processes
Annex 1 and First Inspector Findings from Design to Approval
Richard Denk, SKAN
Annex 1 and First Inspector Findings from Design to Approval
Richard Denk, SKAN
12:30 - 13:30
Lunch
13:30 - 14:15
Isolator Technologies
Case Study from Design to SAT: Aseptic Filling Line for Vials Under Isolator
Marcel Menhorn, Bausch + Ströbel
Case Study from Design to SAT: Aseptic Filling Line for Vials Under Isolator
Marcel Menhorn, Bausch + Ströbel
14:15 - 15:00
Isolator Technologies
An Isolator Project : From User Requirements to Media Fill
Roland Madoerin, SKAN
An Isolator Project : From User Requirements to Media Fill
Roland Madoerin, SKAN
15:00 - 15:30
Coffee Break
15:30 - 16:15
Media-Fill & Sterility
Disinfectant Validation and Efficiency Testing
Jim Polarine, STERIS
Disinfectant Validation and Efficiency Testing
Jim Polarine, STERIS
16:15 - 17:00
Media-Fill & Sterility
Day End Wrap-Up Q&A Session, Modetator: Richard Denk, SKAN
Day End Wrap-Up Q&A Session, Modetator: Richard Denk, SKAN
09:00 - 09:45
Cleanroom Monitoring
What is NOT a Cleanroom Monitoring: EMS and BMS
Haşim Solmaz, LWS
What is NOT a Cleanroom Monitoring: EMS and BMS
Haşim Solmaz, LWS
09:45 - 10:30
Cleanroom Monitoring
Developing a Cleanroom Monitoring System According to ISOE GAMP5
Developing a Cleanroom Monitoring System According to ISOE GAMP5
10:30 - 11:00
Coffee Break
11:00 - 11:45
Cleaning & Disinfection
Challenges in Floor Cleaning and Snitization
Jim Polarine, STERIS
Challenges in Floor Cleaning and Snitization
Jim Polarine, STERIS
11:45 - 12:30
Cleaning & Disinfection
PUPSIT - Solving the Challenges in Final Sterile Filtration
Magnus Stering, Sartorius
PUPSIT - Solving the Challenges in Final Sterile Filtration
Magnus Stering, Sartorius
12:30 - 13:30
Lunch
13:30 - 14:15
Q&A & Testing
EU GMP Annex 1 Requirements for Container Closure Integrity
Derek Duncan, Lighthouse Instruments
EU GMP Annex 1 Requirements for Container Closure Integrity
Derek Duncan, Lighthouse Instruments
14:15 - 15:00
Q&A & Testing
Cleanrooms - Ensuring Compliance and Contamination Control
Arash Zamani, MSC Engineering
Cleanrooms - Ensuring Compliance and Contamination Control
Arash Zamani, MSC Engineering
15:00 - 15:30
Coffee Break
15:30 - 16:15
Validation
Key Aspects of PQ in Cleanrooms
Arash Zamani, MSC Engineering
Key Aspects of PQ in Cleanrooms
Arash Zamani, MSC Engineering
16:15 - 17:00
Validation
Day End Wrap-Up Q&A Session, Modetator: Jason Kelly, LWS
Day End Wrap-Up Q&A Session, Modetator: Jason Kelly, LWS
Day 1Day 2
