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ISPE Singapore Affiliate Conference & Exhibition
ISPE Singapore Affiliate Conference & Exhibition
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17 August 2022
9:00 am - 11:30 am - 17 August 2022

OPENING PLENARY

Virtual - Plenary
17 August 2022
11:30 am - 1:00 pm - 17 August 2022

‘ASK THE EXPERT’ LIVE Q&A SESSIONS

Virtual - Plenary
17 August 2022
1:00 pm - 4:30 pm - 17 August 2022

TRACK A: QUALITY

Virtual - Plenary

4:00 pm

  • How disconnected systems make data integrity issues more likely
  • Tools available to eliminate human error
  • The benefits companies have realized from connecting their systems
1:00 pm - 4:35 pm - 17 August 2022

TRACK B: ATMPs, ASEPTIC PROCESSING & ANNEX 1

Virtual - Room 2


Track Sponsor 


1:10 pm

1:30 pm

A Contamination Control Strategy (CCS) should be implemented across the facility in order to define all critical control points and assess the effectiveness of all the controls. It should be actively updated and drive continuous improvement of the manufacturing and control methods. In the 21st century, it is possible to use appropriate technologies like rapid microbial testing to protect the product and detect rapidly any contaminants, so that decision makers could achieve lean manufacturing, higher throughput and minimal waste.

1:55 pm

United States Code of Federal Regulations and European Union EudraLex “Annex 1” are in alignment that hold times must be established and validated for 
sterilized equipment. This presentation discusses these practices as well as results of unique experimental data used to support sterile hold times. Because sterile hold times are dependent on the wrapping used, defining the sterilization wrapping system (material of construction and closure method) is essential. To test and confirm sterilization wrapping system performance, STERIS designed experiments using various materials and closure methods over a defined hold time. This unique experimental data is the basis for best practice recommendations for sterilization wrapping systems to assist in validation work for site specific aseptic fill / finish items.

3:00 pm

1)      Upstream and downstream development
2)      Manufacturing considerations
3)      Fill finish considerations
4)      Critical QC test
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